This is the single most-confused regulatory term in B2B sourcing. Mislabeling either creates federal liability, and the FDA actively monitors and pursues violations. Get this right.

FDA registration is an administrative requirement. Under the Bioterrorism Act of 2002 and subsequent legislation, any facility manufacturing food, drugs, medical devices, or (under MoCRA) cosmetics for U.S. commerce must register with the FDA and renew the registration every two years. Registration is a directory listing — it tells the FDA the facility exists, what it makes, and where to find it. The FDA assigns each facility a Registration Number.

Registration does not mean: (1) the FDA has visited the facility, (2) the FDA has reviewed any product made there, (3) the FDA has approved anything. A facility can register and be operationally non-compliant — the FDA only catches that on inspection, which can take years between visits.

FDA approval is a regulatory clearance of a specific product. The categories that require FDA approval are narrow:

• New drugs (prescription and OTC monograph drugs): Require an FDA-approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), or compliance with an OTC monograph. Years of clinical trials, hundreds of millions of dollars per molecule.
• Medical devices (Class II and Class III): Require 510(k) clearance or Premarket Approval (PMA).
• Color additives and food additives: Require pre-market approval through specific FDA pathways.
• Infant formula: Requires a pre-market notification and FDA review.

Dietary supplements, conventional foods, cosmetics, and most over-the-counter wellness products are not FDA-approved. They operate under different regulatory frameworks:

• Dietary supplements: Regulated under DSHEA (1994). Manufacturers must follow cGMP (21 CFR 111) and submit a New Dietary Ingredient (NDI) notification for novel ingredients introduced after 1994. There is no pre-market approval of supplement products themselves.
• Cosmetics: Historically minimal pre-market regulation. MoCRA (2022) is adding facility registration, product listing, safety substantiation, and adverse-event reporting requirements — but not pre-market approval.
• Conventional foods: Facilities register; products generally do not require pre-market approval unless they contain a new food additive.

What it means for labels and marketing. A supplement brand may truthfully state its facility is "FDA-registered" or "manufactured in an FDA-registered facility." It cannot state the product is "FDA-approved," "FDA-cleared," or "approved by the FDA." Doing so is a misbranding violation under the Federal Food, Drug, and Cosmetic Act, and the FDA's Office of Dietary Supplement Programs issues Warning Letters routinely for this exact infraction. Look at any FDA Warning Letter database — "FDA-approved" claims on supplement labels appear in dozens of letters per year.

Verifying a facility's registration. The FDA's Establishment Registration database is publicly searchable for drug facilities. Food facility registrations are also tracked but the public database is more limited. Ask the manufacturer for the registration number, then verify the number resolves to the facility name and address you expect.