What is a certified manufacturer?

A certified manufacturer is a company whose production facility an independent body (a certifier such as NSF or LGC, or a site-licensing regulator such as Australia’s TGA or Health Canada) has assessed against a named standard and lists publicly. The certification belongs to that site and standard.

“Certified” on a manufacturer’s website only means something when you can answer four questions: certified by whom, to what standard, for which site, and current as of when? A real certification has a named issuer, a named standard, an address it applies to, and an entry on the issuer’s public list that you can check yourself.

Who does the certifying

Two kinds of body assess supplement manufacturing sites. Certifiers audit facilities against a standard and publish a list of the facilities that pass. NSF certifies facilities to NSF/ANSI 455-2, a good manufacturing practice (GMP) standard for dietary supplements, and LGC runs Informed Manufacturer, which audits a site’s quality systems and tests it for substances prohibited in sport.

Regulators in some countries license manufacturing sites. In Australia, the Therapeutic Goods Administration (TGA) requires sites that manufacture therapeutic goods there, including listed (complementary) medicines, to hold a GMP manufacturing licence unless exempt. In Canada, no one may manufacture, package, label or import a natural health product for sale without a Health Canada site licence. A licence is not called a certification, but it answers the same questions: an independent body has assessed the site and lists it publicly.

Certification belongs to a facility

A certification is granted to a site, not to a brand or a whole company. A company can run several plants, and its certified plant may not be the one that makes your product. Ask which address will make your product, and check that address.

Certifications also lapse. A certificate that was valid when you first spoke to a manufacturer may not be valid when you sign, so check current status on the issuer’s own list before you commit. Our guide on how to verify a manufacturer’s certification walks through the checks.

What “FDA-certified” claims mean

In the United States, the FDA does not certify supplement manufacturers. FDA periodically inspects dietary supplement facilities for compliance with its current good manufacturing practice (CGMP) requirements, but in its own words, FDA “does not issue any certification to indicate CGMP compliance at the conclusion of or at any time after those inspections” (FDA export certification FAQs).

FDA food facility registration is not certification either. FDA does not issue a certificate of registration, does not recognize registration certificates issued by private businesses, and a registration number does not mean FDA has approved or endorsed the facility (FDA on registration certificates). So “FDA-registered” means registered, nothing more, and a supplement maker that calls itself “FDA-certified” or an “FDA-approved facility” is making a claim FDA does not support. Treat it as a red flag.

How certification relates to the law

In the US, 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. Meeting it is a legal obligation, not a credential.

Because FDA does not certify compliance, a third-party GMP certification is one way a manufacturer can 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. Facilities that manufacture, package, or warehouse and distribute supplements can be certified, and NSF publishes a list of them.

Facility certification is not product certification

Some certifications cover products rather than sites. NSF/ANSI 173 verifies that what is on a supplement’s label is in the product, reviews its ingredients for toxicology and contaminants, and NSF periodically retests certified products. It certifies the product, not the facility that made it. A certified manufacturer is about the site; a certified product is about what comes out of it. Our guide to supplement manufacturing certifications covers each one.

How this directory uses the term

Every company in this directory is listed because we found at least one of its facilities on a public certification registry or regulator’s licence list. “Verified” means we found the company on that public listing on the date shown on its profile; it does not mean we audited the facility. How we verify lists the registries we check and explains the details, and you can browse all supplement manufacturers or NSF-certified supplement manufacturers.

Common questions

Does the FDA certify supplement manufacturers?

No. FDA periodically inspects dietary supplement facilities to evaluate compliance with its current good manufacturing practice (CGMP) requirements, but it does not issue any certification of CGMP compliance, either at the end of an inspection or afterwards. A claim to be an “FDA-certified” or “FDA-approved” supplement facility is a red flag.

What does “FDA-registered” mean?

Only that the facility is registered with FDA as a food facility. FDA does not issue a certificate of registration, does not recognize registration certificates issued by private businesses, and a registration number does not mean FDA has approved or endorsed the facility.

If a company is certified, is every product it makes certified?

No. A facility certification covers one site against one standard. A company can run certified and uncertified sites, and a facility certification does not test finished products. Product certifications such as NSF/ANSI 173 are separate and cover named products.

Is a certificate of manufacture the same as being certified?

No. A certificate of manufacture is a document a manufacturer issues itself, stating that goods were made to an order’s specification. It is not a third-party certification.

How does this directory decide a manufacturer is certified?

We list companies we found on public certification registries and regulators’ licence lists. “Verified” means we found the company on the public listing on the date shown, not that we audited it. Our methodology page lists the registries we check and explains the details.

Sources

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