Monday, January 1, 2007

Vitamin Lawyer Client Memos - 2007

...VLUeM . . . VITAMIN LAWYERom Update eMemos

"Supporting Industry Compliance with FDA and FTC Regulations."
Private, privileged and confidential...
Vitamin Lawyer Update eMemo Archives - Index
Ralph Fucetola JD - The Vitamin Lawyer

For the past several years, I’ve provided update memoranda to my regular clients. I’ve now created an Online Archives that will include excerpts from some of the memos, with a hypertext Index.

The Tiny URL for the Archive Index page is:
Online Seminar compilation of briefs and white papers:
For an outline of a typical SOP:
For the latest on Adverse Event Reporting:
Vitamin Lawyer Health Freedom Blog:

Updated Archives:

PRIVATE MESSAGE: The purpose of the...VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Private, privileged & confidential...


12/14/07 - Saving Your Company Money
12/07/07 - Insurance for Your Products
11/29/07 - EU Court: Foods are not Drugs
11/16/07 - AER on Your Labels?
11/09/07 - Codex Meets; eMail Blasts
11/02/07 - FDA Commissioner Warns Industry
10/26/07 - EU Regs; CAM; GMPs
10/19/07 - AER Draft Guidance; Health Claims
10/12/07 - Web Design Help; When to Patent
10/05/07 - 7 Marketing Mistakes to Avoid; Oversight Seal
09/28/07 - Vitamin Label Warnings; Functional Beverages
09/19/07 - Eco Friendly Packaging; SOPs up to date?
09/12/07 - FDA focus on saftety?
08/31/07 - More on cGMPs impact
08/17/07 - Web Site Mistakes - Speaking in NJ 09/19
08/11/07 - Superfooods Market to Double by 2011
08/03/07 - AER Regulations about to be issued.
07/21/07 - FDA Warning; current issues bulletpoints
07/17/07 - Another FDA guidance and a DC Road Trip
07/10/07 - cGMPs, TX AG, Codex degrades standards
06/28/07 - Randomized Clinical Trials; cGMPs posted
06/23/07 - cGMP Rule issued; ingredient testing...
06/07/07 - Summer of Decisions; Define your Market
05/31/07 - Ron Paul's Bill is the Answer to FDA Failings
05/16/07 - Ephedra ban continued: Risk - Benefit Analysis Comes to Herbs
05/11/07 - OMB approves cGMPs- S.1082 amend confirmed
05/03/07 - Responding to Net Attacks; Victory in Congress!
04/26/07 - SUS Page Updates
04/20/07 - Affiliate Programs, update on FDA anti-CAM guidance
04/07/07 - MLMs, AERs, SoPs, FDA on CAMs
03/31/07 - Your FDA Compliance Notebooks, Affiliate Marketing
03/16/07 - Making Claims, SoP Outline, Health Freedom Site attacked
03/02/07 - More SoP, more attacks... Web 2.0
02/23/07 - Record Keeping SoP, attacks and opportunities
02/09/07 - FTC enforcement... Situational Selling
01/27/07 - New attacks on vitamins... and AER - DEATH by Medicine
01/13/07 - Industry growth - Handling negative publicity
...VLUeM Standard Disclaimers:

You got on this e-list by opting in or becoming a client of the Vitamin Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList… ;)

And do remember to check out the ...VLUeM Online Archives:

Online Seminar compilation of briefs and white papers:

For an outline of typical cGMP SOP docs:

For the latest on Adverse Event Reporting:

Vitamin Lawyer Health Freedom Blog:

For Health Freedom Issues:

Ralph Fucetola, JD
The Vitamin Consultancy
All Rights Reserved © 2007 . . .


This issue: saving your company money…

1. Health Freedom Blog update
2. Key food product trends
3. How do your email “click throughs” rate?

1. Vitamin Lawyer Health Freedom Blog & Factoids
New Posting -
NJ Tops Maryland in Compulsory Vaccination Stupidity

eAlerts – STOP COMPULSORY DRUGGING & VACCINATION! please go to: and sign up for the eAlert list today! Better, please tell everyone on your elist to do the same! This list of several hundred thousand purveyors and consumers of natural products and remedies is having a powerful impact…

Practice Note #1: FDA has brought together its various guidances on Food Defense and Terrorism. You can find this information at:

“FDA has simplified these documents by repackaging the information found in each guidance document into the new Food Defense Self Assessment Tool.”

Practice Note #2: It took a couple weeks of persistent emails to Google Adsense, but we just got Adsense to reject a paid ad by a competitor of a client where the competitor had purchased the client’s name to pass-off their inferior product as the real deal… I suspect deciding factors were that the client had her own name as one of her URLs and that it was a well-known name, not just a business phrase, thereby rising to the status of what the law calls a “famous mark.”

2. Key food product trends

From an email: The 10 Key Trends for 2008 are:

“Key Trend 1: Digestive Health – a wellness issue and the biggest opportunity
Key Trend 2: Fruit and superfruit – the future of food and health
Key Trend 3: The marketing power of “naturally healthy”
Key Trend 4: Beauty foods – the newest niche
Key Trend 5: Weight management more about maintaining than losing
Key Trend 6: Mood food feels its way
Key Trend 7: A tipping point for the premiumisation of health
Key Trend 8: Healthy snacking for the “me” generation
Key Trend 9: Kid’s nutrition – connecting to multiple trends is crucial
Key Trend 10: Antioxidants - the new probiotics…

“Premiumization” has become a standard for healthy foods …which brands are able to command price premiums of 100%-800% over regular foods – and how they do it
Green tea, antioxidants, probiotics and fibres are the ingredients with the brightest futures
Omega-3 and plant sterols will continue to be niche ingredients
How packaging innovation is the biggest product differentiator…”

3. How do your email blast “click throughs” rate?

What is the average click-through rate for email newsletters? I reproduce an excellent answer from

Answer: The click-through rate is important because without it, you don't get conversions. However, there's no single benchmark click-through rate, because CTRs depend on many factors: whether you send to a business or consumer audience, the kind of mailing you send, how relevant it is to your audience, how often you send, your opt-in process, your use of personalization and segmentation and dozens of other factors. And most significantly, how many links you have in your email and if you are providing content such as articles, whether you include the entire article within the body of the email or you have a teaser or snippet that requires subscribers to click through to a Web site to read.

Beyond that, many companies calculate and report CTRs differently - using total rather unique clicks. Many subscribers will click on multiple links, which means that CTRs based on "total" clicks are typically about two times higher than those based on "unique" clicks..

That being said, below are some ranges for average CTRs for permission-based house lists. CTRs that we cite are based on unique clicks (only one click per person is counted) and are calculated as: unique clicks/emails delivered:

* B2B newsletters typically range from 5% to 15%. If yours are consistently below that level then among other things, you are probably providing content of little value to your subscribers. Or you may have most of the content within your email, not giving subscribers a reason or means to click-through to your site.
* B2C promotional emails often range from about 2% to 12%. Emails with less than a 2% CTR may be a result of over mailing and questionable opt-in processes.
* Highly segmented and personalized lists (B2B and B2C) are often in the 10% to 20% CTR range. Also, email messages with very strong content but sent to unsegmented lists, like many news or trend-type newsletters, are often in the 10%-15% range.
* Trigger or behavior-based emails (emails that are sent to a recipient based on some behavior they showed, such as clicking on a product link, visiting a specific Web page, etc.) are often in the 15% to 50% range.

If your emails are typically showing under say 2-3% CTRs, some of the causes likely include:

* Poor permission or opt-in processes. This includes pre-checked boxes, not making it clear what type of email they will be receiving, automatically adding someone to receive your email when they've actually signed up for something else such as a whitepaper, etc.
* Poorly written subject lines that do not direct and motivate recipients to take an action.
* Poor delivery rates. If a lot of your emails are getting blocked or filtered and you don't know it, your CTR will obviously be affected.
* Poor open rates. If few people open your email, fewer recipients have a chance to click.
* Poor design and layout. If they can't easily find where to click through or aren't motivated to by your layout - you've got trouble in River City.
* Lack of links. Quite simply, the more links the better. Make it so that readers are continuously stumbling over text and graphic links like they do signage in a retail store.
* No reason to click. If your newsletter has a single or multiple articles in their entirety, then don't expect them to click. You haven't given them any reason. If you are sending a promotional email and you don't include a deadline for the offer, or convey a discount, special offer, limited supply, etc., few people are probably going to take action.


This issue: saving your company money…

1. Health Freedom Blog update
2. Insurance for your products
3. The Electric Tree = savings and more
4. Bayer told to tone down vitamin claims
6. Coming next year: improved format for the VL Update eMemo!

1. Vitamin Lawyer Health Freedom Blog & Factoids
New Posting -

eAlerts – STOP FORCED VACCINATION! If you are on the Natural Solutions Foundation eAlert list you received an alert about the emergency health freedom advocates’ meeting in Tiburon CA I attended. If you want to stay current on health freedom issues, you really need to sign up to the eAlert list - please go to: and sign up today! Better, please tell everyone on your elist to do the same! This list of several hundred thousand purveyors and consumers of natural products and remedies is having a powerful impact in Washington and internationally.

And they’re getting the idea behind The Codex 2 Step:

"Although Codex is not a regulatory body, its decisions are used as a benchmark of discussion should trade disputes arise in the future, and while Codex does not have the same force of law as an EU directive or national legislation, it is used as a reference point for countries that are looking at revising or creating legislation."

For an 8 minute video of me explaining the Codex 2 Step, see:

2. Insurance for your products

Obtaining product insurance has become increasingly difficult as FDA/FTC regulatory oversight has ratcheted up. I’ve worked with one particular agent here in NJ for nearly a decade and many of the Vitamin Lawyer clients have found his services reassuring. Here is the type of information that is needed for the application.

1) Description of all named insured person or entities
2) Financials – latest annual income statement and balance sheet.
3) 5 years of sales/receipts history
4) Product labels & brochures, reflecting ingredients in the products
5) 5 year currently valued company loss runs or “No Known Loss Letter.
6) Expiring program including carrier, limits, deductible, premiums, and term.
7) Does the insured have or plan on having any products containing Organ/Glandular Extracts, Ephedra, Colloidal Silver, Green Tea, Synephrine/Bitter Orange, Kava, Lobelia, Magnolia or Yohimbe products? If so what are the product names, what percentage of their sales is applicable to these products and how many milligrams go in the products? We will need these product names and labels

I have the 8 page application form available; please email me with “Insurance App” in the subject line.

The agent tells me that he spoke with the underwriters. “They are not willing to speculate on the impact [of the new Adverse Event Reporting law that goes into effect on December 22, 2007]. They aren't doing anything [with rates] at the moment, but will be following it over time to determine its impact. … "

3. The Electric Tree = savings and corporate responsibility

Natural Solutions Foundation has been chosen as one of The Electric Tree’s 2008 Corporate Responsibility Designees. What does this mean to your business? If you are located in one of the currently covered states (NY, CT, MA. IL, MD, DE ) and choose to participate, with NO cost to you, The Electric Tree can save between 8 and 14% of your electric power bill… if you spend at least $2,000 per month or more on electricity and are willing to donate half your savings to the Foundation. This can be a “win – win” situation. It is very simple to do. If you have interest, please email me with Electric Tree in the subject line.


4. Bayer told to tone down vitamin claims

December 5, 2007 - The National Advertising Division (NAD) of the Council of Better Business Bureaus is recommending Bayer Healthcare modify or discontinue certain claims surrounding its Vital and Sharp Mind supplement. NAD, the Federal Trade Commission and industry trade associations have been targeting the marketing claims of supplement makers. Because this move involves a large player in the health industry getting its knuckles rapped by a monitoring body, it could send out warning signals to smaller companies about being more careful in marketing their products… NAD found no fault with following its review are that Vital & Sharp Mind "supports memory, mental sharpness, and healthy brain function", as well as that it promotes "memory, concentration, and mental sharpness," and can "keep your mind vital and active." [But] … there was insufficient evidence to support the claim made in a television commercial that Vital & Sharp Mind could assist healthy adults in recalling a list of items that was recited moments earlier… this claim suggests the product can actually assist healthy adults in recalling a list of names that was recited moments earlier. The agency says this level of effectiveness goes beyond the general claim made by Bayer that the product "supports" memory and as such requires further scientific evidence…”

5. Holiday Sale! Vitamin Lawyer Time for Sale…

It’s that time of year when your successful natural product business needs to expense out profits… So, why don’t you prepay The Vitamin Lawyer for consulting time good anytime in 2008? Here’s my special holiday deal: buy two hours at regular rate, $295/hr and get a third hour FREE… that’s a 33% savings! You can reserve as many hours as you’d like. We all know the dollar is tanking… that means all professional fees will be going up this coming year. Lock in 2007 discounted rates now! You can go to my PayPal page, or email me with VL DISCOUNT in the subject line. And have happy holidays; prosperous new year!


6. Upgrading the VL Update eMemo!

Coming next year: this email update system will be replaced by a second, private blog, the Vitamin Lawyer Update Blog, to allow me to keep you up-to-date better than ever! You’ll receive a shorter weekly update email with links to blog articles that will be posted as the information becomes available… more timely information better indexed!


1. Health Freedom Blog update
2. Health Freedom victory in the EU
3. Herbs at a glance… NCCAM listing

1. Vitamin Lawyer Health Freedom Blog
New Posting -
The Tiburon Statement: No Forced Vaccinations!

eAlerts – STOP FORCED VACCINATION! If you are on the Natural Solutions Foundation eAlert list you received an alert the day before yesterday about the emergency health freedom advocates’ meeting in Tiburon CA this past weekend I attended. If you want to stay current on health freedom issues, you really need to sign up to the eAlert list - please go to: and sign up today! Better, tell everyone on your elist to do the same! This list of several hundred thousand purveyors and consumers of natural products and remedies is having a powerful impact in Washington and internationally.

2. Victory for health freedom in the EU

As we’ve been saying for years, "Foods are not drugs..." Now says the European Court of Justice, about the German attempt to ban the importation of garlic capsules:

"Regarding the concept of a medicinal product by function, the Court stated that garlic capsules do not contain any substance other than natural garlic and have no additional effects, either positive or negative, compared to those derived from the consumption of garlic in its natural state. In contrast, a medicinal product must have the function of preventing or treating disease. Beneficial effects for health in general are not sufficient."

This rational and just decision, recognizing, as it does, that foods can have health benefits without that fact categorizing the food as a "medicine," is a major step toward more open and freer healthcare in Europe.

Congratulations to the Court of Justice!

3. Herbs at a Glance…

NACCAM – the National Center for Complementary and Alternative “Medicine” is publishing information about herbs, which can be found at:

You may find this a useful resource to suggest some claims support. WARNING: the site uses the word “treat” inappropriately, confusing normal nutrient effects with treatment of disease… Maybe a US court needs to tell NACCAM what the EU high court just told Germany: food health benefits are not drug claims!

1. Health Freedom Blog Update, Factoid
2. Best Practices Alert: AER on the label??
3. Evidence based healthcare
4. FDA food safety initiative
5. Healthcare professionals take vitamins!

1. Vitamin Lawyer Health Freedom Blog
New Posting -

Supply Side West – Last week; industry association representative comments on the new AER law: “When questioned on the upcoming adverse events reporting (AER) bill, Seckman [NPA executive director] responded that when the legislation comes into effect at the end of the year, there will be an initial spike in incidences as reporting increases. However, he said this will then stabilize and eventually have a positive effect on the dietary supplement industry's image. "Then we will see that the baseline numbers will be low consistently," said Seckman. "We will then look to publicize this in industry."”

eAlerts - If you are on the Natural Solutions Foundation eAlert list you received an alert early this morning (I thinkwe sent it out about 6 AM…) about my foundation co-trustees, Dr. Laibow and Gen. Stubblebine at the Codex meeting. More about that meeting below. If you want to stay current on health freedom issues, you really need to sign up to the eAlert list - please go to: and sign up today! Better, tell everyone on your elist to do the same! This list of several hundred thousand purveyors and consumers of natural products and remedies is having a powerful impact in Washington and internationally. Imagine the impact if the list were One Million Health Freedom Warriors… ready to click their mousse for your right to sell and use high potency products!

2. Best Practices Alert: AER on the label?

I’ve recently seen a few draft labels with statements like “We report all serious adverse events to the FDA.”

Please remove such statements! Mentioning "Adverse Event" might give customers the wrong idea... that they might have an “adverse event” with your product! I have read both the new AER law and the FDA guidance regarding same very carefully (just reread them to be sure) there is NO requirement for any mention of AER on the label!

The law is very specific that filing a serious adverse event report is not an admission of responsibility, but, if you mention AERs on your label, aren’t you admitting that you are selling a product that might harm a customer?

All the law does require is that you to have your company name and an address or phone number on the label. If The Vitamin Lawyer Consultancy reviews your labels, you know they will comply. For more information about the new AER law that goes into effect on December 22, 2007, please see:


3. Evidence based healthcare

From -

Evidence based practice (EBP) is an approach to care wherein professionals use the best evidence possible, i.e. the most appropriate information available, to make clinical decisions for individual patients. EBP promotes the collection, interpretation, and integration of valid, important and applicable patient-reported, clinician-observed, and research-derived evidence. The best available evidence, moderated by patient circumstances and preferences, is applied to improve the quality of clinical judgments and facilitate cost-effective care.

This involves complex and conscientious decision-making based not only on the available evidence but also on patient characteristics, situations, and preferences. It recognizes that care is individualized and ever changing and involves uncertainties and probabilities. Ultimately EBP is the formalization of the care process that the best clinicians have practiced for generations – from the country “Doc” who knew his patients to the practitioner who knew his patients over decades.

Evidence-based practice (EBP) develops individualized guidelines of best practices to inform the improvement of whatever professional task is at hand. Evidence-based practice is a philosophical approach that is in opposition to rules of thumb, folklore, and tradition. Examples of a reliance on "the way it was always done" can be found in almost every profession, even when those practices are contradicted by new and better information.

Evidence-based design and development decisions are made after reviewing information from repeated rigorous data gathering instead of relying on rules, single observations, or custom. Evidence-based medicine and evidence-based nursing practice are the two largest fields employing this approach. In psychiatry and community mental health, evidence-based practice guides have been created by such organizations as the Substance Abuse and Mental Health Services Administration and the Robert Wood Johnson Foundation, in conjunction with the National Alliance on Mental Illness.

This model of care has been studied for 30 year in universities and is gradually making its way into the public sector. It effectively moves away from the old “medical model” (You have a disease, take this pill.) to a “evidence presented model” using the patient as the starting point in diagnosis. EPBs are being employed in the fields of health care, juvenile justice, mental health and social services among others.

Key elements in using the best evidence to guide the practice of any professional include the development of questions using research-based evidence, the level and types of evidence to be used, and the assessment of effectiveness after completing the task or effort. One obvious problem with EBP in any field is the use of poor quality, contradictory, or incomplete evidence. Evidence-based practice continues to be a developing body of work for professions as diverse as education, psychology, economics, social work and architecture.

According to Norcross et al (2006) "the burgeoning evidence based practice movement in mental health attempts to identity, implement, and disseminate treatments that have been proven demonstrably effective according to the empirical evidence". However, Norcross et al (2006) also state that perhaps it is more useful to identify what does not work - discredited psychological treatments and tests, and has conducted survey research on discredited psychological treatments. Examples of discredited psychotherapies include: the use of pyramid structures, orgone therapy, crystal healing, past lives therapy, chiropractic manipulation, neurolinguistic programming and Erhard Seminars Training.

4. FDA food safety initiative

HHS Unveils Plan to Strengthen, Update Food Safety Efforts
Plan uses integrated collaborative approach to meet demands of a global economy to protect American consumers

HHS Secretary Mike Leavitt today announced a comprehensive initiative by the Food and Drug Administration designed to bolster efforts to better protect the nation's food supply. The Food Protection Plan proposes the use of science and a risk-based approach to ensure the safety of domestic and imported foods eaten by American consumers.

"America's food supply is among the safest in the world, and we enjoy unprecedented choice and convenience in filling the cupboard. Yet, we face new challenges to meet both the changing demands of a global economy and consumers' expectations," Secretary Leavitt said. "This Food Protection Plan will implement a strategy of prevention, intervention and response to build safety into every step of the food supply chain."

HHS Deputy Secretary Tevi Troy and FDA Commissioner Andrew von Eschenbach, M.D., presented the Food Protection Plan at a press conference in Washington, D.C.

"FDA must keep pace with this transformation so that the safety of the nation's food supply remains second to none," said Commissioner von Eschenbach. "The Food Protection Plan calls for effective action before an outbreak occurs."

The Food Protection Plan, which focuses on both domestic and imported food, complements the Import Safety Action Plan delivered by Secretary Leavitt to the President earlier today that recommends how the U.S. can improve the safety of all imported products. This year, $2 trillion worth of goods will be imported into the U.S., and experts predict that amount will triple by 2015. The Import Safety Action Plan lays out a road map with short- and long-term recommendations to enhance product safety at every step of the import life cycle. Taken together, the two plans will improve efforts by the public and private sector to enhance the safety of a wide array of products used by American consumers.

Advances in food production technology, rapid methods of food distribution, and globalization have transformed supermarket shelves and restaurant menus, broadened the tastes of consumers, and challenged the existing food protection framework.

"Although our agency clearly needs to maintain and enhance its response capacity, the primary goal is to prevent contaminated food from ever reaching the consumer," said von Eschenbach.

The plan is premised on preventing harm before it can occur, intervening at key points in the food production system, and responding immediately when problems are identified. Within these three overarching areas of protection, the plan contains a number of action steps as well as a set of legislative proposals. Taken together, these efforts will provide a food protection framework that ensures that the U.S. food supply remains safe.

To strengthen its efforts to prevent contamination, FDA plans to strengthen support of food industry efforts to build safety into products manufactured either domestically or imported. The FDA will work with industry, state, local, and foreign governments to identify vulnerabilities and will look to industry to mitigate those vulnerabilities, using effective methods such as preventive controls.

The plan's intervention element emphasizes focusing inspections and sampling based on risk at the manufacturer and processor level, for both domestic and imported products, that will help verify the preventive controls. This approach is complemented by targeted, risk-based inspections at the points where foreign food products enter the United States, including ports.

The plan calls for enhancing FDA's information systems related to both domestic and imported foods to better respond to food safety threats and communicate during an emergency.

The Food Protection Plan's three core elements--prevention, intervention, and response--incorporate four cross-cutting principles for comprehensive food protection along the entire production chain:

* Focus on risks over a product's life cycle from production to consumption;
* Target resources to achieve greatest risk reduction;
* Use interventions that address both food safety (unintentional contamination) and food defense (deliberate contamination); and
* Use science and employ modern technology, including enhanced information technology systems.

