By John C. Hammell, legislative advocate
International Advocates for Health Freedom
2411 Monroe St. Hollywood, FL 33020 USA
fax on demand 954-927-8795
fax 954-929-0507, 954-929-2905, 800-333-2553
I have just witnessed a major SCAM against the people of the United States, and need your help to blow the whistle. (The enclosed form letter makes it easy to fight back.) In an effort to harmonize with Codex, the multinational pharmaceutical industry is manipulating the Presidentially Appointed Commission on Dietary Supplement Labels (CDSL), to the detriment of the public health. It is clear that CDSL is a Trojan Horse planted inside of the Dietary Supplement Health and Education Act by Congressman Waxman in an effort to enable the FDA to regain the upper hand against the dietary supplement industry.
Unless serious changes are made when finalizing their draft report, the Commission will not have properly discharged their duties, they will have grossly exceeded their congressional mandate, and they will be handing the FDA an opportunity to engage in administrative rulemaking which threatens to gut the Dietary Supplement Health and Education Act (which millions of consumers helped to pass). In addition, by expanding the OTC drug category to include herbs and botanicals, CDSL is pushing Codex harmonization by blurring the lines between foods and drugs.
I was one of only a dozen people attending CDSL's final meeting in Reston, Virginia on August 14-15, 1997 when the largest possible number of people were on vacation (thus unable to attend), and Congress is out of session (making it much harder to get oversight).
The Commission blatantly ignored requests from over two thirds of commenters who asked for an extension on the comments period so that they could have sufficient time to procure the Commission's 77 page draft report, and to comment on it. The requests for an extension were made via a form letter that I sent out over the internet at the last minute. (Despite requesting a copy the moment it became available, the Commission didn't send me my copy of their draft report until only two weeks remained in the comments period.)
The Commission must finalize their Report by September 30th*, and we must hold their feet to the fire! (*If you don't read this before Sept.30, 1997 bear in mind that the FDA is required to issue a notice of proposed rulemaking within 90 days from the date of the Commission's report, and to complete rulemaking no later than two years from that date - (protests made after September 30 can still serve to hold their feet to the fire).
Congress handed the Commission an historic opportunity to improve consumer welfare, recognizing that health benefits attainable from dietary supplements would not be realized if consumers were unaware of those benefits from the point of sale. Congress charged the Commission with providing recommendations on how best to reform the FDA's health claims review process "to provide truthful, scientifically valid, and not misleading information to consumers so that such consumers may make informed and appropriate health care choices for themselves and their families."
The US Public Health Service implored American women of child bearing age to prevent neural tube defects by taking folic acid supplements fully two years before the FDA finally approved the claim. Should the FDA be the sole arbiters of truth? Should dietary supplement manufacturers be forced to adhere to their arbitrary dictates when making truthful label claims for their products? Won't the President and Congress please force the Commission to address the issue of harm caused by FDA's prior restraint against truthful claims? Should the Commission be allowed to exceed their statutory authority?
During the two years in which the FDA dragged their feet, 7,500 children were born with crippling birth defects such as spina bifida, an estimated 50% of which could have been prevented if their mothers had taken folic acid during pregnancy. Spina bifida causes permanent deformity, partial to full paralysis, and significantly shortens people's life spans while causing a nightmare of heartache and suffering to afflicted families, and enormous medical expenses for our society. (U.S. Public Health Service, Folic Acid and Pregnancy Data Sept. 14, 1992; see also 59 Fed Reg 433, 434 )
Fully half of the 7,500 birth defects that occurred during the 2 years that the FDA disallowed the claim on folic acid could have been prevented if consumers had had access to the information provided by the US Public Health Service on the labels of folic acid supplements. Don't consumers have a first amendment right to this sort of information?
The Commission on Dietary Supplement Labels certainly doesn't think we do, especially not Margaret Gilhooley, a law professor who used to work for the FDA where she was heavily instilled with their mind set. The same can be said of Ken Fisher, executive director of the Commission who works at Federation of American Societies of Experimental Biology, which does so much subcontracting for the FDA that they might as well be a part of the Agency.
