Republished with permission from Citizens for Health, Natural Health E-News Update, March 25, 2004
On Wednesday, the Subcommittee on Human Rights & Wellness held a hearing entitled "10 Years After the Implementation of DSHEA: The Status of Dietary Supplements in the United States." Suprisingly, the FDA spoke favorably about the act that has given consumers wide access to dietary supplements.
The basic consensus from the group is that even though the FDA has been very slow at implementing portions of DSHEA including the good manufacturing practices (GMP's), the law has served its purpose well in protecting consumers access to dietary supplements, providing them more useful information and protecting safety. Dr. Brackett from the FDA told the committee that the FDA has enough authority and does not need any more in order to protect consumers.
The message was clear that from the FDA's point of view, no more regulatory power is necessary to do its job and therefore it does not support any legislation on the Hill that gives it more authority. Dr. Brackett gave a few examples of products the FDA pulled from the market due to safety concerns and fraudulent claims by the manufacturer. When asked about adverse event reports (AER's), Dr. Brackett told the committee that they, the FDA, have many tools at their disposal to track adverse events including contact by doctors and direct contact by consumers.
He seemed to imply that there is no need for forcing the industry to report adverse events. The voluntary program works just fine and any problems with it result from specific companies and not the industry in general, Bracket said.
Representative Burton did take some time to discuss the ephedra issue. Ephedra has been banned in the United States outside of use in Traditional Chinese Medicine and over the counter preparations. He questioned how the ephedra was used and whether its misuse was the actual problem and not its general availability. It seemed from his questions, that he already knew that the answer lay in the misuse of the substance and that with the warning clearly on the label, it was up to the consumer to exercise good judgment.
Congressman Burton did ask Dr. Micozzi to comment on the use of Dietary Supplements culturally and the scientific evidence that strongly supports their use. Dr. Micozzi said that with the publication in JAMA recently of the benefits of dietary supplementation for disease prevention, there are no more excuses for the medical establishment not to support their use. Dr. Micozzi spoke about various research projects across the country that are scientifically validating what we have known for a long time that dietary supplements are an important part of a healthy lifestyle and can be used to combat various chronic diseases.
The hearing was chaired by Representative Dan Burton and Representative Diane Watson. Congresswomen Davis and Senator Durbin where also in attendance. Senator Hatch sent in written testimony. The roster included Dr. Robert Brackett, Ph.D., Director of the Center for Food Safety & Applied Nutrition from the FDA, Marc Micozzi, MD, Ph.D., Director of the Policy Institute for Integrative Medicine at the Thomas Jefferson University Hospital, David Seckman, Executive Director of the National Natural Foods Association, Annette Dickinson, President of the Council for Responsible Nutrition, Alan Dumoff, JD, MSW, American Association for Health Freedom and Doug Rose, father and dietary supplement advocate.
This report was contributed by Michael Ostrolenk, political director.
Back to top of document
