Health Freedom Action

Health Claim Restriction by FDA

FDA Restricts Truthful Health Claims in New Guideline

Ignoring more than 100,000 emails to Congress in support of truthful health claims, the FDA has directly challenged the Health Freedom Protection Act, HR 2117, with a new draft guidance, "Evidence-Based Review System for the Scientific Evaluation of Health Claims", Docket 2007D-0125, http://www.cfsan.fda.gov/~dms/hclmgui5.html .

This draft guidance represents the FDA's current thinking on the process for evaluating the scientific evidence for a health claim through "Significant Scientific Agreement (SSA) and the definition of "credible scientific evidence" to support a qualified health claim.

The use of SSA and "credible scientific evidence" to determine permitted health claims is both unconstitutional (since it constitutes prior restraint of speech, violating the First Amendment), and an invitation to corrupt "junk science" being manipulated to prevent truthful, useful and helpful information from reaching consumers.

This dangerous standard should be replaced by the concepts and language of HR 2117, the Health Freedom Protection Act introduced by Congressman Ron Paul, 2007, http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117,, which eliminates the use of corrupt science to restrict information by allowing health claims unless the FDA determins that there is no scientific evidence that supports the claim or that the claim is inherently misleading and incapable of being rendered non-misleading through the addition of a disclaimer.

By amending the Guidance in this way, the corrupt misuse of science and the constitutional error or prior restraint of speech are both avoided and the needs of US consumers for truthful health information and claims are served. Your Fax to the FDA will (with an copy to Dr. Barbara Schneeman, who heads the FDA Section on Dietary Supplements) make your pro health and health freedom position clear.

And remember, Congress is listening and watching to see how important this is to you. Your voice counts. Use it!

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November 22, 2009

Subject:

Dear Receiver of Dockets

Re:FDA Draft Guidance "Evidence-Based Review System for the Scientific Evaluation of Health Claims", Docket 2007D-0125,  http://www.cfsan.fda.gov/~dms/hclmgui5.html

These comments are submitted as suggested by Major General Albert N. Stubblebine, Rima Laibow, MD and Ralph Fucetola, JD, trustees, of the  Natural Solutions Foundation with regard to the Food and Drug Administration's above noted draft Guidance with reference to the request of FDA for comments on the proposed Guidance via fax with a copy to Dr. Barbara Schneeman, Department Head of the dietary Supplements area at the FDA.

The Natural Solutions Foundation is a tax exempt, recognized Non Governmental Organization active in the United States and internationally, communicating Natural Solutions to its hundreds of thousands of supporters and beyond.  Natural Solutions supporters, of whom I am one, understand that American's myriad health problems are, in large part, caused by government intervention, with emphasis on FDA and Codex Alimentarius''s  dangerous, wrong-headed, and all too often lethal, over-regulation of  natural foods, remedies and supplements and industry-friendly emphasis on permitting and using dangerous pharmaceutical interventions in preference to natural ones.

Consumers like me need, and have a right to, access to truthful health claims without unconstitutional prior restraint of information.  The Draft Guidance referred to above sets the stage for the corrupt use of "science", "credible science" and "significant scientific agreement" to be manipulated to keep consumers from having the information they need to make the best possible informed choices for their health.

The FDA's history of conflict of interest and regulatory oversight of food supplements for the benefit of the pharmaceutical industry (since supplements are major economic competitors to drugs) makes this draft guidance a very dangerous one for the health and information access of consumers.

Congressman Ron Paul, MD (R-TX) has entered HR 2117, The Health Freedom Protection Act, which provides for a different paradigm for health claims: the burden of proof that a health claim is inappropriate falls on the FDA which can prohibit a health claim if the FDA determines there is no scientific evidence that supports the claim or that the claim is inherently misleading and incapable of being rendered non-misleading through the addition of a disclaimer.

The language of HR 2117 provides an excellent framework for the protection of consumers and the vitiation of the corruption and conflict of interest which the draft guideline as proposed will permit.

I strongly urge the FDA to replace the draft guideline as written with the language of HR 2117 for health and Constitutional reasons.  I value my access to health information about nutrients, food and supplements as much as I value my Constitutional rights.  I am urging my Congressional representatives to co sponsor HR 2117 in the House and introduce identical legislation in the Senate since I know that this language protects me from the dangers of the draft guidance.

The draft guidance states, "This draft guidance document represents the agency's current thinking on 1) the process for evaluating the scientific evidence for a health claim, 2) the meaning of the significant scientific
agreement (SSA) standard in section 403(r)(3) of the Federal Food, Drug, and Cosmetic Act …and 3) credible scientific evidence to support a qualified health claim. …"

"This guidance document describes the evidence-based review system which FDA intends to use to evaluate the publicly available scientific evidence for SSA health claims or qualified health claims on the relationship between a substance and a disease or health-related condition… This guidance document
explains the agency's current thinking on the scientific review approach FDA should use and is intended to provide guidance to health claim petitioners…

"The specific topics addressed in this guidance document are: (1) identifying studies that evaluate the substance/disease relationship, (2) identifying surrogate endpoints for disease risk, (3) evaluating the human studies to determine whether scientific conclusions can be drawn from them about the substance/disease relationship, (4) assessing the methodological quality of each human study from which scientific conclusions about the substance/disease relationship can be drawn, and (5) evaluating the totality of scientific
evidence."

This guidance attempts to impose a high standard on Health Claims. I find this approach contrary to legislative and case law as well as contrary to the spirit of the policy FDA announced in 2004, when it stated:

"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'.''

The case law to which I refer are the leading cases of Thompson vs. Western States and Pearson v Shalala.  These cases addressed FDA's authority to restrict speech regarding health claims.  The courts clearly held that, in the words of then Justice Sandra Day O'Connor, "If the First Amendment means anything, it means that regulating speech must be a last - not first - resort.
 *** We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information."

The Pearson case established the limits of qualified health claims.

In this context, I note Dr. Ron Paul's pending bill, the Health Freedom Protection Act - HR.2117 – which addresses the issues raised by the draft guidance by enacting the standard commercial substantiation requirement instead of the interpretation offered in the guidance.

Essentially Dr. Paul's bill shifts the burden of proof onto the FDA whenever the agency wants to deny the public the benefit of health claims information about Dietary Supplements. It provides that reasonable health claims, with proper disclosure language, shall be allowed "unless the Secretary determines
that -- `(i) there is no scientific evidence that supports the claim; and `(ii) the claim is inherently misleading and incapable of being rendered non misleading through the addition of a disclaimer."

Thus, anything more than "a scintilla" of scientific evidence would allow the making of non fraudulent claims that Dietary Supplements may be of benefit to individuals. The requirements of the bill are consistent with the law that
already governs such matters and ought to be adopted as the standard, instead of the language contained in the draft guidance.

Costs, safety and, most of all, liberty, require that the standard for health claims be set appropriately, if the US Constitution and public are to be served.  The FDA has a responsibility to protect my health and do so in the framework of legislation, case law and the United States Constitution.  This draft guidance fails on all of these counts and should not be implemented without the modifications detailed above.

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