Warning letters are a type of regulatory action the U.S. Food and Drug Administration takes to achieve voluntary compliance and establish prior notice in the industries it regulates under the Federal Food, Drug, and Cosmetic Act. The purpose of a warning letter is to give individuals and firms an opportunity to take voluntary and prompt corrective action before the FDA initiates an enforcement action.
Archived and accessible to the public, warning letters issued by the FDA are a helpful resource to acquire a practical view of the agency’s guidance, policy and requirements for compliance under specific regulations. In particular, FDA warning letters addressing food products identify alleged violations, and provide compliance guidance, with regard to important issues such as labeling requirements, current good manufacturing practice, health or nutrient content claims, serving size and standard of identity.
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