Do supplement formulators need to be FDA-registered or cGMP-certified?

Any facility manufacturing dietary supplements for sale in the United States must comply with FDA cGMP regulations under 21 CFR Part 111. Formulators themselves are not FDA-registered, but the contract manufacturer they work with must be. When evaluating a formulator, confirm which cGMP-compliant facilities they partner with and ask for the facility's most recent third-party audit report. AJ Cosmo Labs vets suppliers before they appear on the platform.