FDA responds to some unacceptable structure/function claims with "courtesy" letters.

STRUCTURE/FUNCTION NOTIFICATIONS HAVE GENERATED FDA "COURTESY" LETTERS in "a couple of cases" to manufacturers registering structure/function claims that were "treatment claims for a disease condition," FDA Office of Special Nutritionals Director Elizabeth Yetley, PhD, told the Commission on Dietary Supplement Labels on Feb. 16. Yetley spoke at the commission's inaugural meeting in Washington, D.C.

Under the Dietary Supplement Health & Education Act, supplement manufacturers are required to notify FDA within 30 days of marketing a product that bears a statement of nutritional support. Originally, the agency responded to these notifications with a brief form letter acknowledging receipt. FDA recently announced, however, that it lacks the resources to reply to the notifications on a regular basis ("The Tan Sheet" Dec. 18, 1995, p. 15).

The agency has divided responsibility for review of structure/function claim notifications between a number of FDAers, Yetley said. However, each FDAer has other responsibilities that "may be of higher priority," she explained. Manufacturers, therefore, should not take lack of response to a claim from FDA as an indication of the agency's approval, she cautioned.

However,"in a couple of cases" in which drug claims masquerading as structure/function claims have come to the agency's attention, letters have been sent to manufacturers "primarily as a courtesy to indicate" that FDA takes issue with the claims, Yetley said.

"At this point," the purpose of the letters is to provide "information and education" to companies that may be unaware of the inappropriateness of their claims, Yetley noted. However, she added, if the claims are not corrected, FDA "later could take action."

To date, FDA has received 330 letters of notification, Yetley told the commission. Of these, "the vast majority" have been notifications of structure/function claims; "some" have been general well-being claims"; and "none have dealt with claims relating to classical nutritional deficiencies," she noted. Most notifications consist of a single-page letter, though some companies also submit related materials, Yetley reported.

Several members of the commission were dismayed by the lack of agency oversight and review of the notification statements.

For example, Margaret Gilhooley, Seton Hall Law School, asked: "How much would it take for FDA to bring court action" against a manufacturer making unacceptable claims? and "How many could you do a year?" Yetley replied that she "couldn't answer that right now."

In addition, Gilhooley queried whether FDA had outlined "what constitutes substantiation" from manufacturers if their claims are challenged by FDA. Although manufacturers are not required to submit substantiation with notification letters, under DSHEA they must have substantiating evidence for the claims in company files and make it available to the agency upon request.

Yetley acknowledged that FDA has "not yet set criteria" for what the agency would consider reasonable substantiation in cases in which the agency questions claims.

The commission's next public hearing is scheduled for March 8 in Salt Lake City, Utah -- to be followed by open sessions April 26 in San Francisco, and June 6 in a Florida city to be announced. The seven-member commission was established under DSHEA to generate recommendations for regulations and legislation related to label claims for dietary supplements ("The Tan Sheet" Oct. 9, 1995, p.1).