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This article was originally published in The Tan Sheet

Executive Summary

HATCH-RICHARDSON BILL IS EXPECTED TO BROADLY DEFINE DIETARY SUPPLEMENTS, Council for Responsible Nutrition President J. B. Cordora told a Rutgers University-sponsored "Designer Foods II: Phytochemicals in Disease Prevention" program in Piscataway, N.J. on March 17. Cordora noted that "all of the discussion [of the proposal] says that the definition of dietary supplement will be broadly defined to make it clear that we're talking about essential vitamins and minerals, herbs, amino acids, and other substances such as geranium, coputan, fish oils and the like." Cordora predicted that the dietary supplemant issue will be aired before Rep. Henry Waxman's (D-Calif.) Energy & Commerce/health subcommittee this spring, possibly as early as mid-May. Subcommittee staff is in the early stages of preparation, and reportedly has not yet set a date for a hearing. "The [regulatory] issue," Cordora maintained, "is to make sure that the products are safe, that the products are made to quality standards, that the products do what they're supposed to do, and that the information that people are given about them is accurate and truthful and not misleading. And that, we hope, is what is going to form the basis of what we expect to be the Hatch- Richardson bill." Though Cordora said he did not want to "pre-empt Congress" by forecasting the content of that bill, he did say that he expected it to address health claims and labeling requirements as well as dietary supplement definitions. He also cited the dietary standards debate centering on RDA and RDI measures as a source of "serious concern to the members of CRN" and a misuse of FDA authority under the Nutrition Labeling & Education Act. "An issue that will be of interest to designer foods is whether the definition will cut out foods that are in conventional form of designer food but yet have the nutritional values that [contain more than 50% Recommended Daily Allowance of key vitamins or minerals]," Cordora added. Cordora noted that it is quite possible that the definition of dietary supplements under the bill could exclude designer food products. "That's something for those people who are interested and concerned about designer foods to get into the debate, and to see if it's advantageous to make the case that designer foods should be allowed within the framework [of broadly-defined dietary supplements]," he stated. The CRN head also told the meeting that "critical to being able to market designer foods is whether you will be able to make the claim, and what scientific hoops and regulatory hoops you're going to have to pass over, and that will involve the standard." "Should it remain as 'significant scientific agreement?'" he asked, and "how should that be interpreted?" Characterizing FDA's position on the subject, Cordora suggested that "if you had a continuum that ran from zero to 10, with 10 being metaphysical certainty of consensus, we believe that the way the FDA has interpreted the first set of claims is that they're much closer to the 10 than they are to the nine and the nine plus." "That's not what Congress intended," he asserted. "We believe that that interpretation should be opened up so that claims could be made where the evidence is in the six-seven, seven-eight or so range." Stephen DeFelice, MD, chairman of the Foundation for Innovation in Medicine, voiced similar reservations about the NLEA earlier in the afternoon, and called for legislation to settle the issue of dietary health claims. "I think many people today in Washington . . . will say the NLEA is a fatal blow to R&D in the science of food and medicine, there's no doubt about that question," DeFelice declared. "The basic principle is if you can't make the claim, you don't spend the money, and you don't want to spend the money for everyone to make the claim." Cordora suggested that the most reasonable settlement of the conflict between industry and FDA lies in developing a "symmetry between the specifics of the claim and what the evidence is that supports it. If you do that, you would have a freer flow of information, you would encourage the kind of information Dr. DeFelice has been talking about, and consumers would have access to more information and the cost of waiting would be severely reduced," he argued. "FDA obviously has its own legislative agenda, and has begun to develop its concepts of how it sees these issues being dealt with," Cordora asserted. "I believe that they probably feel that they could address these without legislation, and they would just like the legislative process not to unfold so that they could deal with these matters within the regulatory schemata," he added. Earlier in the program, John Hathcock of FDA's Office of Special Nutritionals clarified the regulatory distinctions between designer food, which are fortified with dietary supplements, and medical foods, which are used under the care of physicians to provide patients with adequate nutrients for special indications. Hathcock cautioned the audience to avoid giving medical indications to foods because of the complexity and cost of the approval process for such claims. "To a large extent, we don't see that we have the option of applying a risk-benefit analysis to, let's say, a vitamin C supplement," Hathcock explained. "The magnitude of the benefit you really can't compare directly to the risk because a food is either deemed to be safe or it is deemed to be adulterated," he said. "I've heard people who have worked for industry, and work in control of industry, say that they worry about the market share or value of certain information that everybody can make a 'me-too' claim [for]. Is it worth anything?" the FDA staffer asked rhetorically. "The answer is: I don't know." He continued: "But is it worth it from a public policy, national public health issue? I think we need to do what we can to improve our diets. We need strong research and strong educational efforts."

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