FDA Pearson Implementation Faces Further Congressional Criticism

FDA's progress in implementing the Pearson v. Shalala court decision is sharply criticized by Republican Reps. Helen Chenoweth-Hage (Idaho), Ron Paul (Texas) and Bob Stump (Ariz.) in a March 17 letter to the agency.

The letter points out that 14 months have passed since a Washington, D.C. federal appeals court declared FDA's denial of four dietary supplement health claims unconstitutional, requiring the agency to approve them with appropriate disclaimers. "When a federal court holds First Amendment rights violated by an agency of this government, we expect that agency to eliminate the rights violation immediately," the letter states.

Asking FDA "precisely when" it will authorize the four claims in question, as well as three claims submitted for review over the summer, the legislators note: "A recitation of the 'Strategy for Implementation of [the] Pearson Court Decision'...is not necessary."

FDA published its strategy in the Dec. 1 Federal Register, saying it would deny all supplement health claims until it completed a rulemaking amending its regulations on the topic. A public meeting on the topic is scheduled to be held April 4. Issues for discussion were outlined by FDA in a March 16 Federal Register notice (¹ (Also see "Health Claims Based On Varying Levels Of Evidence Need Distinctions - FDA" - Pink Sheet, 20 Mar, 2000.)).

One of the 10 questions appended to the representatives' letter refers to a topic mentioned in the FDA notice. The letter asks if the agency believes it has the authority, outside of the health claims provision of the FD&C Act, to evaluate claims "that associate dietary supplements with mitigation and treatment of disease symptoms among groups with the disease." If FDA believes it does, the letter asks the agency submit by March 31 the statutory sections and legislative history supporting such a position.

The letter also asks FDA if it recognizes it "carries the burden of proof under the First Amendment to justify suppression of a health claim" and if it believes it can suppress a health claim even if a disclaimer would render the claim nonmisleading.

Some questions, such as what correspondence FDA has had with other governmental entities regarding supplement health claims that was not filed in the public docket, are similar to those asked in a March 13 letter from Rep. David McIntosh (R-Ind.). McIntosh also requested FDA respond by March 31.