What is the best certification for a supplement manufacturer?

There is no single best certification for a supplement manufacturer: the right one depends on where the product will be sold and what your buyers need. A manufacturer must first meet the law in your market, then hold whatever certifications your retailers, athletes or label claims call for.

Certifications answer different questions, about different things (a site or a product), for different markets. Start with two questions: where will the product be sold, and what will your buyers or customers ask to see?

Selling in the United States

The legal baseline is the dietary supplement CGMP rule, 21 CFR Part 111. It 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. So what you need from a manufacturer is compliance with that rule.

FDA does not certify that compliance: it does not issue any certification to indicate CGMP compliance. One way to see it from outside is a third-party GMP audit. NSF/ANSI 455-2 is one: a GMP certification standard for dietary supplements based on 21 CFR Part 111 plus retailer requirements and industry practice, with a public listing of certified facilities. A manufacturer certified to it can point you to a third party’s record rather than its own word.

Selling in Australia

Here the question is settled by law. Under the Therapeutic Goods Act 1989, sites that manufacture therapeutic goods in Australia, including listed (complementary) medicines, must hold a TGA GMP manufacturing licence unless exempt. The TGA applies the PIC/S Guide to GMP. For an Australian manufacturer, the licence is the certification that matters first.

Selling in Canada

Also settled by law. No one may manufacture, package, label or import a natural health product for sale without a Health Canada site licence, and licence holders must meet the GMP requirements in Part 3 of the Natural Health Products Regulations.

Sports nutrition

If athletes will take the product, the question is banned substances, and GMP alone doesn’t answer it. Informed Manufacturer certifies facilities: an audit of the site’s quality systems plus swab samples tested for substances prohibited in sport, renewed every year. It does not test finished products and is not a GMP audit, so it sits alongside a GMP certification or licence rather than replacing one. For the finished product, NSF Certified for Sport is a product program that screens for substances banned in sport, and Informed Sport and Informed Choice are LGC’s separate product programs.

Claims about what is in the product

If your concern is whether the product contains what its label says, and nothing it shouldn’t, you want a product certification. NSF/ANSI 173 verifies label claims, reviews ingredient toxicology and contaminants, and NSF periodically retests certified products. It certifies the product, not the facility, so it is not a substitute for a facility certification, and a facility certification is not a substitute for it.

Organic products

For an organic claim in the US, the certification is USDA Organic, issued under the National Organic Program by USDA-accredited certifying agents. You can look up certified operations in the USDA Organic Integrity Database. It covers organic production and handling, not GMP, so an organic product still needs a manufacturer that meets the GMP rules for its market. Browse organic supplement manufacturers in this directory.

What about ISO 9001?

ISO 9001 is a general quality management standard, not a supplement GMP standard. Certificates come from independent certification bodies; ISO does not certify anyone. It can sit alongside the certifications above but does not replace any of them.

Putting it together

US: evidence of 21 CFR Part 111 compliance, such as an NSF/ANSI 455-2 certified facility.
Australia: a TGA GMP manufacturing licence. Canada: a Health Canada site licence.
Sport: a banned-substance program, for the facility, the product, or both.
Label and contaminant claims: a product certification such as NSF/ANSI 173.
Organic claims: USDA Organic.

Whichever you need, it must cover the site that will make your product and be current when you sign. How to verify a manufacturer’s certification shows how to check. Find manufacturers among NSF-certified supplement manufacturers or all supplement manufacturers, and read how we verify each listing.

Common questions

Is NSF/ANSI 455-2 required to sell supplements in the US?

No law requires it. The legal requirement is compliance with the dietary supplement CGMP rule, 21 CFR Part 111. Because FDA does not certify compliance, a third-party GMP certification such as NSF/ANSI 455-2, which is based on that rule, is a way for a manufacturer to show it.

Which certification matters for sports nutrition?

Programs that screen for substances banned in sport. Informed Manufacturer certifies facilities and tests swab samples from the site for substances prohibited in sport. NSF Certified for Sport is a product program that screens for substances banned in sport. Informed Sport and Informed Choice are LGC’s separate product programs.

Is a product certification like NSF/ANSI 173 enough?

It answers a different question. NSF/ANSI 173 verifies that a product contains what its label says and reviews ingredients and contaminants, but it certifies the product, not the facility. If you need assurance about the site, look for a facility certification or licence as well.

Does a manufacturer in Australia or Canada need a licence?

Generally, yes. Sites that manufacture therapeutic goods in Australia, including listed (complementary) medicines, need a TGA 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.

Sources

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