ACP: Governmental Affairs and Public Policy - Letter to FDA expressing concern about the safety and efficacy of certain herbal supplements that are known to have potential harmful side effects

Advocacy

Letter to FDA expressing concern about the safety and efficacy of certain herbal supplements that are known to have potential harmful side effects

August 9, 2004

Lester M. Crawford, DVM, PhD
Acting Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

Dear Dr. Crawford:

On behalf of the American College of Physicians (ACP), representing more than 116,000 doctors of internal medicine and medical students, and the nation's largest medical specialty society, I am writing to express our concern about the safety and efficacy of certain herbal supplements that are known in the medical literature to have potential harmful side effects.

As you are aware, the regulatory standards for pharmaceutical drugs and herbal supplements contrast significantly. While a proposed new drug can only be approved if it is deemed to be safe in multiple human studies, there is no requirement for manufacturers of herbal supplements to provide evidence of product safety to the Food and Drug Administration (FDA) prior to marketing the product. In addition, while pharmaceutical companies are required to notify the FDA if consumers experience serious side effects, the FDA must rely on voluntary reporting from herbal supplement manufacturers to identify potential safety problems.

While many herbal supplements are generally safe, ACP believes that there are a significant number of highly questionable products that most likely would not be allowed on the market if they were subject to pre-market safety testing. We therefore urge the FDA to require pre-market safety testing of all herbal supplements and require manufacturers to report all adverse side effects experienced by consumers to the FDA. Until appropriate studies are available, the College recommends that a boxed warning label be affixed on herbal supplements sold in the United States indicating that the risks and benefits of these products have not been scientifically evaluated.

The College believes that in order to prevent additional deaths and serious injuries that can be caused by herbal supplements, the FDA must take immediate action to ensure the safety of the American public. We look forward to working with the Food and Drug Administration to ensure the safety and efficacy of herbal supplements and to educate both physicians and the public about the health risks of certain herbal supplements. Please contact Renee Zerehi, Associate, Health Policy & Council Activities at 202-261-4555 or rzerehi@acponline.org if you have any questions.

Sincerely,

Charles F. Francis, MD, FACP
President