FDA registered co-packers — what it means and why it matters for your brand.

When brands ask about FDA registration, they usually mean one of two things: FDA facility registration, or GMP compliance. These are related but different, and the distinction matters when you're evaluating a co-packer for your supplement product.

What FDA Facility Registration Means

Under the FDA Food Safety Modernization Act (FSMA) and 21 CFR Part 1, food facilities — including supplement manufacturers and co-packers — are required to register with the FDA every two years. This registration:

• Tells the FDA that your facility exists and where it's located
• Subjects the facility to FDA inspection authority
• Assigns a registration number that can be verified on the FDA website

FDA facility registration is the minimum threshold. It means the facility has notified the FDA of its existence. It does not, by itself, mean the facility has been inspected, audited, or certified to any specific standard.

Overgang is FDA registered. Our registration covers our Minneapolis, MN facility as a food facility handling dry powder supplements and food products.

GMP Compliance — The Standard That Actually Matters

For dietary supplement brands, the more substantive compliance standard is GMP — Good Manufacturing Practice. Under 21 CFR Part 111, dietary supplement manufacturers (including co-packers who produce supplements) are required to follow GMP guidelines covering:

• Personnel qualifications and training
• Physical plant and equipment requirements
• Production and process controls
• Laboratory operations
• Master manufacturing records
• Batch production records
• Returned supplement controls

GMP compliance isn't a one-time certification — it's an ongoing operational standard. The FDA can inspect a facility at any time (usually without advance notice) and assess compliance against these standards.

When FDA Registration Is Required From Your Co-Packer

Amazon: Amazon's supplement category now requires documentation of FDA-registered facilities for supplement listings. If you're selling supplements on Amazon and your co-packer isn't FDA registered, you may be unable to list or may face account issues.

Retail buyers: Major retail buyers — natural grocery, specialty supplement retailers, club stores — increasingly request co-packer documentation including FDA registration numbers as part of supplier qualification.

Investors: If you're raising capital for a supplement brand, institutional investors and due diligence processes often ask about co-packer compliance documentation. An FDA-registered co-packer is a significantly easier conversation than one that isn't.

What to Ask Your Co-Packer About Compliance

• Are you FDA registered? Can you provide your registration number?
• When was your registration last renewed? (Biennial renewal required)
• Do you follow 21 CFR Part 111 GMP guidelines for dietary supplements?
• Have you been inspected by the FDA? What was the outcome?
• Can you provide documentation for our Amazon listing / retail buyer / investor due diligence?

What FDA Registration Doesn't Guarantee

FDA registration is a required baseline, not a quality certification. A registered facility is not automatically a well-run facility. Registration means the FDA knows you exist — it doesn't mean you've been audited, tested, or certified against any specific quality standard.

When evaluating a co-packer, FDA registration is necessary but not sufficient. Also evaluate their operational practices: COA requirements, allergen protocols, yield tracking, quality check procedures during production runs, and their policy when something goes wrong. These operational practices tell you more about a co-packer's actual quality than any registration status.