The Food Protection Plan is available at

5. Healthcare professionals take vitamins!

The Council for Responsible Nutrition (CRN) has announced as part of the initial results from its survey of healthcare professionals that, contrary to industry belief, the sector is in fact both using and recommending dietary supplements.

"It reconfirms what we know: that supplements are very mainstream in the US," CRN vice president of communications Judy Blatman told NutraIngredients-USA. Industry repeatedly claims there is a perceived divide between its products and so-called mainstream medicine - but Blatman says this may not even be as prevalent as once thought and that the key now is to get healthcare professionals to talk more to their patients about the potential benefits of these products.

"We need to make sure that we as an industry are communicating with healthcare professionals and that they are communicating with their patients and getting accurate information," said Blatman… Perhaps even more surprising is that not only did the survey reveal that 72 percent of physicians use supplements… 85 percent recommend them to their patients…”


1. Health Freedom Blog Update, Factoid
2. Codex about to meet on health claims
3. How to improve your email blasts

1. Vitamin Lawyer Health Freedom Blog –
New Posting -

If you are on the Natural Solutions Foundation eAlert list you received an alert early this morning (I think I sent it out about 2 AM…) about my foundation co-trustees, Dr. Laibow and Gen. Stubblebine on their way to the Codex meeting. More about that meeting below. If you want to stay current on health freedom issues, you really need to sign up to the eAlert list - please go to: and sign up today! Better, tell everyone on your elist to do the same. This list of several hundred thousand purveyors and consumers of natural products and remedies is having a powerful impact in Washington and internationally. Imagine the impact if the list were One Million Health Freedom Warriors… ready to click their mousse for your right to sell and use high potency products.

2. Codex about to meet on health claims

By: Alex McNally - Nov. 9, 2007 - Codex members are due to sit down and vote on a series of far reaching rules governing nutrient compounds in foods - and crucially discuss whether health claims should be based only on clinical studies. Although Codex is not a regulatory body, its decisions are used as a benchmark of discussion should trade disputes arise in the future, and while Codex does not have the same force of law as an EU directive or national legislation, it is used as a reference point for countries that are looking at revising or creating legislation.

In Europe, the EU has already unveiled its own health claims regulation - which says claims about foods should be supported by science - and has caused uncertainty for the industry since coming into force in July. The Codex meeting… will vote upon whether scientific evidence should be based solely on clinical studies. This suggestion has come under fire from trade groups who say this would be "unfeasible."

3. Better email blasts for your business

Entireweb always has good advice -- here is the entire article on email blasts

Entireweb Newsletter * November 6, 2007 * ISSUE #385 *

2 Dozen Ways to Improve Your E-Mail Marketing Results

I suppose I can title this article "25 Email Marketing Mistakes I've Made." But rather than focus on the negative, below I've outlined the best practices I’ve come to adopt over the years. Hope you find something here useful.

1. Diversify your Content: If your entire email focuses on one product, service, or topic, you risk alienating all but the few people who will be interested. Unless you have segmented your database based on previous behavior, do not send an email on only 1 topic. I consistently find that the click through rate increases in proportion with varied content.

2. Don't Stress about Spam Words: Many experts will tell you to avoid words like "free" or "sale". In my opinion, ISPs tend to be moving away from content based spam filtering in favor of reputation based filtering. In other words, your sending IP address and from email are more important than whether or not
your email contains certain words. Personally, I've used words like "free" in the subject line without any affect on delivery rates.

3. Make it Readable with Images Disabled: Always take into account the appearance of your email with images disabled. For email clients such as Outlook, this is now the default feature. Even popular web mails like Hotmail now disable images unless the sender is in the address book of the recipient.
The best tactic to create readable emails with images block as an alt description.

4. Create an Online Version: Always provide an online version of your email for users having trouble viewing images. I've calculated from emails I've sent in the past that around 5% of users will use this feature.

5. Remove Inactive Subscribers: Inactive subscribers are the most likely to get you in trouble by clicking the spam button. Consider automatically removing a subscriber that hasn't opened an email in several months.

6. Proofreading: Always have every email proofread by at least 2 detail oriented people. There's nothing more embarrassing than a typo in an email blast.

7. Monitor Replies: When you send out thousands of emails, you're bound to get a few replies. Occasionally, you'll get some good feedback from your subscribers. In addition, some people reply with unsubscribe requests.

8. Unsubscribe at Top: I know what you're thinking, "At the TOP!?" Yes, at the top. Lazy unsubscribers have a tendency to click the spam button instead scrolling down to find the unsubscribe link. By placing the link at the top, you might increase your unsubscribe rate, but that's better than an inflated spam complaint count.

9. Don't Over or Under Mail: If you send too much, you'll get deleted or marked as spam. Oddly enough, if you send once every 3 months you may have the same problem. Keep your brand top of mind for your customers by finding the perfect balance between over and under mailing.

10. Forward to Friend Feature: Many users automatically do this, but it doesn't hurt to ask. First time potential customers can be very open to a company when it is introduced by a friend or colleague.

11. Subscribe Feature for Forwards: Make it easy for potential new subscribers to subscribe if they receive your email as a forward. Include somewhere in the body a subscribe link.

12. White List Reminder: If you want your subscribers to add you to their white list or address book, you need to ask. Sure, not everyone will add you. However, those who do are likely the people who care most about receiving your emails and, therefore, you have the most to lose if your emails get flagged as spam.

13. Single Click Unsubscribe: I generally recommend keeping the unsubscribe as simple as possible. However, you may want to confirm the action if you place your unsubscribe at the top of every email in case users click the link on accident.

14. Privacy Policy: Always place your privacy policy at the bottom of every email. Assure customers that you obtained their email address in a legitimate fashion, and you will not sell their personal info.

15. Don't Rent Lists: Some may disagree on this, but I've never seen anything good come from a rented list. Don't risk your sender reputation with emails from questionable sources. If you want to reach a new audience, consider a joint venture with another firm in a similar but non-competing industry.

16. Develop your Brand: Remember that your emails will slowly build your brand in the minds of your subscribers. Even if they never click-through and make a purchase, be sure to keep a consistent and accurate corporate image with your email content.

17. Call to Action: Each section must contain a specific call to action that avoids vague phrases like "click here." You'll be surprised how an effective call to action button or link can improve your click through rate.

18. Mix Freebies with Products: Too much selling can burn people out. Engage your subscribers with useful, free content. For example, if you sell home theater equipment, send out an article on the explaining the benefits of newer technologies. When you provide additional value to your customers with
learning resources, they are sometimes even willing to pay more for your merchandise. In addition, strategies like this keep your brand top of mind.

19. Find Your "Tuesday": For the eCommerce sites I've worked with, Tuesday morning has always resulted in the best open, click-through, and conversion rates. However, every company is different.

20. Same Day, Same Time: Be consistent in the time you send your emails for two reasons. First, the ISPs see inconsistency as a possible spam flag. Spammers can care less when they send out mass emails. Second, your customers will begin to anticipate your emails at a certain time each week, possibly
increasing the likely hood of them opening and clicking through.

21. Keep the Good Stuff above the Fold: Remember that many email clients will obscure a large portion of your email unless the user scrolls down. Make sure the top 400 pixels are as engaging as possible. I can't tell you how many times I've had to send artwork back to the design department because the top
of the email failed to grab your attention.

22. A/B Test 1 Variable at a Time: It took me far too long to learn this. For years, I would change several factors in each successive email blast, but never could find that perfect mix. If you really want to find out what works, you can only change 1 variable. For example, should the subject line be short or long? Keep the same content and split your list in 2, sending half a longer subject and the other half a shorter one. Do not change any other variables!

23. 600 Pixel Width: Due to the limitations of many email clients, stick with a width somewhere between 500 to 600 pixels wide.

24. Experiment with Subject Lines: I wish there was a magic principle I can share with you about subject lines. Unfortunately, there isn't. The best we can do is test, test, and test again. Sometimes short subjects are better, sometimes long, sometimes intriguing, sometimes urgent, whatever works best for you. Here's a great article on email subject lines.

25. Begin Segmentation & Personalization Now: In a few years, email marketers that don't practice segmentation and personalization will be left in the dust. There are an endless number of ways to segment your email list. Some popular ways are by purchase behavior, geography, or ordering frequency.

As a long term strategy, I would also greatly encourage researching transactional and trigger based email marketing, as they tend to product much better open, click-through, and conversion rates. To learn more about eCommerce Email marketing, please visit the Palmer Ecommerce Marketing Blog.

Justin Palmer offers expert eCommerce consulting services and Do It Yourself search engine optimization lessons. In addition, Justin is the eCommerce director for, which sells Spiritual t-shirts and Witness wear.


Lots of ground to cover in this memo… important information…

1. Health Freedom Blog Update, Factoid & Client GMP Warning
2. Raising the RDA
3. Taking vitamins is good for you
4. Organic is better…
5. Warning from new FDA Commissioner to DS industry
6. SEO for small businesses

1. Vitamin Lawyer Health Freedom Blog –
New Posting -

“In the past, over-conservative government-sponsored [maximum level] standards have encouraged dietary complacency…” - Vitamin Safety Review Panel

Client GMP Warning: This just in: one of the Vitamin Lawyer clients reports receiving a request from his production people: “In the very near future we are going to need a copy of your stability study which substantiates your Exp [expiration] date. FDA requires that this be on file and available for review.” This particular client is wisely having his contract manufacturer laboratory retain samples to test every six months so he will have the data.

Please note that the FDA does not currently require the use of “expiration” or “best if used by” dates.

The new GMP Rule comments state: “if you use an expiration date on a product, you should have data to support that date... We recommended that you have a written testing program designed to assess the stability characteristics of the dietary supplement, and that you use the results of the stability testing to determine appropriate storage conditions and expiration dates… the final rule does not require that you establish an expiration date, we decline to offer guidance on the type of data that are acceptable to support an expiration date, other than to repeat that any expiration date that you place on a product label (including a ‘best if used by’ date) should be supported by data.”

To get on to the Global Health Freedom eblast list, please go to:

2. Raising the RDA

“The US Recommended Daily Allowance/Daily Reference Intakes are too low and most should be raised immediately, says an independent panel of physicians, academics and researchers. In a statement this week, the Independent Vitamin Safety Review Panel said: “Government-sponsored nutrient recommendations, such as the US RDA/DRIs, are not keeping pace with recent progress in nutrition research… In the past, over-conservative government-sponsored standards have encouraged dietary complacency. People have been led to believe that they can get all the nutrients they need from a 'balanced diet' of processed foods. That is not true. For adequate vitamin and mineral intake, a diet of unprocessed, whole foods, along with the intelligent use of nutritional supplements, is more than just a good idea: it is essential.”

3. Taking vitamins is good for you…

Knowledge of Heath, Inc. -
Special Report: Dietary Supplement Fanatics Healthiest Of All - By Bill Sardi © 2007

“They may not be laughing at vitamin supplement fanatics much longer. According to an authoritative study just published in The Nutrition Journal, avid dietary supplement users who, on average, take 17 different supplements daily, were judged to be far healthier than adults who just take a single supplement such as a common multivitamin, or who don't take dietary supplements at all.…While more than half of U.S. adults take dietary supplements, nearly
half of these supplement consumers take only one type of supplement, most commonly an inexpensive multivitamin…Risk for disease was far lower among the multi-supplement users compared to non-users. Risk for diabetes was 73% less, coronary heart disease 52% less, and self-determined health status (report health status was rated as "good or excellent") 74% more often, compared to non-supplement users.

This study may dispel a common belief that a low-dose multivitamin may be sufficient to address essential nutrient shortages. Source: Gladys Block, et al, Usage patterns, health, and nutritional status of long-term multiple dietary supplement users: a cross-sectional study. The Nutrition Journal, 6: 30, 2007

4. Organic is better…

“The biggest study into organic food has found that it is more nutritious than ordinary produce and may help to lengthen people's lives. The evidence from the £12m four-year project will end years of debate and is likely to overturn government advice that eating organic food is no more than a lifestyle choice. The study found that organic fruit and vegetables contained as much as 40% more antioxidants, which scientists believe can cut the risk of cancer and heart disease, Britain’s biggest killers. They also had higher levels of beneficial minerals such as iron and zinc.”

5. Warning from new FDA Commissioner to DS industry

Speaking before the American Society for Pharmacology and Experimental Therapeutics (ASPET) and the American Society for Nutritional Sciences, Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug Administration (FDA), outlined what the agency claims is its science-based approach to regulating dietary supplements

"FDA is absolutely committed to protecting consumers from misleading claims and unsafe products," said Dr. Crawford. "Unlike most foods, some dietary supplements are pharmacologically active. And we have
seen over the last 10 years a huge growth in the dietary supplements industry, including the introduction of products that seem far removed from the vitamins and minerals of the pre-DSHEA days. We have become increasingly aware of the potential health problems some of these products pose."

In the last 6 months, FDA has inspected 180 domestic dietary supplement manufacturers; sent 119 warning letters to dietary supplement distributors; refused entry to 1,171 foreign shipments of dietary supplements; and seized or supervised voluntary destruction of almost $18 million worth of mislabeled or adulterated products. "We will continue to aggressively enforce DSHEA against unsafe or mislabeled products," Crawford said.

The article continues: When DSHEA was passed a decade ago, there were about 4,000 supplements on the market, including vitamins, minerals, amino acids, and herbs and other botanicals. Congress determined that these products were more like foods than drugs, which cannot be put on the market unless a high threshold of evidence about their safety and efficacy is met, and that, like foods, such dietary supplements should in general be given the benefit of the doubt as to safety. A recent Institute of Medicine report, sponsored by FDA, estimated that American consumers spend $18 billion annually on dietary supplements and that there are about 29,000 such products on the market, with another 1,000 new products introduced each year.

Are your papers in order?

6. Search Engine Optimization for Small Business Owners

Entireweb Newsletter * November 1, 2007 * ISSUE #384

Small business owners are often limited by small marketing budgets and manpower. But that doesn't mean they can't compete against larger businesses or websites when focused on search engine optimization. SEO is a basic marketing tool that everyone should use regardless of size...

What makes a keyword competitive? One way to determine the competitiveness of a search term is to simply type that search term into Google and notice the number of web pages that contain that search term. This number appears in the upper right-hand corner of the search results page and appears as, "Results 1 - 10 of about 228,000,000 for [your search term here]." ...From my perspective, when this number is less than 3 or 4 million, the particular search term would not be all that competitive in and of itself.

Determining just how competitive the search term is. There are a variety of methods to determine true keyword effectiveness (KEI, etc.)... In addition to the number of sites that contain your keyword, how well optimized are the top 3 sites that appear on the search result. You can determine this by:

1. Visiting the site and determining the Google PR of the page. This information is available by downloading the Google toolbar and looking in your browser. You will see a green bar and ranking (ex: PR5), which tells you how Google ranks this page/website with regard to popularity. Any site with a Google PR6 or better is well established and will be difficult to outrank in the near term.

2. Visit Google and type , "". Be sure to replace 'competitorwebsite' with the website name you are researching... This will tell you how many sites are linking to this particular website. The larger the number the more difficult it will be to outrank.

3. Look at the website code. Simply visit the competitor's website and go to "View", "View Source". Look for the meta tags of "Title", "Description", and "Keywords"...

Using the above will give you a good sense of whether of not you can compete for given keywords...

About the Author: Michael Fleischner is an Internet marketing expert with more than 12 years of marketing experience...


1. Health Freedom Blog Update, Factoid & Client Notice
2. EU – taking over world food regulations?
3. CAM & Natural Products… perfect together…
4. Public support for CAM reimbursement
5. Fighting over GMP requirements

1. Vitamin Lawyer Health Freedom Blog –
New Posting -

“With food supplements, we have an extremely cost effective and very safe tool to better public health.”
S. Hasslberger -

Notice: Due to the continuing decline of the Dollar and increased costs, The Vitamin Lawyer Consultancy hourly rate has increased to $295 – the regular monthly retainer client rate remains $250 per hour, however.

To get on to the Global Health Freedom eblast list, please go to:

2. EU – taking over world food regulations?

Sepp Hasslberger’s Health Supreme Blog often has a very good knowledge of pending issues. He explores the claim that EU “Napoleonic Code” regulation of foods – including natural remedies, dietary supplements and functional foods – is being spearheaded by the European Union. The most serious problem from the viewpoint of the American wellness marketplace is the old legal distinction between “Code” countries, where whatever is not approved is prohibited, and Common Law countries, like the US, where whatever is not forbidden is allowed; the centuries-old struggle between free markets and mercantilism continues!

Sepp quotes one unnamed source: “One American official says flatly that the EU is ‘winning’ the regulatory race, adding: ‘And there is a sense that that is their precise intent.’ He cites a speech by the trade commissioner, Peter Mandelson, claiming that the export of ‘our rules and standards around the world’ was one source of European power. Noting that EU regulations are often written with the help of European incumbents, the official also claims that precaution can cloak ‘plain old-fashioned protectionism in disguise’.”

“Protectionism” is certainly not a friend of advanced healthcare and wellness companies, especially in our globalized world marketplace. Sepp’s article, on the dangers of “HARMonization” with Codex is a must read.

And what would be the effect of the EU takeover on your business? On your vitamin use? Here is what one UK nongovernmental organization, ANH, noted in a report critical of the “science” behind upper limits: “upper levels being considered for nutrients such as beta-carotene could be exceeded by eating two carrots…”

3. CAM and Natural Products… perfect together…

From The Integrator Blog: Parallel Play or a Potent Alliance? Alternative Medicine Practitioners and the Natural Products Industry are Stronger Together - David Matteson, MPM, MURP, MS

"The Natural Products Industry (NPI) and the complementary and alternative medicine (CAM) industry are each in the midst of a major transformation. Their ability to learn how to 'play' together may be crucial to how well these industries grow and succeed over the next few years.

"There is a natural relationship between these two industries. Many policy makers and many consumers see them as flip sides of the same coin. Yet, these two industries have not really acknowledged their interconnectedness, let alone taken active steps to collaborate on their common political and market interests.”

4. Public support for CAM reimbursement

While I am no fan of licensing laws (‘A license is a limitation…”) An Iowa health reform poll shows 68% of voters want licensed CAM professionals covered in basic insurance benefits.

”A broad-ranging survey on health reform topics by the Gilmore Research Group found that 68% of voters believe basic health care benefits should include coverage for any licensed health care professionals.
Licensed professionals directly noted in the survey of 601 Iowa voters were ‘naturopathic physicians, acupuncturists and chiropractors.’ The survey was commissioned by Code Blue Now! - a national, non-partisan, not-for-profit citizen organization formed to build public consensus in health care policy. The Iowa population was strategically selected to have a maximum influence on the healthcare reform debate.”
5. Fighting over GMP requirements

The FDA’s new Good Manufacturing Practices will be phased in over two years, giving smaller companies some time to get ready… the most difficult area as been the new requirement for “100% Identity Testing” with many companies complaining that there may be no available lab tests that can determine identity where a product has a dozen or more ingredients, some in such low amount as to be nearly nano dilutions.

“The FDA (US Food & Drug Administration) published the final rule on Good Manufacturing Practices, known as GMPs, in June. The soon-to-be-implemented GMP legislation forms part of the 1994 Dietary Supplements Health and Education Act (DSHEA) and is set to provide standards specific to the industry for inspectors to check for purity, safety and legality in manufacturing. Both the Natural Products Association (NPA) and the American Herbal Products Association (AHPA) find fault with the fact that under the current GMPs, only supplement manufacturers, but not ingredient suppliers, can submit petitions for exemptions from 100 percent identity testing.”

It is expected that FDA will accommodate the needs of companies with specialized products that may not be susceptible to the required lab testing.


1. Health Freedom Blog Update & Factoid
2. A Case Study: how NOT to make claims
3. AER draft guidance issued

1. Vitamin Lawyer Health Freedom Blog –
New Posting -

Vitamin D and Longevity - “Published in the September 10 issue of Archives of Internal Medicine, the meta-analysis examined 18 previously published studies which had suggested that deficiencies in vitamin D lead to a higher risk of death from cancer, heart disease and diabetes. However - given that these illnesses account for between 60 and 70 percent of deaths in high-income nations - the current analysis indicates the opposite. In fact, those individuals isolated from the studies who did take vitamin D had a seven percent lower risk of death than those who did not take it. "If the associations made between vitamin D and these conditions were consistent, then interventions effectively strengthening vitamin D status should result in reduced total mortality," wrote the researchers, hailing from the International Agency for Research on Cancer in France and from the European Institute of Oncology in Italy -

2. FDA targets company making cancer treatment claims - By Clarisse Douaud

[VL comments: Here is a good example of how NOT to make claims!]

“In another move to prevent dietary supplements infringing on the territory of pharmaceuticals, the US Food & Drug Administration (FDA) has issued a warning to Zeo Health for three of its products…

“Unlike pharmaceuticals, which must go through a series of pre-market approvals, finished dietary supplements need no pre-market approval. Instead, only ingredients not marketed in the US before October 1994 must be approved by FDA before being used in consumer products…

“Unlike, pharmaceutical drugs, dietary supplements are permitted few health claims… "The therapeutic claims on your web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease," wrote FDA in a letter to the New York state-based company… FDA objects to …promotion …for cancer prevention and treatment. The agency highlights an example of phrasing to this effect as found on the company's website:

"The scientific community has recently had very positive results on the effect of Zeolite on certain types of cancers. In tests on a variety of tumor types, the treatment with Zeolite led to improvement of overall health status, prolongation of life span, and a decrease in tumor size." The insinuation that the supplement can prevent or treat cancer continues in the dosage information provided by Zeo Health.

"For prevention: As a nutritional supplement, take 2 capsules twice daily. As part of Cancer therapy: As a dietary supplement, take 6 capsules three times daily." [VL Notes: these directions are clearly “treatment” directions.]

“FDA also revealed that Zeo Health claims on its website that the supplement Esdifan is recommended for consumers with irritable bowel syndrome and Crohn's disease. "Esdifan is the most effective relief for diarrhea and bad stomach. Better than any drug on the market....," stated Zeo Health on its company website, according to FDA.

“In its website marketing, Zeo Health leapfrogs from cancer prevention to hangover cures in its product claims.

“The company claims that its Zeolite supplement absorbs toxins associated with alcohol before they make it into the organs: "ZEO absorbs the toxins from the alcohol before they are processed into your organs."

