US Congress: Ron Paul Introduces Health Information Independence Act

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Legislation

Congressman Ron Paul introduced, on 18 March 2004, a bill in the US Congress, which would reform the way the FDA assesses health information that manufacturers wish to give on the labels of foods and supplements. A similar bill had been introduced by Paul in the last session of Congress, little more than a year ago.

The idea is that foods, and in particular nutritional supplements, do have immense influence on our health, and choice of food or certain nutrients could be assisted by the general availability of breaking scientific information on the useful properties of certain nutrients and foods.

So far, the FDA has kept an extremely strict control on what may be said about foods' health properties, limiting what can be said to what science, after decades, has finally agreed on as no longer to be denied - such things as "Calcium is good for the bones".

The bill would establish a mechanism for independent scientific review of health information the FDA believes should not be allowed.

Ron Paul's bill comes at a time when similar legislation is being considered for Europe, although the proposal for a European Health Claims directive seems to be going in a much more restrictive direction.

From Congressman Ron Paul (R-Tx)

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 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 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 polices are preventing consumers form 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 non-misleading health claims, and claims that can be rendered non-misleading 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 non-misleading information regarding the health benefits of foods and dietary supplements by cosponsoring the Health Information Independence Act.

Health Information Independence Act (Introduced in House)

HR 4004 IH

108th CONGRESS

2d Session

H. R. 4004
To amend the Federal Food, Drug, and Cosmetic Act to establish a system independent of the Food and Drug Administration for the review of health claims, to define health claims, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

March 18, 2004
Mr. PAUL introduced the following bill; which was referred to the Committee on Energy and Commerce

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A BILL
To amend the Federal Food, Drug, and Cosmetic Act to establish a system independent of the Food and Drug Administration for the review of health claims, to define health claims, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `Health Information Independence Act'.

SEC. 2. FINDINGS.

The Congress finds as follows:

(1) Access to accurate information at the point of sale concerning the effect of nutrients on disease is indispensable to the exercise of informed consumer choice in the marketplace and to the health and welfare of the American people.

(2) In 1999, 2000, and 2001, Federal courts have held that Food and Drug Administration suppression of nutrient-disease information is a violation of the First Amendment to the United States Constitution.

(3) Despite those holdings and despite the courts' orders, the Food and Drug Administration continues to suppress nutrient-disease information that could improve public health, reduce the costs of health care, and promote the welfare of the American people.

(4) The history of the Food and Drug Administration review of nutrient-disease relationships reveals a strong and unscientific bias against food and dietary supplement health claims in direct violation of the constitutional mandates of Federal courts and the intent of Congress.

(5) The Food and Drug Administration favors suppression of health claims over disclosure, despite court imposed constitutional requirements to the contrary.

(6) To ensure that health claims are evaluated rationally, fairly, and in compliance with constitutional requirements and the intent of Congress, the federal government must be denied authority to deny the public access to health information absent probable cause that the claims are untrue, misleading or pose a danger to human health and jurisdiction over health claims evaluation must be removed from the Food and Drug Administration and placed in the hands of Independent Scientific Reviewers who do not harbor a bias against food and dietary supplement health claims.

SEC. 3. AUTHORITY FOR MAKING HEALTH CLAIMS.

(a) Limitation on Agency Authority to Restrict Distribution- Notwithstanding any other provision of Federal law, the Federal Government shall have no authority to restrict the distribution of any dietary supplement or other nutritional food on the basis that the manufacturer is making health claims unapproved by the Food and Drug Administration if--

(1) the product has a label clearly stating that its health claims are not FDA approved; and

(2) such Administration lacks evidence establishing probable cause that the claims contain misleading information posing a threat to the safety and well-being of those who use such product.

(b) Independent Review of Agency Determination of Existence of Probable Cause- In the event that the Food and Drug Administration determines that there is probable cause that the claims for a dietary supplement or other nutritional food contain misleading information posing a threat to the safety and well-being of those who use such product, such Administration shall, before acting against the product carrying the allegedly offensive claims, submit the claims to review before an independent review board as described in the following sections of this Act.

SEC. 4. DEFINITIONS.

Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following