Supplement manufacturing certifications explained

Supplement manufacturing certifications are of two kinds: facility certifications and licences, which assess a site (NSF/ANSI 455-2, TGA and Health Canada licences, Informed Manufacturer), and product certifications, which test products (NSF/ANSI 173). USDA Organic and ISO 9001 are not GMP standards.

Before comparing certifications, ask what each one is about. A facility certification or licence says an independent body assessed a specific site. A product certification says a named product was tested. Neither implies the other. For each certification below: what it covers, whether it applies to a facility or a product, and who issues it.

The legal baseline: GMP and 21 CFR Part 111

What it covers: current good manufacturing practice (CGMP) for dietary supplements in the US. The 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.

Facility or product: the operations of a firm. Who issues it: nobody. It is a regulation, not a certificate. FDA inspects facilities but does not issue any certification of CGMP compliance, which is why third-party GMP certifications exist.

Facility certifications and licences

NSF/ANSI 455-2 (GMP for dietary supplements)

What it covers: a GMP certification standard for dietary supplements, based on 21 CFR Part 111 plus retailer requirements and industry practice. It is part of the NSF/ANSI 455 family, which also includes 455-3 for cosmetics and 455-4 for over-the-counter drugs.

Facility or product: facility. Sites that manufacture, package, or warehouse and distribute dietary supplements can be certified. Who issues it: NSF, which publishes a public listing of certified facilities.

TGA manufacturing licence (Australia)

What it covers: under the Therapeutic Goods Act 1989, sites that manufacture therapeutic goods in Australia, including listed (complementary) medicines, must hold a GMP manufacturing licence unless exempt. The TGA applies the PIC/S Guide to GMP (TGA).

Facility or product: facility. Who issues it: the Therapeutic Goods Administration, Australia’s regulator. It is a legal requirement, not a voluntary certification.

Health Canada site licence (natural health products)

What it covers: no one may manufacture, package, label or import a natural health product for sale in Canada without a site licence, and licence holders must meet the GMP requirements in Part 3 of the Natural Health Products Regulations (Health Canada).

Facility or product: facility. Who issues it: Health Canada. Like the TGA licence, it is a legal requirement.

Informed Manufacturer

What it covers: an audit of the site’s quality systems against the Informed Manufacturer Global Standard, plus a site visit where swab samples are tested for substances prohibited in sport, with annual recertification. It is not a GMP audit, and it does not test finished products.

Facility or product: facility. Who issues it: LGC. Informed Sport and Informed Choice are separate LGC programs for products.

Product certifications

NSF/ANSI 173

What it covers: label claim verification (what is on the label is in the product), a toxicology review of ingredients, and a contaminant review. NSF audits and periodically retests certified products.

Facility or product: product. It certifies products, not the facility that makes them. Who issues it: NSF.

NSF Certified for Sport

What it covers: a product program for sport that builds on NSF product certification and screens for substances banned in sport. Facility or product: product. Who issues it: NSF.

Other certifications you will see

USDA Organic

What it covers: organic production and handling under the USDA National Organic Program. It is not a GMP certification. Facility or product: the certified operation. Who issues it: USDA-accredited certifying agents. Certified operations are searchable in the USDA Organic Integrity Database.

ISO 9001

What it covers: quality management in general. It is not specific to supplements and is not a supplement GMP standard. Facility or product: the certified organisation’s quality management system. Who issues it: independent certification bodies, some accredited by national accreditation bodies. ISO itself does not certify anyone or issue certificates.

Reading certifications together

A GMP facility certification or licence (NSF/ANSI 455-2, TGA, Health Canada) is about how a site manufactures.
Informed Manufacturer is about a site’s quality systems and banned-substance risk, not GMP.
NSF/ANSI 173 and NSF Certified for Sport are about specific products.
USDA Organic and ISO 9001 answer other questions: organic status and general quality management.

Whichever applies, the certification belongs to a named site or product and can lapse, so verify it at the source. To see which one fits your product and market, read what is the best certification for a supplement manufacturer. You can also browse NSF-certified supplement manufacturers and organic supplement manufacturers, and read how we verify the registries we list from.

Common questions

Is GMP a certification?

Not in itself. In the US, good manufacturing practice for supplements is a legal requirement, the CGMP rule in 21 CFR Part 111, and FDA does not issue any certificate of compliance. Third-party standards such as NSF/ANSI 455-2 audit a facility against requirements based on that rule and list the facilities that pass.

What is the difference between NSF/ANSI 455-2 and NSF/ANSI 173?

NSF/ANSI 455-2 certifies a facility’s good manufacturing practice. NSF/ANSI 173 certifies products: it verifies label claims, reviews ingredient toxicology and contaminants, and NSF retests certified products periodically. One says nothing about the other.

Is Informed Manufacturer a GMP certification?

No. Informed Manufacturer, run by LGC, audits a facility’s quality systems against its own Global Standard and tests swab samples from the site for substances prohibited in sport, with annual recertification. It does not test finished products and is not a GMP audit.

Does ISO 9001 certification mean a supplement maker follows GMP?

No. ISO 9001 is a general quality management standard, not a supplement GMP standard. ISO itself does not certify anyone: independent certification bodies issue ISO 9001 certificates, and some are accredited by national accreditation bodies.

Does USDA Organic certify how supplements are manufactured?

It certifies organic production and handling under the USDA National Organic Program, through USDA-accredited certifying agents. It is not a GMP certification.

Sources

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