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DIETARY SUPPLEMENT "SENSIBLE, BALANCED" LEGISLATION ENACTMENT URGED

This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT "SENSIBLE, BALANCED" LEGISLATION ENACTMENT URGED by Reps. John Dingell (D-Mich.) and Henry Waxman (D-Calif.) in an Oct. 18 "Dear Colleague" letter. Dingell, who chairs the House Energy & Commerce Committee, and Waxman, who heads the House Energy & Commerce/health subcommittee, asked their fellow representatives to "reserve judgment on any of the pending measures" on dietary supplements "and join us in the effort to enact sensible, balanced legislation." Dingell and Waxman noted that three bills on the regulation of dietary supplements are pending in the House: Rep. Bill Richardson's (D-N.M.) HR 1709, Rep. Elton Gallegly's (R-Calif.) HR 509 and Rep. Cardiss Collins' (D-Ill.) HR 2923. "While these bills have a number of good features, arguments have been made against each," the two congressmen said. For example, they pointed out that HR 1709 and HR 509 "are viewed by some as depriving FDA of authority to prohibit the sale of supplements that are either unsafe or sold with deceptive health claims," while "others consider HR 2923 as providing too much discretion to the FDA, to the potential disadvantage of the dietary supplement industry." Dingell and Waxman said they "are aware of concerns of the dietary supplement industry about FDA." However, they also noted that organizations such as the American Cancer Society, the American Heart Association and the American Association of Retired Persons have opposed HR 1709 and HR 509 "because they believe these bills will not ensure that supplement products are safe and properly labeled." "To attempt to accommodate the divergent approaches," the congressmen wrote, "we have asked our staffs to work with all interested parties to try to achieve legislation that will establish a clear, fair and enforceable way to ensure consumers that the supplements they take are safe, properly manufactured, and accurately labeled." Dingell and Waxman listed three "essential points" that they asked their colleagues to keep in mind during the legislative process: (1) consumers "want to use dietary supplements and it is incumbent on us to develop legislation that will not permit the arbitrary and unnecessary removal of products from the market"; (2) "current FDA regulation of the dietary supplement industry may seem arbitrary because current law is unclear about the status of these products"; and (3) Congress should keep in mind that FDA is required to promulgate final rules implementing the Nutrition Labeling & Education Act for dietary supplements by Dec. 15. "One question we must ask" in devising legislation, the two congressmen wrote, "is whether there should be separate rules for the labeling and advertising of dietary supplements than for foods." For instance, "should a dietary supplement manufacturer be able to make exaggerated and unsubstantiated claims that its product prevents or treats a disease condition when a food containing the identical ingredient is not allowed to make the same claim?" Dingell and Waxman concluded their letter to House members by acknowledging that "there is a great deal of misinformation being provided to consumers and members of Congress on this issue. We know this makes responding to constituent concerns very difficult." They added: "Please be assured that we are working to try to resolve this matter as quickly as possible." Staffers of Rep. Waxman have reportedly fashioned dietary supplement legislation that, unlike the Richardson and Gallegly bill, would grant FDA additional authority to regulate supplements. The draft proposal may serve as a counterpoint to the Richardson bill as lawmakers attempt to consolidate the pending bills into legislation that satisfies both industry and FDA. Although his House Appropriations/agriculture subcommittee held a hearing on dietary supplements on Oct. 18, Rep. Richard Durbin (D-Ill.) is not expected to jump into the fray by introducing a supplement bill. Rather, staffers of the congressman say, Durbin is monitoring the status of the pending bills in order to gauge whether they will affect FDA funding. On the Senate side, where a companion bill to HR 1709 introduced by Sen. Orrin Hatch (R-Utah) is pending, senators have also been calling for a compromise that reflects a balance between the concerns of FDA and industry. For instance, a group of 10 senators recently wrote to Sen. Edward Kennedy (D-Mass.), whose Senate Labor & Human Resources Committee held a hearing on supplements on Oct. 21, asking that a "creative solution" to supplement regulation be devised that respects the concerns of all interested parties ("The Tan Sheet" Oct. 11, p. 7).

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