“FDA has urged Zeo Health to respond to its letter within 15 working days of receipt, advising the agency of the steps the company is taking to correct the violations. "Failure to do so may result in enforcement action without further notice." -”

3. FDA AER draft Guidance finally issued! Excerpts from the guidance:

“1. When do the requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act become effective? -- The effective date for compliance with the requirements of this law is December 22, 2007.

2. What types of foods are covered by the Dietary Supplement and Nonprescription Drug Consumer Protection Act requirements? -- The requirements of this law only apply to dietary supplements. No other types of food are covered.

5. What is an "adverse event?" -- An "adverse event" is "any health-related event associated with the use of a dietary supplement that is adverse."

6. What is a "serious adverse event?" -- A "serious adverse event" is an adverse event that: Results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.

7. What is a "serious adverse event report?" -- A "serious adverse event report" is a report that must be submitted to FDA on MedWatch Form 3500A when a manufacturer, packer, or distributor of a dietary supplement receives any report of a serious adverse event associated with the use of the dietary supplement in the United States.”

The AER Consultants web site, will be analyzing form 3500A and will be providing assistance for companies to comply.


1. Health Freedom Blog Update / Factoids
2. Contracting with your web designer
3. More on the Chinese ingredient crunch
4. Where are the FDA’s AER Regs?
5. When to patent?
6. Web Design Simple Mistakes and Golden Rules

1. Vitamin Lawyer Health Freedom Blog –
New Posting -

Expanded and updated AER (Adverse Event Reporting) web site, with draft AER Guide:

Factoids: “Food and ingredient prices are growing at a faster pace in China than anywhere else in the world”


2. Contracting with your web designer

I've seen so many clients have awful problems with web designers!

Here's the issue from the designer's viewpoint:

And this one from the company's perspective:

These together should give you a handle on the problem.

3. More on the Chinese ingredient crunch…

High energy and commodity prices have plagued companies at all levels of the food industry for the past few years.

Over the past couple of years alone major players such as CP Kelco, FMC Biopolymer, BASF, Novozymes, Cargill, Danisco and DSM, have all hiked up their prices for products ranging from vitamins E and B3, to sugar molasses and citric acid.

This month DSM announced a ten per cent price increase for all its citric acid, produced in Belgium, on a worldwide basis. The increase, which is effective immediately, was "due to cost increases in raw materials and in energy".

In the wake of "sharp increases" in raw materials, in September the firm further announced a 10 per cent rise in global prices for vitamin E supplies. Orafti pushed up prices of its Beneo fibre ingredient by six per cent.

Bio Springer also said rising costs and shrinking supply of sugar molasses were driving up the cost of yeast extract production, announcing a double digit price increase for its extracts as of next year. Sugar molasses are the main raw material for yeast extracts but over the past three years the cost of sugar molasses has risen by 10 per cent. Energy prices and the impact of the EU's sugar reform were blamed.

This summer Swiss biotech company Lonza announced a worldwide price hike of up to 12 per cent for vitamin B3 in a bid to pass-on increasing production costs…

For more see:

4. Where are the FDA’s AER Regulations?

Industry criticizes FDA for failure to act - where are the FDA regulations?
Companies turning to private experts for guidance.

10/09/07 - FDA must commit to AER guidance
Functional Ingredients Staff

"The detailed data required under new adverse event reports (AERs) laws, need to be made transparent sooner rather than later, a major trade group has told the United States Food and Drug Administration. The Maryland-based American Herbal Products Association (AHPA) has requested what it considers an overdue guidance document to give the supplements industry a clearer idea of what is expected of them when the law kicks in on December 22. FDA guidance was expected on September 19 but has yet to see the light of day.

"AHPA is charging the FDA with failing to provide necessary guidance and made its thoughts known in a formal letter to the FDA and its parent agency, the US Department of Health and Human Services (HHS). The Dietary Supplement and Nonprescription Drug Consumer Protection Act will require serious AERs to be submitted to the FDA. The Act requires the Secretary of Health and Human Services to "issue guidance on the minimum data elements that should be included in a serious adverse event report as described under the amendments made by this Act."

"Congress clearly intended that businesses would have at least 90 days to digest the FDA's guidance and make any necessary changes to their staff or procedures in order be ready to comply with the law when it goes into effect," said AHPA president Michael McGuffin. "The clock is ticking."

For more information on private alternatives to meet the statutory requirements:
5. When to patent.

This is a good background article on patenting: “Patently wise: what, how and where to patent” by Michel Morency and James Ewing

October 10, 2007 - Patent protection can be an effective tool for excluding competitors and generating revenues, if used wisely and married to a company's business strategy. Conversely, obtaining patents can quickly become an expensive and wasteful proposition if done haphazardly and not tied to an effective business strategy.

With the nutraceutical industry spending more and more resources on research and development, companies are turning to patents to protect their new products and investments. However, to get the most out of a patent, manufacturers need to familiarize themselves with the limits and potential of the process.

The first step in designing an effective patent strategy is to understand what a patent can and cannot do for the owner. A patent does permit the patent owner to exclude competitors from making, using, importing and selling the invention, as claimed in the patent.

The fact that a commercial product is described in the patent application is of no use if it is not covered by the scope of the claims. Accordingly, it is important to continuously monitor any claim amendments and any change to the product to ensure that the claims actually cover the final commercial product. A patent does not grant the patent owner the right to make, use, or sell the invention if doing so would infringe another party's patent.

Therefore, a patent strategy should always include a review of third party patents...

Finally, it is important to note that a patent can only be enforced in its country of origin… Obtaining patent protection in several countries can be a very expensive ordeal. The filing and translation costs alone can reach $10,000-15,000 per country. Costs of securing patent protection in a large number of countries can easily reach multiples of $100K or millions over the lifetime of the patents.

A common international patent strategy is to pursue patents in key developed health care markets including the US, Canada, Europe, Japan and Australia... A common misconception is that a company needs to obtain a patent in each and every country in which the product will be sold. A patent is not required to make, use, or sell in a given country; it is only useful to exclude competitors… Your patents are an important asset to your company…

Michel (Mike) Morency, Ph.D., LL.B., is a partner in Foley's Boston office… He can be contacted … via email at - James F. Ewing, Ph.D., J.D., is senior counsel in Foley's Boston office… He can be contacted … via email at

6. Web Design - Simple Mistakes and Golden Rules

Excerpts from: Entireweb Newsletter * October 11, 2007 * ISSUE #378 *

Good web design … sticking to a small set of guiding principles and avoiding some very common mistakes…

1. Keep Everything Obvious - Don't Make Me Think… Visitors to a website expect certain conventions, breaking these is a great way of losing visitors. People expect to find the navigation at the top of a page or on the left hand side. Logos are mostly found on the top left. Much research has been conducted into how people view and use web pages. The good news is that you do not to know all of this; instead look at how larger companies such as eBay, Amazon, Google, Microsoft structure their pages and the language they use, then emulate them.

2. Limit Colours - A website using too many colours at a time can be overwhelming to many users… Limiting a palette to 2 or 3 colours will nearly always lead to a slicker looking design…

3. Be Careful With Fonts - The set of fonts available to all visitors of a website is relatively limited… It is advisable to stick to fonts such as Arial, Verdana, Courier, Times, Geneva and Georgia… Black text on a white background is far easier for the majority of people to read than white text on a black background. If you have large amounts of text then a white or pale background is far more user friendly. Always ensure that there is a good contrast between any text and its background…

4. Plan for Change - …The ability to add or remove content from a website is fundamental… Understanding how to use Cascading Style Sheets (CSS), avoiding unconventional layouts and complicated backgrounds will all help enormously.

5. Be Consistent - Again, don't make your visitors think! About how to use your site at least. If your navigation is at the top on your homepage, it should be at the top on all other pages too. If your links are coloured red ensure the the same convention is used on all sections…

6. Keep it Relevant - A picture is better than a thousand words but if the picture you took on holiday is not relevant to your Used Car Sales website then you should really replace it … If you can take something off of your web page without it adversely affecting the message, appearance or legality of your website you should do it without hesitation… Keeping your content focused will ultimately help your search-engine rankings.

7. Become a CSS Expert - Cascading Style Sheets should be any web designer's best friend. CSS makes it is possible to separate the appearance and layout of your page from the content. This has huge benefits when it comes to updating and maintaining your site, making your site accessible and making your site easy for search engines to read…

8. Avoid Complexity - Using standard layouts for your web page will save you development time and make your site easier to use…

The principles above all border on common sense and are well known to most people, yet so many sites continue to deviate away from them and suffer as a consequence. Following these principles will help you keep away from trouble, although it still doesn't guarantee it!

About the Author: Paul has worked as a programmer and in Web Design for over 15 years. -


1. Health Freedom Blog Update / Factoid
2. DHEA threatened again…
3. Do you sell in Europe?
4. Vitamin Lawyer Oversight Seal
5. 7 Marketing Mistakes to Avoid when Promoting your Business

1. Vitamin Lawyer Health Freedom Blog –
New Posting -

Factoid: "There are currently more than 194 million people with diabetes worldwide, set to exceed 333 million by 2025."

The price of Chinese produced Vitamin C has gone from $3.5 to nearly $20 since July.

2. DHEA Threatened Again

“ ------ Original Message ------
Subject: Action Alert--Stop Congress from Restricting Access to DHEA

Action Alert--Stop Congress from Restricting Access to DHEA

Your access to DHEA is in jeopardy! The Senate is considering a bill, S. 762, to classify DHEA as an anabolic steroid, adding it to the list of controlled substances and removing it from the market. H.R. 1249 is the companion bill in the U.S. House of Representatives. Your immediate help is needed to keep this safe and effective dietary supplement legal and accessible.

DHEA is not an anabolic steroid. It is a naturally occurring hormone that has a wide range of benefits, including maintaining muscle strength and strong bones, boosting immunity, and improving mood and sleep patterns. Further
studies suggest that DHEA may be helpful for such conditions as obesity, cancer and Alzheimers disease. DHEA dietary supplements, which have been on the market for over 20 years, are derived from a plant in the wild yam family; for more information. – ”

We need your help to keep DHEA legal. Send a message to Congress asking your Senators and Representative to oppose S. 762 and H.R. 1249 and any amendment to restrict access to DHEA to minors. Congress should not restrict access to a dietary supplement that has given health to millions of Americans. Take action now!

If you want some background see my article on how I kept DHEA legal in 1995.


3. Do you sell to Europe?

If people in Europe buy through your web site, you do. “The scope of the changes will not just affect food packaging, but any content including websites associated with the food.”

Innocent found guilty over antioxidant health claim
By Alex McNally

10/03/2007 - UK's Innocent has been rapped on the knuckles for making a health claim about its smoothie having a high antioxidant content and detoxifying effect. The Advertising Standards Authority (ASA) said an advert by the firm, which claimed its fruit juice contained more antioxidants than the "five-a-day" portion, was not truthful or substantiated.

The verdict will come as a blow to Innocent and could set a precedent for other companies looking to make claims about antioxidant ability of fruit. It also adds the pressure on speeding up EU rules, which will require all health claims to meet a Commission-improved list. Although no official wording or accepted health claims have been approved, it seems that advertising regulators are already tightening up on health claims in preparation, and food companies should think carefully before making a health claim.

This is the second time in a week a company has come under fire for making a statement about a products' health or nutritional benefit. Last week the UK Tea Council was criticised for exaggerating the benefits of tea, and banned from making further claims about the drinks' antioxidant potential after running a series of adverts...

Under regulation (EC) No 1924/2006, which came into force in the UK from 1 July 2007, any food product claiming to have a health benefit must meet a list of European Commission-approved wording and be supported by scientific evidence.

Although the regulation came into force this month in the UK, the European Commission is not expected to agree a list of approved literature until the end of the year. The scope of the changes will not just affect food packaging, but any content including websites associated with the food.

4. Vitamin Lawyer Oversight Seal
"The trademark Vitamin Lawyer Oversight Seal may only be displayed on a website if the owner of the website meets or exceeds specific standards. Displaying the Seal indicates:

1. The Website content has been reviewed for FDA and FTC regulation compliance by The Vitamin Lawyer.*
2. The Company’s cGMP (Current Good Manufacturing Practices) have been reviewed for government and industry standards.
3. The Company’s product labels are formatted and printed in conformity with FDA regulations.
4. The Company’s Internet advertisements comply with FDA/FTC regulations.
5. The Website’s content has been reviewed for clarity and appropriateness.

Subject to the Vitamin Lawyer Consultancy standard retainer agreement. - Oversight Seal


5. 7 Marketing Mistakes to Avoid when Promoting your Business

Entireweb Newsletter * October 2, 2007 * ISSUE #375

Many people rush into business thinking it will be easy to run, but very soon they realize that it is not as easy as it looks. A successful business is a finely tuned machine. In order to keep your business running smoothly it is important to avoid making mistakes. Here are the 7 most common mistakes to avoid:

1. Not having clear objectives: Many business people start a business without clear objectives. They fail to set realistic goals for their marketing and consequently set themselves up for failure. It is important to make a list of goals and objectives based on a quarterly time line...

2. Neglecting to analyse your potential customers: Neglecting to analyse your potential customers is a dangerous mistake... When you do not analyse your customers wants and needs you do not know what products and services to develop for them. This will lead to targeting the wrong market and neglecting to understand your own niche market...

3. Not testing: By not testing your sales copy and places you advertise with split testing your advertising, you will be losing sales... If you do not test your ad copy and marketing promotions you will not have a proper idea of the ads and promotions that are pulling and what is not working...

4. Not budgeting: Budgeting is extremely important in business. Your business should never run out of money. This is especially true with your marketing and advertising ventures. It is important to have a monthly or quarterly budget for your marketing... Start small, test and then build on successes. This will allow you to always stay solvent and have enough for promotions.

5. Giving up too soon: Companies go out of business at an alarming rate these days. One of the reasons is that the owners give up too soon... You need to give your promotions at least 3 months before you decide to scrap them... As always, test all marketing tactics before you launch a larger promotion...

6. Poor sales copy: How often have you wanted a product but when you read the sales page you had serious doubts? Poor unprofessional ad copy will cost you sales...

7. Not screening your employees carefully...

The golden rule is to diversify. You should always use multiple forms of marketing promotions in your business. Do not just do one or two promotions and then wait for results. This will slow company growth and your business will stagnate...By avoiding these mistakes you will take your company to the success you deserve... So plan ahead and be careful not to make these common mistakes.

About the Author: Sean McPheat is a leading authority marketing consultant and helps businesses across the UK, Europe, US and the Middle East...



1. Health Freedom Blog Update
2. How to Avoid Alienating Search Engines
3. Vitamin Label Warnings
4. Functional Beverages… the future of supplementation?
5. Are your papers in order?

1. Vitamin Lawyer Health Freedom Blog - New Posting

Does the FDA really want public comments?

2. SE Tactics: How to Avoid Alienating the Major Search Engines

Some more good advice from

Each of the major search engines… have quality webmaster guidelines … prevent … manipulation of search engine rankings …. These webmaster guidelines change frequently … and those websites found engaging in these illicit practices are consequently dropped from the search engine rankings....

Being banned or dropped from the search engine rankings can have dire effects on your website traffic, online sales generation and site popularity…

If you wish to avoid alienating the major search engines then do not engage in the following SE tactics:

1. 'Cloaking' or sneaky redirects - displaying different content to the search engines than shown to your normal website visitors including hidden text and hidden links. …
2. 'Doorway' pages created specifically for the search engines that are aimed at spamming the index of a search engine…
3. Don't create pages that install viruses, Trojans or badware. 'Badware' is spyware, malware or deceptive adware…
4. Avoid using software that sends automatic programming queries to the search engines to submit pages or check rankings... you will be penalized for using it.
5. Don't load web pages with irrelevant words.
6. Don't link to 'bad neighborhood' sites who have: Free for all links pages, Link farms - automated linking schemes with lots of unrelated links, Known web spammers or the site has been dropped or banned by the search engines.
7. Avoid 'broken links' or '404 errors,' your site will be penalized for them.
8. Don't display pages with minimal content that is of little value to your site visitors.
9. Do not duplicate content unnecessarily.
10. Do not use pop-ups, pop-unders or exit consoles.
11. Do not use pages that rely significantly on links to content created for another website.
12. Do not use 'cross linking' to artificially inflate a site's popularity... multiple sites cross linking … together, if all sites are hosted on the same servers the search engines will pick this up and the sites will be penalized.
13. Do not misuse a competitors name or brand names in site content.
14. Sites with numerous, unnecessary virtual host names will be penalized.
15. Do not use techniques that artificially increase the number of links to your web pages ie. Link farms.
16. Display web pages with deceptive, fraudulent content or pages that provide users with irrelevant page content.
17. Using content, domain titles, meta tags and descriptions that violate any laws, regulations, infringe on copyrights & trademarks, trade secrets or intellectual property rights of an individual or entity….

About the Author: Rosemary Donald is an SEO Consultant with - & author of the SEO ebook 'Insider Secrets of Rank 1 Websites'

3. Vitamin Label Warnings…

In addition to the statutory FDA “…not evaluated…not intended…” disclaimer, here are some warnings for you to consider for your labels; please note that the AER warning may have to be modified when the final AER regulations are issued in the next couple weeks.

Product Warnings:

- Keep out of reach of children.
- Do not exceed recommended dose.
- Do not use if outer or inner seal is broken or damaged.
- If you have a serious adverse reaction to product, discontinue use
immediately, seek medical attention if necessary, and contact us.
- If you are undergoing treatment for a medical condition or if you are pregnant
or lactating, consult your physician when taking this product.

In addition to the above, you may need a Food Allergy Warning:

“The term “major food allergen” means any of the following: (1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.”

That warning should read: ALLERGY WARNING: contains [list allergens].

Finally, there is a special warning for iron containing pills or capsules: “WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.”

4. Functional Beverages… the future of supplementation? reports: “As part of its newsletter on equity research - Healthy Living Monthly … highlighted an increased consumer focus on health and wellness as a key driver of new trends… growth and innovation will stem from more alternative segments. There will as such be opportunities for functional beverage and ingredients manufacturers alike as these categories grow. But it depends on how they align their resources and efforts.

"The beverage industry has become a leading delivery vehicle for functional nutritional ingredients, is a major beneficiary of the convenience movement in the US, and is desperate, in our opinion, for any new ideas to offset the stagnant market for carbonated soft drinks," write the report's authors.

Canaccord Adams valued the US nonalcoholic beverage market at $100bn in 2005. Carbonated soft drinks (CSDs) take up the majority of this market, with a reported $64.7bn in sales. However, the analyst says growth in the nonalcoholic segment is coming from categories other than soft drinks as consumers move towards healthier options or, at least, options that are perceived as healthier.

The firm conjectures this interest in healthier beverages is in part due to the fact US consumers are increasingly overweight. An estimated 66 percent of adults in the US are either overweight or obese, based on results from the 2003-2004 National Health and Nutrition Examination Survey (NHANES). The rate of obesity more than doubled from the previous NHANES survey - increasing from 15.0 percent (1976-1980) to 32.9 percent (2003-2004).

In terms of recommending how manufacturers large and small ought to innovate in this market, the report repeatedly highlights the example of the rise of energy drink.

"The history of the energy drink category in the United States illustrates both the opportunities and the risks that exist as change occurs within the beverage industry," write the analysts.

While Canaccord Adams has identified emerging trends in the beverage market as being fortification, functionality, and a shift towards premium, "green" and organic products… For instance, instead of water, beverage manufacturers should now look out for 'enhanced' water.

"Don't buy commodity bottled water today, despite its enormous profitability," states the report. "It is late in the trend, and the early adopters are telling us that."

Waters fortified with healthy ingredients hold the biggest potential and are being cashed in on by the beverage giants. Coca-Cola this year forked out $4.1bn to acquire vitamin water company Energy Brands for the manufacture and marketing of new nutritionally enhanced vitamin water lines.

These fortified categories are the way of the future, according to Canaccord Adams… The analyst states that though dairy was once the bastion for beverage fortification, it has given way to alternative drink sources that come with perhaps less calories or fat.

5. Are your papers in order?

With the imposition of new regulations this year, including the long-awaited Good Manufacturing Practices, are your Standard Operating Procedures up to date? Take a look at my standard SOP format outline at: and let me know how if can help your company organize for future success!


1. Health Freedom Blog Update
2. More EU machinations
3. Eco-friendly packaging
4. Boomers and Dietary Supplements…
5. Are your SOPs up to date?

SEPTEMBER 19: Fairfield, New Jersey, 7pm. Dr. Laibow, Gen. Stubblebine III, Ralph Fucetola (the Vitamin Lawyer), Prof. Murray Sabrin (spokesperson for Presidential candidate and US Congressman Ron Paul) and a spokesperson for Presidential candidate Dennis Kucinich are guest speakers at the Health Freedom vs. Health Tyranny Rally.

VFW Post 7925, 45 Plymouth Road, Fairfield, NJ. 937-227-9600.
Your Rights to Natural Health Care are in Jeopardy!


1. Vitamin Lawyer Health Freedom Blog New Posting

Asking Congress to demand FDA reporting on AERs

2. Does the situation in Europe portend developments here?

The FDA’s public policy of “harmonizing” with international regulations suggests so. Here is a report on what is happening in Europe, a potential market for many US dietary supplements and model for US regulators.

“…the harmonization process for EU food laws, including maximum mineral and vitamin levels, has "a long way to go" before completion. European Advisory Services (EAS) said the "vastly different national approaches" currently in place will continue to impact on companies launching onto the European marketplace. Manager of scientific and regulatory affairs Efi Leontopoulou also stressed the strategic importance of the evolving regulatory climate in non-EU countries such as Russia and Turkey, which she described as being "two complex but very promising markets for the food industry." She added that: "Bulgaria and Romania have recently joined the EU and this creates new market opportunities but also more challenges in terms of the harmonization process."

A lengthy wait is predicted due to the number or rules and complexity of the current situation, but EAS was unable to say how long this might take prior to publication. The warning means that uncertainty about what may or may not be imposed for minerals and vitamins will continue to spread through the industry. Some countries could suffer a blow if EU legislation were to proscribe the sale of high dose products or vice versa. In the UK, for example, high dose products account for 12 to 15 per cent of the £220m vitamin and mineral market and could experience trouble... Member states at the moment vary dramatically on maximum and minimum levels, which would come to an end once Europe-wide unification is imposed.

Yesterday reported how lobbyists from Consumers for Health Choice have pleaded with the commission president José Manuel Barroso to not stay away from a heavy-handed approach to maximum levels. The setting of maximum levels forms part of the 2002 Food Supplements Directive, and the new with fortified foods regulation...

"Working with all of these different national legislations in Europe can be quite a minefield for companies, from issues such as the addition of nutrients to foods and the types of ingredients permitted in countries, to details on new product notification requirements and national approaches towards derogations for vitamins and minerals."

