Burton Holds DSHEA/Supplement Hearing

April 1, 2001

5 Min Read
Burton Holds DSHEA/Supplement Hearing

Burton Holds DSHEA/Supplement Hearing

WASHINGTON--Representatives of the dietary supplement industry, consumer watchdog groups and the Food and Drug Administration (FDA) were among the witnesses who testified at a March 20 hearing of the U.S. House of Representatives Committee on Government Reform. The hearing was titled "Six Years After the Enactment of DSHEA: The Status of National and International Dietary Supplement Regulation and Research." C-SPAN taped the hearing and planned to air it periodically into early April.

Rep. Dan Burton (R-Ind.), the committee chairman and a strong proponent of dietary supplements and complementary medicine, opened the hearing with a summary of the historical resistance by the FDA to dietary supplements. He also emphasized the importance of dietary supplements to American healthcare. "My colleagues in Congress and I will continue to protect Americans' rights to access dietary supplements," he concluded.

Rep. Henry Waxman (D-Calif.), the ranking minority member of the committee spoke next, offering some acknowledgement that supplements may have value, but strongly criticizing the dietary supplement industry. He recognized the importance of nutrients such as calcium and folic acid, but expressed serious concern about the potential dangers of ephedra and St. John's wort. Waxman also said that he believes Americans need access to safe and effective dietary supplements, but that these products are "largely unregulated."

The first witness to testify was Rep. Frank Pallone (D-N.J.), who announced that he would join the newly formed Complementary and Alternative Medicine and Natural Foods (CAMNF) Congressional Caucus. Pallone stated his support of the Dietary Supplement Health and Education Act (DSHEA), and also criticized the growing sentiment among some members of Congress that DSHEA should be modified or repealed. "We need to be moving away from a disease care only system and start promoting more wellness and optimal healthcare policies that include dietary supplements and functional foods," he said.

Several industry members testified at the hearing. Loren Israelsen, executive director of the Utah Natural Products Alliance (UNPA), reviewed DSHEA and stated that the top two FDA priorities should be Good Manufacturing Practices (GMPs) and an improved Adverse Event Reporting (AER) system. Next, David Seckman, executive director of the National Nutritional Foods Association (NNFA), discussed the NNFA's GMP certification program and Tru-Label program. Mark Blumenthal, executive director of the American Botanical Council (ABC), focused on herb issues and stated that he believes botanicals should be able to make therapeutic claims. And Karl Riedel, CEO of Nature's Life and a member of the U.S. Delegation to Codex, reviewed the Codex process and stated that fears related to Codex are unfounded. He called for a much more aggressive advocacy of DSHEA by the U.S. delegation to Codex.

Other interested parties testifying included Samuel Benjamin, M.D., chairman of Invite Health and a practicing pediatrician, who discussed the role of nutrition in addressing growing healthcare costs and cited several personal cases in which dietary supplements led to a successful patient outcome; Sidney Wolfe, M.D., director of the health research group at Public Citizen, who expressed concern about the dangers of ephedra and herb-drug interactions, and stated that DSHEA should be repealed; and Bruce Silverglade, director of legal affairs at Center for Science in the Public Interest (CSPI), who stated that some dietary supplements can contribute to health, but that premarket approval of safety and efficacy are needed.

After each witness provided his opening statement, Burton and other committee members asked questions, primarily focusing on ephedra and the issue of industry quality and responsibility. Israelsen, Seckman and Blumenthal supported FDA action in line with industry guidance; Riedel said that many current U.S. uses of ephedra conflict with historical uses; Benjamin said that he could not support the use of ephedra; and Wolf stated that it should come off the market. Following the answers, Burton made reference to a not-yet-published study by Harvard and Columbia Universities that concluded ephedra is safe when properly used.

The final speakers were Joseph Levitt, director of the FDA's Center for Food Safety and Applied Nutrition, and Elizabeth Yetley, Ph.D., U.S. delegate to the Codex Alimentarius Commission on Nutrition and Foods for Special Dietary Uses. Levitt acknowledged that FDA's progress in implementing DSHEA had been too slow, but suggested that this had changed. He referred to the development of a 10-year plan and reviewed its goals. Levitt emphasized that the FDA needs additional funding to properly deal with dietary supplements, and stated that the dietary supplement area is one the agency's smallest programs with only $6 million of the total FDA budget of more than $1 billion.

Burton questioned Levitt on the progress of improving the AER system for dietary supplements, to which Levitt responded that companies could now have better access to AERs involving their products, but that further improvements will require additional funding. Burton also was critical of the lack of dialogue between FDA and the dietary supplement industry and strongly suggested that this be improved. Levitt was also asked whether FDA's 1997 Advanced Notice of Proposed Rulemaking (ANPR) for ephedra prevents the agency from communicating with the dietary supplements industry on the issue, to which Levitt answered "no."

Questions for Yetley focused on the Codex process and the U.S. delegation's commitment to support DSHEA in this process. Yetley stated that "we support access to dietary supplements that are safe and truthfully labeled."

Attendance at the hearing was heavy, with many proponents of the dietary supplement industry there in conjunction with NNFA's Natural Foods Lobby Day. Burton's committee has previously held numerous hearings related to dietary supplements and alternative medicine.

Details on the hearing are available at www.house.gov/reform/.

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