How Supplements Are Regulated

This page describes the United States. Other countries have different rules, and we did not verify them.

What FDA does and does not do

• Under the Dietary Supplement Health and Education Act of 1994, FDA is not authorized to approve dietary supplements for safety and effectiveness before they are marketed. In many cases firms can lawfully market a supplement without even notifying FDA. [1]
• Manufacturers and distributors are responsible for making sure products are safe before they are marketed; manufacturers must produce supplements that meet minimum quality standards, do not contain contaminants or impurities, and are accurately labeled. [2]
• FDA requires safety data for a new dietary ingredient not sold in the US before 1994; it does not review effectiveness. [3][2]
• FDA can act against adulterated or misbranded supplements only after the product is on the market. [3]
• FDA tracks side effects reported by consumers and companies. [3] See Side effects and reporting.
• Rules for supplements are less strict than for prescription or over-the-counter drugs. [3]

Label claims

Supplement labels cannot claim to diagnose, treat, cure, mitigate or prevent disease. They can carry structure/function claims, such as "calcium builds strong bones", which must be accompanied by a disclaimer that FDA has not evaluated the statement. [3] The Federal Trade Commission regulates advertising and requires it to be truthful and not misleading. [3]

What this means for you

A product being on the shelf does not mean it was tested for safety by FDA. Quality varies, so read Product quality and contamination and Reading supplement labels.

FDA's Dietary Supplement Ingredient Directory

FDA launched an Ingredient Directory in 2023. [3][4]