Health claims petitions 18-month deadline for FDA response set in House FDA reform bill.

HEALTH CLAIMS PETITIONS 18-MONTH DEADLINE FOR ACTION BY FDA is a provision of the health claims bill introduced in the House Sept. 11 by Rep. Edward Whitfield (R-Ky.). Under the Food & Nutrition Information Reform Act (HR 2469), FDA would be required to take final action on petitions submitted for approval of health or nutrient content claims for food within a year-and-a-half of submission. HR 2469 is one of three FDA reform bills -- the other two concern drugs and devices -- that comprise agency overhaul efforts in the House. An October conference date for the measure has been identified tentatively.

The 18-month deadline is "consistent" with the ruling of Manhattan federal court in the case Nutritional Health Alliance v. Shalala, the House Commerce Committee, which has jurisdiction over the bill, said Sept. 12.

In the suit, filed in June 1995, NHA and New Nutrisserie charged that the 1990 Nutritional Labeling & Education Act violates the First Amendment right of free speech by failing to impose a deadline for FDA to make a final decision on proposed health claims for dietary supplements ("The Tan Sheet" Feb. 10, p. 6). On March 17, FDA proposed a nine-month deadline for either claims authorization or denial, which NHA considered "excessive" ("The Tan Sheet" April 21, p. 14).

The food health claims bill also permits FDA to make regulations proposed by the agency effective immediately, pending consideration of comments. "FDA would be required to consider public comments and issue a final rule within 270 days," the Commerce Committee states, adding the rule "would be subject to judicial review."

The bill's provisions for health claims are the same as those in the Senate FDA reform bill (S 830), now scheduled for a cloture vote Sept. 16 following compromise on the issue of national uniformity for cosmetics. Similar health claim provisions were included in a bill introduced July 22 by Rep. Fred Upton (R-Mich.) ("The Tan Sheet" July 28, p. 3).

However, HR 2469 adds provisions for the use of nutrient content claims, whereby these types of claims could be made in instances where no formal FDA regulation has been issued for the claim if another scientific body of government, such as the National Institutes of Health or the National Academy of Sciences, has published an "authoritative statement" providing the basis for the claim. The claim must not be misleading, must be an accurate representation of the statement that forms its basis and must be submitted to the agency at least 120 days before introduction to the market, according to the House bill. Under its provisions, a health claim could be nullified or modified by HHS or by order of a federal court.

The bill would eliminate the requirement that labeled health claims be accompanied by a referral for consumers to "see back panel for nutrition information." Mandatory labeling of nutrition information "has been present on virtually all food products for several years, and consumers are aware of their presence and location," the Commerce Committee said. The bill also would eliminate the requirement that a "food product's radiation disclosure statement be more prominent than its ingredient listing" and would ease requirements for the marketing of margarine products, Commerce said.

The latest effort at FDA reform in the House follows last year's unsuccessful attempt. House FDA reform measures fizzled in the 104th Congress, with a similar three-pronged bill design failing to make it to the floor after several attempts at scheduling them for Commerce Committee mark-up ("The Tan Sheet" Oct. 7, 1996, pp. 7-8). The previous House FDA reform bill was introduced by Rep. Scott Klug (R-Wis.), one of 16 co-sponsors of the current measure.