Are herbal supplements safe?

Herbal supplements are regulated by the FDA, but not as drugs or as foods. They fall under a category called dietary supplements. The rules for dietary supplements are as follows:

• Manufacturers don't have to seek FDA approval before selling dietary supplements.
• Companies can claim that products address a nutrient deficiency, support health or are linked to body functions — if they have supporting research and they include a disclaimer that the FDA hasn't evaluated the claim.
• Companies aren't allowed to make a specific medical claim. An example of a specific medical claim might be, "This herb reduces the frequency of urination due to an enlarged prostate."
• Manufacturers must follow good manufacturing practices to ensure that supplements are processed consistently and meet quality standards. These regulations are intended to keep the wrong ingredients and contaminants out of supplements, as well as make sure that the right ingredients are included in appropriate amounts.
• The FDA is responsible for monitoring dietary supplements that are on the market. If the FDA finds a product to be unsafe, it can take action against the manufacturer or distributor or both, and may issue a warning or require that the product be removed from the market.

These regulations provide assurance that:

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

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

These products can pose unexpected risks because many supplements contain active ingredients that have strong effects in the body. For example, taking a combination of herbal supplements or using supplements together with prescribed medications could lead to harmful, even life-threatening results.

It's important to talk with your doctor before using herbal supplements.