Thursday, January 1, 2004

Vitamin Lawyer Client Memos
2004 through 2006

The Vitamin Consultancy
Below are archived copies of selected client memos from 2004 through 2006

12/12/06 - CAM - SEO - SoP and a year-end opportunity!
11/16/06 - Managing a Business Crisis
10/23/06 - More on SoPs and SEO
10/12/06 - VL Free Online Seminar; Codex DVD
10/06/06 - Register Food Processing Facilities; Nanotech Coming...
09/15/06 - "promotes and markets... for serious disease conditions"
09/08/06 - AERs and QCs - more regs for industry
07/05/06 - FDA inspections & SoPs - Operations Manual
06/08/06 - SEO, FTC Policing Claims, SUS Updates
01/12/06 - New Law Threatens Internet Communications - Disclaimer
01/09/06 - Allergy Labeling; Credit Card Compliance Letter; Biography
10/31/05 - Codex: Revised Vitamin and Mineral Guideline
01/13/05 - Structure and Function Claims Review
10/04/04 - Standard Operating Procedures (Operations Manual)


Here’s what I cover in this memo:
1. Paying for Complementary, Alternative Medicine (CAM) Therapies.
2. More on SEO…
3. Knock, knock… a year-end opportunity!
4. Emergency Management SoP
1. Paying for CAM Therapies.
NCCAM - the federal agency that is supposed to represent the public’s interest in Advanced Healthcare (what the gov’t calls “Complementary and Alternative Medicine”) has a web site with some useful information for practitioners. For example,
“In tax year 2005, the IRS allowed taxpayers to deduct medical expenses for a limited number of CAM services and products, such as acupuncture and chiropractic care. These expenses were generally allowed for taxpayers and their spouses and dependents.”
To find out more about resources for funding such health care costs, see:
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2. Search Engine Optimization. is an excellent source of information about searching the web. That’s why I’ve forwarded a number of their articles to this elist. Last week's article has good some really good advise. What particularly struck me were:
“Let's clear the decks, your opening headline (which should be an H1paragraph, by the way) should say in no uncertain terms what it is you are offering vis-a-vis service or product. (Not to mention the benefit of owning the damn thing.) This is the line that both search engine and customer will see first. It is the line that convinces both to stick around. In addition, this headline should reflect and tie-in neatly with your HTML meta tags of Title, Description and Keywords. *** Make no mistake, your headline is crucial for winning good search engine listings and for making sales.”
“Google, Yahoo and MSN seemingly account for around 75% of the Internet's search traffic. And if you are nuts enough to want to add that lot up, you may find that it will run into many billions of searches per month. *** Anyhow, by extrapolation, it appears that the remaining, lesser known search engines must handle 25% of the traffic between them, which I can tell you with some accuracy amounts to about 950 million searches a month. *** “Wow!” you say. And quite right, too. What seems plain from all of this is that if you aren't deliberately targeting the smaller engines, you are neglecting, even rejecting some 25% of your potential customers.” - Entireweb Newsletter - December 5, 2006 - #289
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3. Knock, knock… an end of the year opportunity!
As some of you may know, I am the Chairman of the Board of Directors of MagnetoCore Corporation – - which is licensed to sell Foundation of Magnetic Science certified products. That site is about our wellness products. The company is also developing a line of Fluid Conditioning products for uses that range from engine enhancement to agricultural applications. You can see some more about those applications at a site maintained by one of our Manufacturer’s Reps, - these products will also shortly have their own web site. The Board, at its monthly meeting last week, adopted a resolution allowing us to sell some shares in the company at a special rate. The opportunity is limited to $5,000 per investor (minimum, $500) and includes one warrant per share purchased. If you are interested, let me know and I’ll arrange for a conference call with our new President, Lou Elwell. I’ll need to know the best number and time to call.
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4. Emergency Management SoP.
Following up on the Emergency Management note in the last issue of this eMemo, I’ve prepared a new page for my form Standard Operating Procedures Manual. That page codifies an Emergency Planning structure for your business. If you are a retainer client of mine, you will receive a copy of the new page by separate email. If you are a client who has ordered a SoP Operations Manual in the past and want a copy of the update page, just send me an email note and I’ll send you the page. If you do not have a SoP manual but want one, let me know and I’ll quote you a price to customize it for you.
That’s all for now – I hope you find this information useful!
And -- happy holidays and a prosperous new year!
Ralph Fucetola JD

