Brackett & Dickinson testify on behalf of DSHEA before Senate Subcommittee.

On June 8th, the Senate Subcommittee on Oversight of Government Management. The Federal Workforce, and the District of Columbia held a hearing titled, "The Dietary Supplement Safety Act: How is FDA Doing 10 Years Later." Offering testimony at this hearing were Robert Brackett, director of the Center for Food Safety and Applied Nutrition (CFSAN), Washington, D.C., and Annette Dickinson, president, Council for Responsible Nutrition (CRN), Washington, D.C. Both gave an extensive background on DSHEA, including its purpose and FDA's role in enforcing the law. They also discussed adverse event reporting (AERs) for dietary supplements in terms of what is currently in place and what can and should be done about this issue in the future.

Mr. Brackett highlighted AERs as an important tool for FDA to help identify potential safety problems with dietary supplements. He went on to say that CFSAN has already put in place a system--CFSAN Adverse Event Reporting System (CAERS)--to monitor AERs for CFSAN-regulated products (i.e. food, dietary supplements, cosmetics). According to Mr. Brackett, CAERS began collecting reports after June 15, 2003, and it unifies CFSAN's adverse event reporting through one common portal. Dr. Brackett also discussed on the status of dietary supplement GMPs, indicating the publication of the final rule remains a high priority for FDA, and that FDA is working to reviewing 1600 pages of comments. In summing up his testimony, Dr. Brackett went through a detailed list of the most recent enforcement actions carried out by FDA and FTC against misleading or adulterated dietary supplement products.

Ms. Dickinson's testimony took a different route. According to Ms. Dickinson, dietary supplements are used by 70% of the population at least some of the time and by 40-50% of the population on a regular basis. "This is just as true in Iowa and Illinois as it is in New York and California," she said. She also pointed out that were it not for two highly controversial products--ephedra and androstenedione--the dietary supplement industry would be rightly recognized to have as good a safety record and as strong a benefit profile as any other food category. She gave an indication in her testimony that it is time to move on from these two issues and focus on the larger public health picture and how dietary supplements can play a role. "If current FDA actions are upheld, as we expect they will be, these two ingredients will not longer be an issue when the next Congress convenes in 2005, and hopefully we will be able to work together on different types of hearings--hearings exploring the benefits of dietary supplements and the potential healthcare cost savings that could be realized if more people used supplements on a regular basis," she said.

About AERs, Ms. Dickinson said they are mandatory for some drugs, vaccines and medical devices, but voluntary for OTC drugs subject to monographs, and for conventional foods and dietary supplements. She said since one ephedra company denied and then released thousands of AERs to FDA, there has been pressure to require AERs for dietary supplements. She also pointed out that if there were to be such a requirement, it would be important for it to contain at least the protections for reporting companies and for individuals that are included in the regulations applicable to other FDA-regulated categories. Ms. Dickinson said right now the legislative proposals currently on the table tend to exceed requirements applicable to pharmaceuticals and other product categories. Also important, she said, is how those AERs are interpreted and used. "Some of the legislation on the table appears to assume that every adverse event is meaningful and is a true indictment of the product said to be associated with it, and this is simply not the case," she said.

In conclusion, Ms. Dickinson said the overwhelming majority of dietary supplement products are manufactured by responsible companies operating under stringent GMPs and providing science-based formulations with substantiated claims. She said the problem lies with industry critics portraying the fringe products as representative of this industry as a whole. She also said that if this industry's products were regulated as drugs, they would also cost as much as drugs and perhaps be restricted in availability.--R.M.W.