Without making ANY attempt to examine the numerous problems caused by the FDA's prior restraint on health claims, the Commission blindly endorses "significant scientific agreement" which allows the FDA to arbitrarily block truthful claims, and makes NO EFFORT to provide an alternative to this barrier! Charged with examining this situation under DSHEA, in which dietary supplements are regulated as foods, they decide that they are providing an "alternative" for claims to be made by recommending that the OTC drug category be expanded to include herbs.
At a time when pharmaceutical companies are forming mergers with dietary supplement companies in an effort to take over the industry, are consumers interests really served when the Commission attempts (in its draft report) to expand the OTC drug category to include herbs and botanicals?
From a standpoint of emerging international law, when Congress has been ceding more and more authority via trade agreements to international regulatory bodies such as the Codex Alimentarius Commission, the Dispute Settlement Body of the World Trade Organization, and others, does it help consumers and the interests of small to mid sized vitamin companies when the Commission attempts to blur the line between food and drugs by expanding the OTC drug category to include herbs and botanicals? In comments representing the Life Extension Foundation and the National Health Federation, Suzanne Harris, JD, of the Law Loft discusses how the Commission is attempting to engage in Codex harmonization.
Citing the example of folic acid outlined above, attorney Jonathan Emord filed comments with the Commission which proposed an alternative means by which the Commission could have properly adhered to the will of Congress in order to provide consumers with sufficient health information at the point of sale via labels and labeling.
Representing 11 clients including the American Preventive Medical Assn, the National Health Federation, Julian Whitaker, MD, Durk Pearson and Sandy Shaw, Emord's comments were presented to the Commission in the form of a legal brief which insisted that they properly discharge their duties, and not go beyond their statutory authority by making recommendations (such as the recommendation that the OTC drug category be expanded to include herbs), which Congress did not authorize them to make.
Emord presented a "split label" approach containing five levels of claims. In levels 1-3, the FDA does not approve the claim, and can state so on their half of the label, but the manufacturer can cite evidence which backs the claim, with progressively more evidence existing to distinguish between a level two claim from a level one claim, and a level three claim from a level two claim. This evidence could be in the form of one or more peer reviewed studies. A level 4 claim is approved by the FDA, and a level 5 claim is approved by some other governmental body, such as the US Public Health Service. (More than one level of claim can be asserted within any label or labeling.)
This approach by Emord would solve the problem that Congress asked the Commission to address. If it had been in place, thousands of children could have been spared the crippling birth defects caused when their mothers did not take sufficient folic acid during pregnancy. In his comments, Emord cites all the case law pertaining to the first amendment, showing that the FDA has no legal right to block the making of truthful claims (such as folic acid), and he demands the removal of all ultra vires recommendations from the Commission's final report: recommendations concerning the safety of dietary supplements, the format of letters of notification for statements of nutritional support, the maintenance of files substantiating those claims, OTC regulations for botanicals, and funding and incentive for scientific research. Emord's comments can be viewed at http://www.emord.com
Commissioner Margaret Gilhooley, (who used to work at the FDA) and is currently a law professor at Seton Hall University stated that the Commission was acting fully within its scope and that Emord was taking too narrow an interpretation of their Congressional mandate under DSHEA.
The only concessions the Commission agreed to make in light of Emord's comments was to agree to state in their final report that Emord's first amendment law suit against the FDA was in progress in the courts. In an attempt to address Emord's concern that any of the Commission's recommendations could be taken by the FDA and used as a basis for administrative rulemaking, the Commission stated that they never intended for all of their recommendations to be used as a basis for rulemaking, but that many of them were only intended for general consideration by the President and Congress. In light of this, the Commission stated that they would clarify their intent by specifically identifying which of their recommendations were only intended to be general advice to Congress, as opposed to recommendations for rulemaking.
(When reached for comment, Todd Harrison in Emord's office stated: "We will be closely monitoring their final report the moment it is completed.")
Dovetailing with Emord's comments are the comments submitted by Suzanne Harris, JD of the Law Loft on behalf of the Life Extension Foundation, and National Health Federation which call attention to how expanding the OTC drug category to include herbs and botanicals is unwise from a standpoint of emerging international law. (Conveniently, the Commission did not examine any of Harris' comments, stating that to do so would exceed their statutory authority.)