Here’s what I cover in this memo:
1. Managing a Crisis: Preparing for the Unexpected
2. Quick Dissolve Strip Vitamin & Nanotech Delivery System
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1. Managing a Crisis.
The late Harold Geneen, the creator of one of the early, great conglomerates, ITT, wrote in his classic book Managing that “Management Manages…” and this mantra is especially useful to remember when your business finds itself in a sudden crisis. But also remember that old saw: within every adversity are the seeds of a greater benefit, or as the Chinese put it, every crisis is an opportunity.
Companies, especially in volatile industries that are subject to regulatory reversals and strong competition, need to pre-plan to deal with the unexpected. How would you deal with a manufacturing error that might make your product dangerous? What would you do if someone that everyone in the company relies upon were suddenly taken away by illness or other emergency? What if a key employee is called to active duty, or arrested, or leaves for a better job? Crises take many forms, from surprise regulatory inspections to accidents and litigation to a blizzard. Management needs to have - in place - contingency plans, or at least someone who can consider contingencies, before the crisis.
Here are some things to consider:
* Pre-position a crisis management committee – an Emergency Manager needs to be ready in advance
Consider - staffing the committee, day-to-day management, setting and meeting goals
Review insurance coverage; maintain emergency contact information; SoP status
* Pre-position your outside experts for availability during an emergency
* Pre-position media outreach – spin to turn losing into winning
* Prioritize the targeted audiences with whom you need to communicate during a crisis:
* What message for what group: customers, employees, investors and, agencies
* Who delivers what message to whom and how does it get out: fax, phone, email
* Interact with the FTC, FDA and state authorities during a company crisis
* Deal with concerns from local, national or international audiences
“Management manages…” and you need to prepare for emergencies and discontinuities in advance. Your Standard Operating Procedures are important here: during an emergency good SoPs allow others in the company to perform the tasks normally handled by an absent team member. Remember that The Vitamin lawyer Consultancy has small-business friendly SoP – Operation Manual formats available.
Perhaps the most important duties of the Emergency Manager before the crisis is to make sure that (1) insurance, (2) emergency contact information and (3) SoPs are all in place. When the crisis comes upon the company, reacting quickly and communicating the right message to the key audiences becomes the priority.
2. Quick Dissolve Strips – an advanced delivery system to consider for water-soluble dietary supplements, herbals, homeopathic and nanotech products. Take a look at Winning Business Solutions for more information:
That’s all for now – I hope you find this information useful!
Thank you and have a joyful, family-filled Thanksgiving!
Ralph Fucetola JD

Here’s what I cover in this memo:
1. SoPs – More on Operating Procedures
2. Top Ten SEO Factors – from Entire Web
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1. SoPs - More on Standard Operating Procedures
I know I’ve been telling you quite a bit over the past couple months on Standard Operating Procedures. There is an important business reason for that: bit by bit the FDA is coming out with more requirements that apply to dietary supplement companies, enforcing a provision in the 1994 DSHEA law giving FDA authority to codify current Good Manufacturing/Marketing Practices in the industry.
In comments to one member of Congress, discussing a meeting on SoPs, FDA stated: “The agenda included topics regarding the small business entities' manufacturing practices and standard operating procedures for: (1) personnel; (2) buildings and facilities; (3) equipment; (4) laboratory operations; (5) production and process controls; and (6)
warehousing, distribution and post-distribution of' raw, intermediate and final products . The meeting included a discussion about the verification of the identity, purity and composition of dietary supplements and dietary supplement ingredients.”
There has been continuing controversy regarding SoPs for the industry. GNC made its position clear in 2003, “FDA asserts that “dietary supplements have their own set of unique requirements as a result of the characteristics and hazards due to their ‘hybrid’ nature, e.g., dietary supplements can be considered as falling somewhere along the continuum between conventional foods on the one hand and drugs on the other.” Dietary supplements in fact fall within the food category and were treated as a food item for their entire history. DSHEA in 1994 confirmed the food status of dietary supplements and provided an expanded definition of the category.
As a result, the original intention of FDA to have formal cGMP in place several years ago has been delayed. Now the agency seems to be imposing the regulations in a more piecemeal strategy. I’ve recently been reading FDA warning letters that cite a lack of an SoP as a concern of the agency.
To anticipate these developments, I’ve created a standard Operations Manual for my Vitamin Lawyer Consultancy clients. As the SoP is developed, it will cover all the areas cited by the FDA above. The most recent addition to the SoP is a page of instructions about reviewing Advertising Claims, whether on labels, literature or web sites. Those clients who are on a regular monthly retainer agreement with me have received that additional page already.
As an “added value” to my extended client base, I would be happy to provide a copy of this SoP page upon request. Of course the best way to be kept up to date is to be a regular monthly retainer client. And, you receive two added bonuses: a lower hourly rate and the use of my Vitamin Lawyer Oversight Seal. Drop me an email if you’d like more details.
See also [includes outline of SoP]: 07/05/06See also [Crisis SoP]: 11/16/06
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2. Some more good SEO advice from Entire Web -
"Entireweb Newsletter - October 24, 2006 - ISSUE #277
Top Ten SEO Factors

These are what I believe to be the top 10 most important things (not necessarily in order) that you need, in order to get your website found in the search engines.

There are many other factors as well, but if you follow these guidelines, you'll stand a much better chance, and you'll be off to a good start.

1. Title Meta Tags

The title tag is what displays as the headline in the SERPs (Search Engine Results Pages). It's also what displays in the top blue band of Internet Explorer when your site is displayed
Your title tag of your website should be easy to read and designed to bring in traffic. By that, I mean that your main keyword phrase should be used toward the beginning of the tag. True there are websites being found now that do not use the phrase in the title, but the vast majority still do as of this writing.
Don't make the mistake of putting your company name first, unless you are already a household name, like Nascar or HBO. People are likely searching for what you have to offer, not your name.
Your title tag should be written with a capital letter starting the tag, and followed by all lowercase letters, unless you're using proper nouns. Some people prefer to capitalize every word, too.

2. Description Meta Tag

The description tag is the paragraph that people will see when your page comes up in the search results.
Your description tag should be captivating and designed to attract business. It should be easy to read, and compel the reader to act right now and follow your link. Without a description tag, search engines will frequently display the first text on your page. Is yours appropriate as a description of the page?
A proper description tag is what people will see below your title. You should make proper use of punctuation, and with readability, use your subject and geographical references.

