[Congressional Record Volume 150, Number 34 (Wednesday, March 17, 2004)]
[Extensions of Remarks]
[Page E391]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                  HEALTH INFORMATION INDEPENDENCE ACT

                                 ______
                                 

                             HON. RON PAUL

                                of texas

                    in the house of representatives

                       Wednesday, March 17, 2004

  Mr. PAUL. Mr. Speaker, I rise to introduce the Health Information 
Independence Act. This act restores the right of consumers to purchase 
the dietary supplements of their choice and receive accurate 
information about the health benefits of foods and dietary supplements. 
The Health Information Independence Act restricts the Food and Drug 
Administration's (FDA) power to impede consumers' access to truthful 
claims regarding the benefits of foods and dietary supplements to those 
cases where the FDA has evidence that a product poses a threat to 
safety and well-being or that a product does not have a disclaimer 
informing consumers that the claims are not FDA-approved.
  Claims that could threaten public safety, or that are marketed 
without a disclaimer, would have to be reviewed by an independent 
review board, comprised of independent scientific experts randomly 
chosen by the FDA. However, anyone who is, or has ever been, on the 
FDA's payroll is disqualified from serving on the board. The FDA is 
forbidden from exercising any influence over the review board. If the 
board recommends approval of a health claim, then the FDA must approve 
the claim.
  The board also must consider whether any claims can be rendered 
nonmisleading by adopting a disclaimer, before rejecting a claim out of 
hand. For example, if the board finds that the scientific evidence does 
not conclusively support a claim, but the claim could be rendered 
nonmisleading if accompanied with a disclaimer, then the board must 
approve the claim provided the claim is always accompanied by an 
appropriate disclaimer. The disclaimer would be a simple statement to 
the effect that ``scientific studies on these claims are inconclusive'' 
and/or ``these claims are not approved by the FDA.'' Thus, the bill 
tilts the balance of federal law in favor of allowing consumers access 
to information regarding the health benefits of foods and dietary 
supplements, which is proper in a free society.
  The procedures established by the Health Information Independence Act 
are a fair and balanced way to ensure consumers have access to truthful 
information about dietary supplements. Over the past decade, the 
American people have made it clear they do not want the Federal 
Government to interfere with their access to dietary supplements, yet 
the FDA continues to engage in heavy-handed attempts to restrict such 
access.
  In 1994, Congress responded to the American people's desire for 
greater access to information about the benefits of dietary supplements 
by passing the Dietary Supplements and Health and Education Act of 1994 
(DSHEA), that liberalized rules regarding the regulation of dietary 
supplements. Congressional offices received a record number of comments 
in favor of DSHEA.
  Despite DSHEA, FDA officials continued to attempt to enforce 
regulations aimed at keeping the American public in the dark about the 
benefits of dietary supplements. Finally, in the case of Pearson v. 
Shalala, 154 F.3d 650 (DC Cir. 1999), reh'g denied en banc, 172 F.3d 72 
(DC Cir. 1999), the United States Court of Appeals for the DC Circuit 
Court reaffirmed consumers' First Amendment right to learn about 
dietary supplements without unnecessary interference from the FDA. The 
Pearson decision anticipated my legislation by suggesting the FDA adopt 
disclaimers in order to render some health claims non-misleading.

  In the years since the Pearson decision, Members of Congress have had 
to continually intervene with the FDA to ensure it followed the court 
order. The FDA continues to deny consumers access to truthful health 
information. Clearly, the FDA is determined to continue to (as the 
Pearson court pointed out) act as though liberalizing regulations 
regarding health claims is the equivalent of ``asking consumers to buy 
something while hypnotized and therefore they are bound to be misled.''
  The FDA's ``grocery store censorship'' not only violates consumers' 
first amendment rights, but, by preventing consumers from learning 
about the benefits of foods and dietary supplements, the FDA's policies 
are preventing consumers from taking easy steps to improve their own 
health!
  If Congress is serious about respecting first amendment rights, and 
the people's right to act to improve their own health, we must remove 
the FDA's authority to censor nonmisleading health claims, and claims 
that can be rendered nonmisleading by the simple device of adopting a 
disclaimer.
  In conclusion, I urge my colleagues to help establish an objective 
process that respects consumers' first amendment rights to 
nonmisleading information regarding the health benefits of foods and 
dietary supplements by cosponsoring the Health Information Independence 
Act.

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