To The Receiver of Documents

Re:FDA Draft Guidance \"Evidence-Based Review System for the Scientific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]{.underline}](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 Guidancewith reference to the
request of FDA for comments on the proposed Guidance stated at:
[[www.fda.gov/OHRMS/DOCKETS/98fr/E7-13274.htm]{.underline}](../www.fda.gov/OHRMS/DOCKETS/98fr/E7-13274.htm)-
07-09-2007

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Draft Guidance referred to above sets the stage for the corrupt use of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supplements are major economic competitors to drugs) makes this draft
guidance a very dangerous one for the health and information access of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, even \"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.

Christy Hepp

80 Vaux Way

Newnan, GA 30263