What aspect of herbal supplements distinguishes them from conventional medicine as per FDA regulations?

Herbal supplements are distinct from conventional medicine in that they do not require FDA approval before they are marketed. This is due to the regulatory framework established by the Dietary Supplement Health and Education Act of 1994, which categorizes herbal supplements as dietary supplements. Unlike pharmaceuticals, which must undergo rigorous testing and obtain FDA approval to ensure safety and efficacy, herbal supplements can be sold without this pre-market testing.

This does not mean that herbal supplements are without oversight; rather, the FDA can take action against products that are found to be unsafe or improperly labeled after they are on the market. The lack of pre-market approval allows for a wider variety of products to be available to consumers, which is an important characteristic that sets herbal supplements apart from conventional medications.

In contrast, conventional medicines must provide evidence from clinical trials demonstrating their safety and effectiveness before they can be legally sold. This is a key differentiator that has implications for how consumers approach the use of herbal supplements versus conventional pharmaceuticals.