"Disease" Definition Is Key Issue In Structure/Function Claims Rule - Henney

The appropriateness of the new definition of "disease" included in FDA's April 1998 proposed rule on structure/function claims is a key issue emerging from the more than 100,000 comments received on the proposal, FDA Commissioner Jane Henney, MD, noted at a House Government Reform Committee hearing March 25. The hearing was called to review FDA's implementation of the Dietary Supplement Health & Education Act, and, in particular, the structure/function claims proposal.

"Most of the concerns center around the issue of the disease definition that was used...that relied very heavily on reference books, from medical dictionaries and the like," Henney said. "We still have a way to go in our evaluation of all the people who commented on the particular definition we have selected and whether it was too broad," she continued. "So, we will be working diligently on coming to closure on that...before we would issue a final" rule.

The proposal attempts to delineate acceptable structure/function claims for dietary supplements from unacceptable disease claims ("The Tan Sheet" May 4, 1998, pp. 3-7). However, the definition of disease has been criticized by industry and members of Congress, including committee Chair Dan Burton (R-Ind.), as so broad it would hamper the information flow intended under DSHEA.

Disease is defined in FDA's proposal as: "Any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, system (or combination thereof) of the body that is manifested by a characteristic set of one or more signs or symptoms (including laboratory or clinical measurements that are characteristic of a disease), or a state of health leading to such a deviation, impairment or interruption."

"As a physician," Burton asked Henney, "can you really accept the definition of disease as the absence of a normal state?" Henney said she is "going to be compelled to look at this issue both as physician and commissioner. And I have not come to a conclusion in that matter yet." Noting "there is some concern among some members of Congress and many of the public that [DSHEA] would be circumvented by that regulation," Burton said, "I presume that you're going to take a hard look at compliance with the statute."

Asked by Rep. Henry Waxman (D-Calif.) to explain the agency's concern with disease claims, Henney said consumers would "clearly be misled" by a disease claim that is "wrong or at best, false and misleading." There is also the issue of "making a drug claim in terms of infringing upon the drug industry's mode of working within the agency...where rigorous premarket approval clearly is required," she pointed out.

Waxman noted "FDA has been criticized because the line between the structure/function and the disease claim is not always clear, but I don't think that's your fault. The statute forces you to draw a distinction between the two types of claims when in fact there may be no clear distinction."

So far, FDA believes it has adequate authority to properly regulate dietary supplements, Henney told the committee. However, she added, "I would say that we are very early into the implementation of" DSHEA, and "if we...find ourselves in a situation where we do not have adequate authority to protect the public health, we will bring it to your attention."

Henney highlighted the recently announced initiative within the Center for Food Safety & Applied Nutrition to develop a "strategy for achieving effective regulation of dietary supplements under DSHEA" by the end of 1999. The initiative will involve "ample opportunity for stakeholder input," she noted. CFSAN's priorities for 1999 were announced in January ("The Tan Sheet" Feb. 1, p. 9).

The strategic initiative will address "all elements" of the dietary supplement program, including the "definitional boundaries" between dietary supplements and conventional foods, drugs and cosmetics and clarification of what types of claims can be made for dietary supplements.

The initiative also will address Good Manufacturing Practice regulations, adverse event reporting review and follow-up, research needs, enforcement and resource needs. FDA is "committed to accelerating the development and implementation of GMP regulations," Henney said. "I have made it one of my priorities."

Testifying as a longtime dietary supplement advocate, actress Raquel Welch said the "broad restrictions and confusing rules" in the structure/function proposal amount to "killing a flea with a cannon." The celebrity, along with several witnesses appearing on behalf of industry, called for the withdrawal of the proposed structure/function claims rule in their testimony.

Citizens for Health Chairman James Turner said the group is "prepared to go to court and argue that the intent of Congress when the bill was passed was to recognize by law the definition" of disease "FDA had in place at that time." Citizens for Health organized a grassroots letter-writing campaign opposing the structure/function proposal. Turner asserted the public docket actually contains more than 175,000 letters, in contrast to Henney's estimate.

D.C. attorney Scott Bass (Sidley & Austin) said the structure/function proposal "undercuts the purpose that Congress had in enacting Sec. 6 of DSHEA" that deals with statements of nutritional support. "FDA attempted in good faith to try to draw a line" between structure/ function claims and other types of claims, but the proposal "went into much too much detail" and was "too broad in scope," he said (see related story, p. 5).

Several members of the President's Commission on Dietary Supplement Labels also testified at the hearing, including Herb Research Foundation President Robert McCaleb. He said the proposed rule "appear[s]...to be an attempt to turn back the clock, to circumvent the will of Congress and of the people and to prevent the very types of claims that DSHEA was written to allow."

In written testimony, Council for Responsible Nutrition Scientific & Regulatory Affairs VP Annette Dickinson, PhD, suggested FDA should follow the example set by the Agriculture Department when it withdrew a proposal on "organic" products in response to public comments. "FDA should simply withdraw the structure/function proposal" and instead "rely on the language of DSHEA, which clearly states that statements of nutritional support cannot mention a disease," she recommended.

However, Margaret Gilhooley, Seton Hall University School of Law, suggested in written testimony the "FDA proposal needs to be revised to restrict supplement claims that relate to the maintenance of bodily conditions and functions closely associated with the occurrence of disease and beyond the ability of the consumer to evaluate."

Bass proposed formation of a joint government/ industry "advisory group" to provide "non-binding interpretations of claims that cross the line." He suggested the group could be modeled after advisory panels such as the American Association of Feed Control Officials, which determines "applicable testing guidelines and appropriate claims for ingredients placed in pet food."