MORE DIETARY SUPPLEMENTS TO BE REGULATED?

SPECIAL TO FREE-MARKET NEWS NETWORK, DEC. 20, 2004 -- In the past year, two significant federal dietary supplement legislations have banned previously legal supplements. But these initiatives are just the beginning of a renewed effort to actively pursue legislation against the dietary supplement industry. In Congress right now are three bills with much more far-reaching implications than the two passed this year.

There are those who oppose this trend, arguing that individual consumers should have the right to choose among nutritional products – and to determine what they should and should not ingest. The Health Information Independence Act (HR.4004) – opposing the trend of restricting nutritional choice - calls for a “restoration of rights” for American consumers who wish to retain the availability of a wide selection of dietary supplements.

In a speech introducing this bill, Rep. Ron Paul (R-TX) – a long-time free-market advocate - said the FDA’s “grocery store censorship” violated consumers’ First Amendment rights by preventing them from taking steps to improve their own health and further noted that, “the American people have made it clear they do not want the federal government to interfere with their access to dietary supplements.”

The new spate of proposed dietary regulations may be seen as a reaction, in part, to the steroid-scandal now engulfing Major League Baseball, in which several of the nation’s most prominent players have been linked to ingesting muscle-building – and health damaging - supplements. Proponents of increased regulations maintain that further safeguards are needed to ensure the nutritional protection of the American public.

The first and most visible of these proposed laws is S.722, the Dietary Supplement Safety Act, introduced by Senator Dick Durban (D-IL). This bill carries a number of weighty initiatives apparently aimed at counteracting certain freedom-of-choice safeguards contained in the Dietary Supplement Health and Education Act of 1994 (DSHEA) while opening the door to future FDA regulation and bans.

• Requires manufacturers to submit “adverse event reports” to the FDA for all complaints received regarding their products, regardless of the circumstances surrounding the “event”.

• Gives the FDA the authority to demand a manufacturer conduct market surveillance of any given product to check for adverse experiences from use and submit their findings to the FDA.

• Requires manufacturers to gain approval before bringing to market any product defined as a stimulant.

• Would place all products associated with or marketed for “muscle growth” under the Controlled Substances Act (CSA).

• Effectively shifts the burden of proof of a product’s safety from the FDA to the manufacturer, in direct opposition to the intent and wording of the DSHEA.

• Could allow a product to be banned following the submission of just a single isolated “adverse event”.

The bill has been portrayed by Senator Durbin and his supporters as a positive law for consumers – especially those searching outside of the remedies offered by the modern medical industry, and who may not be capable of sorting through manufacturers’ claims of various nutritional benefits.

Opponents maintain that the bill will increase bureaucracy and expense for supplement manufacturers, thereby hurting the free market development of new advancements and shutting out smaller companies from the ability to compete.

The Association of American Physicians and Surgeons and The National Health Federation oppose S.722.

A second, less visible bill pending in Congress is also much stronger than S.722. The Dietary Supplement Access and Awareness Act (HR.3377), introduced by Rep. Susan A. Davis (D-CA) simply suggests drug-like regulation of any and all products not classified as either a vitamin or mineral.

According to the specific wording of HR.3377, a “supplement” under the DSHEA would be amended to say any product that “does not bear or contain an herb or other botanical, an amino acid or a dietary substance used by man to supplement the diet by increasing the total dietary intake”.

Under this bill, only basic vitamins and minerals would be left standing under the protections of the DSHEA and everything else would be reclassified and regulated as a drug.

The third bill before Congress, less obvious in its regulatory aims, seeks millions more in funding for the FDA. The DSHEA Full Implementation & Enforcement Act of 2003 (S.1538), introduced by Senators Tom Harkin (D-IA) and Orrin Hatch (R-UT), is an appeal for more than $100 million dollars spread out over several years to see to better enforcement of the DSHEA.

While the DSHEA contained significant nutritional freedom-of-choice safeguards, opponents fear that so much money flowing into the FDA earmarked to enforce DSHEA will ultimately result in a regulatory regime that will have a dampening effect on the entire supplement industry.