With the advent of NAFTA, GATT, and the prospect of future trade agreements such as multilateral agreement on investments looming, the United States continues to yield much of its sovereignty to such international regulatory bodies as the World Trade Organization, World Health Organization, Codex Alimentarius Commission, International Council on Drug Regulating Authorities, etc. In fact, the Department of Health and Human Services (which oversees FDA) has an Office of International Relations, which has been taking steps to insure that the process of harmonizing US food and drug law with international regulatory requirements is continuous.
Harris states that the Commission acknowledges the trend towards harmonization and discusses WHO's efforts to regulate herbs as drugs, but makes no effort to examine the public health ramifications (vis a vis consumer access to natural products, and truthful health information about them) if the United States were to start regulating herbs as drugs.
Harris makes a specific argument from a standpoint of health freedom as to why it is not in the best interest of Americans to allow WHO to turn dietary supplements into drugs, and Congress should download her entire set of comments, the conclusion from which I summarize here:
"From a standpoint of maximum availability of the greatest number and combinations of botanicals at the lowest prices and in the widest range of potencies, this is clearly not a good idea. (To regulate dietary supplements as drugs.) It also directly benefits the European phytopharmaceutical companies at the expense of American producers and the consumer."
Harris goes on to state that (ironically) the same process which is boxing us in, can be used to our benefit. Here is how:
"Botanicals fall within the definition of food as set up by the Codex Alimentarius Commission. So do other dietary supplements. This means that a challenge to the laws of other countries that exclude our products as drugs could be mounted at the Dispute Settlement Body of the WTO. In order to prove that its laws were not undisguised trade barriers, a nation defending its treatment of botanicals as drugs would have to show:
In addition, Harris points out that the dietary supplement business is a multi-billion dollar business. She points out that "our trade ambassador, Charlene Barshefsky has already bragged to a Senate Committee that we are forcing biotech foods down the throats of resisting foreign countries." (The implication being that we could utilize similar tactics, to utilize the Dispute Settlement Body to force countries which currently regulate dietary supplements as drugs, to have to justify their trade barrier on a basis of appropriate risk management, based on a consistent level of risk decision.)
When President Clinton signed DSHEA into law in 1994, he had this to say:
"...in an era of greater consciousness among people about the impact of what they eat on how they live, indeed, on how long they live, it is appropriate that we have finally reformed the way the Government treats consumers and these supplements in a way that encourages good health."
In enacting DSHEA, Congress estimated that "almost 50% of the 260 million Americans regularly consume dietary supplements as a means of improving their health. In that same year (1994) the United States was expected to spend more than $1 trillion on health care-- about 12 percent of the country's gross national product. Congressional findings reported in DSHEA state that preventive measures, including education, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases, and reduce long term health care expenditures." The Act adds that "consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements."
When considering the Commission's obvious effort to ignore the will of Congress and to exceed their statutory authority, is important to understand the climate existing in 1993 which led to millions of consumers writing to Congress in an effort to pass DSHEA to defend their health freedom.
In 1990, a stealth bill designed to attack the dietary supplement industry, the Nutrition Labeling and Education Act was passed into law. This legislation was fast tracked through the house before consumers became aware of it, and it was headed for the Senate when a large number of us jumped into the fray to try to curb its worst excesses. The legislation affected nutrition labeling, and blocked the making of truthful health claims by creating an undefined, and undefinable standard of "significant scientific agreement" (which means whatever the FDA wants it to mean, and has enabled them to block a host of truthful claims, leading to unnecessary death and suffering as will be discussed in detail below.)
On June 18, 1993, the FDA published an Advanced Notice of Proposed Rulemaking (ANPR) concerning regulation of dietary supplements. This ANPR referenced a number of factors that led to the revision of dietary supplement regulations. These factors included increased consumer use of dietary supplements, an internal FDA three-year review of possible regulatory approaches, occurrence of eosinophilia myalgia syndrome as a consequence of a contaminated batch of l-tryptophan, and (alleged) reports of serious illnesses as a result of using botanical supplements.
The ANPR, also called "the Dykstra Report", suggested that vitamins and minerals should be limited to low multiples of the RDIs, that some botanical products were inherently drugs and not dietary supplements, and that many dietary supplements, including amino acids, were unapproved food additives. This ANPR infuriated the consuming public and the dietary supplement industry because FDA was clearly trying to repropose regulatory provisions which had been withdrawn or struck down in court actions in previous years. Thus, this ANPR was a significant motivating factor in efforts to develop and secure passage of DSHEA in 1994.
