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DIETARY SUPPLEMENT LEGISLATIVE APPROACH RETAINING FDA AUTHORITY

This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT LEGISLATIVE APPROACH RETAINING FDA AUTHORITY "to identify and act against unsafe products before people are injured" was suggested by Rep. Henry Waxman (D-Calif.) at a July 29 hearing before his House Energy and Commerce/health subcommittee. Waxman also recommended that legislation on the regulation of dietary supplements should "guarantee the availability of safe dietary supplements as long as they make no unproven claims." Waxman observed that the question of how to regulate dietary supplements has evolved into an "extremely contentious issue," pitting many consumers and the dietary supplement industry against FDA. "Part of the problem," Waxman stated, "is that the FDA has received very mixed signals from Congress and the public." He said he hoped that the legislative process could settle the issue. The California congressman is expected to propose alternative legislation to bills introduced earlier this year by Sen. Orrin Hatch (R-Utah), Rep. Bill Richardson (D-N.M.), and Rep. Elton Gallegly (R-Calif.). Despite their differences, the bills would essentially establish a new regulatory framework for dietary supplements that allows health claims and potency levels to be unregulated by FDA unless clear safety issues emerge. Commenting on the three bills, Waxman characterized them as "certainly thought provoking" and said he is looking forward "to working with all three authors to address this very important issue." Waxman also is understood to be communicating with Sen. Edward Kennedy (D-Mass.) on a dietary supplement legislative proposal. At a June 30 meeting convened by the Council for Responsible Nutrition, Waxman staffer William Schultz suggested that a central principle of any supplement legislation would be a mechanism to ensure dietary supplement safety ("The Tan Sheet" July 5, p. 10). Schultz emphasized to CRN that, regardless of industry or congressional support garnered for the Hatch and Richardson bills, it would be "inconceivable" that legislation would reach the House floor without the approval of Waxman. In testimony before the subcommittee, FDA Commissioner David Kessler noted that the Richardson bill (HR 1709) would "require FDA to abandon its traditional role of gatekeeper," characterizing this as a "function that is designed to protect consumers and enhance freedom of choice by keeping unsubstantiated health claims out of the marketplace." The current standard, which places the burden of safety on manufacturers, Kessler said, "allows FDA to act quickly in cases of real harm." Under the proposed legislation, the burden of proof would switch from the manufacturer to the agency, "ingredient safety would be presumed, and products would be sold until evidence of harm is identified," the commissioner stated. "At that point, it might be too late for consumers who had unknowingly been exposed to long-term health risks such as cancer or other serious or irreversible diseases," Kessler declared. Kessler added that "other provisions in the bill could tie FDA up in lengthy administrative proceedings and litigation before final action could be taken to protect consumers from false and deceptive claims." In response to a Waxman query about whether FDA would support postmarket surveillance of dietary supplements, Kessler stated: "If you don't have premarket review, you are going to put FDA in the position of chasing after problems after they have occurred." Furthermore, "you are going to force the American taxpayer, in the end, to foot the bill to chase after the product and [to] do the kind of testing to be able to make a case in court," Kessler asserted. Richardson's legislation would also eliminate the requirement that manufacturers establish the scientific validity of a nutrient-disease relationship before making a health claim, Kessler pointed out. Under HR 1709, "a claim could be made as long as it accurately described the supporting evidence," Kessler said, adding: "Thus, a claim could be based on one small preliminary study that in no way establishes the nutrient-disease relationship." At the hearing, Rep. Richardson questioned FDA's criteria for allowing health claims, particularly in the case of the association between daily intake of 400 mcg folic acid by women of childbearing age and the reduction of the risk of conceiving a child with a neural tube defects. "Given the abundant data on folic acid and birth defects, why did it take your agency so long to approve this health claim," Richardson asked Kessler. "What was it that you were unable to do after substantial scientific evidence was very clearly stated?" In reply, Kessler expressed concern regarding fortification of the food supply with folic acid, an option endorsed by FDA's Folic Acid Subcommittee ("The Tan Sheet" April 19, p. 4). "Just think about it," Kessler said, "allowing a substance to be added to everyone's food -- everyone in America, 200 mil. people. We cannot be wrong in a dose" that is used to fortify the food supply. "It is a very important decision and it has to be done right." As little as 1 mg folic acid is associated with pernicious anemia in the elderly, Kessler noted. Regardless, Kessler assured the subcommittee that FDA would propose a folic acid health claim "next month" ("The Tan Sheet" June 21, p. 5). Kessler warned, however, that the folic acid issue "is complicated and we have just got to get it right." Referring to the length of time it took FDA to review the folic acid evidence, Richardson shot back: "I understand that, but you were wrong, Doctor, you were wrong and now science says [so]." National Cancer Institute Director Samuel Broder sat at the witness table with Kessler and supported the commissioner's position that health claims for supplements need to be supported by the current standard of "significant scientific agreement." He added: "We cannot do our job without a strong FDA." To back up its position that some dietary supplement manufacturers are making unsubstantiated health claims, FDA released a report at the hearing that lists over 500 supplement products carrying unsupported claims (see following story). In a statement before the subcommittee, Sen. Hatch maintained that "legislation establishing sensible regulation is necessary because FDA has a chronic history of seeking to overregulate supplements." Hatch said his bill "will help stop the hysteria and media hype seeking to stir up public demand for or against more government oversight." Hatch concluded that consumers are looking toward Congress to "make sure that Americans can continue to choose to use supplements." In brief testimony before the subcommittee, Energy and Commerce Committee Chairman John Dingell (D-Mich.) called for "facts and figures, not myths and exaggeration," in the dietary supplement debate. "The polar difference between these [contrasting] viewpoints indicate that there is strong need for us to engage in real fact-finding and careful analysis." Dingell said he wished to dispel the myth that "FDA wants to ban supplements. Every fact available to me indicates that FDA is neither on a mission to destroy the nutritional supplement market, nor the industry, nor does the agency have the resources to accomplish such a mission." He noted that the supplement industry "attracts millions of consumers and billions of dollars." Despite the size of the market, however, "these products have been regulated in an inconsistent and ad hoc fashion" and "few studies have been done to demonstrate the active relationship between nutrition and health," he said. To date, HR 1709 has 50 cosponsors while its Senate counterpart S 784 has 22, according to Hatch's testimony. Sen. Claiborne Pell (D-R.I.) signed on as the most recent cosponsor to S 784 on July 28. Gallegly said that his Health Freedom Act of 1993 currently has 42 cosponsors in the House.
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