In a hearing yesterday the chair of a Senate subcommittee on government oversight expressed his concern about the adequacy of dietary supplement legislation and regulations in protecting the safety of consumers, particularly in regard to ephedra, and vowed to take action in a number of areas.
“Either the law is bad [DSHEA], the resources are not being given to you, or there is no will to deal with this threat,'' said Sen. Richard Durbin (D-Ill.), chair of the Senate oversight subcommittee on governmental affairs, to a witness from the Food and Drug Administration (FDA). Durbin was particularly critical of what he believed were the FDA’s insufficiencies in regulating ephedra products.
The hearing, titled “When Diets Turn Deadly: Consumer Safety and Weight-Loss Supplements,” included witnesses from the government and academia. Michael McGuffin, president of the American Herbal Products Association, represented the industry. Although a variety of supplements were discussed, Durbin took care to point out that he had no issue with vitamins and minerals and suggested altering the definition of dietary supplements to make this distinction.
“I believe we should modify the current definition of dietary supplement categories, . . . to highlight the difference between vitamins and minerals, potent herbal products that act like drugs, and animal derivatives,” said Durbin, “as well as [excluding] steroid precursors like andro from the dietary supplement category.”
Among the other items Durbin said he would press for were:
- Legislation to establish a scientific commission to “conclusively” address the question of dietary supplement safety
- Banning the sale of some dietary supplements to minors, including ephedra
- Mandatory reporting of adverse events by supplement manufacturers
- Determination by the FDA of whether dietary supplements containing ephedra are an “imminent health hazard” and if so, their restriction in sale
- Immediate release of good manufacturing practice regulations by the FDA
“The significance of this hearing remains to be seen, but it definitely constitutes a shot across the bow in our efforts to protect DSHEA,” said David Seckman, NNFA’s executive director and CEO. “Certainly, there were issues addressed in the hearing that the industry and Sen. Durbin could agree upon, such as issuing GMPs, revamping the AER system and increasing clinical research. However, redefining the term “dietary supplements” or creating special categories for non-vitamin and mineral supplements would require an entire reworking of DSHEA. A more constructive approach, both for the industry and consumers, would be for Congress to provide the support and motivation necessary to the FDA and others to fully implement an essentially good law.”
For more on the hearing, including submitted witness testimony visit the subcommittee Web site at: www.senate.gov/~gov_affairs/ogm.htm