04/26/07 - SUS Page Updates

04.26.07 - VITAMIN LAWYER UPDATE e-MEMO

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

1. Dietary Supplement SUS page update: www.VitaminIndustryCompliance.com

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: www.siteusestatement.com – if your web site needs a proper SUS, please email me with “SUS” in the subject line.

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

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 - www.prncomm.net - 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!

04/20/07 - Affiliate Programs, update on FDA anti-CAM guidance

04.20.07 - VITAMIN LAWYER UPDATE e-MEMO

--------------------------------------------------------
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.

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.

--------------------------------------------------------

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 http://tinyurl.com/2u7ghc 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 http://www.healthfreedomusa.org 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!”

04/07/07 - MLMs, AERs, SoPs, FDA on CAMs

04.07.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
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:

http://www.nutraingredients.com/news/ng.asp?n=75425&m=1NIE402&c=jegwylrviswtnqa

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 ConsumerLab.com 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 ConsumerLab.com 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 NutraIngredients-USA.com 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'decisionnews.com

---------------------------------------------------------

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: http://tinyurl.com/2eu6yj

---------------------------------------------------------

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.”

http://www.nutraingredients-usa.com/news/ng.asp?n=75506&m=1NIU404&c=jegwylrviswtnqa

More on AER services: www.aer-consultants.com

---------------------------------------------------------

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: http://www.fda.gov/ohrms/dockets/dockets/06d0480/06d0480.htm

You can submit your comments through Natural Solutions Foundation at: http://tinyurl.com/2u7ghc

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 Lawyer.com Consultancy
http://www.vitaminlawyer.com
All Rights Reserved

03/31/07 - Your FDA Compliance Notebooks, Affiliate Marketing

VLUeM – 03.31.07 - VITAMIN LAWYER UPDATE e-MEMO

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

1. Your SoP & Substantiation Notebooks & FDA Inspections

Updated here: www.VitaminIndustryCompliance.com

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 BiomagScience.com 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: http://home.earthlink.net/~lifespirit23/support-lifespirit.htm .

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.

---------------------------------------------------------

www.addme.com
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, eAffiliatez.com – 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 - http://www.titushoskins.com/ © 2007 Titus Hoskins.

---------------------------------------------------------
Well, that’s all for now.

Ralph Fucetola, JD
The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com
All Rights Reserved

03/16/07 - Making Claims, SoP Outline, Health Freedom Site attacked

03.16.07 - VITAMIN LAWYER UPDATE e-MEMO

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

1. MAKING CLAIMS & NEW DIETARY INGREDIENTS

Say your company needs a "DSHEA compliance" letter from The VitaminLawyer.com 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: http://www.fda.gov/ohrms/dockets/98fr/98n-0044_gdl0001.pdf. 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.

---------------------------------------------------------

2. RECORD KEEPING SoP AND EMPLOYEE MANUAL

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 - http://tinyurl.com/2eu6yj

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 ralph.fucetola@usa.net 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: http://tinyurl.com/2eu6yj

---------------------------------------------------------

3. HEALTH FREEDOM SITE ATTACKED ON 03/12:

The websites of the Natural Solutions Foundation - www.globalhealthfreedom.org and www.healthfreedomusa.org – 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: http://www.healthfreedomusa.org/index.php?page_id=219

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
http://www.vitaminlawyer.com

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

Also, do see Nutricide, now on YouTube at: http://video.google.com/videoplay?docid=-5266884912495233634&q=Nutricide

03/02/07 - More SoP, more attacks... Web 2.0

03.02.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
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
---------------------------------------------------------

1. RECORD KEEPING SoP AND EMP MANUAL

[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 -
http://tinyurl.com/2eu6yj    Updated: www.VitaminIndustryCompliance.com]

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 ralph.fucetola@usa.net 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: http://tinyurl.com/2eu6yj

---------------------------------------------------------
2. FLAWED ANALYSIS – OR NEW APPROACH NEEDED FOR PRODUCTS?

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.”

http://www.nutraingredients-usa.com/news/ng.asp?n=74582&m=1NIU228&c=jegwylrviswtnqa

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: http://www.sciencedaily.com/releases/2007/02/070228172604.htm -- 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.]

---------------------------------------------------------
3. WEB 2.0 FOR “NEWBIES”

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, Del.icio.us, 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, Del.icio.us, 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, Del.icio.us, 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 www.bizwaremagic.com ...”

Well, that’s all for now. Remember to check the SoP contents tables at: http://tinyurl.com/2eu6yj



Ralph Fucetola JD
http://www.vitaminlawyer.com

02/23/07 - Record Keeping SoP, attacks and opportunities

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

1. HARVARD MEDICAL SCHOOL REPORT PERPETUATES ANTI-NUTRIENT LINE

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."”

www.nutraingredients-usa.com/news/ng.asp?n=74406&m=1NIU221&c=jegwylrviswtnqa

---------------------------------------------------------

2. HEALTHCARE SPENDING TO INCREASE

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.

---------------------------------------------------------

3. RECORD KEEPING SHORT FORM SoPs

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 ralph.fucetola@usa.net 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.

www.VitaminIndustryCompliance.com

Well, that’s all for now.
Ralph Fucetola JD
http://www.vitaminlawyer.com