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").