Congressman Ron Paul
U.S. House of Representatives
February 27, 2002
Mr. Speaker, I rise to introduce the Health Information Independence Act of 2002. This act takes a major
step toward restoring 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
repeals the Food and Drug Administration's (FDA) authority to approve health claims of foods and dietary supplements.
Instead, that authority is vested in an independent review board. The board is 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 commission. 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 non-misleading 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 non-misleading 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 access to dietary supplements.
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), which
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 court anticipated my legislation by suggesting the FDA adopt disclaimers in order to render some health claims non-misleading.
In the more than two 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.'' Therefore, if Congress is serious about respecting the First Amendment rights of the people, we must remove FDA authority to censor non-misleading health claims, and those claims which can be rendered non-misleading by the simple device of adopting a disclaimer, by passing my Health Information Independence Act.
In conclusion, I urge my colleagues to help establish an objective process that respects consumers' First Amendment rights to non-misleading information regarding the health benefits of foods and dietary supplements by cosponsoring the Health Information Independence Act.