3. Keywords Meta Tag

The importance of Meta keyword tags fluctuates from month to month among different search engines. There is a debate in the SEO community as to whether or not they help at all on certain search engines. In fact, in the summer of 2004 it appeared as if they were losing importance altogether.
However, you'll NEVER be penalized on any search engines for using relevant targeted keywords in moderation, and they can only help you with most, especially Yahoo.
Avoid stuffing your keyword metatags with too many keywords. Just use relevant tags that apply directly to the content of that particular page, and don't overdo it.

4. Alt Tags

The small yellow box that comes up when your mouse cursor is placed over an image is called the ALT tag. Every relevant image should have an alt tag with your key words or phrases mentioned in the tag.
A proper ALT tag goes after the file name, and before the Align indicator. * - The ALT tag is no longer being considered for ranking purposes by some search engines. That said, it still cannot HURT you, and will still help you with some engines. My recommendation is to continue to use them, but be sure to avoid keyword stuffing. Besides, who knows when the pendulum will swing back the other way?

5. Header Tags

The text of each page is given more weight by the search engines if you make use of header tags and then use descriptive body text below those headers. Bullet points work well too. It is not enough to merely BOLD or enlarge your text headlines.

6. Link Text

Search engine spiders cannot follow image links. In addition to having image links or buttons on your web pages, you should have text links at the bottom or elsewhere. The text that the user sees when looking at the link is called the link text. A link that displays products does not carry as much weight to the search engines as a link called oregon widgets. Link text is very important, and is actually one of the most frequently overlooked aspects of web design that I've seen.

7. Site Map

Using a site map not only makes it easy for your users to see the entire structure of your website, but it also makes it easier for the search engines to spider your site. When the search engine spiders come to visit, they will follow all of the text links from your main index page. If one of those links is to a site map, then the spiders will go right to the sitemap, and consequently visit every page you have text linked to from that site map. On the site map page, try to have a sentence or two describing each page, and not just a page of links.

8. Relevant Inbound Links

By relevant, I mean similar industry or subject related sites. Right now, no single strategy can get your site ranked higher faster than being linked to by dozens of other relevant websites. It used to be that the quantity of incoming links mattered most, but today, it's much better to have three highly relevant links to you from other popular related websites than 30 links from unrelated low ranked sites. If there are other businesses in your industry that you can trade links with, it will help your site enormously. Link to others, and have them link to you. It's proven, and it works. To see who's linking to you, in Google type the following... links:

9. Your Content

Not to be forgotten of course, is the actual content of your webpage. It must be relevant helpful information that people want to read. These days, each webpage should be laser focused on one specific product or subject, in order to rank highly for that search phrase. The days of writing one webpage to appeal to dozens of search terms are long gone. Ideally, each page should have between 400 to 650 words on it. Too few, and the search engines won't consider it to be relevant enough. Too many words and the search engine spiders may have a hard time determining the actual subject or focus of the page.

Use your keywords or phrases often, and use them at the beginning of your paragraphs wherever possible. Don't overuse them and make the page sound phony, but don't write a page about a certain subject, and not mention that subject repeatedly either. Reading it out loud to yourself is a great way to judge how natural your text sounds.

Concentrate on writing quality pages that actually appeal to the human reader. Write pages that provide the reader with exactly what they are looking for; that is, information about the exact search phrase they've entered.

10. Avoid Cheating

With all of these tidbits of information, it's tempting to think that you can stuff 100 keywords into your title, or create a page with the phrase oregon widget company being used 100 times in headers, text links, ALT tags, bullet points etc. but that cannot help you. In fact, it can penalize you, and get your website banned from certain search engines.
About the Author: Scott Hendison is an internet consultant that specializes in search engine optimization and internet marketing. He has written over 100 articles that are available on his website. He has also developed a tutorial area for beginning search engine optimization, at 'SEO101'."
That’s all for now – I hope you find this information useful!

Here’s what I cover in this memo:
1. Vitamin Lawyer Free Online Seminar: Over the years I’ve written many briefs and white papers about dietary supplement regulation and about alternative health care practices. I’ve posted these on an index page that you can find at:
Here are some of the titles:
Alternative Practices and the AMA Code of Ethics
The Practice of Alternatives is not the Practice of Medicine
Mum Marketing -- Niches on the Internet

