Are herbal sleep supplements regulated by the FDA?

Question

Noddie Night · Accepted Answer

Only partly. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, supplements fall under food-based rules in a category of their own, not the drug rules, so they do not need FDA approval before they are sold. Companies are responsible for making sure their products are safe and properly labeled. The FDA can act against an adulterated or misbranded supplement after it reaches the market.

Prescription drugs must be reviewed and approved by the FDA before sale. Supplements do not go through that process. The National Center for Complementary and Integrative Health adds that the FDA cannot review supplements for safety before marketing, steps in only after a product is on the market, and that a 2012 government study found 20 percent of supplements made illegal claims.

Supplement labels carry a notice that the FDA has not evaluated their statements. Noddie Night is a dietary supplement and carries that notice.

Because contents can differ from labels, read ingredient lists and warnings, and talk to your doctor if you are pregnant, nursing, taking medication or have a medical condition.

Are herbal sleep supplements regulated by the FDA?

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