FTC to FDA: Misleading Health Claims Should Be Modified, Not Banned

WASHINGTON--The Federal Trade Commission (FTC), in its response to the Food and Drug Administration (FDA) request for comment on how to apply the First Amendment to product claims, reported that banning a claim for being misleading would be unconstitutional, but modifying the claim would not be. FTC's comments were filed Sept. 13 and released to the public Sept. 20.

FTC was responding to the May 16 Federal Register notice in which FDA asked for public comment concerning how it could continue to protect the public health without imposing unnecessary restrictions on speech. (More on FDA's notice can be found at www.naturalproductsinsider.com/hotnews/25h17112828.html.)

"[I]naccurate or misleading claims have no protection under the First Amendment and need to be purged from the marketplace to protect and enhance the value of the free flow of truthful information," FTC stated in its comments. "In practice, consumer protection agencies often must choose between the risk of allowing commercial speech that might prove to be false or misleading and the risk of banning commercial speech that might prove to be true."

FTC reported that its enforcement approach focuses on deceptive speech and favors requiring information be elucidated rather than banned in order to stand up against constitutional challenges. However, FTC did not take a position on whether FDA's current practices regarding free speech are constitutional.

Additionally, FTC reported that because its experience is relevant to the marketing and advertising claims made for products, the commission did not address the standards used by FDA to determine whether to allow the sale of products. The agency noted, however, that advertising language for products such as dietary supplements is understandably more flexible to allow a broader range of claims so long as they are accurate and not misleading.

"[W]e have found that the First Amendment commercial speech doctrine is fully compatible with our vigorous consumer protection program," FTC stated. "FTC's post-market review of advertising claims and application of tailored remedies in advertising cases curb deception without overly restricting truthful commercial speech, thus promoting the goals embodied in the First Amendment.

"Applicable First Amendment law looks in part to the availability of less restrictive alternatives, such as mandated disclosures," FTC added. In addition, the commission stated FDA should look at emphasizing ways that favor disclosures and qualifications in lieu of outright bans. "[We believe our] experience in policing advertising and labeling claims may assist FDA in its efforts to conform its own regulatory practices to the First Amendment, while still advancing its important mission to protect and promote public health."

More on FTC's comments can be found at www.ftc.gov/opa/2002/09/fdacomment.htm.