In 1994 Congress passed the Dietary Supplement and Health Education Act (DSHEA). Prior to DSHEA, vitamins, minerals, and amino acids were considered to be the major supplements. With the new law, the definition was expanded to also include “herbs or other botanicals, amino acids, dietary substances that supplement the diet by increasing total intake, or a concentrate, metabolite, constituent, extract, or combination of any of the above supplements.” Since DSHEA was passed five years ago there has been an explosion in the marketing and use of supplements, especially herbs and botanicals. DSHEA has given manufacturers more freedom to market products as dietary supplements, with less regulation from the Food and Drug Administration (FDA) than is imposed on new food additives and drugs. There is leniency in that while DSHEA provided specifics about product labeling and advertising, pre-market review of dietary supplements is minimal. As a result, the dietary supplement industry remains largely unregulated compared to the vigorous requirements that pharmaceutical companies must meet to market new drugs.
Dietary supplements are NOT drugs. A drug is an item intended to “diagnose, cure, mitigate, treat, or prevent diseases”. Before marketing drugs must undergo clinical studies to determine their effectiveness, safety, possible interactions with other substances, and appropriate dosages. The Food and Drug Administration (FDA) must review these data and authorize the drug's use before they are marketed. In contrast, the FDA does not authorize or test dietary supplements which can go to market without testing for efficacy thus skipping the years-long process that drugs must undergo. The FDA is also prohibited from taking a supplement off the market unless it can prove that using the supplement will create a medical problem. (This happened recently when five companies in California were forced to recall products containing glyburide and phenformin, glucose lowering medications, which were in products being sold as “Chinese Herbs”).