The Right of the Public to the Truth - Current Vitamin Marketing Rules

The Herbalists' Charter -- Ancient Rights for Modern Practitioners
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2. Here’s some insider information on the Codex Alimentarius (World Food Code) issue and the future of international regulation of the Dietary Supplement marketplace.
“Codex is a winnable battle. It takes awareness, motivation, hope and tools to win. And it takes people. You know that we don't have the major media fighting to be first in line to tell the story of Codex and the industrialization/pollution of our food supply. They are not itching to let everyone in America know that despite the fact that nutrients are safe and effective, to say nothing of inexpensive, they make most drugs unnecessary…” Dr. Rima Laibow.
See exciting excerpts from Dr. Laibow’s hard-hitting DVD, Nutricide, now posted at:
The Codex Nutritional Foods Committee (CCNFSDU) is meeting in Thailand at the end of this month, and for the first time ever, the organization’s autocratic chair will be held by someone who is more favorable to nutrients than the current leadership. This same meeting is required to consider the WHO/FAO Global Strategy on Diet, Physical Activity and Health, having before it the 11 pro-health principles offered by South Africa. You can see a media release regarding these at:
It is important to SUPPORT the Natural Solutions Foundation, who helped develop the 11 Point Program, and thereby ensure that Foundation representatives can get to Thailand for what will be a very important meeting that will effect the way Vitamin Companies in the U.S. do business, not just globally, but domestically as well. It is expensive for NGO (Non-Governmental Organization) groups like NSF to fund such efforts, since they must rely entirely on private donations, unlike the bureaucrats and pharma cartel lobbyists who have plenty of money!
Check the video to learn why. Then donate, as though your Health Freedom depended on it, which, in my humble opinion, it does:
Thank you!
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… J
Here are the items I am covering in this e-memo:
1. Registration of Food Processing Facilities
Says FDA – “Domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register their facility with the FDA.” Among the foods included are that class of foods known as Dietary Supplements. See:
“Who must register? Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register the facility with the FDA.” The web page states that this requirement applies to Dietary Supplements.
There are three simple steps on the web site to register:
“1. Verify that your computer system meets the minimum system requirements.
2. Create an Account for the online FDA Industry Systems.
3. Register or Update a Food Facility.”
If you do not do your own manufacturing, processing, packaging or holding, the company you contract with for those services needs to be registered. You should ask for that company’s registration information.
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2. Nano Technology
Here are excerpts from a recent online report; note how innuendo and distortion are used to equate dangerous drugs that kill hundreds of thousands each year with generally safe food products [my comments in brackets]:
FDA not ‘nano-ready’, says report
By Clarisse Douaud
10/5/2006 - A former FDA deputy commissioner for policy has denounced the agency's capacity to properly regulate nanotechnology products including supplements, a criticism that could inflame debate leading up to the agency’s first major public meeting on the atomic technology.
In a report commissioned by the Woodrow Wilson Center's project on emerging nanotechnologies, University of Maryland School of Medicine professor Michael Taylor concluded the US Food & Drug Administration's resource base is severely eroded. This is despite what appears to be a recent nanotechnology policy kick-start at the FDA.
The report reveals regulatory weaknesses affecting new products, such as certain dietary supplements and cosmetics, using the technology. Critics say questions over nanotechnology safety have not been answered and the FDA is not in a position to effectively police it. . . .
Nanotechnology is the ability to control things at an atomic and molecular scale of between one and 100 nanometers and has been met with enthusiasm across a variety of industries. Critics highlight the murky area of how nanoparticles affect toxicity and say nanoparticles should be treated as new, potentially harmful materials and tested for safety accordingly.
[A word to the wise: Foods (which is what Dietary Supplements are, after all) are NOT TOXIC chemicals, like pharmaceutical drugs are, and there is no evidence that nano-sized particles of those same Foods are any different. After all, the body breaks the nutrients down to molecular particles in order to use them. The above statement by the “expert” follows the political line laid down by new world order entities such as Codex, the World Food Code control organization.] …
Unlike pharmaceuticals, which must go through a series of pre-market approvals, finished dietary supplements need no pre-market approval. Under the Dietary Supplement Health and Education Act (DSHEA), which is part of the Food and Cosmetics Act, only ingredients not marketed in the US before October 1994 must be approved by FDA before use in consumer products.
Thus, as it stands, pre-market regulation of nanotechnology in dietary supplements does not fall under FDA's regulatory umbrella, nor – according to Taylor – can fit into the agency's budget. . . .
"Business and health leaders alike should join in ensuring that FDA has the scientific tools and knowledge it needs to say 'yes' to safe and effective new products," said Taylor.
[Note: the “safe and effective” standard is the Drug standard. By law and court decision, Dietary Supplement Foods need only be safe when used as directed. The government does not evaluate the efficacy of Foods, only consumers on the open market can do so.]
The market stands to benefit from nanotechnology and therefore, stands to lose a lot according to Taylor, if it is not thoroughly regulated.
[The above statement is only possible from a former government employee who has never heard about the self-regulating abilities of the marketplace and has purposely remained ignorant of the disasters of government regulation, which have led to millions of unnecessary deaths.] …
FDA's nanotechnology public meeting will take place October 10, 2006 in Bethesda, Maryland. …
“FDA is interested in learning about the kinds of new nanotechnology material products under development in the areas of foods (including dietary supplements), food and color additives, animal feeds, cosmetics, drugs and biologics, and medical devices…” states an online FDA notice for the upcoming meeting. ...
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3. VLUeM Archives now online!
I’ve provided update memoranda to my regular clients for several years. I’ve now begun to create an Online Archives of the memos, working backward. So you can find everything you ever wanted to know about regulating the vitamin industry… sort of. See the Index at: I would appreciate any feedback.

The FDA issued the following press release last week:
"At the request of ...(FDA), on September 5, 2006, U.S. Marshals seized quantities of Ellagimax capsules, Coral Max capsules, Coral Max without Iron capsules, and Advanced Arthritis Support capsules... valued at approximately $55,000.00."
[Note the following claim that the NEW drug and misbranding provisions apply to dietary supplements as well as to drugs, when the DS is being promoted, in FDA's opinion, as a "drug."]
"The products are alleged to be in violation of the new drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act."
"Although these products are labeled as "dietary supplements," they are being promoted with claims typically associated with drug products. These claims are evident in the products' labeling, including various promotional literature, an audio cassette tape, and two Internet Web sites owned and used by the firm. ..."
"[Company's] labeling promotes and markets these products for serious disease conditions, including but not limited to cancer, arthritis, fibromyalgia and seizures."
[And now, what to expect.]
"Following an investigation of the firm's marketing practices, FDA advised Advantage Nutraceuticals that the claims related to prevention or treatment of diseases in many of its products' labeling make these products subject to regulation as drugs. Despite FDA's warnings, the firm failed to take sufficient steps to come into compliance with the Act. During subsequent inspections, FDA inspectors found that the offending claims were still being made."
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Note that "sufficient steps to come into compliance..." was the issue. This case appears to be another example of "guilty until proven innocent" in that no independent third party determined that the steps the company took were "sufficient." The companies that will survive in what is becoming a much stricter regulatory climate are those that are ready to react quickly. Oh, and if you are one of those companies trying to take "sufficient steps," not keeping a large inventory in your main plant is probably a good idea too.
You need to pay attention to your site claims on a continuing basis, and that is what the Vitamin Lawyer Oversight Seal program is all about. See: for details.


