FDA Food Approval Process

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The FDA food approval process https://prime-consultants.org/fda-food- ... l-process/ ensures that food products entering the U.S. market are safe, properly labeled, and meet regulatory standards. While most conventional foods do not require prior approval, certain categories like food additives, dietary supplements, and novel ingredients must go through rigorous evaluation.

For food additives, companies must submit a Food Additive Petition or demonstrate safety through a Generally Recognized as Safe (GRAS) notice. Dietary supplements require compliance with Current Good Manufacturing Practices (cGMP) and proper labeling but do not need pre-market approval unless they contain new dietary ingredients (NDIs), which must be reviewed.

The process includes reviewing scientific evidence, assessing potential risks, and ensuring accurate labeling to prevent misleading claims. Post-market monitoring and inspections further ensure compliance. Navigating FDA requirements can be complex, so companies often engage regulatory experts to streamline the process, ensuring safe and successful entry into the competitive U.S. food market.