Are Herbal Supplements Regulated by the FDA?
Herbal supplements fall under a category known as dietary supplements, which are regulated by the U.S. Food and Drug Administration (FDA). However, it is important to note that the regulation differs significantly from that of pharmaceutical drugs. The FDA does not require herbal supplements to prove their safety or effectiveness before they are marketed. Instead, the responsibility lies with the manufacturers to ensure their products are safe and accurately labeled.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 provides a framework under which herbal supplements are governed. This act allows herbal supplements to be considered safe until proven otherwise. Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to help ensure product quality, but compliance is not always strictly enforced.
While the FDA can take action against products that are deemed unsafe or misleading, it typically does so after issues arise. Therefore, consumers should be cautious and do thorough research when selecting herbal supplements. It is advisable to consult a healthcare professional before starting any new supplement regimen, especially for those with existing health conditions or who are taking other medications.