For those of you who are new to the VLUM, 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…R

Here are the items I am covering in this e-memo:

1. Adverse Event Reporting – the latest on the bill to grant the FDA new powers to control Vitamins.
2. Ephedra re-banned!
3. The Vitamin Lawyer Oversight Seal and Quality Control (QC) Practices.


Is "AER" coming to the Dietary Supplement world? The Dietary Supplement and Non-Prescription Drug Consumer Protection Bill, S.3546 was introduced on June 21st and was put on the Legislative Calendar on September 5th. It is expected to be voted on before the election this November.
Says FDA News: “The Senate is planning to vote on one drug safety bill this week and another before the end of the month, a spokesman for Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Mike Enzi (R-Wyo.) said. First up will be "The Dietary Supplement and Nonprescription Drug Consumer Protection Act," which would amend the Federal Food, Drug, and Cosmetic Act (FDCA) to require OTC and dietary supplement companies to provide notice of serious adverse events to the FDA. The bill… is expected to go to the Senate floor this week..” Some suggest that AER will be bad for the industry and I understand their concerns: nutrients are foods and should not be subjected to “drug-like” controls. But consider, if AER rules had been in place a decade ago, would Tryptophan have been banned because one manufacturer made one bad batch? Would Ephedra have been banned if a reporting system had been in place to show the actual safety of that herb, when used as directed? You can get more information at:
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An appeals court has just overturned Judge Campbells’ well-reasoned decision from April 2005, that “…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...” This appeal court action is being appealed further to the US Supreme Court that will thereby have an opportunity to confirm that Nutrients are Foods, not Drugs!


An important part of the developing “Current Good Manufacturing Practices” (cGMPs) in the vitamin industry is Quality Control. The Vitamin Lawyer has developed format Operations Manual sections for QC that tracks FDA requirements and the probable requirements of the AER bill. One of the keys to meeting the new requirements will be standardized QC controls – in a manual format for the FDA to review if (and when) they come to your plant for a surprise inspection. Please contact me if you need help with your Operations Manual.

One way to assure your customers quality claims is to qualify for and post the Vitamin Lawyer Oversight Seal -- the seal is proudly displayed on web sites that meet exacting standards for claim language and disclaimer usage. See for a sample of the Seal. The Vitamin Lawyer’s monthly retainer clients not only have the privilege of using the Oversight Seal, but also receive discounted rates for services. Let me know if you are interested.

That’s all for now. Have a great autumn!

