June 24, 2002: What are the Safety Issues with Herbal Products?

Currently, up to 50% of consumers use some type of herbal supplement.  Frequently, the consumer does not consider this to be medicine and the physician is unaware of the ingestion of these products.  For the next few weeks, I am going to review some of the more popular products.

Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, herbal products are categorized as dietary supplements and are therefore exempt from regulations that govern prescription and OTC medications.  Manufacturers accept responsibility for the safety of the dietary supplement.  Supplement manufacturers are not required to provide the FDA with either safety information before marketing a product or post-marketing safety reports as long as its ingredients were on the US market before 1994.  
Even if one assumes ingredients in herbal preparations are safe, product integrity is questionable.  Due to lack of quality control, product potency and purity can vary between batches and manufacturers.  Purity of herbal products is not monitored by a regulatory agency.  In contract to herbal products, pharmaceutical products must be monitored for purity, potency, dissolution rate, and content uniformity.  
Next week:  Part II

As always, if there are any questions, call the MTPC.

I am interested in any questions that you would like answered in “Question of the Week.”  Please e-mail me with any suggestions at donna.seger@Vanderbilt.edu

Donna Seger, M.D.
Medical Director
Middle Tennessee Poison Center