"FDA Approved" signifies that the U.S. Food and Drug Administration has determined a product is safe and effective for its intended use after a thorough scientific review. This approval requires demonstrating that the product's benefits outweigh its risks through rigorous testing, including clinical trials, and that the product is manufactured to high-quality standards.
FDA-Approved vs FDA-Compliant
"FDA Compliant" means a product, process, or facility meets the specific regulations and standards set by the U.S. Food and Drug Administration (FDA) for safety and quality in sectors like food, pharmaceuticals, and medical devices. It signifies that the manufacturer followed the established rules for manufacturing, handling, labeling, and distribution, even if formal pre-market approval from the FDA was not required. Compliance helps ensure products are safe for consumers, but it is distinct from FDA "approval," which is a more rigorous process that only applies to certain products.