…A working party of Member States is expected to sit down and discuss maximum health claims next week, and the Commission is expected to propose a directive with actual figures in 2009.”

3. Eco-friendly packaging

A recent issue of a nutrition industry magazine carried an interesting article on eco-friendly packaging. The two newest offerings are Polyactide (PLA) plastic bottles (made from corn and readily biodegradable) and Tetra Paks. The PLA is colorful, costs less than petroleum-based plastic and uses less energy to produce. The Tetra Paks, vaguely rectangular in shape, are mostly recyclable paper, but with a special aseptic process that allows liquids long shelf life without degrading the ingredients high temperatures, irradiation, etc.

Tetra Pak is at: and you can Google “Polyactide bottles” for a number of links.

From “Design of the Times” September 2007 Nutrition Industry Executive –

4. Vitamins, minerals and boomers…

“Men and women over the age of 51 who regularly take dietary supplements are more likely to get adequate amounts of several vitamins and minerals than those who do not, a study suggests. Researchers writing in the Journal of the American Dietetic Association also found that a substantial portion of people in this age range do not get enough vitamins and minerals from their diet alone and the use of supplements is necessary. Not only do these results give the supplements industry a boost, but they could also help supplement providers in deciding which age group to target with marketing, as well as giving a clear indicator of what nutrients should be included… They concluded that a large "proportion of older adults do not consume sufficient amounts of many nutrients from foods alone. Supplements compensate to some extent, but only an estimated half of this population uses them daily…”

5. Are your SOPs up to date?

With the imposition of new regulations this year, including the long-awaited Good Manufacturing Practices, are your Standard Operating Procedures up to date? Take a look at my standard SOP format outline at: and let me know how if can help your company organize for future success!



1. Health Freedom Blog Update
2. News bits… Vit. C shortage?
3. Reminder: Update Archives are at:

1. Vitamin Lawyer Health Freedom Blog New Postings

Divesting the FDA and A Little History of Regulations

From an FDA warning letter issued last week: "...FDA's focus on fraudulent products marketed on the Internet for serious and life-threatening diseases. Individuals and firms that do not resolve violations of the Federal Food, Drug, and Cosmetic Act risk injunction to halt the illegal activities, seizure of violative products, and other regulatory sanctions."

2. News Bits…

From New Hope Media: Dietary ingredient shortage!
“Retailers may have to start charging their customers more for dietary supplements containing vitamin C by the end of the year as manufacturers are forced to pass on higher prices from suppliers. Prices for vitamin C are ballooning because of supply shortages out of China, the world's primary supplier, and the use of corn, a source of vitamin C for mass production, as a biofuel, said Ed Keenan, vice president of marketing at New York-based supplements manufacturer, FutureBiotics. Keenan said Chinese suppliers claim they are shutting down plants to remodel them to meet Western standards of production. China supplies about three quarters of the global vitamin C market. "What they've done is squeeze production. They're holding back in their production," Kennan said of the Chinese production companies. "The whole industry is going to be hit by a severe shortage."

AHPA Speaks Out:
The American Herbal Products Association has submitted comments to the US Food and Drug Administration, urging it to assist the dietary supplement industry in complying with good manufacturing practices, adverse event reporting, and new dietary ingredient safety regulations. The Maryland-based association was responding to calls for input from the FDA's Center for Food Safety and Applied Nutrition. "The dietary supplement industry faces two major new regulatory requirements, as does the agency: a final rule on current good manufacturing practice for manufacturing, packaging, labeling, and holding dietary supplements, which were released this past June, and the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a new law requiring serious adverse event reports associated with dietary supplements and over-the counter drugs be submitted to the FDA, which goes into effect this December," AHPA stated.
NAC & Gambling:

“A common amino acid sold as a dietary supplement could help diminish pathological gambling addictions, according to a new study. Researchers at the University of Minnesota uncovered the link following an eight-week trial involving 27 people who were given increasing doses of N-acetyl cysteine. By the end of the pilot study, published in the September 15th issue of Biological Psychiatry, 60 percent of the participants reported having less urges to gamble. The potential significance of these findings is huge - given the widespread damage caused by addictive gambling.”

Symbols of Harmonization?

“The US government yesterday concluded a hearing examining the implementation of a nation-wide food labeling system to provide consistent nutrition information on product labels. .. FDA this week held a two-day meeting to gather comments from industry, health groups, advocacy organizations and medical experts on the use of a labeling program similar to the UK's traffic light system. Indeed, a number of countries around the world have already instituted voluntary labeling systems for government-designed nutrition symbols. These symbol systems vary in their format. Some systems have detailed graphic illustrations that indicate the content of a number of selected nutrients, while others simply present a single icon indicating that a food is healthful, with further information available elsewhere, such as in booklets and web sites. In the US, the food and beverage industry has identified the need to spell things out simply for consumers..”
And this, from Nutrition 21, indicating that the middlemen are moving into marketing as the new GMPs become effective.

“Nutrition 21, the developer of chromium-based Chromax, announced it has entered into definitive agreements to privately place shares and warrants to fund $17.75mn for marketing and retailing of its condition-specific products. The New York state-based company previously used its science portfolio to support branded ingredient Chromax's use in supplements. However, the company has opted for a change in direction and invested heavily in promoting Chromax directly as a finished supplement product through food, drug and mass retail outlets. The company is going to attempt to take the market by storm, because it says its products have the potential to be attractive to a wide variety of consumers.”

3. Reminder: Update Archives at:

Here are some of the topics of recent Updates.

08.31.07 - More on cGMPs impact
08.17.07 - Web Site Mistakes - Speaking in NJ 09/19
08.17.07 - Superfooods Market to Double by 2011
08.03.07 - AER Regulations about to be issued.
07.21.07 - FDA Warning; current issues bulletpoints
07.17.07 - Another FDA guidance and a DC Road Trip
07.10.07 - cGMPs, TX AG, Codex degrades standards
06.28.07 - Randomized Clinical Trials; cGMPs posted
06.23.07 - cGMP Rule issued; ingredient testing...
06.07.07 - Summer of Decisions; Define your Market
05.31.07 - Ron Paul's Bill is the Answer to FDA Failings
05.16.07 - Ephedra ban continued: Risk - Benefit Analysis Comes to Herbs
05.11.07 - OMB approves cGMPs- S.1082 amend confirmed
05.03.07 - Responding to Net Attacks; Victory in Congress!
04.26.07 - SUS Page Updates



1. Health Freedom Blog Update
2. More on the GMPs

1. Vitamin Lawyer Health Freedom Blog New Posting

More News on Lobbying Congress to Divest FDA of Food Authority.

2. More on GMPs

I’ve been reading the GMPs that were issued in June. You can read my initial blog on them at: .

Meanwhile, a number of organizations have also been reviewing the new Rules and I’ve been reviewing what they are saying. AHPA (American herbal Products Association) has been part of the process from the start. Here are excerpts from a report they’ve prepared (my headings in ALL CAPS).

BACKGROUND: "…compared to the existing cGMP for conventional foods, which is expressed … in just under six thousand words, the final rule on dietary supplement cGMP will be codified in 21 CFR 111 in over sixteen thousand words."

"Publication of this final rule is the culmination of a process that was begun in 1995 with the submission to FDA of an “industry draft” by AHPA, CRN, NDMA (now CHPA), NNFA (now NPA), and UNPA. This draft was published as an advance notice of proposed rulemaking on February 6, 1997, and followed by publication of a proposed rule on March 13, 2003" The final rule was published June 22, 2007 and can be seen at:

APPLIES TO: “The rule applies to all firms that manufacture, package, label or hold dietary supplements for sale in the U.S. and Puerto Rico, with the exception of retailers who hold dietary supplements “for the sole purpose of direct retail sale to individual consumers.” The final rule notes, however, that this retailer exception does not extend to “a warehouse or other storage facility for a retailer,” or to “a warehouse or other storage facility that sells directly to individual consumers.”

STRUCTURE OF RULE: The Rule is divided into 16 parts:

“Subpart A General Provisions (*)
Subpart B Personnel
Subpart C Physical Plant and Grounds (* as Buildings and Facilities)
Subpart D Equipment and Utensils (* as Equipment)
Subpart E Requirement to Establish a Production and Process Control System (*as Production and Process Controls)
Subpart F Production and Process Control System – Requirements for Quality Control
Subpart G Production and Process Control System **
Subpart H Production and Process Control System – Requirements for the Master Manufacturing Record
Subpart I Production and Process Control System – Requirements for the Batch Production Record
Subpart J Production and Process Control System – Requirements for Laboratory Operations
Subpart K Production and Process Control System – Requirements for Manufacturing Operations
Subpart L Production and Process Control System – Requirements for Packaging and Labeling Operations
Subpart M Holding and Distributing
Subpart N Returned Dietary Supplements
Subpart O Product Complaints
Subpart P Records and Recordkeeping”

* From the Food GMPs
** “Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement”

APPLIES TO SOME CAM PRACTITIONERS: "FDA also noted in the preamble to the final rule that it “would be appropriate to consider the exercise of our enforcement discretion, on a case-by-case basis, to determine whether to apply the requirements of this final rule” to health care practitioners, such as acupuncturists, herbalists, and naturopaths who are “adequately trained in their profession” and who provide supplements that they prepare in “one-on-one consultation[s].” The agency stated, however, that it is “not considering exercising our enforcement discretion with respect to practitioners who prepare batches of herbs and sell them to individual consumers without determining whether the dietary supplement is appropriate for each consumer’s needs in a one-on-one personal consultation, or those that prepare batches of a dietary supplement for which there is a known or suspected safety concern.”"

Since that’s written in bureaucratic “bass-ackwards” let’s make that clearer: IF you do individualized one-on-one counseling, the FDA does NOT expect you to meet GMPs; if you repackage ingredients without one-on-one consultations, you will be treated as a distributor and be required to meet GMPs.

I’ve also read the United Natural Products Alliance report on the GMPs. In general their analysis is similar to AHPA. Some points they note (quotes are from the FDA Rule comments):

PRODUCT COMPLAINTS: “The final rule defines product complaint…examples of product complaints are foul odor, off-taste, illness or injury, disintegration time, color variation, tablet size or size variation, under-filled container, foreign material in a DS container, improper packaging, mislabeling or DS that are super potent, sub-potent or contain the wrong ingredient or contain a drug or other contaminant (e.g., bacteria, pesticide, mycotoxin, glass, lead)…”

QUALITY: “Quality means that the dietary supplement consistently meets the established specifications for identity, purity, strength and composition and limits on contaminates and has been manufactured, packaged, labeled and held under conditions to prevent adulteration…”

GMP TRAINING: While FDA will not provide GMP training materials, “…paragraph, § 111.14(b)(2) requires you to make and keep documentation of training, including the date of training, the type of training and the persons trained.”

BATCH TESTING: “We are persuaded that as an alternative to testing each finished batch of product, we can allow for the use of a statistically sound sampling and testing program for finished batches of DS unless a manufacturer chooses to test every batch. Such a sampling and testing program is feasible when controls are implemented earlier than the final product stage in the manufacturing process. Controls include the use of a C of A from a qualified supplier for specifications other than the identity of a DI and the establishment and monitoring of in-process manufacturing controls.”

“We agree with the comments that if we reduce the requirements for testing at the finished batch stage, then it is critical that you determine whether components meet specifications. We address this issue in the following two ways: (1) Each manufacturer must confirm the identity of each component prior to use (you must test or examine DIs to verify the identity but may rely on a C of A to confirm the identity of components other than DS) and (2) Each company must confirm other required specifications for components prior to use, either by relying upon a C of A or by testing or examining the components.”

“Because of the critical importance of insuring the proper identity of DIs – they are the central defining ingredient of a DS – we are requiring each firm that uses a DI to perform its own testing or examination for identity of each DI prior to use. Firms may not rely upon a C of A provided by suppliers to determine the identity of a DI before use. … We believe that the minimum criteria that we are establishing for a C of A, together with the requirement that a firm relying on a C of A must qualify a supplier and periodically repeat that qualification process can prevent the problems that have occurred with faulty certificates in the past.”

“Under final § 111.75(a), a firm may rely upon a C of A from its supplier of a component provided that certain criteria are met which include the following: (1) The firm first qualifies the supplier by establishing the reliability of the supplier’s C of A through confirmation of the results of the supplier’s tests or examinations; (2) The C of A includes a description of the tests or examination method(s) used, limits of the tests or examinations, and actual results of the tests or examinations; (3) The firm maintains documentation of how it qualified the supplier; (4) The firm periodically reconfirms the supplier’s C of A; (5) The firm’s quality control personnel review and approve the documentation setting for the basis for qualification (and re-qualification) of any supplier.”

PRODUCT SPECIFICATIONS: “The requirement to establish specifications is not limited to when a manufacturer purports that its product possesses attributes of strength and composition on the label. One comment asks for guidance as to what constitutes an official or scientifically valid standard for specifications. We are not aware of any officially recognized standard for specifications… the manufacturer establishes the set of criteria to which a product should conform to be considered acceptable for its intended use. In general, a specification may include a list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges or other criteria for the tests described.”

COMPLIANCE NOTIFICATION: “…an unqualified statement such as ‘produced in compliance with dietary supplement current good manufacturing requirements,’ without more, could suggest the product may be safe and effective or somehow superior to other DS products that are subject to the same CGMP requirements (id.) [and] would likely be considered misleading …, but that including language clarifying to consumers that all DS must be manufactured in compliance with CGMP requirements, and that such compliance does not mean that the DS is safe or effective, may be a way to cure that unqualified statement … Thus, we are not prohibiting voluntary statements on the DS label, provided that such statements are truthful and non-misleading…”

GMP & AER: And, despite the new AER law, “We continue to strongly recommend that firms that receive product complaints, that are not ‘serious adverse events’ notify us about any illness or injury, because, for example, we may have additional expertise or data that may be helpful in investigating the complaint or determining whether the problem applies to more than one product…We encourage you to include our recommendations in the written procedures that you develop for handling product complaints.”

CONCLUSION: Your bottom line: over the next three years, as GMPs become effective first for large firms, then in 2 years for medium firms (under 500 employees) and finally in three years for small (under 20 employees) individual firms will have to manage their compliance with the requirements. The Vitamin Lawyer Consultancy will be available to help.

STANDARD SOP: Expect my revised Standard Operating Procedures (for Dietary Supplement companies and for CAM practitioners) providing for phasing in the GMP requirements, to be available in the next month or so. I’ll let you know as soon as they are ready. You can see outlines of my pre-final rule SOPs at - these will be re-organized to fit the 16 GMP categories noted above. I estimate it will take 2 – 3 hours to customize the revised formats for each operating company responsible for GMPs.



1. Health Freedom Blog Update
2. Web Site Mistakes
3. Wiki Biased Editing Exposed
4. I’ll be speaking in NJ on September 19th

1. Vitamin Lawyer Health Freedom Blog New Posting

New link established to allow Health Claims comments to FDA! Comments end: 08/31/08.

2. Entireweb Newsletter * August 14, 2007 * ISSUE #361 *

Excerpts from: Do You Make These Mistakes With Your Web Site?

“… no web site is absolutely perfect… But there are some basic web site mistakes …
- Not enough content. - …minimal information along with their contact information on their web sites … today's web visitors are looking for … lots of good quality content … build credibility for your business.
- Old or outdated content. - If you want visitors and search engines to pay attention to your web site, you need to keep adding new content and updating the existing information....
- Not being search engine friendly. - … in order to be included in the search engine databases.
- Not monitoring your site in the search engines. - … Monitoring your web site means that you can react to changes and take appropriate steps to make sure your site shows up in the search results and that web traffic keeps flowing.
- The site is built using Frames or Flash. - Not too many web sites still make this mistake…
Making your web site the best it can be is a very effective and affordable marketing option for most small businesses. Of all the other types of advertising and marketing that you do each year, your web site has the potential to be seen by more customers, can continue to promote your company perpetually through links, is always accessible to customers, and can instantly reflect changes and provide fresh information to draw people in….”
About the Author: Lauren Hobson is the Editor of Biz Talk Newsletter and the Five Sparrows Marketing Blog from Five Sparrows, LLC at

3. Wiki Biased Editing Exposed

Has your company been the victim of derogatory Wikipedia postings?

Says “The credibility of the online encyclopedia Wikipedia has taken another dive after a newly developed software program exposed how the CIA, corporations like Diebold and others routinely edit entries to bury criticism and manipulate the truth . . . Now a CalTech graduate student has developed a software tool that threatens to slam the final nail in the coffin of any credibility Wikipedia had left… Wikipedia Scanner -- the brainchild of CalTech computation and neural-systems graduate student Virgil Griffith -- offers users a searchable database that ties millions of anonymous Wikipedia edits to organizations where those edits apparently originated, by cross-referencing the edits with data on who owns the associated block of internet IP addresses," reports Wired News.”

"The Wikipedia Scanner ( also allows users to type in an IP range and find out which organizations are editing what pages on Wikipedia."

Adds PrisonPlanet: "Though Wikipedia's raison d'etre is obviously based around allowing users to edit the content, the checks to prevent abuse and organized partisan attack campaigns against certain subjects or ideas are non-existent and the absence of any kind of reasonable moderation is destroying Wiki's reputation. ... Wikipedia is fast becoming a complete anathema to reliable research and will see its wavering reputation as a trustworthy source for information quickly evaporate if it continues to allow itself to be abused by intelligence agencies, corporations and dedicated trolls."

Over the past two years we've noted that attempts to put positive postings on Wikipedia about alternative healthcare and natural nutrients has been met with attacks by "Quackwatch" types, even as the "official" Quackwatch sites and founders have been found by courts to be untrustworthy of belief. Will see over the next few months if Wikipedia is capable of reforming itself to regain its credibility.

4. I’ll be speaking in NJ on September 19th - Here’s the flyer from NJNHP:

New Jersey Natural Health Professionals & Natural Solutions Foundation
Health Freedom vs. Health Tyranny: Your Voice Matters

September 19, 2007 7:00 p.m. - 10:00 p.m.
VFW Post 7925 - 45 Plymouth Road - Fairfield, New Jersey

Guest Speakers:
Rima E. Laibow, MD
Founder Natural Solutions Foundation
Maj. Gen. Albert N. Stubblebine III (US Army Ret.)
President Natural Solutions Foundation
Ralph Fucetola, JD
Best known as “The Vitamin Lawyer”
Professor Murray Sabrin
Spokesperson for Presidential Candidate & U.S.Congressman Ron Paul

For more information/reservations, please contact:
Sharan Woods, President
New Jersey Natural Health Professionals
Fairfield, New Jersey



1. Health Freedom Blog Updates
2. Superfoods market to double by 2011

1. Vitamin Lawyer Health Freedom Blog New Postings

AER Regulations Immanent… EU Backs off banning natural vitamins!!

2. Superfoods market set to double by 2011 - Alex McNally

“Aug. 10, 2007 - The superfood and drink market is expected to almost double in the ten year period up to 2011, says a report published today, with soy products and exotic fruits leading the charge.

…Michael Hughes, market analyst and author of the report Super Food and Drinks: Consumer Attitudes To Nutrient Rich Products, said shoppers are actively seeking nutrient rich fresh, organic and functional food and drinks and turning their backs on foods high in fats, sugars and salts… Hughes said: "The trend towards 'positive nutrition' is well reflected by the recent popularization of superfoods, especially in the UK and US."

As a result, superfoods and drinks, like acai and goji berries, are seeing a surge in demand. Datamonitor defined superfoods for the purpose of the report as foods rich in "specific nutrients and phyto-chemicals (i.e. anti-oxidants) and are promoted as being able to improve health condition and/or disease prevention." A spokesperson told that the definition includes both foods which are naturally high in nutritional value and those with added nutrition. This means it can include much of the functional food market. Many food and drinks associated with superfood status have also enjoyed healthy growth in the last five years and this - in part - can be attributed to this status, he added. Hughes said: "The popularization of superfoods means that many food and drinks now have a 'healthy-halo' which significantly influences consumer preferences."

Exotic, highly fashionable fruits such as acai berries, goji berries and pomegranates have all risen in popularity, with pomegranate currently one of the most fashionable superfood ingredients, the analyst said. In the period January 2005 to May 2007, there had already been a 500 per cent increase in the number of products using pomegranate as an ingredient compared to the period 1999 to 2004.

Hughes added: "Right now, pomegranate is the hot ingredient, but this is likely to be superseded given that new ingredients are being continuously touted. "Monitoring these developments will be vital if industry players are going to fully capitalize on the superfoods movement." … Green tea sales have grown substantially in the US. The market grew from €18m ($119m) in 2001 to €116m ($160m) in 2006… Datamonitor also identified an opportunity for manufacturers to respond to growing time constraints which are leading to people in Europe missing around 100 meals a years because they do not have time. The report suggests companies can take advantage of this by offering nutritionally enhanced snacks as a substitution for missed meals.



1. Health Freedom Blog Update
2. AER Regulations Immanent
1. Vitamin Lawyer Health Freedom Blog New Posting
FDA enabling act delayed! Hope abounds…

2. AER Regulations Immanent

This late breaking news from NutraIngredients. Please note this indicates that FDA is about to issue the Adverse Event Reporting regulations mandated by the law President Bush signed last December. The law is supposed to go into effect 12/22/07. These guidelines would be the 4th major guideline about Dietary Supplements issued by FDA over the past half year or so.... an unprecedented level of regulation enhancement.

