FDA Approval

FDA approval means the U.S. Food and Drug Administration has reviewed and authorized a product for safety and effectiveness before it goes to market.

FDA approval is required for prescription drugs, certain medical devices, and some biological treatments, but not for dietary supplements, cosmetics, or most over-the-counter products. FDA approval confirms that a product has passed tough FDA review to ensure it’s safe, effective, and made to high quality standards.

Want to learn more about FDA compliance and dietary supplements specifically? Check out our blog post: "Does the FDA Regulate Supplements? A Guide for Your Supplement Business."