DIETARY SUPPLEMENT SAFETY MECHANISM CITED AS KEY PRINCIPLE FOR LEGISLATION

DIETARY SUPPLEMENT SAFETY MECHANISM CITED AS KEY PRINCIPLE FOR LEGISLATION by William Schultz, a staffer for Rep. Henry Waxman (D-Calif.), at a June 30 conference held by the Council for Responsible Nutrition, Schultz, counsel for the House Energy and Commerce/health subcommittee, asserted that a central "principle of legislation" on dietary supplements is "some kind of safety mechanism whereby we can be more confident in the safety of these products." Schultz speculated that ensuring safety of dietary supplements "may involve some kind of comprehensive review because now the FDA doesn't know what [dietary supplement] products are out there . . . much less have any idea if they're safe." He added: "Any responsible piece of legislation is going to have to address this issue." Dietary supplement bills supported by the industry have already been introduced by Rep. Bill Richardson (D-N.M.) and Sen. Orrin Hatch (R-Utah), and do not specifically propose a mechanism for ensuring dietary supplement safety ("The Tan Sheet" April 12, p. 6). Hearings on the bills (HR 1709 and S 784) are expected at the end of July (see preceding story) in the health subcommittee, chaired by Waxman, as well as in Sen. Edward Kennedy's (D-Mass.) Senate Labor and Human Resources Committee. Another tenet of successful legislation mentioned by Schultz would be to ensure a "fair system" of dietary supplement regulation by FDA. Schultz declared that the current regulatory situation for dietary supplements under the food additive provisions of the FD&C Act "is not acceptable." He suggested that the law needs to be refined "so that when the FDA finds safety problems, it goes after a product on the basis that it is unsafe." Similarly, when FDA "finds that there's a problem with the claim, then the issue is the claim." Under the current regulatory system as described by Schultz, FDA "has a general policy of allowing these products to be sold, but when it finds a problem . . . it brings a lawsuit against the company and says: 'You never got premarket [approval] from us.'" A "fair system" would entail having "fair decision-makers" reviewing potential health claims for dietary supplements, the Waxman staffer noted. "We need to get to a situation where the people making decisions on the claims for these products look at them in a fair way" and have the "expertise that they need to have." This includes not reviewing health claims "from the perspective of the drug section of the FDA or the food section of the FDA," Schultz underscored. "We have to find a way that we can set up the FDA . . . so that when somebody comes to the FDA wanting to make a claim, they can be confident that they're going to get the expertise" necessary and "a fair look," he declared. "Fairness also means timely decisions," Schultz emphasized. "It is unacceptable to file a claim . . . and not get a decision on it in a fairly short period of time." He added that "if we're going to require premarket review of claims . . . we have to find a way of assuring that these decisions will be made in a timely manner." Responding to a question about how FDA would handle the expected onslaught of health claim applications expeditiously under such a program, Schultz suggested that legislation could require FDA to "have an advisory panel" to review claims. Although the Nutrition Labeling & Education Act requires that health claims be evaluated by the agency, both the Richardson and Hatch bills would exempt dietary supplement health claims from FDA preclearance. Richardson's bill, however, would mandate notifying FDA that a health claim will be made in product labeling within 30 days of the product's market introduction. Two other essential principles that should be incorporated into dietary supplement legislation, according to Schultz, are: that "products ought to be available if they're safe and if they don't make any misleading claims"; and that health claims should be "based on science" and approved by FDA in the same manner as conventional foods. "You've got to think very carefully [about] how you justify a different system for [supplements] versus food products," Schultz stated, and "I would strongly advise you not to go that route." Schultz warned the CRN audience that, regardless of industry or congressional support garnered for the Hatch and Richardson bills, it is "inconceivable to me that this legislation could get to the House floor next fall without it being something that Congressman Waxman agreed to." "There cannot be a hearing" on the legislation "unless he desires to have a hearing," Schultz declared. "The legislation cannot be marked up" in the health subcommittee unless Rep. Waxman "chooses to put the legislation on the calendar," he said, and "then it cannot go through the full" Energy and Commerce Committee unless Committee Chairman John Dingell (D-Mich.) clears it for consideration. Legislation "can't get to the House floor unless it goes through the committee," Schultz pointed out, concluding that "there are a number of players in this [dietary supplement debate] and you have to deal with all of them." While "there's a real desire" to move forward on dietary supplement legislation this year, Schultz cautioned, "it's not something that has to be done. It's not something that can't theoretically be addressed by the FDA" administratively.