This Vitamin Lawyer Update is addressed primarily to the Dietary Supplement formulators and marketers on my eList.
1. FDA Inspection - What to expect from an FDA site inspection
2. Codex Meeting in Geneva - Latest internationalist regulations
3. SoP- Operations Manual - Why a good SoP Manual helps with QC requirements.
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1. FDA inspections
According to the respected vitamin industry publication FDA News, "The FDA conducted more than 19,000 inspections, issued more than 6,000 Form 483s and sent out 535 warning letters in fiscal 2005 alone. With an estimated $22 million in new user fees in 2007, the FDA plans to fund increased reinspections and follow-up work."
While most of these inspections are in the other areas FDA regulates: drugs, cosmetics, OTCs and devices, the number of inspections are increasing in the Vitamin industry as well.
So, how do you prepare for a possible inspection?
Primarily by having your physical location clean and orderly while making sure your paper work is in order.
This is what FDA will look for:
1. Quality Control to assure that every product is tested upon receipt from manufacturer
2. Complaint procedures to ensure that all adverse reactions are identified
3. Training programs for customer service and sales people
4. Disclaimers must be located at the site of the claim
5. New dietary ingredient, structure and function and health claim filings
6. Copies of labels and ads will be required to be provided.
Of the above, the most important are probably:
1. Copies of your Structure and Function Notices to the FDA (this notice is required within 30 days of whenever you make or change a claim made about a dietary ingredient). Up 'til now, FDA has not had the resources to police the S&F Notice requirement so few marketers file them; I recommend that marketers do prepare and file these notices for at least their most important products. Of course, The Vitamin Lawyer has proper formats for the notice; estimate: about 1 hour legal time to do a notice properly.
2. Copies of your labels and ads.
3. Operations Manual – including QC, complaint (adverse reaction) and staff training information; a standard Employee Manual and the Rules for your online affiliation program could be part of this too. The Vitamin Lawyer has the proper formats available for much of this.
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2. Codex Meeting in Geneva
The Codex Commission is meeting this week in Geneva. The international organization appears to be increasingly chaotic as various nations try to assert their interests against the globalizing interests of the US and EU.
From the standpoint of the US Dietary Supplement industry, the most important development thus far at the meeting was an admission by the Codex Secretary that, in the proposals before the Commission, “No sentence provides that Codex standards and related guidelines are mandatory…” This admission, in keeping with the provision in the Codex Statute that its guidelines are “advisory” means the US supplement industry can continue to develop regardless of international regulations – so long as Congress does not adopt those restrictive international norms, or permit the FDA to “backdoor” those restrictions under the guise of “harmonization.”
For an up-to-date report on one observer’s view of what is happening in Geneva, see:
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3. SoPs Manual - Standard Operating Procedures
The summer time tends to be a little less hectic than other times of the years, so this might be the best time for you to engage the Vitamin Lawyer in preparing your Operation Manual so you can be ready in the event of a surprise FDA visit. Good Quality Control (QC) procedures necessitate the existence of an Operations Manual. My simple format for small supplement purveyors includes the following sections.
A. Refund, Delivery & Returns Policies
B. Standard Disclaimers; Site Use Statement
C. Standard Testimonial Waiver
D. Email Privacy Policy
E. Document Retention Policy
F. Quality Control Procedures
- Standards, Complaints and Policy Coordination
G. Order Processing Procedure
H. Bookkeeping and Account Management
I. Order Record Keeping and Retrieval; AER Reporting
J. Emergency Planning and Crisis Management
[added 11/16/06]
Contact me at if you want a customized OPs Manual; please put "Op Manual" in the subject line.
[03/16/07 update: For an outline of the VL standard SoP and Employee Manual, see:]
Well, that’s all for now.
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This memo is going out to the Vitamin Lawyer eList. If you do not want to receive occasional information from me, please let me know. The purpose of the Vitamin Lawyer Update Memo is to keep my client base and others involved in the nutritional and complementary markets up-to-date on developments.
1. SEO - Search Engine Optimization - Since many recipients are Internet marketers, I often provide information about optimizing search engine ranking. At the end of this email is a copy of a recent piece from Entire Web that I think you will find interesting. Link to Article.
2. The FTC is getting more active in the vitamin world - "Lee Peeler, Deputy Director of the FTC’s Bureau of Consumer Protection, said [in Congressional testimony], “Although many supplements offer the potential for real health benefits to consumers, unproven products and inaccurate information can pose a threat to the health and well-being of consumers and cause economic injury.”
“The Commission has focused its enforcement priorities on national advertising claims for products with unproven benefits; products promoted to treat or cure serious diseases; products that may present significant safety concerns to consumers; and products that are deceptively marketed to or for children and adolescents,” the testimony stated. The FTC has filed fourteen complaints in the past year against companies making allegedly unsubstantiated or false advertising claims for dietary supplements and other natural healthcare products, including oral sprays, creams, and patches. Also, in the past year, the Commission obtained orders against forty companies and forty-four individuals, which prohibited the unlawful practices and required the defendants to pay a total of $35.5 million in consumer redress, disgorgement, and civil penalties."
Please read the above , again, carefully… “a word to the wise…”
3. Health Freedom – Here’s a link to the Citizen’s Petition pending before the FDA on certain health freedom issues.
4. Note to clients: If you haven't had your web Site Use Statement (Disclaimer / Disclosure / Privacy statements) reviewed in over a year, you should consider having it reviewed. I've added several paragraphs to my standard SUS format to cover recent changes in the law, including the recent Food Allergens Notification law and some even more esoteric developments. I charge 1/2 hour to update your SUS.
Ralph Fucetola JD
There are 2 different types of search engine optimization, on-page and off page. Here you'll learn the differences between them, and basic tips to getting your website optimized for the search engines.
What Is The Difference Between On-Page And Off-Page Search Engine Optimization
The difference is that on-page optimization involves changing elements of your actual webpages that most visitors to your site wont even notice. For example, having your keywords in specific places or writing the title a certain way. Basically it's tweaking all elements of a page which are a factor for ranking well in the search engines.
Where as off-page optimization , is partially out of your control. You do have some control over it, but it's largely dependant on what others think about your website, unless you take an active role in off-page optimization. Off page optimization is quite a large topic, so I'll talk about it in a separate article.
Basic On-Page Elements You Need To Tweak:
For starters , you need to give your pages a title between the <> - < /title > tags in the head section of the page. Make it a descriptive title with at least 1 keyword. 4 words maximum is usually enough. Please don't leave the title as "untitled", and don't set it to "home" or "Page 1" or anything like that. Doing so won't help your search engine rankings one bit.
Next you need to write a description using the description meta tag i.e. < name= "Description" content= "yourdescriptionhere">. This should go in the head part of the html, after the <>
Now You need to use the keyword meta tag . Just as a side note, most search engines don't often use meta tags anymore, but it certainly wont hurt your rankings. Here's what the keyword meta tag looks like, < name= "Keywords" content= "your,keywords,here">. Include each keyword / keyphrase once. Do not repeat your keywords over and over in the keywords tag, once each is fine.
Ok now we need to change elements of the page than people will actually see. The stuff you just typed in will only be readable by search engine spiders when they crawl your pages, apart from the title of your page of course.
First you need to have a header in a "tag." It doesn't look particularly pretty, but it's effective. It lets the search engine spider know, that the piece of test in the tag is important. Now you need to write a header in the that contains your keywords. It's pretty similar to just having the page title on the actual page. Doesn't need to be long, just a few descriptive words about what the following page is about.

This next one is the part I'm going to have to leave in your hands. If you haven't got any content on the page, then you need to write it. Try to include the keywords about 3 times in the top third of the page. Only put them where it will read correctly. For example don't put them all in one sentence because it will sound silly. Try to make your content an absolute minimum of about 400-500 words.

Do you have images on your webpage ? Then you need to give them "alt" tags. These are just incase a user cannot display or chooses to not display images for whatever reason. Instead, they will see whatever you place into your alt tag. Only put in your keyword as part of the alt tag if it is relevant. The alt tag should be descriptive to the image.

Make the above changes to your webpages and you should see a nice rise in your search engine ranks when they next index your site. It will definately pay off in the end. Best of luck!

