ISO 22716, cGMP and FDA registration are three different things, and manufacturers benefit from you not knowing the difference. One is a certificate you can verify. One is an expectation with no certificate attached. One is a filing that is often misdescribed as an approval. Here is what each actually means, and the four questions that separate a real claim from a decorative one.
The three compared
| What | What it is | Who issues it | What you receive | Independently verifiable? |
|---|---|---|---|---|
| ISO 22716:2007 | A certifiable international standard for cosmetics GMP | Third-party audit | Certificate with number and scope | Yes, if accredited |
| cGMP | A regulatory expectation of good manufacturing practice | No single issuing body for cosmetics | No certificate exists | Only via an audit standard such as ISO 22716 |
| FDA registration | An administrative filing of the facility and its products | Self-filed with the FDA | Establishment identifier (FEI) | The number is checkable; it is not an approval |
What is the difference between ISO 22716, cGMP and FDA registration?
They are three different kinds of thing, which is why they get confused. ISO 22716 is a certifiable standard: a third-party body audits you against it and issues a certificate with a number and a defined scope. cGMP, current Good Manufacturing Practice, is a regulatory expectation rather than a certificate, so nobody issues you a cGMP certificate for cosmetics. FDA registration is an administrative filing that puts your facility on record and gives you an establishment identifier. One is audited, one is expected, one is filed.
Is ISO 22716 the same as cGMP?
Not the same, but closely related. ISO 22716 is the international standard describing good manufacturing practices for cosmetics, and it is the document most third-party audits are conducted against. When a cosmetics manufacturer says it operates to cGMP, the credible version of that claim is usually an ISO 22716 certification behind it. Without a certificate number and standard, cGMP compliant is a statement about intent rather than an audited finding.
Does FDA registration mean my product is FDA approved?
No. The FDA does not approve cosmetic products or the facilities that make them, and describing a cosmetic as FDA approved is a misstatement. Under the Modernization of Cosmetics Regulation Act, cosmetic manufacturing facilities are required to register and to list their products, and registration produces an establishment identifier known as an FEI number. That number is real and checkable, which makes it worth asking for. It is not an endorsement of anything.
What should I actually ask a manufacturer for?
Four things. The standard they are certified to, in full, for example ISO 22716:2007. The certificate number. The certified scope, because a certificate naming skin care does not cover your shampoo. And whether the certificate is accredited, because an accredited certificate can be verified independently and an unaccredited one relies on the issuing body alone.
What does accredited certification mean?
A certification body can itself be accredited by a national accreditation body, and those accreditation bodies sign the IAF Multilateral Recognition Arrangement. When that chain exists, the certificate can be looked up in a public register rather than taken on trust. When it does not, the certificate may still reflect a real audit, but you have no independent way to confirm it. Ask which applies and treat the answer as information rather than as a pass or fail.
How does Moe’s Group answer these questions?
ISO 22716:2007 for cosmetics GMP, certificate 25-I-0062, scope covering production of skin care, hair care and oils. ISO 9001:2015 for quality management, certificate 25-A-3813 Rev.1, accredited by the United Accreditation Foundation under CB-MS-12771. ISO 45001:2018 for occupational health and safety, certificate 25-O-2855 Rev.1, accredited by the Korea Accreditation Board under KAB-OC-70. FDA registered facility, establishment identifier 3041507202. Every certificate is downloadable, and the accredited ones can be checked at iafcertsearch.org without asking us.
The four questions, in order
- Which standard, in full? ISO 22716:2007, not “GMP certified”.
- What is the certificate number? If none is offered, stop here.
- What is the certified scope? It must name your product category.
- Is it accredited, and by whom? Determines whether you can verify it yourself.
A note on regulation: under the Modernization of Cosmetics Regulation Act, cosmetic facilities must register and list products, and the FDA has been directed to establish good manufacturing practice requirements for cosmetics. That framework has been developing, so if a specific regulatory obligation matters to your product, confirm the current position with the FDA directly rather than relying on any manufacturer’s summary, including ours.
Verify us rather than trust us
- Download every certificate we hold
- Check the accredited ones at iafcertsearch.org
- Check certificate validity with the issuing body at gicert.org
- Company registration number 873300160 appears on all three certificates
Talk to us
If you are comparing manufacturers and want documentation for your own due diligence, ask and we will send it. See also how to choose a private label manufacturer.