Since herbal supplements are not FDA-approved, are they safe and effective?
Herbal supplements (sometimes called herbal medicines) are natural compounds derived from plants, including leaves, bark, roots, seeds, or flowers, which can be used for potential therapeutic benefits within complementary medicine when used appropriately under the care of a practitioner. Many herbal supplements have evolved into FDA-approved medications through formulation and clinical trials. “It has been estimated that as many as one third to one half of currently used drugs were originally derived from plants.” Did you know that over 3500 years ago, Sumerians and Egyptians used willow bark as a painkiller and antipyretic? Today, this herbal supplement is known as aspirin.
Herbal supplements are not subject to approval by the FDA since they are categorized as dietary supplements rather than drugs. Therefore, they are not regulated by the FDA and have not been tested in FDA-approved clinical trials to prove their effectiveness in treating or managing medical conditions. Consequently, they are intended for use as complementary therapy.
The following review article concludes that “of the top 10 herbs, 5 (ginkgo, garlic, St. John’s wort, soy, and kava) have scientific evidence suggesting efficacy.”
Herbal product | Medical condition that the supplement is likely effective treating | Potential side effects |
Ginkgo biloba | Dementia Claudication (which is leg or arm pain caused by insufficient blood flow during exercise that can suggest peripheral artery disease) | Case reports of bleeding |
Garlic | Elevated cholesterol | Mild gastrointestinal side effects and case reports of bleeding |
St. John’s wort | Mild to moderate depression | Concerns for multiple drug interactions |
Soy | Elevated cholesterol | Concerns regarding long-term estrogenic effects |
Kava kava | Anxiety | Severe liver toxicity |
Bent S. Herbal medicine in the United States: review of efficacy, safety, and regulation: grand rounds at University of California, San Francisco Medical Center. J Gen Intern Med. 2008 Jun;23(6):854-9. doi: 10.1007/s11606-008-0632-y. Epub 2008 Apr 16. PMID: 18415652; PMCID: PMC2517879.
Despite safety concerns due to insufficient clinical trials deterring some patients, approximately 20% of the population uses herbal products. When considering herbal supplements, patients need to consult with a healthcare professional, including naturopaths, to understand which herbal products might be effective and the possible contraindications and potential side effects associated with those herbal supplements. Since herbal medicines are not subject to the same testing, labeling, and manufacturing standards as traditional prescription and over-the-counter medications, it is important that any herbal medicine product be of good quality and recommended by a healthcare practitioner. Ongoing follow-up with your provider is important to monitor for any side effects.