What is the Difference Between "FDA Compliant" and "FDA Approved"?

July 13, 2010

Is there a difference between the terms "FDA Compliant" and "FDA Approval" for a product?


The U.S. Food and Drug Administration (FDA) has stated that it "objects strongly" to the phrase "Approved by FDA" in connection with the marketing or labeling of a product that has been processed through the food additives regulations (see Compliance Policy Guide (CPG) Section 500.300 or click here). However, a firm may state that it is selling a regulated food additive or that its chemicals are in compliance with the food additive provisions of the Federal Food, Drug, and Cosmetic Act.