Thursday, April 26, 2007

04/26/07 - SUS Page Updates


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

1. Dietary Supplement SUS page update:

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

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

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

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


2. Vitamin Lawyer on Internet Radio this Friday

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

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

Friday, April 20, 2007

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


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

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

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 to make your comments.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Saturday, April 7, 2007

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

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

1. MLM Marketing

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

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

And what it says about "Pyramid Schemes" -

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

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

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


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


3. SoP Outline Web Page

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


4. AHPA on AERs

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

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

More on AER services:


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

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

Guidance at:

You can submit your comments through Natural Solutions Foundation at:

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

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