It should be obvious to consumers that the Commission is attempting to enable the FDA to engage in administrative rulemaking so as to once again move things in the direction of a pharmaceutical takeover of the industry, as envisioned by the Dykstra Report.
Consumers may be surprised to learn that all the vitamin trade associations (as well as a consortium of pharmaceutical interests called the European-American Phytomedicines Coalition) are pushing hard for the OTC drug category to be expanded to include herbs and botanicals. These trade associations (and Congress) clearly needs to be reminded that the European-American Phytomedicines Coalition, Utah Natural Products Alliance, National Nutritional Foods Assn, American Herbal Products Assn, and Council for Responsible Nutrition, represent the profit making needs of industry, NOT the will of the consuming public! It becomes very problematic as the pharmaceutical industry moves into the dietary supplement industry via mergers, acquisitions and strategic alliances.
The trade associations, (and Citizens for Health which seems to serve as their mouthpiece), would have us believe that consumer access is in no way threatened by a move to expand the OTC drug category to include herbs. They argue that the products can still be sold as dietary supplements, its just that limitations on health claims that can be made under DSHEA disallow the making of therapeutic claims, which consumers should be able to benefit from. Since these companies can make higher profits if they can make therapeutic claims, they badly want the OTC drug category to be expanded to include herbs.
While such a move might benefit large vitamin companies, (such as Nature's Way), which is already FDA certified to manufacture OTC drugs, what about the numerous smaller companies which aren't certified to manufacture OTC drugs? What about the push towards Codex harmonization that would be fostered by blurring the line between foods and drugs which we worked so hard to create under DSHEA? What about the first amendment implications here and the fact that the Emord lawsuit is still working its way through the courts?
Clearly, the European-American Phytomedicines Coalition is trying to move in on the N. American market, and clearly the American vitamin trade associations have dollar signs in their eyes, but wouldn't it make sense for them to reconsider what they are pushing for in light of Emord's and Harris's comments to the Commission? Shouldn't we all point these comments out to them? If Codex harmonization keeps being pushed this way, in the end, won't the pharmaceutical industry take over the dietary supplement industry to the detriment of consumers?
How empowered will consumers be to improve their health and that of their family if the commission finalizes their report to uphold the FDA's ongoing block against the making of truthful health claims through labels at the point of sale? Isn't the FDA being empowered here to keep harming people such as the kids born with birth defects because their mothers were unable to learn how folic acid could prevent them?
How empowered will consumers be if the Commission expands the OTC drug category to include herbs, when this would require expensive drug review processes in order to make claims that have already been thoroughly documented? How empowered will consumers be if the Commission furthers Codex harmonization, which in the end threatens to severely restrict consumer access to dietary supplements as has already happened in the Nordic countries, and as is happening now in Canada? The President and Congress must be appraised of the comments submitted by Emord and Harris to the Codex Commission. Please network this information, and send the enclosed form letter to your Senators and Congressmen, as well as to the Commission. The Commission's draft report, Emord's and Harris's comments can be downloaded from the I.A.H.F website at www.iahf.com
In a move that ties in closely with the effort being made to attack us through CDSL's Report, the FDA's Office of International Relations installed several "harmonization clauses" in S.830, the FDA Reform Bill.) The harmonization language will force US food and drug law to be made the same as the European Unions, (where dietary supplements are heavily restricted and regulated as "drugs.")
As of 9/13, despite receiving thousands of my form letters protesting the harmonization language in S.830, from all 50 states, the Senate Labor Committee and Jefford's office show no sign of willingness to remove this language, and the bill goes to the Senate floor this coming Tuesday.
Although I haven't given up trying to negotiate the removal of the harmonization language from S.830, thus far, Sean Donahue, Health Policy Analyst for the Senate Labor Committee shows every sign that he intends to ignore our protests, falsely claiming that the bill wouldn't effect dietary supplements, that it was written to help the offshore sales of medical device manufacturers by slashing through red tape. This is just a smokescreen. Bruce Artem in Senator Hatch's office was unaware of the threat posed by this situation when I talked with him, and it is clear that we have a major education campaign ahead of us on this issue because a lot of Congressional staff can't follow what is going on.
