Are herbal supplements regulated?

Herbal supplements are regulated by the U.S. Food and Drug Administration (FDA), but not as strictly as prescription or over-the-counter (OTC) drugs. They fall under a category called dietary supplements.

Dietary supplement makers don't need FDA approval to sell their products, but they must:

• Ensure that their supplements are free of contaminants and that they're accurately labeled.
• Have research to support claims that a product addresses a nutrient deficiency or supports health, and include a disclaimer that the FDA hasn't evaluated the claim.
• Avoid making specific medical claims. For example, a company can't say: "This herb reduces the frequency of urination due to an enlarged prostate." The FDA can take action against companies that make false or unsupported claims to sell their supplements.

These regulations provide assurance that:

• Herbal supplements meet certain quality standards
• The FDA can remove dangerous products from the market

However, the rules don't guarantee that herbal supplements are safe for anyone to use.