REP. WAXMAN HEARINGS ON DIETARY SUPPLEMENTS EXPECTED BY LATE JULY

REP. WAXMAN HEARINGS ON DIETARY SUPPLEMENTS EXPECTED BY LATE JULY, according to William Schultz, counsel of the House Energy and Commerce/health subcommittee. Speaking at a June 30 Council for Responsible Nutrition conference in Washington, D.C., Schultz said Chairman Henry Waxman's (D-Calif.) health subcommittee intends "to have hearings on this issue in July; I would guess it would be the latter half of July." Sen. Edward Kennedy's (D-Mass.) Senate Labor and Human Resources Committee also is expected to hold hearings during the summer on dietary supplements. Rep. Waxman "would like to see constructive legislation come out of this debate," Schultz told the group. Although it is not "inevitable that there will be legislation" that will be passed, Schultz explained, "I sense that there's a window to do something now" with dietary supplement legislation before Congress takes up a health care reform package in the fall. Dietary supplement bills were introduced by Rep. Bill Richardson (D-N.M.) and Sen. Orrin Hatch (R-Utah) in April ("The Tan Sheet" April 12, p. 6). Rep. Richardson told the CRN conference that he would like to have a total of 100 cosponsors for his bill (HR 1709) "prior to the hearings taking place" in order to "show strength at the hearing." The bill had "over 42" sponsors on June 30, according to Lisa Westfall, Richardson's health staffer. The New Mexico Democrat called on the industry to help draw out the grass roots support for his dietary supplement legislation. "We need to get more grass-roots movement to show that this is very important to the American consumer," the congressman declared. CRN President J. B. Cordaro assured Richardson that some of the group's members would be meeting "with about 17 members and/or staff" of Congress on June 30 and July 1 "to try to get as close to those 100 cosponsors as we can." Senate Labor and Human Resources Committee minority staffer and Chief Health Advisor Patricia Knight suggested that a willingness to compromise will be necessary in order for the bill to have a chance of moving through Congress. "We're all going to have to pull together to try to work out some compromises," Knight told the CRN meeting. She speculated that the "final bill won't be totally acceptable to every single person, but I think on balance . . . it will be acceptable to all of you." Schultz also highlighted the importance of compromise in his speech before CRN, but warned that the chances of a dietary supplement bill reaching the House floor are poor without the support of Rep. Waxman (see following story). Knight also criticized components of FDA's advanced notice of proposed rulemaking on the regulation of dietary supplements, released June 18 in conjunction with proposed regulations implementing the Nutrition Labeling & Education Act for supplements ("The Tan Sheet" June 21, p. 1). "We have a good deal of concern" about FDA's proposal to establish safe maximum intake levels for vitamins and minerals, Knight said. She characterized the proposal as "another attempt to get around the [Rogers-] Proxmire amendment." Knight also criticized FDA for not consulting with Sen. Hatch "before [the ANPR] was published." However, she said that while FDA did not pursue "the open dialogue . . . that we would have liked," communications between FDA and Hatch have improved since the publication of the proposal. On June 23, FDA Commissioner David Kessler met with Sen. Hatch and separately with Rep. Richardson and National Health Alliance Director Gerald Kessler to discuss dietary supplement issues. Sen. Hatch also has met with HHS Assistant Secretary for Health Philip Lee on supplements. Lee was confirmed as HHS assistant secretary by a Senate voice vote on July 1. Knight also objected to FDA's proposal to regulate "amino acids and herbs . . . as drugs" on the grounds that such an approach is not "workable." She added: "I don't mean to say we're going to be totally unreasonable in what happens with the final legislation but . . . I think it's fairly clear to us that herbs and amino acids, as with vitamins and minerals, are not drugs and should not be regulated as such." To "try to do that," she argued, "would really fly against the intent of our legislation." The Hatch bill specifies that dietary supplements cannot be considered "drugs." The minority staffer noted that groups representing the conventional food industry have visited Hatch's office to express concerns that the Richardson/Hatch legislation would enable a more lenient standard for allowing health claims for dietary supplements than for foods. Both bills do not require FDA preclearance for supplement health claims. Knight acknowledged that "we recognize their concerns and I think we need to find a way to address that." FDA Deputy Commissioner for Policy Michael Taylor told the CRN audience that the agency is "comfortable" with applying the same standards for dietary supplement health claims as for conventional foods, per NLEA. Taylor underscored that "nothing that FDA is doing under NLEA" will affect consumer access to the "vast majority" of vitamins and minerals on the market, and that the agency does not intend to "convert" dietary supplements to prescription drugs. Addressing complaints about the ANPR, Taylor said that FDA is considering whether "the public interest would be served" by establishing a maximum safe limit for vitamins and minerals, but has not yet decided which mechanism to use. The deputy commissioner indicated that a safe upper limit requirement may be warranted by a few vitamins that pose toxicity concerns at higher levels and by future health claims that might encourage higher consumption of certain nutrients. Taylor reiterated that FDA is interested in receiving comments from the industry on this issue to determine if it is "worth our effort" to devise maximum limits. Taylor also noted that FDA's proposal to call for data on amino acid supplements is intended to help the agency decide which regulatory approach is best for the products. He added that the agency "would be open" to a legislative resolution on how to regulate herb products. Taylor concluded his remarks by urging the industry to engage the agency "seriously and scientifically" in comments on the ANPR and the NLEA proposed regs, and promised that FDA would consider all serious comments.