10/26/07 - EU Regs; CAM; GMPs

... VLUeM – 10.26.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update, Factoid & Client Notice
2. EU – taking over world food regulations?
3. CAM & Natural Products… perfect together…
4. Public support for CAM reimbursement
5. Fighting over GMP requirements
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1. Vitamin Lawyer Health Freedom Blog –
New Posting - http://vitaminlawyerhealthfreedom.blogspot.com/

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

Notice: Due to the continuing decline of the Dollar and increased costs, The Vitamin Lawyer Consultancy hourly rate has increased.

To get on to the Global Health Freedom eblast list, please go to: http://www.globalhealthfreedom.org
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2. EU – taking over world food regulations?

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

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

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

www.newmediaexplorer.org/sepp/2007/10/15/codex_alimentarius_will_eu_laws_become_world_standard.htm

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

nutraingredients.com/news/ng.asp?n=80871&m=1NIEO25&c=jegwylrviswtnqa
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3. CAM and Natural Products… perfect together…

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

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

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

theintegratorblog.com/site/index.php?option=com_content&task=view&id=368&Itemid=189
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4. Public support for CAM reimbursement

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

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

theintegratorblog.com/site/index.php?option=com_content&task=view&id=365&Itemid=189
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5. Fighting over GMP requirements

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

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

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

nutraingredients-usa.com/news/ng.asp?n=80939&m=1NIUO26&c=jegwylrviswtnqa

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

04.20.07 - VITAMIN LAWYER UPDATE e-MEMO

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

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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!”