Congress Tells FDA 

Approve Claims of Pearson First Amendment Decision

Congress of the United States
House of Representatives
Washington, DC 20513

February 25, 1999

Dr. Jane E. Henney
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Commissioner Henney:
We are writing to express our agreement with the United States Court of Appeals for the District of Columbia's holding in Pearson v. Shalala that the Food and Drug Administration's (FDA) final rules prohibiting certain nutrient-disease relationship claims are invalid under the First Amendment to the United States Constitution. We request that the FDA spare the taxpayers the cost of further legal proceedings in this matter. Instead the FDA should take a first step toward allowing consumers unfettered access to information about dietary supplements by immediately approving the four claims at issue in the Pearson case.

The federal courts have now joined Congress in recognizing that the FDA's power to act as Big Mother by restricting access to dietary supplements violates the First Amendment and is not in the best interest of consumers. For far too long, the FDA's regulations of dietary supplements have reflected the belief that, as the Pearson court put it, allowing consumers access to information on dietary supplements not approved by the FDA is the equivalent of "asking consumers to buy something while hypnotized and therefore they are bound to be misled." We join the court in rejecting this argument as "frivolous" and condescending to the American people.

Even when applying the considerably more lenient test used to judge regulations of "commercial speech," the Court of Appeals found the FDA violated the First Amendment by denying the claims at issue in Pearson. As you are no doubt aware, the Court found that the FDA could have accomplished its goals with "the less draconian means" of allowing the manufacturers to make unapproved health claims accompanied by a disclaimer letting consumers know that the claims were not FDA approved.

While it does not reflect our long-range policy goals, adoption of a disclaimer for non-approved health claims would certainly be a positive step toward respecting consumers' rights to receive truthful information about health care products free of government interference. As the court observed, in order to justify the FDA's regulations one has to assume that " . . . the public is not sophisticated enough to realize the limitations of advertising, and that the public is better kept in ignorance than trusted with correct but incomplete information." (Quoting Bates v. State Bar of Arizona, 433 US 350 (1977) at 374-375.) We join the court in rejecting this assumption and hope that at long last the FDA will also realize that restricting access to information is not in the public's interest.

The court also found that the FDA regulations relied on an impermissibly vague standard of "significant scientific review." Of course, clear standards of legal and illegal conduct are but the minimum citizens in a free society should expect from their government. Standards like "significant scientific agreement" violate Americans constitutional right to regulations that provide "sufficient warning that men may conform their conduct so as to avoid that which is forbidden," (Rose v. Locke, 423 US 48, 50, 96 S/Ct. 243, 244, 46 L/Ed.2d 185, 188 (1975)) thus allowing government officials to arbitrarily punish citizens for activities the citizens had no reasonable way of knowing were illegal!

In conclusion, we once again urge the FDA not to pursue, at taxpayer expense, further litigation in this matter, but instead work to fulfill the commands of the courts, the intent of Congress, and the will of the people that Americans have greater access to information about the health benefits of dietary supplements.


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