Are supplement manufacturers FDA approved?

No. FDA does not approve dietary supplements before they are sold and does not certify supplement manufacturing facilities. Facilities must register with FDA and follow the CGMP rule, 21 CFR Part 111, which FDA enforces through inspections, so the useful checks are a manufacturer’s FDA inspection classifications, warning letters and recalls, plus any third-party GMP certification.

“FDA approved”, “FDA registered” and “FDA certified” appear on many supplement manufacturers’ websites. Only one of them describes something FDA actually does for supplement facilities, and it isn’t approval. Here is what FDA does, what it doesn’t, and which public records tell you more than any of those phrases.

FDA doesn’t approve supplements or certify facilities

Under the Dietary Supplement Health and Education Act (DSHEA), FDA does not have the authority to approve dietary supplements before they are marketed. No supplement or supplement formula is “FDA approved”, whoever makes it.

FDA doesn’t certify supplement facilities either. It inspects them, but in its own words it “does not issue any certification to indicate CGMP compliance at the conclusion of or at any time after those inspections” (FDA export certification FAQs). A manufacturer that calls itself “FDA approved” or “FDA certified” is claiming something FDA does not grant.

Registered is not approved

Facilities that manufacture, process, pack, or hold dietary supplements must register with FDA before beginning those operations. So “FDA registered” describes a legal requirement, not an endorsement. FDA also does not issue certificates of registration or recognize ones issued by private businesses, and a registration number does not mean FDA has approved or endorsed the facility.

What FDA does: CGMP rules and inspections

The dietary supplement CGMP rule, 21 CFR Part 111, applies to anyone who manufactures, packages, labels or holds a dietary supplement, including foreign firms whose supplements are imported or offered for import into the US. FDA’s oversight includes inspecting dietary supplement manufacturing establishments. The results of those inspections, not a registration number, are what FDA’s records can tell you about a manufacturer.

How to look up a manufacturer’s FDA record

Inspections

The FDA Data Dashboard inspections page lists inspections with their final classification:

NAI: No Action Indicated
VAI: Voluntary Action Indicated
OAI: Official Action Indicated

Classifications are based on the findings of the inspection and FDA’s review for compliance. Know the limits: the data is updated weekly and only includes final actions, so inspections awaiting final enforcement action are left out, as are inspections conducted by states. The wider FDA Data Dashboard covers US domestic and foreign inspections, and also compliance actions and recalls.

Warning letters

FDA’s warning letters page can be searched by company name and filtered by date and issuing office, and shows whether a response or closeout letter was posted. FDA notes that matters described in a warning letter may have been the subject of later interaction between FDA and the company, so read any response or closeout letter too.

Recalls

FDA’s recalls page lists recalls from press releases and other public notices, but not all recalls have a press release or appear there. Enforcement reports on food product recalls are searchable through openFDA, where recalled products are classified by the level of hazard involved.

For all three, search under the legal name and address of the site, which may differ from the brand name you know.

What third-party GMP certification adds

Because FDA does not certify CGMP compliance, a third-party GMP certification is a way for a manufacturer to show it. NSF/ANSI 455-2 is a GMP certification standard for dietary supplements based on 21 CFR Part 111 plus retailer requirements and industry practice, and NSF publishes a public listing of certified facilities. No law requires it, but unlike “FDA approved”, it is a claim you can check. What is the best certification for a supplement manufacturer? covers the alternatives for other markets and needs.

What our manufacturer profiles show

Each profile in this directory has an FDA recall records section and, where we find a match, an FDA inspections section:

Inspections are matched to a company by facility ZIP code (or city outside the US) and company name, and show each inspection’s classification and date. The section only appears when we find a match, since a missing match is more often a matching gap than a clean record.
Recalls are matched from FDA’s enforcement reports by company name only, so a recall filed under a different name won’t appear, and a different company with the same name could.

Both link to the FDA record, and how we check explains the matching. Treat them as a starting point and confirm on FDA’s own pages.

Next step

Start from NSF-certified supplement manufacturers, check each one’s FDA record as above, then request quotes from your shortlist. Questions to ask a supplement manufacturer lists what to ask next.

Common questions

What does “FDA registered” mean for a supplement manufacturer?

That the facility is registered with FDA as a food facility, which facilities that manufacture, process, pack or hold dietary supplements must do. FDA does not issue registration certificates, and a registration number does not mean FDA has approved or endorsed the facility.

Is there such a thing as an FDA-approved supplement facility?

No. FDA inspects dietary supplement facilities for CGMP compliance but does not issue any certification of compliance, at the end of an inspection or afterwards. Treat “FDA approved” or “FDA certified” claims about a facility as a red flag.

What do NAI, VAI and OAI mean?

They are the classifications FDA gives inspections: No Action Indicated, Voluntary Action Indicated and Official Action Indicated. The FDA Data Dashboard publishes final classifications, and leaves out inspections still awaiting final enforcement action.

How do I check if a supplement manufacturer has had a warning letter?

Search FDA’s warning letters page by company name. Try the legal name of the site as well as the brand name, and read any response or closeout letter listed with it.

Does FDA inspect supplement manufacturers outside the US?

The CGMP rule applies to foreign firms whose supplements are imported or offered for import into the US, and the FDA Data Dashboard covers both US domestic and foreign inspections.

Sources

Search the directory for certified or licensed manufacturers, or read how we verify each listing.