The FDA and DSHEA: 10 Years Later

Congress passed the Dietary Supplement Health and Education Act 10 years ago. The Act granted the FDA the authority to protect the public from potentially unsafe dietary supplement ingredients that had not been sold previously in the U.S. While a report from the American Botanical Council's journal HerbalGram indicated that 70 percent of new submissions have been rejected, previously marketed dietary supplements were left with no safety control. Reports of poor manufacturing standards are prevalent in publications such as Consumer Reports and medical journals. And safety/efficacy studies are criticized for their poor design. The public originally urged Congress to refrain from major limitations on dietary supplements, but the widely publicized dangers of using certain products has slowly changed public opinion. The death of a well-known baseball figure, linked with his use of ephedra, dramatically affected public concern for better information on the safety of these products. As a result, the FDA has announced three major regulatory initiatives. The first initiative is designed to improve the evidence provided to the FDA for their safety and enforcement decisions. Working with a variety of partners such as the NIH Office of Dietary Supplements, NCCAM, and national or regional toxicology centers, the FDA has outlined innovative research designs with specific criteria that will enable researchers to provide better-quality evidence upon which to base decisions. The second initiative is the development of a "signal detection" process to quickly identify issues of concern regarding safety. Forming a systematic approach for dealing with the numerous reports from federal, state, media, consumer groups, and others will allow a more comprehensive view of risk. The third initiative will address the need to establish industry-wide standards for quality "seed to shelf" manufacturing. Ensuring product purity, quality, strength, composition, and appropriate labeling is crucial. Input is still being sought on this third initiative. The executive summary can be accessed at http://www.nap.edu. Return to Top