Natural News - June 1999

FDA To Take New Look At Definition Of Disease

WASHINGTON—The FDA's 1998 proposed regulations on structure/function claims are far from a done deal.

At issue is the proposal's definition of disease, defined as any deviation from a normal state. That loose definition created heated industry and political debate as to whether the rules complied with the structure/function claims allowed by the Dietary Supplement Health and Education Act of 1994 (DSHEA). An estimated 175,000 people submitted comments about the proposal, prompting a hearing by the House Government Reform and Oversight Committee in late March.

Reform committee chairman Rep. Dan Burton, R-Ind., called the hearing to review FDA's implementation of DSHEA with specific emphasis on the structure/function proposal. The hearing left industry advocates optimistic that the agency will not only retract the proposal but that future relations with FDA will improve.

"The hearing provided an opportunity to have the new FDA commissioner [Jane Henney] speak on record and say that FDA has authority to regulate dietary supplements," says Beth Clay, a staff member for the House Reform Committee. The admission was significant for the dietary supplements industry, which has felt repeatedly stung by FDA allegations that it is "unregulated" under DSHEA, and, further, has struggled to define where Henney stands since her appointment last year. The commissioner previously served under former FDA commissioner and DSHEA-opponent David Kessler.

Henney also said during the hearing that it would take some time to sort through the unexpectedly large pile of comments, but that it was clear the definition of disease needs some reworking.

"The hearings were right on target," says Michael Q. Ford, executive director of the National Nutritional Foods Association in Newport Beach, Calif. "They couldn't have gone any better than if I had scripted the whole thing."

Among those testifying on behalf of the industry were attorney Scott Bass of the Washington law firm Sidley & Austin; Herb Research Foundation President Robert McCaleb, who also served on the President's Commission on Dietary Supplement Labels; and actress Raquel Welch, who said she had been taking dietary supplements since "one million years B.C.," (the name of her 1966 sci-fi film) and decried the confusing rules and broad restrictions in the structure/function proposal.

In his statement, Bass suggested the formation of an industry/government advisory group to "provide nonbinding interpretations of claims that cross the line." In turn, McCaleb emphasized the improvements in product research and consumer education prompted by DSHEA. "It is time for the FDA to abandon its continuing battle against dietary supplements, and against the right of the public to access truthful information about the known effects of supplements," McCaleb testified.

In further testimony, Henney acknowledged past feuds between the industry and FDA and expressed her hope that relations could improve. She also recognized the importance of supplements to consumers. "The dietary supplement industry sells products on which millions of Americans rely," Henney said, adding that FDA is now "committed to developing a positive working relationship with the industry, so we may together meet our goals of providing safe products to the American public."

— Karen Raterman