What does “FDA registered” mean?

What the regulation says

21 CFR 207.77 is titled “What legal status is conferred by registration and listing?” It says registering an establishment or listing a drug does not denote approval of the establishment, the drug or the company's other drugs, and does not mean a product may be legally marketed. It says the same about FDA accepting registration or listing information, including a drug in its database, or assigning an NDC.

The section also says FDA cannot conclude from registration or listing that a company intends to make drugs or that a product is a drug, though registration may be evidence of intent.

Claims of approval based on registration

The regulation also addresses representations that create an impression of official approval because of registration or a registration number. It treats these as misleading and as misbranding. Read the full section on the cited page, because we read it through a summary.

How to read the phrase

• Ask which FDA action the claim refers to. Registration, approval and inspection are different things.
• A registration or NDC number tells you a filing exists. It does not tell you FDA reviewed the product.
• “FDA registered” next to a product claim is worth a second look, especially next to health claims.