About the Author: Stephen Warren is the creator of There you'll learn how to make a great site and turn it into a money making machine in no time. Your free to publish this article on any website, providing it is unedited and complete.

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On January 5th the US president signed another complex and confusing law that has a serious threat to Internet communications buried in it.
The law is The Violence Against Women and Justice Department Reorganization Act, and the relevant section is 113. It states:
"Whoever...utilizes any device or software that can be used to originate telecommunications or other types of communications that are transmitted, in whole or in part, by the Internet... without disclosing his identity and with intent to annoy, abuse, threaten, or harass any person...who receives the communications...shall be fined under title 18 or imprisoned not more than two years, or both."
It is my opinion that this restriction will most likely not stand up against constitutional scrutiny. There is law backing anonymous political statements, reviewed by Justice Thomas in '95 -
"After reviewing the weight of the historical evidence, it seems that the Framers understood the First Amendment to protect an author's right to express his thoughts on political candidates or issues in an anonymous fashion."
I'm sending this alert out so that people are aware of this new law and can more carefully express themselves. For example, if you were to post an anonymous comment about, say, some company CEO, you might want to include some sort of disclaimer, such as "This statement is being made to express my opinions and understanding of the truth in the matter; it is not intended to annoy, abuse, threaten, or harass any person."
I still don't understand why Congress doesn't get it -- the First Amendment states explicitly "Congress shall make no law..." abridging freedom of speech -- "no law" means just that: NO LAW.
Here is a cogent comment I received from a knowledgeable source:
“It turns out that the statute can only be used when prohibiting the speech would not violate the First Amendment. If speech is protected by the First Amendment, the statute is unconstitutional as applied and the indictment must be dismissed. An example of this is United States v. Popa, 187 F.3d 672 (D.C. Cir. 1999). In Popa, the defendant called the U.S. Attorney for D.C on the telephone several times, and each time would hurl insults at the U.S. Attorney without identifying himself. He was charged under 47 U.S.C. 223(a)(1)(C), and raised a First Amendment defense. Writing for a unanimous panel, Judge Ginsburg reversed the conviction: punishing the speech violated the Supreme Court's First Amendment test in United States v. O'Brien, 391 U.S. 367 (1968), he reasoned, such that the statute was unconstitutional as applied to those facts.”
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This is your periodic Vitamin Lawyer update memo, provided to my client base and others interested in dietary supplement matters. If you don't want to receive such occasional messages, please reply to this email with "remove" in the subject line.
This issue covers:
Happy new year!!
Ralph Fucetola JD
1. FDA Allergy Label Rule
The Food Allergen Consumer Protection Act went into effect 01/01/06. The Act is at:
On 12/14/05 a Guidance was published at:
The new law requires disclosure on the label of any ingredient including a major food allergen: "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"
There is no exemption for dietary supplements.
2. PR Web MEDIA RELEASE: Credit Card Processors Compliance Letters
January 9, 2006
On-line Lawyer Reports Internet Merchants May
Now Need Credit Card Website Compliance Letter
Newton, NJ: Ralph Fucetola, J.D., confirms reports that major credit card companies have recently demanded its dietary supplement and online pharmacy merchants obtain regulatory compliance letters from an attorney expert in the field.
Over the past two weeks, Counsel Fucetola has learned from certain clients who prefer to remain anonymous that MasterCard has been contacting merchant services and vendors with on line pharmacies and nutritional websites. The credit card company now appears to require merchants to provide a form letter from a qualified attorney stating that their websites comply with all government rules and regulations. Additionally, they must acknowledge an attorney will review the site annually to assure continued compliance.
Ralph Fucetola, a.k.a. as The Vitamin Lawyer ( has been retained by a number of merchants to review specific websites and provide the required documentation. As an attorney of 34 years, he has been reviewing web content for regulatory compliance for over a decade. He is available to consult on a retainer basis; rates are reasonable and due to Internet accessibility, clients can expect a timely response. Please contact him at
For general FDA compliance, the Vitamin Lawyer ( offers a service that allows the site to display the Vitamin Lawyer Oversight Compliance Seal.
3. Biography: Ralph Fucetola JD received a B.A. with Distinction from Rutgers University, 1967 and a Juris Doctor (Doctorate in Law) from Rutgers Law School, 1971. He practiced law for 34 years, specializing in Nutrient and Alternative Health Law. Counsel Fucetola has been widely recognized as a leading attorney in the field, receiving numerous awards, including a Citation of Merit from the National Health Federation ( in 1979 and a Meritorious Service Award (from the institute for Health Research, for his role in the 1995 DHEA Cases on behalf of the Life Extension Foundation. Counsel Fucetola limits his consultancy to claims, advertising and label review, asset protection, and consulting with marketers, consumers, advocates and local attorneys regarding Health Care Freedom issues, petitions and litigation.
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Happy Halloween! First the Trick, then the Treat . . .
Did you know that the number of FDA warning letters has increased over 300% during the past year? The FDA’s ad bureau indicates it intends to take whatever action is necessary to stop “misleading” advertisements. Even if you do not sell directly to the public, your website claims and exhibit booth signs at trade shows can be Red Flags. In addition to the language you use, your images, colors or even font variations could lead to citations for violations! In the increased regulatory climate spurred by recent developments in international trade regulations, all companies need to review their claims and revise the language they use to be even more carefully considered.
And the Treat . . .
