FDA Facility Registration
RegulatoryAlso known as: FDA Registered, Food Facility Registration
FDA registration required of food and supplement facilities unless a 21 CFR 1.226 exemption applies.
What It Means
Under the Bioterrorism Act (2002) and FSMA, all domestic and foreign facilities that manufacture, process, pack, or hold food (including dietary supplements) for US consumption must register with FDA unless an exemption in 21 CFR 1.226 applies. Registration is renewed biennially. It is a legal requirement, not a quality credential, and does not involve any FDA inspection or approval. FDA facility registration records are not publicly searchable, so independent third-party verification of registration status is not possible through public databases.
What It Is Not
Registration does NOT mean FDA has inspected, approved, or certified the facility. Every supplement manufacturer must register unless a 21 CFR 1.226 exemption applies. Advertising 'FDA Registered' as a differentiator implies a distinction that does not exist: every non-exempt competitor must be registered too.
Evidence and References
- regulationFDA Food Facility Registration
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