CRN urges FDA interpret adverse events bill with caution - By Clarisse Douaud

08/03/2007 - The Council for Responsible Nutrition (CRN) has expressed its concern to the US Food & Drug Administration (FDA) over alleged labeling requirements the agency may include in its upcoming adverse events reporting guidance ... The points in question pertain to a requirement for labels to include a full street address as well as introductory language informing customers how … [report adverse events] … ‘To issue guidance that would require de facto label changes would cause a great deal of confusion…’ wrote [CRN] in the July 31 letter addressed to … FDA's Center for Food Safety and Applied Nutrition… Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was passed in December 2007 and will oblige supplement manufacturers, packers and distributors to notify FDA of any serious adverse adverse events reports (AERs). The bill is applauded by industry associations for its potential as an extra post-market precautionary measure to secure more credibility for supplement makers… now anticipating the imminent release of FDA's guidance on "the minimum data elements that should be included in a serious adverse event report". The document will essentially outline how the bill is to be interpreted … The so-called introductory language would instruct consumers how to use the contact information. For … example…: "To report an adverse event, contact..." and "If you experience problems with this product, contact…"



1. Health Freedom Blog Update
2. Recent FDA Warning Letter
3. Bulletin Points: Current Regulatory Issues

1. Vitamin Lawyer Health Freedom Blog New Posting

New posting on newest FDA draft guidance on Health Claims:

Dr. Laibow remarks that the guidance is “apparently in direct response to Dr. Ron Paul's Health Freedom Protection Act, HR 2117…” and offers a link to protest this to the FDA:


2. Here are excerpts from a warning letter FDA issued a couple weeks ago

It shows us current thinking on “drug” claims for Dietary Supplements and gives a “text book” example of what claims not to make:

“This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at … and has determined that the products … are promoted for conditions that cause the products to be drugs under … the Federal Food, Drug, and Cosmetic Act (the Act) ... The therapeutic claims on your web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. … Examples [X} “…Cancer Prevention and Treatment” … "The scientific community has recently had very positive results on the effect of … on certain types of cancers. In tests on a variety of tumor types, the treatment with … led to improvement of overall health status, prolongation of life span, and a decrease in tumor size. Also, in local applications of … to skin cancer, it reduced tumor formation and growth." … "For prevention … As part of Cancer therapy"

*** [Y] The Hangover Preventive" … "When you drink alcohol, the body tries to break down the toxins.... These toxins are not fully broken down and cause damage to your organs. The side effects of this damage, we call a `hangover' such as headache and nausea, as well as other ill effects that we can't see (liver damage)…. absorbs the toxins from the alcohol before they are processed into your organs."

The above claims about individual products are supplemented by claims on your homepage about your products in general and by metatags you use to bring consumers to your website. Examples of the metatags include "cancer prevention," "toxin removal," and "Natural supplements that... are proven to inhibit cancerous tumor growth, and will even prevent hangovers.... Effective … cure." ***

Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, the products are also "new drugs"… New drugs may not be legally marketed in the U.S. without prior approval from FDA …. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

In addition, we note that your website states the following: "This form of [Y] is approved by the FDA as completely safe...." We have cited several examples in this letter to demonstrate that you are not in compliance with FDA requirements. Further, FDA has not reviewed the safety of [Y], nor its interactions with other substances. Therefore, the use of this statement to promote your products is false or misleading in that it implies FDA approval or sanction of your product and its purported uses. The false and misleading information misbrands your[Y] products ... ***

The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. …Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.”

Students of the Vitamin Lawyer Red Flags Review School will readily see all the mistakes the marketer made… all the dangerous claims and over the line statements. A word to the wise…


3. Some Bullet Points regarding current regulatory issues

* Since the last days of 2006 there have been a series of challenges to Health Freedom
o Adverse Event Reporting Act [December 2006]
o FDA CAM Draft Guidance [Fed Reg. Notice on 02/26/07]
o USDA & Codex: Organic Standards Diminished
o Codex: Raising Toxic Levels, Mandating Irradiation
o Codex: GM (Genetically Modified) Labeling Failures
o FDA GMPs (Good Manufacturing Practices for Dietary Supplements)
o Senate & House adoption of FDA enabling bills [S.1082 & HR.2900]
[Only S.1082 contains DSHEA protection language]
o Failure of US House to consider Health Freedom Protection Act – HR.2117
[Although over 100,000 messages to Congress demanded protection]
* Now the FDA has directly challenged HR.2117 with a new draft guidance
“Evidence-Based Review System for the Scientific Evaluation of Health Claims”
o Citation:
o Draft guidance document represents the agency's current thinking on
+ 1) the process for evaluating the scientific evidence for a health claim,
+ 2) the meaning of the significant scientific agreement (SSA) standard
+ 3) credible scientific evidence to support a qualified health claim.
* Ron Paul’s Health Freedom Protection Act (HR.2117)
o Health Claims must be allowed unless the FDA determines that –
+ (i) there is no scientific evidence that supports the claim;
+ (ii) the claim is inherently misleading and incapable of being rendered non-misleading through the addition of a disclaimer

The opportunity should be clear: resubmit HR.2117 as the Health Freedom Restoration and Protection Act with language addressing each of the pending challenges noted above.

“It is all within our grasp, the restoration of the republic and our sovereignty … federalism, free enterprise, peace, prosperity, and the kind of future we all want for our families, ourselves, and our fellow Americans. The dream can be a reality … Instead of wars and inflation and spying and poverty, we can have peace and freedom and the blessings for our children and grandchildren of doing better than we have, of secure retirements and childhoods. No more theft -- of our savings or our liberty.” - Ron Paul at Google on 07/13/07



1. Health Freedom Blog Update
2. Another FDA Guidance: Health Claims Substantiation

1. Vitamin Lawyer Health Freedom Blog New Posting

The House passed the FDA enabling act last week and we visited Washington…

Things are about to get very exciting as Dr. Ron Paul leads the way in countering recent attacks on Health Freedom by the FDA, Congress and Codex!


2. New FDA Draft Guidance: “Evidence-Based Review System for the Scientific
Evaluation of Health Claims” -

Following closely after the FDA draft anti-CAM guidance, this new draft guidance, just published, continues the FDA’s policy of more closely regulating the natural products industry. There is a 60 day comment period that should run until the end of August.

Says the introduction: “This draft guidance document represents the agency's current thinking on 1) the process for evaluating the scientific evidence for a health claim, 2) the meaning of the significant scientific agreement (SSA) standard in section 403(r)(3) of the Federal Food, Drug, and Cosmetic Act … and 3) credible scientific evidence to support a qualified health claim. … This guidance document describes the evidence-based review system that FDA intends to use to evaluate the publicly available scientific evidence for SSA health claims or qualified health claims on the relationship between a substance and a disease or health-related condition… This guidance document explains the agency's current thinking on the scientific review approach FDA should use and is intended to provide guidance to health claim petitioners … The specific topics addressed in this guidance document are: (1) identifying studies that evaluate the substance/disease relationship, (2) identifying surrogate endpoints for disease risk, (3) evaluating the human studies to determine whether scientific conclusions can be drawn from them about the substance/disease relationship, (4) assessing the methodological quality of each human study from which scientific conclusions about the substance/disease relationship can be drawn, and (5) evaluating the totality of scientific evidence.”

This guidance attempts to impose a high standard on Health Claims. Dr. Ron Paul’s pending bill, the Health Freedom Protection Act, HR.2117 addresses this further FDA power grab by imposing the standard commercial substantiation requirement. Essentially this bill shifts the burden of proof onto the FDA whenever the agency wants to deny the public the benefit of health claims information about Dietary Supplements. It provides that reasonable health claims, with proper disclosure language, shall be allowed "unless the Secretary determines that -- `(i) there is no scientific evidence that supports the claim; and `(ii) the claim is inherently misleading and incapable of being rendered nonmisleading through the addition of a disclaimer." Thus, even "a scintilla" of scientific evidence would allow the making of claims that Dietary Supplements may be of benefit to individuals. The requirements of the bill are consistent with the law that already governs the agency's position, announced in 2004, "FDA intends to apply a standard for substantiating claims for dietary supplements that is consistent with the Federal Trade Commission's (FTC's) standard for dietary supplements and other health related products of 'competent and reliable scientific evidence'.'' The text of the bill, reintroduced on May 7, 2007, can be found at:

This latest FDA Guidance needs further analysis and comments will be addressed to the FDA recommending that Dr. Paul’s approach be substituted for the overly bureaucratic approach favored by the Agency.



1. Aspartame, etc. now Dietary Supplements?
2. Texas AG and Testimonial Claims
3. More on the new cGMPs
4. Health Freedom Blog Update

1. Codex, the World Food Code, continues to degrade food standards…

Rome 07.06.07 – “…the Codex General Standard for Food Additives (GSFA), which sets down the conditions for permitted food additives for all supplements, has now agreed the higher levels for castor oil, polysorbates, polyvinyl alcohol, acesulfame potassium, aspartame, cyclamates, neotame, saccharin, and sucralose. A US-led working group had been charged with drawing up a list of allowed additives and with setting levels based on technical justification and safety. The group had previously drafted lower than expected guidelines….”

You can keep up with the Byzantine world of the Codex Mandarins at


2. “The Texas Attorney General last week charged supplement manufacturer Mannatech for illegally marketing using dubious claims and testimonials about the health benefits of its products.

”Mannatech, its owner and related entities were found in violation of the Texas Deceptive Trade Practices Act, which can result in civil penalties of $20,000 per violation, as well as going against the Texas Food, Drug, and Cosmetic Act, which can result in up to $25,000 per day, per violation.

”State judgments such as these can pick-up where the Federal Trade Commission - which is increasingly on the look-out for misuse of consumer testimonials - has not reached, or not yet reached.

”Mannatech has in particular been charged with encouraging salespeople to make use of misleading testimonials. … "With today's enforcement action, the Office of the Attorney General seeks to shut down an elaborate scheme to defraud innocent consumers across the nation," Texas Attorney General Greg Abbott said in a written statement.

”According to the Office of the Attorney General, exaggerated claims relating to the therapeutic benefits of Mannatech's dietary supplements and products were used to unlawfully mislead consumers with cancer, Down's syndrome, cystic fibrosis and other serious illnesses.”

A word to the wise should be sufficient: Testimonials are not substantiation. Says the FTC in its Testimonial Guide,

“Endorsements must always reflect the honest opinions, findings, beliefs, or experience of the endorser. Furthermore, they may not contain any representations which would be deceptive, or could not be substantiated if made directly by the advertiser.”


3. More on the new cGMPs

As I continue to read the 467 page Good Manufacturing Practices document recently issued by the FDA I will continue to send off “tidbits” that exemplify the spirit of the new regulations.

For example, from the Economic Impact section:

“We find that this final rule will have a significant economic impact on a substantial number of small entities.... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business. …very small … and … small dietary supplement manufacturers … will be at risk of going out of business.... costs per establishment are proportionally higher for very small than for large establishments....The regulatory costs of this final rule will also discourage new small businesses from entering the industry.”


4. Health Freedom Blog

The Vitamin Lawyer Health Freedom Blog is now at The address is:

I just posted more information on the House and the pending FDA “revitalization” bill, based on contact from the office of a friendly Congressman.



1. RCT (Randomized Clinical Trials) and nutrients
2. New cGMPs now available on net
4. CRUSH media release: Silver Safety Standard

1. RCT (Randomized Clinical Trials) and Nutrients

This article by Dr. Melton is cogent and worth reading. The article goes to the heart of the coming cGMPs – how will you substantiate the claims you make about your products? How will you prove the identity and quality of the ingredients? If you have the time to think about what your company will be doing in two years when the cGMPs become effective for small companies, this is something you need to think about… and, yes, you do need to start thinking now…

Clinical trials - gold standard or white elephant?

25/06/2007 - Randomised clinical trials are the ultimate. Forget what the observational studies tell us, if the RCT gives us an answer it must be the final word, right? Wrong.

The value of such trials for the food industry is undeniable, but too often nutrients are pulled out of context, following the same methodology as used for the testing of drugs.

But let's not forget that by following the drug model we are supplementing the diet with one or two nutrients, each at a single dose, for a set period of time. Can a time-constrained randomised trial really capture a lifetime of consumption with respect to chronic disease?

Randomised clinical trials work by randomly assigning a group of volunteers to receive an active compound, be it a drug or nutrient(s), or a non-active comparison, be it an inactive form of the active compound or a placebo. Observational studies, as the name suggests, observe a population and relate dietary intakes of food and nutrients to the occurrence of disease.

We need to consider the science as a whole and not blinker ourselves with results of one big clinical trial, regardless of how much money it costs and what universities were involved.

For food items that do not normally form part of the usual food chain, randomised clinical trials are the best of the best because such compounds can be tested and retested successfully.

Phytosterols, probiotics, or botanical supplements, for example, fit into this category.
Indeed, clinical trials on phytosterols have shown time and again that daily consumption of 1.5 to 3 grams of phytosterols/-stanols can reduce total cholesterol levels by eight to 17 per cent, representing a significant reduction in the risk of cardiovascular disease.

Studies looking at how these results transfer into real free-living populations have backed up the clinical trials, showing a stabilisation of cholesterol levels in certain populations.

So we know the benefit of clinical trials. But when we start using this approach for vitamins, minerals, antioxidants and other nutrients, we come a little unstuck.

Some may say that I'm over-reacting, but let's just look at the report published in the New Scientist magazine that slammed antioxidant supplements as myth.

Despite a vast body of observational/ epidemiological studies linking an increased dietary intake of antioxidants from fruits and vegetables to reduced risks of a range of disease, including cancer, cardiovascular disease and diabetes, when such antioxidants have been extracted and put into supplements, the results, according to RCTs, do not produce the same benefits and may even be harmful.

So the author of the article, Dr. Lisa Melton from the London-based registered charity, the Novartis Foundation, concluded that antioxidant supplements are too good to be true.

Is this really the answer or is it due to poor study design? Would a two-year trial of vitamin E, let's say, really produce a reduction in the risk of a chronic disease?

To illustrate this point further, we only need to go back to last year's Women's Health Initiative (WHI) trial that followed 18,176 post-menopausal women taking calcium (1000 mg) and vitamin D (400 IU) supplements. A similar population (N=18,106) was given a placebo. The subjects were followed for about seven years and the researchers reported that the supplements 'had no effect' on the risk of colorectal cancer.

None of the women had the cancer at the start of the study and colorectal cancer has a long latency period of 10 to 20 years, which begs the question - could we really have expected to see an effect?

We also need to remember that nutrients often work in synergy with one another and exert effects on multiple body tissues, unlike pharmaceuticals.

Additionally, many randomised clinical trials look at the effect of nutrients in diseased populations. Surely the damage of a lifetime's poor nutrition has already been done. When we obtain negative or null results from such trials, should we really be surprised?

The power of nutrients is in the prevention, not cure, of disease.

So what should we do? I don't pretend to have any answers. These are for ladies and gentlemen with infinitely bigger brains than me.

Realistically, there are no viable alternatives out there at present. Randomisation is the best way of limiting bias that creeps into every study, and controlling, specifically with placebo, is the best way to make comparisons.

For those times where randomised trials clearly aren't the best option, then we probably need to look at the observational studies and mechanistic studies in greater depth, and place more value on them.

The research community as a whole must work together to re-evaluate how to get the most from research into nutrition. Lots of different types of studies are out there. Let's make the most of what we already have.

Stephen Daniells is the Food Science Reporter for and He has a PhD in Chemistry from Queen's University Belfast and has worked in research in the Netherlands and France.

If you would like to comment on this article please contact stephen.daniells'at'

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2. FDA publishes Current Good Manufacturing Practices for Dietary Supplements

I’m reading them, but so can you, at: (467 pages when downloaded to MS Word; the actual rule doesn’t start until page 426, after 359 comments…).

Here are some comments by FDA, from the commentary preceding the new rule, that tell us a lot about where the present administration of FDA is taking us: “…we disagree with the comments asserting dietary supplements have a track record of safety such that dietary supplement CGMP requirements are unnecessary. Section 402(g) of the act does not require us to establish a ‘bad’ track record of safety in the manufacture of dietary supplements before we may issue a dietary supplement CGMP rule. Furthermore, we disagree with the comments comparing dietary supplement safety to drug safety; there are different statutory requirements, different regulatory requirements, and different safety evaluations for dietary supplements and drugs.”

We can hope there will be a change of Agency attitude when the Administration changes in about a year and a half; especially if the good doctor from Texas replaces the current Texan occupying the White House. I’ll provide more tidbits as I read the materials.


3. Health Freedom Blog

The Vitamin Lawyer Health Freedom Blog is now at The address is:

I just posted a link there to an 8 minute presentation I taped for Natural Solutions Foundation, for use with health-friendly delegates at next week’s Codex Commission meeting in Rome.


4. CRUSH Silver Safety Standard

The Committee on the Responsible Use of Silver in Health (of which I am a member) is releasing the final version of its Silver Safety Standard (The “12 for 25 Rule). The media release will be posted on PRWeb shortly and can be seen at or on my Blog.

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1. cGMP “Final Rule” Issued: all ingredients to be tested within 3 years!
2. Vitamin Lawyer starts Health Freedom Blog at
-------------------------------------------------------- Index

1. Excerpts from the FDA announcement follows. The terminology is fairly much what I had predicted in previous postings, focusing on “identity, purity, strength, and composition” – however, the enforcement procedures seem more extreme than had been predicted from the draft rule and may represent a further ratcheting of enforcement in general.

Announcement: “The U.S. Food and Drug Administration today (06/22/07) announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled. ***

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints. ***

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling. ***

FDA also is issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing … if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient. ***

The final CGMP and the interim final rule are effective August 24, 2007. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with … less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

It is certainly time to make sure your Standard Operating Procedures meet the new standards, as those standards become effective. I will continue to monitor this situation and inform this email list as modified SOP documents are ready.


2. Health Freedom Blog Upgraded

The Vitamin Lawyer has just started a Health Freedom Blog at The address is: – the earliest postings from my original health freedom blog at have been reorganized to start the replacement Blogspot blog. Additional material is added as available.

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1. Summer of Decision “Not Unreasonable…”
2. Entire Web: Define Your Target Market
-------------------------------------------------------- Index

1. A Summer of Decision: Suggested Amendments to FDA "Revitalization" bill - "Not Unreasonable"

This is a summer of significant decisions in the Dietary Supplement and Natural Products marketplace.

Take Action: Natural Solutions:

Wellness Resources:

From Wellness Resources: "The Senate has recently passed bill S.1082, commonly known as the FDA Revitalization Act. ...the legislation, as currently written, opens the door for considerable regulatory confusion enabling the FDA to use this legislation to undermine my access to safe and effective dietary supplements. There must be no confusing the safety of drugs and the safety of food and food ingredients – which are governed by different laws. ...members of Congress are not intending to create such concern among the 150 million Americans who rely on dietary supplements to assist their health, and this matter is easily corrected with the following amendment, which will not in any way stop the FDA from identifying truly contaminated food that poses a risk to human health.

"Changes in Existing Law. The following provides a print of the existing statute or part or section thereof to be amended or replaced so as to delete the words “or unreasonable” (existing law proposed to be omitted is enclosed in black brackets, existing law in which no change is proposed is shown in roman):

"CHAPTER IV – FOOD - SEC. 402 (f) – (1) If it is a dietary supplement or contains a dietary ingredient that – (A) presents a significant [or unreasonable] risk of illness or injury under — (i) conditions of use recommended or suggested in labeling, or (ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use:

"Changes in Proposed Bills Proposed amendment to S.1082 and HR.1561:

"The bills are hereby amended to prohibit the Foundation or Institute from evaluating the health benefit or efficacy of foods, dietary ingredients, and dietary supplements and to limit review of foods, dietary ingredients and dietary supplements to a determination of whether they are safe. In assessing whether dietary ingredients and dietary supplements are safe, the Foundation or Institute shall not compare product risks with health benefits or efficacy. Instead, the Foundation or Institute shall determine whether the product presents a significant risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are recommended or suggested in labeling, under ordinary conditions of use..."

My comment: it may seem small, but the words "not unreasonable" do have a big impact... and it is in the small space made by such words (or their deletion!) that Health Freedom has room to grow. This amendment, together with the wording of Dr. Paul's HR.2117, would go a long way toward protecting our access to truthful information about the health benefits of foods. Please note that S.1082 does not explicitly mention Dietary Supplements (except for the DSHEA Exemption Amendment adopted 94 to 0) so the suggested Emord Amendment would change existing law to be more protective of Dietary Supplements by attaching the change to the pending pro-FDA bill, the same parliamentary procedure that has been suggested with Dr. Paul’s bill.

One concern I do have with this amendment is that the recent Supreme Court Ephedra decision, not to review the appeals court upholding the Ephedra ban, effectively means that nearly any risk of illness may be considered "significant" and therefore, the amendment may not be strong enough. However, it may be possible to get it adopted… one step at a time!

This is an especially exciting time to be in the Dietary Supplement / Natural Products market. While stricter regulations seem on the way, scientific advances and ongoing clinical studies point the way to better and more effective products. The problem is not in the science or the production; the problem is in the politics. These products are generally recognized as safe when used as directed, like any food. We therefore need to reject the big government notion that tells us we will only be safe if bureaucrats have more control over us. That nostrum is provably wrong, as we see from the failure of government, with plenary power over approving drugs (as to efficacy and safety) to protect the public from what some estimate to be hundreds of thousands of unnecessary deaths each year from lawfully utilized prescription drugs.

The next few weeks, as the FDA “revitalization” bill is amended or not, and adopted, or not, will tell us a lot about the future of this market. Other important regulatory events are happening this summer as well: the FDA anti-CAM guidance may be finalized; the new Dietary Supplement “Good Manufacturing Practices” have been finalized and should be issued. And, as always, the FDA’s announced intent to “HARMonize” our freedoms to international rules (even where that decreases our access to safe products), operating through the North American Union, Codex and the new US/EU cooperation agreement, remains an ever present threat.

This will be a summer of rapid events; stay up to date, even between VLUeM Memos, by checking my Vitamin Lawyer Health Freedom Blog at: - updated every couple days; also . . .


Advertisement – Now more than ever - “your papers must be in order…” Check my SOP/GMP Information Web Page at: to learn what you need in order to stay on top of changing regulations.

-------------------------------------------- Index

2. Defining Your Target Market

This Entireweb newsletter could be so useful to especially new companies that I am forwarding the entire piece…

> Entireweb Newsletter * ISSUE #340 -

> Define Your Target Market in 5 Easy Steps

> This report is designed for entrepreneurs, small business owners, independent contractors and anyone who needs to build relationships and develop leads or referrals in order to promote and increase their business.

> The information in this report is given based on the assumption that YOU know your product and service inside and out and you have already defined your business goals and have somewhat of a business plan in order.

> The next step would be to narrowly and clearly define your target market, your ideal prospect.

> Some people believe that their products or services would be perfect for everyone. For example, Mary Kay Cosmetics - no offense to my MK friends or other people in the health industry who say 'anyone with skin' needs a facial or 'anyone who has stress' need a massage. Then there are people in the home improvement industry who say, 'anyone with a house' needs my landscaping, my windows, my furniture or my loan, etc.

> For most small businesses however (1-5 employees or even more), I don't believe this is the most effective way to try to generate new leads and customers. If you determine the right target market to fit your business, you figure out the best ways to reach them AND if you figure out the best message to reach them with you will be spending your marketing dollars wisely. Business owners who don't plan ahead to figure out who their target market is before they open their doors end up spending a whole lot more money trying to figure it out by trial and error and that's expensive.

> Would you shell out $200 for a pair of shoes without trying them on? Plunge into a steaming bath without dipping a toe in first? Of course not-but people do the business equivalent every day. Many an entrepreneur has found out too late that nobody wants to buy hand-quilted Christmas stockings at $24.99 a pop, or that wealthy customers won't schlep to the unfashionable part of town for luxury stationery.

