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This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT LEGISLATION IS NOT "INEVITABLE" in the next session of Congress, House Energy & Commerce/health subcommittee counsel William Schultz told the Food & Drug Law Institute's Annual Educational Conference in Washington, D.C. on Dec. 15. "There is real interest in moving legislation," Schultz noted, "but I wouldn't say it's necessarily going to happen or it has to happen." Schultz said that subcommittee Chairman Henry Waxman (D- Calif.) is "not going to move legislation, he's not going to agree to legislation unless it's something that he thinks is responsible or that he's comfortable with." He added that he believes that House Energy & Commerce Committee Chairman John Dingell (D-Mich.) "would say the same thing, and it's hard for me to see how legislation moves without their agreement." Under bills introduced in April by Sen. Orrin Hatch (R-Utah) and Rep. Bill Richardson (D-N.M.), health claims for dietary supplement products would not be subject to preclearance by FDA ("The Tan Sheet" April 12, p. 6). Hatch's bill (S 784) currently has 63 cosponsors while 211 members of Congress have signed on to the Richardson bill (HR 1709). Prior to Dec. 15, dietary supplements had been exempt from the Nutrition Labeling & Education Act health claim provisions due to Sen. Hatch's Dietary Supplement Act of 1992. Now that the Hatch moratorium has expired, FDA has until Dec. 31 to publish a final rule on supplement health claims, which would go into effect by June 30, 1994. Schultz attributed the "enormous interest" in dietary supplements on Capitol Hill to the intense lobbying campaign being waged by industry. "I think it is the issue that is most written about by constituents; it's the issue most talked about when members go back and speak to their constituents," Schultz said. However, he added: "It's an issue where the interest has been created by what I think is a campaign of absolute deception." He noted that many constituents have expressed the concern that the NLEA will create a situation in which supplements will be available only by prescription. Energy & Commerce Committee staff member Kay Holcombe told the FDLI meeting on Dec. 14 that Dingell is "very, very anxious to reach some kind of agreement on dietary supplements regulation/legislation that will resolve consumers" concerns, that will take into account the concerns of the industry and that will recognize the . . . proper regulatory responsibilities of FDA." With legislation on President Clinton's health care reform package a priority in Congress, the time remaining in the current congressional session for passing dietary supplement legislation is limited, Schultz pointed out. The health subcommittee is committed to reporting out a bill in early March on health care reform, he said. The process of moving the legislation through the Rules Committee, the House floor vote and the conference committee will follow, he noted, adding that he suspected that "once we start into that, we won't emerge until the last day of the session." Rep. Waxman is "very committed" to the "significant scientific agreement" standard for dietary supplement health claims provided under NLEA and "he thinks it's worked very well," Schultz said. He added, however, that other issues relating to access, "timing" and "how the decision is made" are "very much on the table." FDA's Mitchell Zeller, special assistant for policy in the Office of the Commissioner, said the agency "very, very strongly [believes] in the significant scientific agreement standard. We don't see why a different system either less or more rigorous should be established for dietary supplements." Zeller noted that "if Congress is going to legislate," the agency will "advocate that any legislative initiative that takes on labeling issues . . . reaffirms the standard for significant scientific agreement for dietary supplements." He predicted the issue of significant scientific agreement will be picked up by Congress when it reconvenes and "one way or the other, my guess is there will be some form of legislation that will pass." On the likelihood of legislation to extend the effective date of the health claim regs for supplements, Schultz said that he "certainly would not be surprised if there were such an effort." However, he pointed out that "there was such an effort at the end of this Congress and it failed" ("The Tan Sheet" Nov. 29, p. 1). "So the fact that it would be tried doesn't mean that it would necessarily happen," he said. Schultz also suggested that the June 30, 1994 effective date for the regs will be "used as a kind of benchmark to try and get legislation and if we don't do it by then, it just gets harder."

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