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This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT SEPARATE REGULATORY CATEGORY SUGGESTED BY SEN. KENNEDY at an Oct. 21 hearing of his Senate Labor & Human Resources Committee. Noting that "there's a big concern over FDA's use of the food additive provisions" to regulate dietary supplements, Sen. Edward Kennedy (D-Mass.) said that "my own sense, and I think there is some pretty general agreement, is that we ought to create a separate category at FDA" for the regulation of dietary supplements. Responding to Kennedy's suggestion, FDA Commissioner David Kessler declared: "I think you're 100% correct." Although the "food additive section [of the FD&C Act] has been upheld for multi-ingredient dietary supplements," the applicability of the food additive provisions for single-ingredient supplements has been problematic, Kessler said, alluding to federal court rulings that FDA was incorrect in regulating black currant oil in single- ingredient capsules as a food additive. "I don't think this issue" of whether the food additive provisions should apply to all dietary supplements "was ever clearly addressed by Congress and I think its worth addressing," Kessler concluded. Senator Tom Harkin (D-Iowa), who sits on the committee, suggested that Congress should provide FDA with guidance on how to interpret the term "significant scientific agreement" in authorizing health claims for supplements. Harkin suggested that "maybe" Congress did not "do [its] job properly" when passing the Nutrition Labeling & Education Act because the law does not define "significant scientific agreement." Consequently, he suggested that the standard applied by FDA in approving health claims is similar to the one used for drugs. Harkin concluded: "I do believe that we are going to have to give some guidance and direction on what we mean by significant scientific agreement." Asked by Harkin whether agreement among 51% of scientific experts would be appropriate, Kessler replied: "51% of what? . . . 51% of the members of the National Academy of Sciences? It becomes hard to come up with a precise definition where you plug [a figure] into a computer." FDA Deputy Commissioner for Policy Michael Taylor assured Harkin that FDA recognizes that the law is "very clear that the significant scientific agreement standard is a more flexible standard than the drug standard." Harkin questioned whether the definition of "significant scientific agreement" must "only reflect studies published in major medical journals, which often have a bias against accepting studies about nutrition in general." The congressman noted that the bias against unconventional medicine was "one of the reasons" for establishing the National Institutes of Health's Office of Alternative Medicine. The Iowa senator also asked whether FDA would allow an "advisory board made up of the non-traditional types of medical researchers" to review health claims. Kessler replied that he "would welcome the director of the [OAM] to serve on an advisory committee" as well as others who are "grounded in science." Based on FDA's delay in approving a folic acid claim, Harkin also suggested that Congress may want to impose a time frame for reviewing claims. Asked by Harkin whether six months would be, a "reasonable" review time, Kessler answered affirmatively but with the caveat that FDA must have the resources "to be able to do that." Earlier during the hearing, Kessler promised Kennedy that FDA would be "willing to work with [his] committee in coming up with reasonable deadlines" for approving health claims. Apart from reiterating remarks he made at an Oct. 18 hearing before the House Appropriations/agriculture subcommittee, Kessler appealed to the Senate committee to "work together" with FDA to "ensure the availability of safe dietary supplements that do not cross the line separating legitimate claims from bogus assertions." To accomplish this, Kessler suggested that the committee could take three actions: (1) "write to your constituents and tell them that Congress is working with the FDA to maintain access to dietary supplements"; (2) "give FDA an effective means to deal with demonstrable safety problems and to ensure that these products are properly manufactured"; and (3) "hold manufacturers of dietary supplements to the same standards that you previously established for health claims on foods." Kessler also asked the "committee to consider" a "systematic safety review" for dietary supplement products currently on the market. Kessler had previously extolled the benefits of a systematic safety review at the Oct. 18 House subcommittee hearing, noting that such a review "may be worth doing" even though "it will be expensive." A systematic safety review of currently marketed dietary supplements has also been urged by a group of attorneys general from II states ("The Tan Sheet" Oct. 11, p. 8), and is included in legislation introduced by Rep. Cardiss Collins (D-Ill.) ("The Tan Sheet" Aug. 16, p. 4). Kennedy, who was recently urged by a group of senators to help devise a "creative solution" for the regulation of dietary supplements ("The Tan Sheet" Oct. 1 1, p. 6), emphasized at the hearing that "we are interested in trying to find some common ground" on supplement legislation and "are hopeful that that can be done" before Congress adjourns for winter recess. Kennedy noted that, in developing a compromise that will satisfy both the dietary supplement industry and FDA, "two of the major concerns are the possible bias of the FDA against supplements" and the "long delays in approving" health claims. The committee chairman also asked Kessler whether FDA would be "willing to open up the [health claim] approval process to outside experts" and whether the agency would be able to "meet deadlines" in approving health claims. Kessler responded affirmatively to both questions. Other senators present at the hearing were Nancy Kassebaum (R- Kan.), Orrin Hatch (R-Utah), Harris Wofford (D-Penn.), Paul Simon (D-Ill.), Jeff Bingaman (D-N.M.), Paul Wellstone (D-Minn.), Claiborne Pell (D-R.I.), and Howard Metzenbaum (D-Ohio), who criticized the dietary supplement industry's grassroots campaign in support of bills introduced by Hatch and Bill Richardson (D- N.M.). Richardson testified at the hearing. Referring to an argument made by the supplement industry that it should not matter whether unsubstantiated claims are made as long as a product is safe, Metzenbaum maintained: "That is not the issue. It is not an issue of no harm, no foul. It is a matter of deceptive advertising. It is a matter of being honest and truthful with consumers." On the other side of the spectrum, Hatch presented a report charging that an FDA report on false and misleading supplement claims is "riddled with inaccuracies".

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