> The irony: Conventional market research is expensive (corporations regularly budget tens or hundreds of thousands of dollars for it), but no one needs it more than a startup entrepreneur. A couple of marketing blunders won't put a giant manufacturer out of business, but just one can sink an entrepreneur like a bolt of lightning.

> Defining Your Target Market

> Your "target customers" are those who are most likely to buy from you. Resist the temptation to be too general in the hopes of getting a larger slice of the market.

Try to describe them with as much detail as you can, based on your knowledge of your product or service and how it will benefit them.

> Step 1: Ask yourself some questions to get started

> 1. Are your target customers male or female?

> Figure 75-80% of your target customers would be which? If it's split, narrow it down another way but more than likely you can narrow down the gender.

> 2. How old are they?

> Give an age range of 10-20 years max, otherwise you might have two target markets. Remember, the marketing messages towards different age groups will be quite different most likely depending on your product or service.

> 3. Where do they live?

> Is geography a limiting factor for any reason? Can you narrow it down to specific zip codes or counties? The larger the geographical area you choose, the more people you will find but the less likely you'll be able to afford to market to all of them so narrow it down and expand out later.

> 4. What do they do for a living?

> You can get a mailing list by industry or profession and specific title for example.

> 5. What does their specific profession say about their lifestyle?

> Is it very busy with little time to shop? Would they be likely to be familiar with the internet for their shopping, researching, news and event information? Would they be commuting more in their car?

> 6. How much money do they make?

> This is most significant if you're selling relatively expensive or luxury items. Most people can afford a latte. You can't say the same of custom murals. Narrow this down to a specific range also and high enough that you will weed some people out or again, you'll have way too many people to afford to market to.

> 7. Are there kids in the household?

> What ages might they be? How many would there likely be? What does this say about their lifestyle - are they carpooling, or soccer parents where they are rarely home? Do they possibly eat out a lot or have less 'family' bonding time? Or are they empty nesters where they might spend more time at home watching television or reading?

> Step 2: Get specific

> What other aspects of their lives matter? Here are some examples to think about, see how your target market compares or how you can get more specific with them.

> * If you're launching a roof-tiling service, your target customers probably own their homes. In addition, they probably own homes with older roofs like shake roofs; you can get a list of homes by their age.

> * If you're a realtor, you might be interested in targeting first time homebuyers in which case you might find them to be likely to live in apartments or rentals of which you can get a list of those too.

> * If you're selling your own individual artwork but you can't create multiple paintings with the same picture, you may have to sell the unique pieces at local art shows rather than selling them online.

> * If you're planning to open a custom-tailoring shop and need busy executives to come for three fittings, you may need to limit it to your local area.

> * If you're a direct jewelry consultant needing women to gather for parties in someone's home, you'll want to go where many women meet like mom's groups, women's professional organizations, day cares or grocery stores.

> * If you're a business or life coach and want to coach only over the phone then you'll most likely want to do more online marketing and make sure to have a really top notch website since that's mostly what people are going to see for their first impression. You can network locally too but the more 'known' you are in person, the more people will want to do business with you in person.

> Step 3: Keep your mind open to any information

> Keep a list of primary research questions handy, such as:

> * Who influences your customers and how? Spouses, neighbors, peer groups, professional colleagues, children and the media can all affect buying decisions. Look for hints that one or more of these are a factor for you.

> * Why do they buy? Distinguish between the features and the benefits your product or service offers. Features describe what it is; benefits are what your customers get out of it. The latter is why your customers pay you. Are they looking for a status symbol, a savings in time or energy, a personal treat or something else?

> * Why should customers choose you and not your competition? What can you offer that the competition doesn't?

> * How do your customers prefer to buy? Many businesses benefit from the broader market provided by the Internet and mail order, while others do better with a physical presence. Don't assume you fall into one category or the other; customers may surprise you.

> Step 4: Identify Your Ideal or Favorite Client

> Think about your favorite client - who are they, name them, write down everything you know about them, their family status, age, sex, marital status, where they live, where they work, possible income level, their shopping characteristics.

> * Do they like to use coupons or shop on certain days?

> * Do they call you at the last minute to get something from you?

> * Do they value your service/product?

> * Is that type of client the most profitable type you have or the most non-profitable and you just like them?

> Step 5: Determine their profitability to your business

> Which type of clients will make you the most money, bring you joy and refer you tons of business? These are the types of clients you ultimately want, now where are they?

> Ask Yourself:

> * Who is the most profitable type of client? The one who will make you the most amount of money the fastest and with the least effort - do you like working with them? If not, you won't be totally happy with only this type of person, maybe you need a combination of the two.

> * How often will they be able to buy or consume your product or service? If they can only possibly purchase your services every 10-20 years (getting a new roof for example), do you never market to them again after the sale or do you heavily market to them after the sale by every means possible for at least 1 year to get all the referrals you could possibly get out of them in that time?

> * How likely are they to know others like them they can refer to you? Normally, very likely, in which case following up with them before, during and after the sale is huge - and if you don't ask for referrals in each stage of the sale continuously then shame on you.

> * What is really important to them when it comes to your product or service? Not what you think they should know or like, but actually what they care about, like, ask for, thrive on, are passionate about, etc. These are your target market's "Hot Buttons" and these are what you should be addressing in your headlines, letters and marketing efforts at all times because these are why the client would choose to buy.

> Defining your business' target market is absolutely critical to any small business. Everything you do in your marketing, advertising, design, publicity and networking will depend on who your target market is and what matters to them. Making decisions on your marketing and advertising without fully defining your target market or knowing them in depth could be detrimental to your business and you could be making some costly mistakes!

> About the Author: Katrina Sawa, Relationship Marketing Expert, helps entrepreneurs and independent consultants build their database of clients and prospects, determine the best ways to market their business to their target market, teach them how to network, develop follow up systems, marketing and advertising plans and find ways to get free or low cost publicity which all lead to more customers and increased sales! Visit her at



Ron Paul’s Health Freedom Protection Bill is the answer to the FDA’s failings…

Head of FDA wants to work more closely with Drug Companies...

Report from Gardner Harris - "May 30 - When Dr. Andrew C. von Eschenbach took over the Food and Drug Administration in 2005, the agency had a crisis over drug approvals that had missed or ignored dangerous side effects in Vioxx, antidepressants and other prominent medications. Dr. von Eschenbach promised improvements, and agency officials said they would no longer be caught flatfooted on drug safety. But this month, The New England Journal of Medicine published a study suggesting that a major diabetes pill, Avandia, might increase the risk of heart attacks.

Concerns over that drug and others have led Republicans and Democrats in the House and the Senate to call for investigations. A House hearing is planned for June 6. Dr. von Eschenbach said in a briefing on Wednesday that his agency needed to collaborate more closely with drug companies.

’The point is that we need to look at the role of the F.D.A. in being a bridge to the future, not a barrier to the future,’ he said at his office here."

My question: is working closely with Drug Companies the solution... or the problem?

I suggest that a better solution would be promoting natural remedies without dangerous side effects; not putting up bureaucratic barriers to them. This
can best be done by allowing people access to truthful information about traditional, non-drug approaches; by letting natural product purveyors make
serious health claims... exactly what Ron Paul's Health Freedom Protection Act would do.

In the twelve hours since sent an email blast seeking support for the Paul bill over 10,000 people have written their
congresspeople supporting the bill! We still need hundreds of thousands to move Congress.

Here's where to do it: or

Protect our herbs, vitamins, minerals and natural remedies from bureaucratic meddling!!


EPHEDRA BAN CONTINUED: Risk - Benefit Analysis Comes to Herbs
The United States Supreme Court decided not to hear the Ephedra case appeal on May 13, 2007. This decision leaves standing the appeal court reversal of the Utah district court's voiding of the FDA's ban on the Chinese herb Ephedra. Take a deep breath! That means, in effect, a drug industry risk/benefit standard has been imposed on at least part of the Dietary Supplement industry. Instead of the standard of “safe if used as directed,” which is the standard that applies to all foods, herbs can now be subjected to the type of analysis that applies to drugs.

But not equally, as the Ephedra case shows. Let's take Aspirin for example: tens of millions use it daily; 1500 die each year. Apply Risk/Benefit Analysis: drug allowed. Another example: Viagra(R) - hundreds of thousands use it; hundreds are harmed yearly. Drug allowed. Now take Ephedra: at its height, 25,000,000 used it daily. Over ten years, there were 5 deaths that may have been associated with Ephedra abuse; not using it according to directions. Result: the herb is banned. To this observer, this does not appear to be equal treatment. Or based on science and reason.

According to NutraIngredientsUSA, "The most recent court ruling on Ephedra blurs the distinction between supplements and drugs and could force the industry to conduct clinical tests, says the Natural Products Association..." The "once-popular herbal, was banned by the FDA's final rule in 2004 on the grounds that it does not present a significant health benefit to outweigh the reported increased risk of heart attack, stroke and death. ... A year later the ban was successfully challenged by Nutraceutical in a Utah court since the 1994 Dietary Supplements Health and Education Act (DSHEA) does not make mention of risk-benefit balance in establishing whether a supplement presents an unreasonable risk. Rather, the FDA drew on the medical devices provisions of the Food Drug and Cosmetics Act, which does state that this is a determining factor. ... Since then the pendulum has swung back and forth on appeal..."

Judge Campbell's reasoning, however has not been rejected by the Supreme Court, as it decided in its discretion, not to hear the case. Future cases asserting the same legal claim, that Congress intended Dietary Supplement law to be harmonized with food law, not drug law, could be further strengthened by steps the US Senate took last week to exempt Dietary Supplements when it approved enhanced powers for FDA.

In the 2005 case, Judge Tena Campbell held, “...the legislative history of the DSHEA indicates that Congress generally intended to harmonize the treatment of dietary supplements with that of foods when it added the dietary supplement subsection to the food adulteration provision…”

It is therefore incumbent upon Congress to protect this salutary policy and further enhance it, by writing a much stronger exemption for all foods and natural products into S.1082, the FDA Revitalization Act of 2007 when it comes before the House. Keep your mouse-tail twitching and stay tuned to get ready to bombard Congress with one simple demand:

"Protect our herbs, vitamins, minerals and natural remedies from bureaucratic meddling!!"

Check for further details.

To contact Congress:


...VLUeM - 05/11/07 - Vitamin Lawyer Update Memo
1. New GMP Standards Cleared by OMB
2. Vitamin Lawyer Health Freedom Blog: DSHEA Exemption?
1. New GMP Standards Cleared by OMB – as reported on the Internet
Completes Effort to Implement Key Aspect of DSHEA
>Washington – Sen. Orrin G. Hatch (R-Utah) today announced the Office of Management and Budget has given final clearance for good manufacturing practices (GMP) regulations for dietary supplements.
>“Finally!” Hatch said. “This is very good news. Senator Harkin and I have been pushing the FDA to publish these for more than a decade.”
>Hatch is one of the principal authors of the Dietary Supplement Health and Education Act of 1994, which gave the FDA the authority to write GMP guidelines specific to supplements. GMPs are the standards inspectors will use to assure purity, potency, and all the other requirements of clean, legal manufacturing.
The GMPs are expected to be published within the next five weeks.
>“GMPs are crucial because they assure the public that the products they are buying live up to their labels,” Hatch said. “Since it took an unusually long time to issue these final guidelines, I want to review the final version very carefully to make certain they are good regulations. Every indication leads me to believe the Administration was very sensitive to the impact the GMPs might have on the industry, especially on small businesses.”

We are likely to get a look at the GMPs within the next few weeks. I will keep this elist informed of these developments, that I have long predicted. When the GMPs are issued, I will update the standard Vitamin Lawyer Consultancy SOPs (Standard Operating Procedures) to conform. My current formats are outlined at:

2. Vitamin Lawyer Health Freedom Blog

The political situation, as it impacts Dietary Supplements and Alternative Practices is moving so fast that a couple of Update eMemos a month cannot keep up, so I’ve started a blog on these issues: - you need to be aware of the latest developments… and two of those are: (1) Dr Ron Paul, congressman from Texas and presidential candidate, called the draft FDA CAM guidance “an abuse of FDA power…” and (2) despite some confusion on the issue, we have written confirmation from Sen. Kennedy’s office that the Senate did approve SAmend 1022 (94 to 0), exempting DSHEA products from the Kennedy FDA enhancement bill (but, the broader exemption for all food and natural products needs to be added when the House considers the bill). More at

Let Congress hear from you:

PRIVATE MESSAGE: The purpose of the ...VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Please take a look at – we have a new look and better indexing.
1. Strategies for Responding to Net Attacks – Fake Ratings Sites
2. Strategies for Responding to Net Attacks – DoS Preparation
3. Health Freedom Issues: VICTORY IN CONGRESS TODAY!

1. Strategies for Responding to Net Attacks – Fake Ratings Sites

Here is a copy of an email I just provided to one of my regular clients:

“There are several strategies that can be used to respond to fake "third party" sites that are actually competitor sites designed to denigrate competing products. These responses vary from mild to extreme; from inexpensive to very expensive.

But, before getting to those strategies, some preliminary issues may help understanding how far to go.

First, who actually owns the offending site? I searched the WhoIs database at and find a "private registration" through Network Solutions (NS is the original & "Cadillac" of the URL registrars). The problem is, the register does not have to cooperate without starting a lawsuit and serving a subpoena on it; one trick is to start a small claims action (which is relatively cheap) and issue the subpoena from that.

Second, does anyone actually see the offending site? I checked the rating for the offending site. It has worse than a 3,000,000th rating. Your rating is in the Top One Million. So this offending site may not be much of a problem. By the way, being in the Top One Million is a good thing!

Here are some options:

0. Create & promote a competing site with similar name & image to dilute the offending site's search engine status.
1. Legal letter from attorney to offender, sort of saying: “Cease & Desist your defamatory posting and stop using our trademark!” with copies to URL register and ISP.
2. Written complaint for unfair competition, false claims, to appropriate Attorney General Consumer Protection Agency; copy to offender.
3. Same as #2, but to Federal Trade Commission, if more of a federal issue situation.
4. Lawsuit in state court for unfair competition, trademark violations, etc.
5. Lawsuit in federal court under cyber protection laws (such as the Cybersquatting Act).”


2. Strategies for Responding to Net Attacks – DoS Preparation

It takes a sophisticated opponent to engineer Denial of Service (DoS) attacks on a web site. Individual computers and even local networks have to be commandeered and turned to the nefarious task of massively requesting information from the attacked site, so it crashes under the assault. Since the attack is coming from many IP addresses, it is difficult to stop.

These are certain simple steps you can take, with your webmaster, to minimize the threat. The first step is to always have a mirror site on another server. Then, if attacked, the alternate site can take over until the attack stops. There is a certain way to code your site that can minimize the effect of a DoS attack. I acknowledge receiving this information from Mike Adams of – a great Internet source of information. For various reasons, I am not publicly releasing this information. If you would like to know more about this, please email me at and put “DoS” in the subject line.


3. Health Freedom Issues Continue to Reach 100,000’s

During the past 5 weeks we have seen an awesome outpouring of citizen protest against a growing list of FDA, congressional and international pressure on our health freedoms. Around 180,000 people sought to file comments with the FDA about the draft CAM guidance, before the comment period ended. At the same time, several troubling bills are wending their way through Congress and Codex, the UN food agency, continues to be a battleground. Commenting on this, Dr. Rima Laibow, MD, Medical Director of the Natural Solutions Foundation - – recently stated on her blog:

"Right now the American Public is being whipsawed: first the dangerous FDA CAM Guidance (Complimentary and Alternative Medicine/Modalities) which threatens to turn all health practices into medicine which only physicians could practice and the foods and supplements supporting natural health into
unlicensed drugs – and, yes, there is a real danger to your health freedom despite a good deal of internet chatter to the contrary!) - and now the sudden advancement of Senator Ted Kennedy disastrous bill, S 1082 (“the FDA Revitalization Act of 2007”, plus the identical House bill) from Committee to the floor of the Senate for a vote in the immediate future without public hearings. It would be easy to succumb to “health freedom vigilance fatigue”, which is, I believe, exactly what the intended effect is supposed to be. There is even speculation that Senator Kennedy moved this bill forward so rapidly BECAUSE the American public responded so vigorously to the CAM Guidance and are presumed to be preoccupied with it."

You can keep up with the latest developments at the Health Freedom Blog:

VICTORY IN CONGRESS! And some very good news: Congress has accepted the following amendment to S.1082 - Enhancing Drug Safety and Innovation Act of 2007 - from Sen. Durbin. It appears that Congress heard our concerns! Hundreds of thousands of messages to FDA no doubt reverberated through the halls of Congress. The amendment was adopted with 94 out of 100 votes.

Sec. X08. Rule of Construction

Nothing in this title (or an amendment made by this title) shall be construed to affect--

(1) The regulation of dietary supplements under the Dietary Supplement Health and Education Act; or

(2) The adverse event reporting system for dietary supplements created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act.

Like many victories in Congress, you hardly ever get everything you want. A leading supplement industry lawyer, J. Emord originally proposed exempting all "foods" from the new law (Counsel stated: "It is a fundamental tenet of food and drug law that foods and food ingredients are presumed to be safe and have to be established to be adulterated only if they present a significant or unreasonable risk of illness or injury.") This approach would have offered even greater protection for natural products, but we are grateful that enough members of Congress heard the loud shout from the public and responded so quickly to at least protect DSHEA products -- the power of Internet politics at its best.



1. Dietary Supplement SUS page update
2. Vitamin Lawyer on Internet Radio this Friday

1. Dietary Supplement SUS page update

One of the main services The Vitamin Lawyer Consultancy provides to its vitamin purveyor and alternative health care practitioner client base is to keep you updated with the latest changes in the Disclaimers and Disclosures that you need on your web site. Due to recent legal developments, I’ve modified my standard Site Use, Privacy, Disclosure, Disclaimer Statement by adding two new paragraphs. If you are using my format, you would add these after the section on food allergen labeling. The new clauses are:

"This Organization is in compliance with the terms of the Dietary Supplement and Non-Prescription Drug Consumer Protection Act of 2006 and will make all required Adverse Event Reports (AER).

To the best of the knowledge of the Organization, none of our products are classified as “CAM” (Complementary and Alternative Medicine) Products and they are not labeled with claims to treat disease."

For more information about SUS contents, see: – if your web site needs a proper SUS, please email me with “SUS” in the subject line.


2. Vitamin Lawyer on Internet Radio this Friday

I’ll be chatting with counsel Jim Turner on his Of Consuming Interest Internet Radio show this Friday, April 27th from 3 to 4 PM, EDT - - this is Gary Null’s internet radio network. Our prime topic will be Complementary and Alternative Modalities.

We will discuss the latest developments in the FDA anti-CAM guidance public outcry. To date, over 144,000 people have told the FDA , “We’re as mad as hell and we won’t take it any more!” While the FDA spin masters now assure us we have nothing to fear, lawyers in the field view the guidance as potentially dangerous to health care freedoms. We’re happy to take your questions and comments about this and the other pending attacks on health freedom, like CODEX, the NAU (Trilateral Cooperation Charter) and a bunch of bad bills recently introduced or threatened by the friends of Big Pharma in Congress. We will also focus on strategy going forward: how to deconstruct an agency that has confusing and conflicting authority and a record of mounting failure. It is sobering to realize that as many people die each year of properly prescribed, FDA approved, drugs, as have protested the anti-CAM guidance!



1. Affiliate Program Upgrade: Higher Commissions!
2. FDA Anti-CAM Guidance Update: Hot Button Issue!

1. Magnets for Wellness: Just a note to my clients with online businesses: BiomagScience has seriously upgraded its affiliation program: raising the commission rate from ten to 25% and the override (for sites that join through your site) from five to 10%! As I noted in past eMemos, joining affiliation programs is a quick way for you to bump up sales on your site; just remember to set up the html so the banner opens a new window, that way people don’t leave your site when the click through. You can join at:

The “Body Electric” is also a body magnetic and the use of magnetism in self-help and as a therapy that may benefit normal structure and function is growing. Sports medicine, especially, is beginning to accept the benefits of magnetism in promoting healing and raising cellular energy levels. BiomagScience offers magnet products and clearly described protocols developed by the Foundation for Magnetic Science.


2. FDA Anti-CAM Guidance Update: For those of you who have been trying to reach me with less success than usual, I apologize. I’ve been “riding a tiger” with the FDA’s proposed new controls on Complementary and Alternative Practices – over 90,000 comments have been generated to FDA in a bit over a week! This has been very controversial, with some observers suggesting the new “Guidance” does not represent a new power grab by FDA. Naïve, Naïve! Here is my latest commentary on the issue:

CAM Practices, Products and FDA Regulation: A Threat Assessment

The US Food and Drug Administration is a confusing and confused agency, charged with administering federal controls over foods, drugs and medical devices under a patchwork of laws and regulations that have drastically increased costs to American consumers and slowed health care progress, without demonstrable safety benefits. It is therefore inevitable that many actions taken by the agency are likely to do more harm than good. Such is the case with the proposed Complementary and Alternative “Medicine” (CAM) guideline that the agency proposed at the end of December, public comment period to extend through April 30th. You can go to to make your comments.

It is true the FDA anti-CAM guidance merely restates the existing law [as FDA sees it] -- that, if you intend to "treat disease" with a CAM product, that product (for example, says FDA, a “juice”) is a "drug." By codifying this in a guidance document, FDA is setting the stage for another push to control and restrict CAM practices. The FDA uses the term “CAM product” in the guidance, although Congress has never defined such a term. The agency seeks to create a “status” of being a certain type of product when all Congress has authorized is that the FDA can regulate certain products “intended” to “treat disease.” Of course, the responsible FDA Senior Science Advisor did say, in a very recent interview, this is not FDA’s “intent” and using “CAM Products” is just a matter of convenience. Of course, as good Americans, we should all believe exactly what the FDA tells us; trust the agency’s intent; shut up and take all our prescriptions.

In addition to telling us that a juice intended to “treat disease” would be a drug, a careful reading suggests even items used in religious healing ceremonies could now be subject to regulation as drugs or medical devices. Holy water, anointing oils, prayer beads, rosaries, sweat lodges and even religious paintings or icons could be classified as drugs or medical devices and essentially outlawed by the FDA. Does this sound absurd? Well, it is absurd!

Certainly, all this appears a bit less absurd if we are considering using an herb or dietary supplement to stay healthy. Says the FDA, if any supplement is used to treat a symptom, then it is a drug and will be regulated by the FDA, just like any prescription drug.