We are going to have to vigilantly monitor any house bill that could be used as a companion bill to S.830, and will have to attack any harmonization language in it. The greatest danger is that they will introduce a bill only specifically for medical devices (not specifically mentioning dietary supplements), and they could put harmonization language in it that would effect dietary supplements (and all foods), and it might be hard to get consumers up in arms.
Consumers need to be aware of this ploy, because I am anticipating having to generate a huge grass roots campaign against any bill that could be used as a house companion bill to S.830. If our food and drug law gets harmonized with the EU's, it will destroy our access to high potency vitamins, and many supplements would be totally unavailable as companies would be driven out of business. To learn more about the campaign to amend S.830- please visit the IAHF website. Be ready to help strip harmonization out of any house bill that could be used as a companion bill. It pays to educate your Congressman in advance, not to sponsor any bill with harmonization language in it- because it cedes control of whole sectors of our economy to international organizations such as the Codex Alimentarius Commission.
Your help is badly needed to protest CDSL's final report. The Commission must finalize their Report by September 30th*, and we must hold their feet to the fire! (*If you don't read this before Sept.30, 1997 bear in mind that the FDA is required to issue a notice of proposed rulemaking within 90 days from the date of the Commission's report, and to complete rulemaking no later than two years from that date- (protests made after September 30 can still serve to hold their feet to the fire.)
(Form letter on next page should be sent to your Senators and Congressmen, President Clinton, and to the Commission on Dietary Supplement Labels- NOT to IAHF)
Dear President Clinton, Members of Congress, and Ken Fisher, Ph.D. Executive Director of the Commission on Dietary Supplement Labels (CDSL):
President Clinton, when you signed the Dietary Supplement Health and Education Act of 1994 into law, you stated that "...in an era of greater consciousness among people about the impact of what they eat on how they live, indeed, on how long they live, it is appropriate that we have finally reformed the way the Government treats consumers and these supplements in a way that encourages good health."
I wish what you said in 1994 were true today, but through their draft report which was released on August 14-15, CDSL is attempting to sidestep the will of Congress by not properly discharging their duties under DSHEA, and by grossly exceeding their statutory authority. CDSL will finalize their report by September 30th. FDA is required to issue a notice of proposed rulemaking within 90 days from the date of the Commission's report, and to complete rulemaking no later than two years from that date. If you receive this prior to Sept.30, you must hold the Commission's feet to the fire. If you receive it after Sept.30, you must disallow the FDA from using their report as a basis for rulemaking.
CDSL intends to uphold FDA's (undefined) significant scientific agreement standard, which FDA arbitrarily uses to block such truthful claims as the one on folic acid in the prevention of neural tube defects.
CDSL did nothing to address the problem posed by the FDA's prior restraint against truthful claims such as in the case of folic acid. An estimated 7,500 children were born with birth defects during the two years in which the FDA dragged their feet on the making of this claim which had been previously approved by the US Public Health Service. I demand that you force CDSL to properly address this matter, and if this doesn't reach you before Sept.30th, that you disallow the FDA from using CDSL's final report as a basis for rulemaking.
Moreover, CDSL went far beyond their statutory authority under DSHEA in their draft report. They have no legal right to expand the OTC drug category to include herbs. From an emerging international law perspective, it is imperative that we not blur the line between food and drugs. To do so constitutes Codex harmonization. I oppose all efforts to harmonize US food and drug law with that of the European Union. To "harmonize" doesn't just mean "make compatible with" it means "to make the same as." Dietary supplements are very heavily restricted in the EU, and its getting worse there. The UK is attempting to limit consumers to just 10 mg of vitamin B-6 without a prescription. In Norway, you can't get vitamin C above 200 mg without a prescription. I strongly oppose CDSL's effort to blur the line between foods and drugs. Please learn more by downloading Emord's and Harris's comments to CDSL, as well as the CDSL draft report from the IAHF website at www.iahf.com
Please let me know if you intend to protect my rights and hold CDSL and FDA's feet to the fire.
Signed: ______________________________________ Date: ____________
City: _______________________ State: ____________________ Zip: ___________