While there is controversy in the nutrient world at present, there is also hope. The series international meetings and decisions that have occurred since April of this year, moving international regulation into new areas, will continue to impact the industry in the coming months (there’s a UN Food Safety Agency meeting soon). In July Codex, the World Food Code, adopted what could turn out to be more restrictive regulations (the Vitamin and Mineral Guideline - what do international “upper limits” for foods/nutrients have to do with promoting international trade?).
However, there is some hope that saner approaches may yet prevail. Some observers see that hope in comments made at the same Codex meeting in July that adopted the VMG, by representatives of Codex’s UN parent, WHO/FAO, demanding that the agency take into consideration the value of nutrition in health. Others see a real potential for the parent organizations to enforce their views, thereby limiting the impact of the new restrictions. A 2002 Joint WHO/FAO Report chastised Codex for a number of failings and WHO/FAO have adopted policies favoring nutrition for health, something that does not yet appear on the Codex agenda. That Report is at:
How can your company insure that Codex VMG restrictions will not adversely affect you? One step I’ve been involved in is helping to prepare an alternative VMG (a pro-freedom version of the Codex regulations adopted in July) that actually promotes dietary supplementation and does not subject vitamins and minerals to “toxic risk analysis” as though they were dangerous medications or industrial chemicals, instead of food! Since Codex Guidelines, according to the Codex Statute, are only "advisory" (Codex General Principle 1), countries can adopt the alternative VMG instead and remain WTO compliant.
The alternative VMG could very well be adopted by a number of countries that are unhappy with Codex restrictions on traditional nutritional approaches (especially countries that cannot afford getting “addicted” to the pharma cartel’s toxic drugs). My take on this is that small to mid-sized companies will continue to find international and domestic US markets in high potency nutrition. Our vigilance is necessary, though, since international trade agreements (such as CAFTA) typically include language subjecting their provisions to Codex standards.
The revised VMG has now been posted on the internet, at: - you can also go to the Health Freedom site - - and sign a petition supporting the revised VMG. This revision was presented to the FDA, at a public hearing, on October 18th. I am told that it came as a surprise to some of the attendees. That’s good.
I think some people in the vitamin field will be very surprised to see that a positive approach of engaging the international bureaucracy could result in real advances toward greater freedom of choice, worldwide. While some may feel more comfortable “taking to the streets,” I am convinced that our best chances now rest with a policy of engaging the international bureaucracy so freedom of choice views get noticed and accommodated.
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Happy new year! It’s time for your annual Nutrient Claims check-up!
The FDA continues to increase enforcement of its regulation of Dietary Supplements. In a recent Warning Letter to one vitamin company, for example, it found that the following statements were “drug claims:” "Nature’s answer to prescription medication" and "Nature’s alternative to prescription medication." The FDA also cited phrases such as, “seems effective in . . . reducing depression . . . ." In another recent warning letter, the FDA complained against the phrase, “the number one remedy against obesity.”
In yet another warning letter, Neutraceutica was told that its claim, “possibility of cancer and other diseases may be eliminated in the first days of the use” was an unproven drug claim. This is one time when I find myself agreeing with the FDA.
Staying up to date with changes in the law is also important. For example, a little known clause in the Farm Security and Rural Investment Act amended the Food and Drug Act to provide that the term “ginseng” can be used only for derivatives of the genus Panax, not the genus Eleutherococcus (though both are commonly known as “ginseng”).
What changes have you made in your web site during the past year that may put you at risk? If you have added new claims, have you notified the FDA of the new structure and function claims?
Now’s the time (while I’m snowed in here in the hills of Sussex NJ) for us to catch up on these necessary aspects of your legal needs. Please give me a call at 973-300-1519 so we can discuss your needs. These issues can be critical – and expensive -- for your company, if not addressed in a timely manner. That’s why I’ve sent you this email to remind you it is time for your annual FDA/FTC compliance check-up.
Ralph Fucetola JD
PS – if you need help in creatively constructing structure and function claims, let me know. In the first example above, “the number one remedy against obesity” the company could have stated, “a leading supplement to support normal weight…” As always, clients on regular retainers are guaranteed no increase in fee rates and may qualify for the Vitamin Lawyer Oversight Seal (see for details).
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2006 UPDATE: The Vitamin Lawyer has a model Op Manual format for you! See: #07/05/06-3
For OTC and pharmaceutical companies, the Number One violation citation in FDA review letters is Failure to Establish or Implement SoPs.
As cGMPs (Current Good Manufacturing Practices) are imposed on the Vitamin Industry, similar concerns will become important to you.
One important step in getting ready for GMPs is to begin to document your procedures. Get a loose leaf note book and start to include the steps you need to take to meet cGMPs. Include at least the following areas:
1. SoPs - Some of the elements to consider in developing your SoPs -
Information gathering procedures
Laying the framework — components, types and formats
Who's responsible for writing, reviewing, approving, distributing and maintaining your company's SoP
How detailed should they be?
How frequently should they be reviewed and updated?
Steps for auditing your procedures
How to manage changes and updates
How to motivate staff to follow them
2. Adverse Event Reporting & Consumer Complaint Records
3. Packing and shipping procedures & records
4. Risk Managment Policy
5. Document Retention Policy
6. Banking Procedures
7. URL maintenance and management
Eventually, you will need to develop an Operations Manual encompassing the above and other issues. As a small business owner, you should be able to feel confident that you can absent yourself from the business and the normal business procedures will be sufficiently documented that others can carry on while you are... on vacation... learning new things... whatever!
2006 UPDATE: The Vitamin Lawyer has a model Op Manual format for you! See: #07/05/06-3See also [Crisis SoP]: 11/16/06
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