The FDA does give us a little hope -- the supplement will be exempted if it is "generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling." This is essentially the same standard used for substantiating drug claims. In 2004 the FDA gave us the standard for making claims about foods and dietary supplements: "FDA intends to apply a standard for substantiating claims for dietary supplements that is consistent with the Federal Trade Commission's (FTC's) standard for dietary supplements and other health related products of 'competent and reliable scientific evidence'.'' Quite a difference! This is just one difference the anti-CAM guidance will codify. And after codification comes enforcement. All alternative practitioners should take note!

In other words, your freedom to use a dietary ingredient as therapy that may benefit a condition will be at the discretion of FDA “experts” who will determine whether to regulate it as “medicine.” Given the abysmal track record of FDA experts, this could be really bad news.

With so much latitude, I cannot predict just how far the FDA might go to restrict access to herbs, minerals and supplements, as well as other CAM products. Many pro-health freedom groups are offering their concerns too. For instance, one commentator, Jenny Thompson of the HSI Newsletter suggested, “…[FDA] could take a widely used supplement off the market if the label states a benefit; such as using lutein to reduce the damage from age-related macular degeneration, or using chondroitin and glucosamine to reduce joint pain, or using probiotics to address digestive problems - the list goes on and on…” The AAHF (American Association for Health Freedom is concerned that “the two biggest [problems with the guidance] are broadening the definition of “health claim” and the desire to pre-empt the states in the regulation of some health care issues”

The health freedom movement began to take notice of the pending anti-CAM guidance in late March. At the start of April, I assisted one group, Natural Solutions Foundation, to write its commentary to submit to the FDA, with emphasis on what we see as the important distinction between "treatment of disease" and its non-medical alternative, under AMA Ethics Code Opinion 3.04, "therapies that may benefit." The comments raised three demands:

1. A public hearing by the FDA before the finalization of the guidance.

2. Changing the title of the guidance to use the phrase “Complementary and Alternative Modalities” and not the prejudicial “Complementary and Alternative Medicine” as in the draft.

3. FDA recognize that “therapies that may benefit” are not the same as “treatment of disease” and do not have to be regulated as “medicine.”

The organization then alerted its elist and asked its supporters to also file comments with the FDA, supporting the group’s requests. We apparently touched a hot button issue; over the following week the buzz spread on the Internet

Propelled by this strong public support, I believe we now have an opportunity to turn this FDA "end run" around and use it to protect CAM practices. We are now seeking support from members of the US Congress to demand that FDA hold public hearings before making the guidance final. If FDA fails to hold such hearings, it would be time for Congress to step in, hold hearings, and propose legislation to protect CAM practices from FDA action that would deny Americans access to alternatives. With John Galt, we want to say, “Get out of my way!”

It has been settled law in this Country for over a century that medical regulations exist to protect the public, not to entrench licensed allopathic medicine to the detriment of all the evolving healing arts, which would refer to as “CAM practices” – though Traditional and Advanced Health Care might be a more appropriate term.

"The state has not restricted the cure of the body to the practice of medicine and surgery -- allopathy, as it is termed, -- nor required that, before anyone can be treated for any bodily ill, the physician must have acquired a competent knowledge of allopathy and be licensed by those skilled therein. To do that would be to limit progress by establishing allopathy as the state system of healing, and forbidding all others. This would be as foreign to ours ystem as a state church for the cure of souls. All the state has done has been to enact that, when one wished to practice medicine or surgery, he must, as a protection to the public [not to the doctor], be examined and licensed by those skilled in surgery and medicine. To restrict all healing to that one kind -- to allopathy, excluding homeopathy, osteopathy, and all other treatments -- might be a protection to doctors in surgery and medicine; but that is not the object of the act, and might make it unconstitutional, because creating a monopoly." North Carolina's Supreme Court in State v MacKnight, 42 S.E. 580, 1902 at p 582.

As NSF’s medical director, Rima Laibow, MD, has noted,

“Throughout the world today people are looking to traditional methodologies and leading-edge CAM techniques because they offer alternatives to toxic, expensive drugs with their dangerous side effects, other invasive technologies of modern medicine, and un-manageable and unreasonable costs. This search for alternatives is protected by the fundamental right of individuals to communicate and learn; to heal and be healed.”

You can read more about this issue and add your comments to the FDA through the Natural Solutions Foundation, a non profit NGO at and submit your comments from the home page. Since the FDA Dockets Supervisor tells us her 9 member staff is overwhelmed -- apparently the system crashed and only about 102,000 of the over 245,000 people who have tried to post comments have succeeded so far – we have now made arrangements to email directly to the FDA and expect all future comments to get through, so if you did not succeed last week, please try again. The last time Americans got this mad about health freedom, we got DSHEA. This time, we will protect our complementary and alternative practices; our vitamins, herbs, minerals and healing arts. We are “mad as hell” and “we aren’t going to take it any more!”


Ralph Fucetola, JD - The Vitamin Consultancy
All Rights Reserved

1. MLM – Multilevel Marketing
2. Wanted: Testing for Supplements
3. Updated SoP Outline
4. AHPA on AERs
5. FDA to issue Guidance on CAM – comments requested!

1. MLM Marketing

MLM Marketing, of which Online Affiliate Marketing is a subset, appears increasingly important in the Vitamin Industry, while, at the same time, every successful MLM seems to feature vitamin products. Here is what Wikipedia has to say about Multi-Level Marketing" -

"In a typical multi-level marketing or network marketing arrangement, individuals associate with a parent company as an independent contractor or franchisee and are compensated based on their sales of products or service, as well as the sales achieved by those they bring into the business. *** Multi-level marketing has a recognized image problem due to the fact that it is often difficult to distinguish legitimate MLMs from illegal scams such as pyramid or Ponzi schemes. MLM businesses operate legitimately in the United States in all 50 states and in more than 100 other countries, and new businesses may use terms like "affiliate marketing" or "home-based business franchising". However, many pyramid schemes try to present themselves as legitimate MLM businesses."

And what it says about "Pyramid Schemes" -

"A pyramid scheme is a non-sustainable business model that involves the exchange of money primarily for enrolling other people into the scheme, usually without any product or service being delivered. Pyramid schemes have existed for at least a century. *** There are other commercial models using cross-selling such as multi-level marketing (MLM) or party planning which are perfectly legal and sustainable."

It was in 1979 that the Federal Trade Commission (FTC) ruled in the case of In re Amway (93 F.T.C. 618) that MLM marketing was legal. Some of the largest marketing companies in the world use MLM systems to provide goods and services to the public. Some famous examples come to mind. Amway. Mary Kaye. Market America. Nikken. Shaklee or Tupperware. These companies market billions of dollars in products and services annually.

It can be fairly said that Multi-Level Marketing appears here to stay and has been strengthened by the rapid development of the Internet Market (for both ease of record keeping and direct online sales). While, in the past, there may have been some abuses by some companies, the continued participation by millions of people in MLM companies (around the world) and the rapid growth of online affiliate sales, shows strong market acceptance and a continuing role in the global economy.


2. Wanted: Testing for Supplements – An important Nutraingredients commentary:

02/04/2007 - The dietary supplement industry needs an independent testing program that is recognizable to consumers in order to enhance the credibility of its products as well as encourage solid science and sourcing.

As it stands now, the industry lacks a familiar stamp of approval on labels that can let consumers know if the product in their hand stands out in any way from others on the shelf. This means companies that go the extra mile - those that invest heavily in research and development or oversee all sourcing of their ingredients - are not necessarily rewarded.

Many other consumer goods industries - such as dental products - have stamps of approval that can help point consumers to products with effective value-added ingredients, etc. The dietary supplement industry should apply a similar model, but with the added clout of a testing program behind the labels.

The obstacles frequently cited against this type of program are the cost of such an initiative, as well as what group or groups would assume the responsibility.

While the Natural Products Association, NSF International and US Pharmacopeia offer testing programs in the United States, they are either not yet wide enough in scope, or are not recognizable as label 'stamps of approval' to consumers.

The story in Europe is differs slightly with the finer points of the 2002 food supplements directive (especially vitamin and mineral) still to be hammered out. EU regulations. But even though industry may have its eye elsewhere, building consumer confidence in should always be a priority.

As such, a universal testing program would require an advertising campaign to familiarize consumers with the concept so that they know what to look for on product labels.

And once consumers start to look for stamps of approval on bottles, industry will be compelled to follow all the necessary steps to get such certification. This will also buffer the effect of allegations in the industry that target some companies and not others.

In January, American allegedly found high lead content in certain supplement brands, including a multivitamin for women sold by The Vitamin Shoppe. Traces of dangerous compounds are a genuine concern for the industry and until one independent body tests decides what constitutes 'dangerous' levels, the charges made by businesses such as will continue to scare consumers without providing any straight forward solution.

An independent testing program would also urge companies to become accountable for their ingredients and oversee the entire supply chain before their product goes to market. This could dissuade companies from relying on suppliers that contract from other suppliers in such a way that the end manufacturer has never even set foot in the facility where its product may have originated.

Also, any companies that cut their active ingredients with undeclared fillers would also be punished or, at least, would lose out on the bonus of certification.

Adulterated versions of relatively expensive ingredients such as hoodia gordonii or saw palmetto would become less easy for companies to proffer. Sold as an appetite-suppressant, cactus-like plant hoodia is sourced from South Africa, while saw palmetto for supporting prostate health is sourced and wild-harvested from Florida.

Consumers would finally know that what is on the label is what is really in the bottle.

However, none of this will come about until the majority of the industry is motivated enough to invest in its own long term livelihood instead of letting some companies take the easy way out while others invest in science and the consumer is caught somewhere in the middle trying to decide which product is legitimate.

Clarisse Douaud is a reporter with and has lived and worked in Canada, Ireland, Argentina and France. If you would like to comment on the piece, send an email to: clarisse.douaud'at'


3. SoP Outline Web Page

I’ve compiled the information presented in various Update eMemos regarding Standard Operating Procedures on the updated outline page at:


4. AHPA on AERs

The natural products industry is starting to get ready for Adverse Event Reporting, as this article shows -

“4/4/2007 - The American Herbal Products Association has joined the ranks of trade associations preparing the dietary supplement industry to comply with impending adverse events reporting (AER) legislation... Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was introduced in June 2006 as a means of obliging supplement manufacturers, packers and distributors to notify the Food & Drug Administration (FDA) of any serious adverse events reports. The AER legislation is set to come into practice by the end of 2007, meaning companies will have to have their reporting systems in place… Following the bill's passing at the 'eleventh hour' in December, the responsibility of informing industry was left in the hands of trade associations…. AHPA claims companies will be able to distinguish between a complaint and an adverse event.”

More on AER services:


5. FDA to issue Guidance on CAM – Comments requested!

The Food and Drug Administration is about to issue its “Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.” The “guidance” is just as bad as you imagine… however, first, they have to accept comments from the public on the proposal, and we hope to force a public hearing. Comments due by April 30th.

Guidance at:

You can submit your comments through Natural Solutions Foundation at:

I helped write the NSF comments and would appreciate your support by submitting your comments in support of ours!

Well, wish me a Happy Birthday – I was born this date in ’45.
Ralph Fucetola, JD - The Vitamin Consultancy
All Rights Reserved

1. Your SoP & Substantiation Notebooks & FDA Inspections
2. Grow Your Online Affiliation Program!

1. Your SoP & Substantiation Notebooks & FDA Inspections

I’ve been asked what a Dietary Supplement marketer ought to have available for an FDA visit, in the event of a surprise agency inspection.

Ideally, you ought to have a couple loose leaf note books, (a) one entitled "Standard Operating Procedures Notebook" (or “SoP Notebook”) and (b) the other entitled “Substantiation Notebook.”

(A) The first Notebook should contain your:

(1) Operations Manual/SoPs and Employee Manual
(2) Formula sheets
(3) Label copies (with dates as to when they were in use)
(4) Literature copies (likewise dated)
(5) Copies of your Structure and Function Notices
(6) Insurance Policy binder page
(7) Certificate of Incorporation (or LLC Certificate of Formation)
(8) EIN and Bank Account number information

(B) The second Notebook contains information that substantiates the claims you are making. This Notebook should have a section for each product and each claim for the product, by ingredient.

(1) Abstract pages of scientific journal articles regarding the ingredients
(2) Clinical study reports about the ingredients and combinations of them
(3) Ethnographic reports on traditional uses
(4) Expert opinion letters

If you are ever visited by FDA, for one of their famous "surprise visits" having this stuff together so you can give them a copy would make them very happy.

2. Grow Your Affiliate Program

The Vitamin Lawyer Consultancy does provide Affiliate Program Rules. Let me know if you want to establish an Affiliation Program.

Besides the right Rules, of course, you need the right software. One good program that I can recommend is the program used by for its online biomagnet sales program. It is a two step program, so, typically, you will see two banners from it on Affiliate web sites. One is for retail sales of biomagnets (for which you receive a sales commission), and the other is a “Become a Biomagscience Affiliate” banner, where another web site can join as an Affiliate, and your site earns an override on all retail sales through that site. If you go to the following page, you can see that banner: .

But that’s just the start. After you have your web site and your affiliation program, you need to market it! If you do it right, you can expect very significant sales growth!

Here are excerpts from a piece through Add Me Newsletter about being an affiliate marketer.

How To Immediately Boost Your Affiliate Marketing Sa'les
By Titus Hoskins

Affiliate marketing is a very competitive field. Savvy affiliate marketers use every tactic they know to get the upper hand over their competition. It can mean the difference of whether or not they get that all important sa'le.

One of the best ways to boost your affiliate sa'les is to take full advantage of brand name recognition. … Popular brand names with popular trendy products sell the best.

If you're an affiliate marketer you must choose the products you promote with the utmost care; in many cases this is where you will determine the outcome of your marketing efforts…

As an affiliate marketer you can promote anything, why not choose the most popular brands and products. Just look for popular trends and join the bandwagon. Sure, the competition might be stiffer but the demand for these products will also be greater.

If you join affiliate networks like Commission Junction [or, for another example, – rf] they will show you the companies with the highest sa'les volume in their system. Study this sa'les data before you pick your affiliate companies or products.

You can even use Google Trends to tell which products are popular and in which countries. Do some market research first and pick the most popular products to promote.

Many marketers keep an eye on their PPC (Pay Per Click) keywords for any surges in searches or impressions. A big jump could mean an increase in popularity for that product or company.

* Be Aware of “The Buzz” Factor …Certain brand names and products have buzz. …

* Can It Only Be Bought Online? … One of my most successful tactics has been to pick products or offers that are only available online. Dell products come quickly to mind. … Online coupons and exclusive deals also increases your affiliate sa'les. Look for these and display them along with your popular brands for they will increase your sa'les. Everybody loves a deal!

* Use Brand Names In Your Site Copy and PPC Advertising … You must always check with your affiliate company what rules they have about displaying brand names and trademarks on your site copy. Most companies will supply their affiliates with web content they can use for promotion.

Most Companies have strict rules prohibiting affiliates from using certain brand name keywords in their PPC advertising. Each company is different, so check before you proceed with any PPC campaigns.

However, one of the most effective ways for PPC advertising is to use the particular brand name and product name in your PPC ads. Savvy affiliate marketers have figured this one out long ago, it mainly has to do with finding the buyer at the right stage in their buying process. If they're looking a particular product ; they may already have their minds made up and are ready to buy…

* A Rose Is A Rose Is A Sa'le! … In conclusion… Keep your eyes peeled for popular trends and shifts in the marketplace so you can adjust your marketing to meet these new demands….

About the Author - The author is a full-time online marketer. For the latest and most effective web marketing tools try: Internet Marketing Tools - © 2007 Titus Hoskins.

Well, that’s all for now.

Ralph Fucetola, JD
The Vitamin Consultancy
All Rights Reserved


1. Making Claims & New Dietary Supplements
2. Record Keeping SoP and Employee Manual – Online Outlines Available
3. Health Freedom Site Attacked


Say your company needs a "DSHEA compliance" letter from The Consultancy about a new product. The threshold issue is whether the product is a "new dietary ingredient". We start by noting whether the product is found in the IBIDS data base. Then we check to see if similar products are found in the general FDA data base and look for references indicating whether FDA treats the product as a new dietary ingredient.

Journal abstracts showing the product being studied prior to the DSHEA "grandfathering" date of June, 1994 can be useful. Such information could show that the product was part of the food supply before the grandfathering date. This will negate the new dietary ingredient issue (which would have required prior FDA approval before marketing -- with proof of safety).

The other part of the DSHEA compliance issue has to do with the claims to be made for the product. If there are no claims being made, other than "a good source of [ingredient]" or "advanced bioavailable form of [ingredient]" (with substantiation for these claims, of course) then there would be no claim issues. Simple general “support of normal structure and function” claims are allowed. Even “immune system support” claims could be allowed:

"A “claim that a product "supports the immune system" is not specific enough to imply prevention of disease because the immune system has both structure/function and disease fighting roles. A general claim of this type doesn’t specifically focus the intended use of the product on the disease aspect of the system’s function."

Here is access to the FDA guidance: Once these threshold issues are resolved, it becomes possible to provide a DSHEA compliance letter for use with potential distributors, online affiliates and joint venturers.



SoP – Standard Operating Procedures – are an important part of cGMPs (current Good Manufacturing (Marketing) Practices. I’ve created a new web page with outlines of the contents of the SoP and EM documents -

A primary concern of small, leading edge dietary supplement purveyors is how to deal with the new wave of regulation that seems to be sweeping the industry. The first rule of bureaucracy is, “Are your papers in order?” Well, are they? In the context of current Good Manufacturing/Marketing Practices (cGMPs) your “papers” are the documentation of your business activities, from buying your products, through advertising, selling and shipping them. And then, dealing with customer issues, refunds, recalls, adverse event claims, etc., etc.

To make it as simple as possible, I’ve developed a shorter and simpler “Record Keeping SoP” version of my Standard Operating Procedures/Employee Handbook (SoP/EMs) that is made for smaller, Internet oriented dietary supplement and alternative therapy companies. For a bit over an hour of my time, I can customize the Record Keeping SoP format for your company, so you will know what documents you need to keep and for how long. Just email me at with “Record SoP” in the subject line and I’ll let you know what information I need and how you can reserve the time for your SoP.

You can now also take a look at the Tables of Contents of the Record Keeping SoP (actual document: 5 pages), the Standard SoP Manual (16 pages) and the Employee Manual (22 single-spaced pages) that I’ve posted at:



The websites of the Natural Solutions Foundation - and – disappeared from the Internet within hours of the site exposing the genocidal agenda “the illness industry.” The sites are online again, but with a number of images and other information still missing. You can read the original article and the Internet attack at:

Here is what Dr. Laibow had to say in an email blast while the sites were down: “…our hosting company… locked our site with no reason given, no warning and no explanation. When I called to talk to someone about this I was told that the supervisor was "on leave," the manager was "not here," probably would not call me back when he got there, and that there was no one to talk to about the fact that my site was locked for no apparent reason at all. All this after 19 minutes and 45 seconds of international phone call holding. Why is our site blocked? Because, according to the technical services person, the site was locked in the computer with no explanation and can not be unlocked until I talk with the right person. Who is that? He does not know… The War on Freedom IS a War on Health Freedom… I wrote about the genocidal intent of the illness industry called Big Pharma in my latest email to you. Funny, immediately after that our site is mysteriously locked for no reason. Hmmmmm. Could it be that the Power Beast does not want you to know about these realities? Looks like it, doesn't it…”

As of today, the two parts of the site that still do not work, curiously, are the email sign-up and the Organics 4 U Shop. So no one can join or help support NSF*. Curious and curiouser… If you’ve chosen to be in this industry, you need to acknowledge its realities.

Ralph Fucetola JD

* The Foundation can receive donations through PayPal, however.
You can PayPal to and the donation will go directly to the Foundation.

Also, do see Nutricide, now on YouTube at:


1. Record Keeping SoP and Employee Manual – Online Outlines Available
2. New Meta-Analysis Attacks Antioxidant Vitamins: Is it flawed? What to do?
3. Web 2.0 – What the Entrepreneur Should Know


[I was asked to repeat this information from previous eMemos. I’ve created a new web page with outlines of the contents of the SoP and EM documents - ]

A primary concern of small, leading edge dietary supplement purveyors is how to deal with the new wave of regulation that seems to be sweeping the
industry. The first rule of bureaucracy is, “Are your papers in order?” Well, are they? In the context of current Good Manufacturing/Marketing
Practices (cGMPs) your “papers” are the documentation of your business activities, from buying your products, through advertising, selling and
shipping them. And then, dealing with customer issues, refunds, recalls, adverse event claims, etc., etc.

To make it as simple as possible, I’ve developed a shorter and simpler “Record Keeping SoP” version of my Standard Operating Procedures/Employee
Handbook (SoP/EMs) that is made for smaller, Internet oriented dietary supplement and alternative therapy companies. For a bit over an hour of my
time, I can customize the Record Keeping SoP format for your company, so you will know what documents you need to keep and for how long. Just email me at with “Record SoP” in the subject line and I’ll let you know what information I need and how you can reserve the time for your

You can now also take a look at the Tables of Contents of the Record Keeping SoP (actual document: 5 pages), the Standard SoP Manual (16 pages) and the Employee Manual (22 single-spaced pages) that I’ve posted at:


Study alleges link between antioxidants and increased mortality.

“2/28/2007 - A meta-analysis of 68 randomized trials with antioxidant supplements has reported that vitamins A and E, and beta-carotene may increase
mortality risk by up to 16 per cent, but vitamin C did not have an effect on mortality and the antioxidant mineral selenium was associated with a nine per
cent decrease in all-cause mortality. … The pooled analysis, published in the Journal of the American Medical Association, could have significant
negative effects on the sale of antioxidant dietary supplements… The new pooled analysis has already drawn criticism from both inside and outside the
dietary supplements industry concerning the methodology applied, and the conclusions drawn. … The most prevalent criticism of the study has come from
the diverse nature of the studies pooled together, described by one industry expert as comparing "apples and oranges"… A wealth of epidemiological
evidence has linked dietary antioxidant intake to reduced risk of a wide-range of diseases, such as cancer and cardiovascular disease, but when such
antioxidants have been extracted and purified, or synthesized and put into supplements, the antioxidants, according to randomized clinical trials (RCTs),
do not always produce the same positive results. … [The meta-analysis] findings contradict the findings of observational studies… that antioxidants improve health.”

The language used in the reports about the meta-analysis does appear carefully chosen to overstate the risks and understate the benefits. The bottom line for vitamin purveyors: (1) if these allegations begin to impact the market, consider substituting whole food sources of ingredients for extracts; (2) budget the funding needed for RCTs and (3) note the astoundingly positive results for Selenium: a 9% decrease in mortality. Think Whole Food Supplements!

