To date, scores of companies have petitioned FDA for the use of various qualified health claims for their products or ingredients. Unfortunately, the rate at which qualified health claims are being processed and approved, according to many experts, has been less than acceptable. This is what impelled Senators Tom Harkin (D-IA_ and Orrin Hatch (R-UT) to send a letter to FDA Commissioner Lester Crawford on July 7th, inquiring why the agency has not acted more promptly to process these claims. The letter said even though FDA has established interim rules for considering qualified health claims, and regulatory guidance from 21 CFR 101.70 has been provided, the Senators believe there is a clash between the rules and guidance. “We believe a conflict exists between the interim guidance and 21 CFR 101.70 on two issues: 1) the maximum amount of time FDA is allowed to review claims and 2) the treatment of allowed extensions requested and granted by the agency. Besides the confusion this has led to in the industry, the Senators were most concerned about the fact that several petitioners have had claims pending longer than FDA’s interim guidance allows. As such, they suggested that FDA clarify the rules under which FDA is processing qualified health claims petitions. They also called for FDA to disclose how many qualified health claim petitions it has received, the length of time it has taken to approve each one, how many full-time equivalents (FTEs) are devoted to review the petitions and the grade levels of the reviewers.