Senator Tom Harkins’ record is that of an avid proponent of federally-mandated consumer protection – and his new bill notes that eventually the FDA may require between $24 and $65 million dollars per year just to “enforce” the DSHEA.

The above bills are part of a larger wave of laws recently passed that aim to reduce or eliminate the availability of various nutritional supplements that are seen by opponents as potentially hazardous to health.

The first of these came this past April in the ban of the popular weight-loss herb ma huang (ephedrine). While ephedrine has been used in Asia for thousands of years, the recent, highly-popularized death of at least one top U.S. athlete – inaccurately linked to ephedrine-ingestion – helped fuel support for the bill in Congress.

Next, the Anabolic Steroid Control Act of 2004, was signed into law by President Bush last October and will become effective January 22, 2005. This bill bans all muscle-building supplements known as “prohormones”, with the exception of the mild testosterone-precursor dehydroepiandrosterone (DHEA), used typically by older males for combating the rigors of age on virility.

Prohormones drew the attention of mainstream America when it was learned that baseball home-run king Mark McGwire was using the then-popular prohormone androstenedione. Though considered safe and relatively mild ......... For the complete article visit us @ FreeMarketNews.com

Thanks for the ping! This is my main field of interest and has been all my life. I'm very worried about having my supplements "approved" by the WHO Codex Alimentarium commie fascists.

Here is an excerpt of article about supplements in Canada that I just found online. Canada seems to be moving faster than we are toward lockstep dictatorial control of the nutrition industry. We may not be far behind. You can read more at http://sumeria.net/health/hpb-codex.html

EXCERPT:
The three Nazi-connected German drug companies have stated their main purpose as being to "...create a set of international standards to guide the world's growing food industry and to protect the health of consumers." If you really believe that, I have some ocean front property for you at half price in Saskatoon. The drug company backed proposals call for the following:

1. No vitamin, mineral, herb, etc., can be sold for prophylactic (preventative) or therapeutic reasons.

2. Natural remedies can be sold as food but they must not exceed the potency (dosage) levels set by the commission. This means that consumer access to dietary supplements will be limited to the RDA dosage as a maximum limit for vitamins (vitamin C - 60 mg, vitamin E - 15 mg, etc.). Supplements without an RDA (e.g. coenzyme Q10) would be illegal to sell because they would all become drugs.

3. Codex regulations for dietary supplements would become binding, eliminating the escape clause within the General Agreement of Tariffs and Trade (GATT) that allows a nation to set its own standards. This applies to all member countries of the U.N. Any nation that does not accept and apply these new standards will be heavily fined by the World Trade Organization (WTO), creating the potential for crippling entire sectors of the nation's economy.

4. All new supplements would be banned unless they went through the Codex approval process.

Five steps have already been taken in the Codex process over the past few years. Remember Canadian Bill C-7 which was passed eventually in Canada as C-8? The similarity of the process, the secrecy, and the wording between the Codex proposals and the Canadian laws is uncanny.

Voting in favour of adopting the German proposal has been overwhelming (16 for and 2 against in the most recent vote). (WITH ONLY UK AND USA VOTING AGAINST( The Codex process is now at "Step Five" - formalization and debate concerning the specific features.

In two years, Codex could jump from step 5 to step 8 to finalize these restrictions. The Codex proposals already exist as law in Norway and Germany, where the entire health food industry has literally been taken over by the drug companies. In these countries, vitamin C above 200 mg is illegal as is vitamin E above 45 IU, Vitamin B1 over 2.4 mg and so on. Shering-Plough, the Norway pharmaceutical giant, now controls an echinacea tincture which is being sold there as an OTC drug at grossly inflated prices. The same is true of ginkgo and many other herbs. Only one government controlled pharmacy has the right to import supplements as medicines which they can sell to health food stores, convenience stores, or pharmacies.

