Safety and Efficacy Issues
With the passing Dietary Supplement
Health and Education Act (DSHEA) of 1994, the production of herbal remedies
increased. However they do not require approval by the FDA. Safety
and efficacy is not guaranteed. Problems include:
1. Varying amounts of
2. Additive effects of an active
drug, that produces adverse effects.
3. Contamination of herb with toxic
pathogens and/or chemicals.
4. Accidental substitution of a herb with
a toxic species.
5. Labeling - does not include proper
dosing guidelines or warnings. They must provide a disclaimer stating the
FDA has not reviewed the herb and it is not intended to be used as a drug.
Only 7 herbs are approved by the FDA
Recommendations for Safe
36 are considered by the
German Commission E to be effective