[03/02 Update: Linus Pauling Institute blasts AMA fake meta-analysis: -- the Institute points out obvious flaws in the report and show the bias of the authors, who started with 815 trials, selected out 68 of them, ignored the most valid trials, and then manipulated the statistics to provide the preordained result. Voodoo science at its most obvious.]


Excerpts from: Becoming the Spider: Next Generation SEO Tactics

"Just when you believed you had all your SEO tactics figured out, the web goes and changes on you. ... Web 2.0 changes the whole ballgame. It not only places the Internet user squarely in the middle of things, but it gives that user the means and power to create and manipulate data. Web 2.0 dramatically changes how we view and use the web. ... Just what exactly is Web 2.0? ...perhaps the simple definition can be found in the word "you"! Time magazine probably summed it up best by making reference to the "you" in user generated content. Web 2.0 is basically all the platforms that give us this brave new
user-powered interactive Internet, generally referred to as 'social media'. .. Web 2.0 can be seen or manifested in such sites as YouTube, MySpace,, Digg, Squidoo. ... Web 2.0 uses scripting languages such as Python, Perl PHP, RSS... to construct interactive platforms that websites can
use to create all this user-generated content. ... If you have used Google Earth, you will realize how powerful and revolutionary these new applications
can be, not to mention, they are a whole lot of fun. ... all webmasters should optimize their sites for this new Web 2.0 and take full advantage of all the
SEO possibilities presented by this brave new Internet. … Here are a few SEO suggestions you can try:

1. RSS/Blogging. You must place a blog and RSS feed on all your sites. This is a fairly simple procedure to do with free server-based programs... Having a
blog and RSS feed will place your site into the whole tagging process. Each category you create in your blog will be seen as a tag by such sites as
Technorati. RSS stands for 'Really Simple Syndication' and your RSS feeds will get your content distributed across the web. ...

2. Create some Google Juice! Join as many of these highly interactive sites as you can: MySpace, YouTube,, Digg, Wikipedia ... my favorite is
Squidoo, where you can create Lenses on different topics that interest you. User driven content that's utilized by all the major social media sites. Of
course, link back to your sites in your posts and creations in these user-created content havens and watch your PR ratings go way up.

3. Use Interactive Scripts. Place interactive JavaScripts and platforms on your own sites. Have membership forums, polls, blogs, feedback forms,
user-contributions... to build unique content driven sites. Become the spider!

4. Tagging (Folksonomy). Be constantly aware of the tags (keywords) you're creating with your blogs and sites. This can have a very beneficial effect on
your traffic and rankings. Closely relate these tags to the content on your sites and build higher rankings in all the major search engines.

5. The Long Tail. Especially important for affiliate marketers, you need to cover special niches where there is less competition and content. These narrow
niches make up a large portion of the whole vast web, creating content in these unique areas will get your site included in the search engines a lot
quicker and keep them there a lot longer.

6. Holistic Web 2.0! Be constantly vigilant in placing your sites in the whole 'Interactive Game', building links and partnerships with the important
YouHubs: MySpace,, YouTube, Digg, Squidoo... the more connections you have, the more your own sites will prosper.

"... Web 2.0 will play an ever increasing role in the development and evolution of the web. Make sure your sites are optimized and in the 'You'
game. Create blogs, RSS feeds, interactive forums, membership areas, user-generated content and truly make your sites interactive havens in their
own right. Just remember to tag everything and your sites will reap the benefits of this new Web 2.0 generated SEO gold rush. ... The author [Titus
Hoskins] is a full time Internet Marketer with numerous sites on the web, including two niche sites on Internet Marketing. His main site is ...”

Well, that’s all for now. Remember to check the SoP contents tables at:

Ralph Fucetola JD


1. Harvard Joins Anti-Nutrient Crusade
2. The Future for Healthcare: $4.1 Trillion!
3. Record Keeping Short Form SoP


The report speaks for itself, but do note how it is being used to create publicity for the idea of implicitly pre-market controls over nutrients, as though nutrients were not as safe as any other category of food.

“The report, "Vitamins and Minerals: What You Need to Know", gives consumer advice…Directed at the general public, the report could stir up the issue in the nutraceutical industry surrounding what body should give a stamp of approval for supplements, and whether an independent body is needed for such a purpose.

“"Choose products that bear the US Pharmacopeia Dietary Supplement Verification Program (USP-DSVP) mark, which indicates that the supplement manufacturer has complied with certain standards," says the report.

“Via its recommendations, the Harvard report is also critical of dietary supplements that go beyond the vitamin and mineral category.

“"Generally, if you're hoping for phytochemical benefits, you'll do better in the produce department than the supplement aisle," according to the report. "There is virtually no evidence that herbs and other nonvitamin ingredients added to supplements, such as echinacea, are essential for your health."

“The report questions another key area for the supplement industry - the benefit of different sourcing for vitamins in minerals.

“"It doesn't matter whether vitamin C is derived from organic rose hips or synthesized in large batches in a laboratory," says the report. "Your body will use the resulting product similarly."”



FDA News reports today: “”Healthcare spending will continue to grow more quickly than the economy over the next decade … according to a report from economists at the Centers for Medicare & Medicaid Services (CMS). Healthcare spending in 2016 could reach $4.1 trillion, representing 20 cents out of every dollar spent, according to the report, which was published in Health Affairs. In 2006, healthcare spending was $2.1 trillion, the economists estimated. …

spending growth will reach 7.8 percent by 2009 because of accelerating medical price inflation and increases in pharmaceutical use. By 2016, health spending could be 19.6 percent of the gross domestic product, the report said.



A primary concern of small, leading edge dietary supplement purveyors is how to deal with the new wave of regulation that seems to be sweeping the industry. The first rule of bureaucracy is, “Are your papers in order?” Well, are they? In the context of current Good Manufacturing/Marketing Practices (cGMPs) your “papers” are the documentation of your business activities, from buying your products, through advertising, selling and shipping them. And then, dealing with customer issues, refunds, recalls, adverse event claims, etc., etc.

To make it as simple as possible, I’ve developed a shorter and simpler version of my 50+ page Standard Operating Procedures/Employee Handbook (SoP/EMs) that is made for smaller, Internet oriented dietary supplement and alternative therapy companies. For an hour of my time, I can customize the Record Keeping SoP format for your company, so you will know what documents you need to keep and for how long. Just email me at with “Record SoP” in the subject line and I’ll let you know what information I need and how you can reserve the time for your SoP.

Well, that’s all for now.
Ralph Fucetola JD

The purpose of the ...VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. You got on this e-list by opting in or becoming a client of the Vitamin Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList… ;)
And do remember to check out the ...VLUeM Online Archives: and my Online Seminar compilation of briefs and white papers: .
This issue focuses on two areas: (1) FTC plans to police the vitamin market and (2) some more tips from Entire Web.

1. FTC Enforcement Plans
2. Increase Conversion with Situational Selling

1. FTC Enforcement Plans from Nutra Ingredients USA (article excerpts below)

“2/8/2007 - The Federal Trade Commission has said that it will continue to prioritize policing dietary supplement marketing practices, thereby sending out a warning to companies making exaggerated or unsubstantiated claims. .

“The deceptive marketing of products that may affect consumer health and safety will continue to be an FTC priority,” said the FTC in its budget request summary submitted to Congress on February 5. “The FTC will focus on health care products, including dietary supplements.”

“The authority rang in the New Year with a $25m-clamp-down on parties behind the deceptive marketing of four major weight-control supplements: Xenadrine EFX, CortiSlim, TrimSpa, and One-A-Day WeightSmart. [The Vitamin Lawyer notes: none of my clients!] . . .

“Going forward, the FTC will continue its aggressive program by focusing its law enforcement on violations that create the greatest risks to consumer health.” . . .


2. Increase Conversion with Situational Selling from EntrieWeb - (article excerpts below)

“. . . [R]eally good salespeople are trained to discover details about the customer before trying to pitch a particular item. A question like, "Hi, how are you? What sport do you play?" is a great opening line. It gets the customer to focus on a general topic, and then persuades him or her to narrow down the choices. And a focused customer is a buyer, not a browser.

“What does this have to do with your online sales? Plenty. Especially if you'd like to increase your conversion by 50 percent or more.

“You see, if you focus just on increasing traffic without increasing your profit per visitor, well, you're missing out on more money. Or more e-mail opt-ins. Or whatever it is that you do to monetize your site. Fewer clicks and more sales should always be the goal. You'll improve those two metrics when your site successfully gets visitors to focus right away on the homepage and then proceed directly to checkout.

“That's where the "situational sell" can be your super-cybersalesperson. On a website, you can give visitors a few choices that best describe their situation, and entice them to click on the description that puts them into a specific segment of the market.

“The situational sell is a way to pitch products and information strictly from the customer's point of view. If you're selling sports merchandise online, you would want to get customers to click on their favorite team right away, and then choose the item they want to buy. … Think of the situational sell as pre-qualifying your visitors, before they get a chance to wander aimlessly through your site. If you pre-qualify them, you can funnel them through the sales process a lot faster.

“One traffic school website who tried this tactic ended up increasing its email opt-ins by a whopping 60 percent! How did they do it? Instead of simply listing the names of the courses it offers, the website asks visitors what type of driver they are, literally. On the site you'll see 3 boxes in a row in the main body area. Each box contains a unique headline, a photo to illustrate the idea, and a description of services within the category.

“Box #1 contains the headline "New Driver?" and includes a picture of teenagers laughing and hanging out in a school parking lot. Box #2 carries the headline "Too Many Tickets?" and includes a picture of a driver getting a ticket. Finally, Box #3 has the headline "Trying to pass the state exam?" along with a picture of a recent immigrant holding paperwork.

“Under the headlines, a series of links appear. This is also a great place to include your top-tier keywords. Once a visitor clicks on one of those links, he or she is guided to a page specifically geared to sell products or services to their demographic

“The beauty in setting up a 'situational sell' website is that it's a very flexible way to market one type of product to a wide selection of site visitors.

“If you're selling e-books or informational products, there will be different features or advantages that you'll want to highlight, depending on the visitor. By segmenting your visitors first on your homepage, you can funnel them to specialized pitches.

“The situational sell sounds logical because it is logical. But in the day-to-day minutia of maintaining a website, the big details sometimes get lost in the shuffle. Take a fresh look at your homepage and give your visitors a fresh perspective. Try the situational sell. It will make your visitors comfortable, they'll feel as if you already understand their point of view, and you'll most likely be rewarded with higher conversions.”


About the Author: Diane Metz writes about website marketing and development. She offers free, unique content to select websites. Her companies include Crown CD Manufacturing, which specializes in CD duplication and CD replication, for marketing, music, promotions and software - .


I am happy to be able to bring you Diane Metz’ interesting piece on Situational Selling. I think it is a useful marketing concept that can help you design a stronger web site. The great genius of the Internet is its ability to connect people and information. The more you are able to link the right people with the right product the more likely you are to have a sale. So good luck on your web site optimization!

Well, that’s all for now.
Ralph Fucetola JD

Vitamin Lawyer on HealthRadio; Vitamin Shoppe under attack; DEATH by medicine

Vitamins are under major media attack -- again. A new Adverse Event Reporting Law has been signed by the President. These issues are so important for Dietary Supplement Purveyors, that I reproduce below most of the report from Nutraingredients-USA and devote this entire issue of my Update eMemo to the attack:

The Vitamin Shoppe calls for independent testing procedures - By Clarisse Dou

1/26/2007- Following the withdrawal of its women’s multivitamin product - as a result of allegations of high lead content by - the Vitamin Shoppe has expressed both its desire to get to the truth of the matter and for industry to devise new testing methods.

NutraIngredients-USA ran an article Wednesday on the Vitamin Shoppe's decision to withdraw its "Especially for Women" multivitamin. The decision was sparked by the highly publicized results of a study conducted by industry watchdog that pinpointed 11 products - out of 21 tested - as not meeting their labeled contents and standards.

The Vitamin Shoppe… said… “Our industry badly needs an independent testing procedure that truly has the best interests of the consumer at heart…”

ConsumerLab said the Vitamin Shoppe’s multivitamin was contaminated with 15.3 micrograms of lead per daily serving. This is more than ten times the amount of lead permitted without a warning label in California – the only state to regulate lead in supplements – and several times the normal daily exposure to lead…

The Vitamin Shoppe has also stood by its assertion that its products are manufactured according to Good Manufacturing Practices (GMPs). “We have strict checks and record keeping requirements that follow "Good Manufacturing Practices" for food and all products delivered to our distribution facility.”

Draft current GMPs were published in 2003, but the final version of the guidelines are reported to still be going through a law-making process at the Office of Management and Budget.

“There is a proposed regulation for GMPs that are specific for dietary supplements that have been in discussion since 1995… “We regularly audit our contract labs to assure that they are complying with our educated best guess as to what these proposed regulations will entail and for the legally required compliance with food GMPs.”

Copyright - Unless otherwise stated all contents of this web site are © 2000/2007

So, what does this mean to the average vitamin company? These are the points to consider –

First: cGMPs are about to become a center of the attack on the industry.

Second: the attack continues, in different ways and places. Just a week ago Tuesday, the New York Times carried a major article attacking vitamins as potential poisons – my comments and those of Maury Silverman – prepared for my appearance last Saturday on HealthRadio - Dr. Alan Pressman, - are below:

Date: Thu, 18 Jan 2007 03:26:45 PM EST
From: "Ralph Fucetola JD"

Subject: The Safety of Dietary Supplements

Well, Dr. Pressman, I looked at the NY Times propaganda piece.

I'd be happy to appear on your show this Saturday. What strikes me is the extraordinary SAFETY of supplements -- one death in 60,000 complaints, for example, with many ten millions of users - 230 deaths in 23 years. Compare that to aspirin - 1,500 deaths per year, every year. Etc.

With the new Adverse Event Reporting law, we may get better statistics over the next few years. See: .

Among other failures, the Poison Control people are not collecting the right information. It has been suggested by some critics of such studies that often the adverse reaction is caused by the interaction with drugs and it is the drug that is to blame, not the food substance.

Maury Silverman recently wrote me (about implementing the new AER law):

"Implementing 'objectively' has been stated many times here, meaning to first identify concurrent use of foods and dietary supplements with drugs of any kind, be they prescription, OTC, or illegal/illicit/counterfeit.

"Once that is done on the MedWatch form your company now must fill out once a complaint comes to you that must be reported to FDA, the FDA should screen out drug-drug interactions & drug-nutrient interactions, (which are inherently drug problems). The current MedWatch form is very inadequate to gather this

"This is important so that:

" (1) the dietary supplement ought not be blamed for a serious adverse event prompting a lawsuit against your company, or yourself since you are so
numerous on the record as disbelieving and/or being delusional on this matter.

" (2) The FDA can require labeling of the drug, for contra-indications, known drug-drug and/or drug-nutrient interactions. As drugs are so inherently
more dangerous than foods and dietary supplements, better labeling of drugs, first, is vital importance to the nutrition industry and the public health.

" (3) Drugs can be labeled for the nutritional deficiencies they cause. That goes also for alcohol, caffeine, and nicotine when poor nutrition is concurrent.

" (4) More 'E' can be put into the full implementation of DSHEA. This means more quality information from the nutrition community on how to avoid
adverse events, when there is concurrent usage with drugs.

"The problem is too often that the medical establishment does not educate or train its practitioners on nutrition and the healing qualities of natural products. They are more likely than not, drug salespeople. From when I was a youngster, I do remember that people grew up on food and good nutrition, not DRUGS.

"I suggest here that you look at the article in the October 9, 2006 issue of Archives of Internet Medicine titled: "Factors Associated with Dietary Supplement Use among Prescription Medication Users". (166: 1968-74, 2006)"

Allen, Thanks for the opportunity to respond to obvious BS.

Third: The current attack on vitamins needs to be seen in light of AER – Adverse Event Reporting. AER implementation will be directly tied to these developments. And, a word to the wise: The new AER law is not concerned with the general propaganda that nutrients are not safe, as a class of food. Nutrients are generally recognized as foods, and foods are generally recognized as safe when ingested as directed. AER is concerned with specific batches of specific products and whether they are contaminated or otherwise unwholesome. AER may provide the ammunition to yet again prove nutrients safe.

Please review what we have to say about AER developments on the AER Consultants web page, – we will post information on developments there. AER Consultants will engage with the FDA on the issues that need to be covered by the AER regulations to protect the industry as well as the consumer. Your thoughts on that would be appreciated, so please let me know what you think needs to be included.

What can concerned citizens, health freedom activists, alternative practitioners and dietary supplement purveyors do to protect their access to wholesome, high potency nutrients? Stay informed! Be ready to make your views known. Support health freedom groups like - if you are in the industry, realistically analyze the situation and remember, “Management manages…”

And now for the counter-punch... DEATH by medicine:

Previously published by the Life Extension Foundation, Gary Null and several other healthcare professionals lay it out: government-approved, standard medicine is the single greatest CAUSE of preventable death in the USA. While we've known this for a while, it's useful to see the statistics all brought together in one article, especially now that Dietary Supplements and natural alternatives seem under heavy media attack.

Well, that’s all for now.

Ralph Fucetola JD

For those of you who are new to the ...VLUeM, the purpose of this e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. You got on this e-list by opting in or becoming a client of the Vitamin Lawyer Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own elist… :)

And do remember to check out the Online ...VLUeM Archives: and my Online Seminar listing of briefs and white papers: .
Here’s what I cover in this memo:

1. Vitamin Industry continues rapid growth.
2. Handling negative search engine postings

1. RAPID GROWTH! -- It’s going to be a great new year! The latest figures show that Vitamin Industry sales have increased to over $28,000,000,000 – that’s 28 billion dollars – per year! As recently as 1993 some sources list annual dietary supplement sales at under one billion dollars. In about a decade and a half, sales may have risen at the astounding average annual rate of two billion dollars a year! What’s your share of the industry? Where will this rate of growth take it over the next decade? Are you ready to rise with this rising tide – or, rather, with this tsunami of sales? Looks like an interesting year ahead!
-------------------------------------------------------- Index

2. NEGATIVE WEB PUBLICITY -- I’ve recently been asked by several people to help clear search engines of negative postings. While their own web sites rank near the top for their chosen search terms, or for their own names or company names, they also found some rather negative postings also having very high search engine positions. This is especially true regarding negative postings from such sources as the now largely discredited “Quackwatch” web sites. Once a “quack attack” has been launched, though, it tends to linger on the web. When, as was recently the case, a negative posting including confidential government investigative materials that are privileged by law, a strongly worded Cease and Desist letter from a lawyer to the Internet Service Provider (ISP) providing the web space for the offending site will often cause the deletion of the page. Other times, litigation is necessary. See my site, . The Vitamin Lawyer is available to send C&D notices for you, or to consult with local counsel if litigation is needed. The sooner you start, the quicker the negative web pages will disappear!

But, often, there are “lawyerless” approaches that can help reduce the search engine ranking of negative postings. The following excerpts from a recent issue of Entireweb Newsletter contain a wealth of ideas to deal with negative press.

"Entireweb Newsletter * January 9, 2007 * ISSUE #299 - Ten Tips To Clear Search Engines of Negative Press

"What do you see when you search for your company or brand name? Is there anything on the first page of the search engine results that you wouldn't be proud to display on your home page? Consumer review sites, blogs and forums have made it easy for anyone to say whatever they want about your company, whether they be disgruntled customers or competitors who like to play dirty. ... If you're in a situation where negative publicity is front and center in search results, there are ways you can reclaim search engine real estate for your corporate identity. Though you can't make negative results disappear from the search engine indexes entirely, the following strategies can help them slip off the first few pages of search engine results.

"1. Good Old Fashioned Networking - Even if you take none of the advice following in this article, the first thing you should do is contact the webmasters of the sites in question with a polite request for removal of negative comments. There's a good chance they'll be willing to co-operate. ...

"2. Tap Into the Power of Wiki - Wiki websites allow users not only to add their own content, but also edit pages. ... There are many wiki pages like and that you can use to create content about your company. ...

"3. Raise Your Profile - Some websites like allow you to post your company's profile. ...

"4. Wet Your Pen - Articles can help you kill three birds with one stone. Not only can articles rank for your company name, they also build valuable backlinks to your site and position you as an expert in your field. You can use your company name in the resource box at the end of an article along with a link back to your site...

"5. Become A Socialite - Using social bookmark sites like Netvous and is an easy way to quickly create a page that ranks for your name. ... The links themselves are not given much weight by search engines, but you have an opportunity to use your company name in the titles and descriptions of your bookmarks and photos. ...

"6. Become A Lensmaster - A company blog is certain to rank well, and it's easier than ever to create one with When you create a "lens" for your site, you can easily upload pictures and also make use of tags. Unlike other blogs, Squidoo won't show the posting date, so your lens won't look neglected if you ever stop posting. You can build your blog's link popularity by submitting it to blog directories like LSBlogs and BlogHub, and linking to it from your site...

"7. Broadcast Yourself - Do you have promo videos or other visual media about your site? Why not create a channel [on sites like YouTube]..

"8. Explore Shopping Engines - If you sell products online, consider listing them in comparison shopping sites, or "shopping engines" like, Bizrateor Nextag. ...

"9. Use Directories For Deep Links - Search engines still consider a page's number of relevant backlinks to be a strong indicator of quality and relevance to a search term. Octopedia, WorldSiteIndex and Microsoft's Small Business Directory are a few examples of solid directories ...

"10. Post An E-Help Wanted Sign - Leverage the strength of sites like to post your company's current job offerings. Make sure you use your company name first in the posting headline...

"Tracking Results - I strongly recommend setting up an account with Google Alerts (free) which monitors the top 50 results, or with Google Alert, a professional tracking system that will monitor the top 200 results for you for as little as $4.95/month. You will be notified daily when new references to your name have been found in Google - not only to see when your articles, profile pages, blog posts and so on get indexed, but also to keep on top of any new negative or positive references to your name outside of your own reputation management efforts.

"How Long Will This Take? - Results may vary but they won't come overnight. You will get out of your reputation management efforts what you put in. It could take anywhere from a few months to a year. Expect monitoring and tweaking your strategy to be a long-term activity. As new pages are being added daily to the Web, search results for your name can fluctuate daily, even hourly... The key is to look at reputation management as a long term activity and to take advantage of all the options you have to keep the search engine results positive.

"About the Author: Linda Bustos is the Marketing Director for Image X Media, a Vancouver web design and Internet marketing firm. She also blogs about social media and business."

Well, that’s all for now.
Prosperous New Year!

Ralph Fucetola JD


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