According to Dr. Matthias Rath, researcher and author who discovered a correlation between vitamin C deficiency and heart disease, the three Nazi-linked drug companies pushing so hard for the German proposal - Hoechst, Bayer and BASF - are also manufacturers of heart drugs. Obviously, with the vitamin competition gone, nothing will stop their profits.

The Spies Among Us

"HPB is interested in receiving any information for purposes of following up on any firms that continue to sell or distribute DHEA in violation of the Food & Drug Act and Regulations".
-- D.W. Shelly, Chief, Drug & Environmental Health Inspection Division.

HPB Chief Shelly is asking you to report any of your colleagues obstinate enough to sell DHEA. This sort of unpaid spy work was a favorite tactic of totalitarian regimes like the Nazis before WW II and the Communists before the Berlin wall came down. How economical!!
About a month ago, I was asked by Alive magazine to write an article about Codex. At the time, Rhody Lake, editor of Alive was told by representatives of both the HPB and the CNHPA (Canadian Natural Health Products Association) that Codex was not a threat to public access to natural health care products.

The facts do not support this belief. While the CNHPA says that it works on behalf of the natural products industry, it appears to support the HPB's removal of products from health food store shelves.

For example, in an Oct. 9, 1996 press release, the CNHPA said, "In light of the recent crackdown by Health Canada on the sale of the hormone, melatonin, in health food stores, the Association recommends that stores cease the sale of DHEA immediately."

Is the CNHPA in collusion with the HPB? Their actions seem to indicate that. So do their words: "...the Supplement Manufacturers' Committee is in almost daily negotiations with Health Canada in the area of regulatory affairs and working, with some success, toward special recognition..." What success? The reality is that these "daily negotiations" have been a dismal failure, making public access to health products worse than at any time in the history of Canada. According to John C. Hammell, legal advocate for the U.S. based Life Extension Foundation, the Nazi-linked proposals have the backing of Canadian and French Codex commission representatives.

In June of 1996, the Codex Executive committee created an "expert panel" on herbs which was expected generate a "negative list" to prevent public access to certain herbs internationally. The formation of this "expert panel" was advocated by none other than the Canadian and Austrailian representatives.

During the October 1996 Bonn, Germany Codex discussions only the United States and the United Kingdom voted against such a list and against limiting other supplements to a maximum international RDA.

Why then are the HPB and the CNHPA denying that the Codex proposals will have any impact on the availability of nutritional supplements in Canada? Either spokespersons for these two groups are ignorant about the proposals or they are lying to the public in order to protect drug company interests. After all, several voting member companies of the CNHPA are owned by or are subsidiaries of major drug manufacturers or pharmaceutical chains.

Neither group can be trusted to give the public straight answers about the Codex scam when, in fact, they are a part of the group trying to outlaw melatonin, DHEA, Kava kava, amino acids, and several dozen herbs. Some members of the CNHPA are in a clear conflict of interest since they stand to gain financially when the supplement prices are boosted through the roof. It should be noted that the CNHPA was formerly called the Canadian Health Food Association. Did changing its name have anything to do with drug company wishes? Further evidence of Canadian involvement with Codex is the HPB position on what is or is not a food or a drug. For example, garlic, ginger, licorice, and peppermint are considered to be foods when sold as spices. If a grocery store manager makes claims for their therapeutic effects, they then become drugs via a hocus pocus mechanism which still remains to be defined. Perhaps one of the drug owned supplement firms that are members of the CNHPA can explain how this occurs.

If Codex and the HPB have their way, your favourite supplements will be replaced by expensive, patented, over-the-counter or prescription drugs. Just look what has already happened to amino acids like tryptophan. Once available for under $20 for a bottle of 100 tablets of 500 mg at your local health food store, the same tablet is now only available by prescription at a cost of over $120 by prescription.
END EXCERPT

Please ping other interested freepers. We all need to get off our respective and collective tushes and hammer on the doors of our US senators and congresscritters. My local congressional rep is a far-left liberal. And you know what? He'll go to bat for our side on this issue. Question is, what will Republicans do? Bush can't seem to give enough to the drug companies. He'd better hear from his loyal conservative constituency on this topic all day every day from now on.

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