Congressional Hearing Revisits DSHEA

WASHINGTON--Spokesmen from the Food and Drug Administration (FDA), industry associations and consumer groups were among those testifying at a hearing held June 8 on the current regulation of dietary supplements. The hearing, "Dietary Supplement Safety Act: How is FDA Doing 10 Years Later," was convened by the Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia. Only two of the 11 committee members were in attendance--Sen. George Voinovich (R-Ohio), the chairman, and Sen. Richard Durbin (D-Ill.), the ranking member and a long-standing opponent of the Dietary Supplement Health & Education Act (DSHEA).

Among those who spoke at the hearing were Robert E. Brackett, Ph.D., director of FDA's Center for Food Safety and Applied Nutrition (CFSAN); Anthony Young, general counsel to the American Herbal Products Association (AHPA); Annette Dickinson, Ph.D., president of the Council for Responsible Nutrition (CRN); and Charles Bell, programs director for the Consumers Union, the publisher of Consumer Reports. Speakers were held to abbreviated comments, though their prepared statements were entered into the record.

In his prepared statement, Brackett gave an overview of the statutory requirements of DSHEA, listed enforcement actions from the past two years as illustrative of the agency's work in the area, and acknowledged the need to promulgate final GMP (good manufacturing practice) regulations. "The publication of the final rule on dietary supplement GMPs remains a high priority for FDA," Brackett said. "This proposed rule, if finalized as proposed, will give consumers greater confidence that the dietary supplements they choose to use will have the identity, strength, purity and composition that they are represented to have." Brackett also discussed the new adverse events reporting system (CAERS) put in place in 2003.

AERs were the focus of Young's statement, as AHPA has been active in the area. In March 2003, the association filed a citizen's petition with FDA to request the agency create regulations mandating reporting of serious AERs with the same safeguards in place for pharmaceutical AERs. Dickinson also addressed AERs in the CRN statement, and agreed that the reporting requirements should not exceed those for pharmaceuticals. She further noted concerns about the two most controversial products--ephedra and androstenedione--should be put to bed before Congress convenes in 2005. "Hopefully, we will [then] be able to work together on different types of hearings--hearings exploring the benefits of dietary supplements and the potential health care cost savings that could be realized if more people used supplements on a regular basis," she said.

Not all of the statements were positive about the current regulation of dietary supplements. "For the last 10 years, consumers have borne the unacceptable risks and consequences of a law that allows untested supplements to be aggressively marketed and sold, with no prior safety testing and evaluation," Bell's statement read. He requested Congress implement a pre-market approval process for dietary supplements and mandate AER reporting. Bell's statement also referred to the recent Consumer Reports article on "dangerous" supplements, which industry groups have characterized as overwrought and misleading.

According to industry members in attendance at the hearing, there were some tough questions posed to the speakers, though it did afford an opportunity to revisit main points and clarify possible misinterpretations of information previously presented. There was a positive response to industry's willingness to work within a mandatory AER system, provided the system is no more restrictive than that for pharmaceuticals and encompasses over-the-counter (OTC) drugs. And the committee members remained visibly perplexed by the fact that after 10 years, there have not been final GMPs released and only recently has FDA actively used its enforcement powers granted under DSHEA. Ultimately, observers noted the continued attention to DSHEA underscores the need for active industry self regulation.