Do I need FDA food facility registration?

Worked example

A hot sauce company makes its product in a commercial kitchen in Texas and sells to grocery distributors and online. It manufactures food and is not a farm or restaurant, so the checker returns FDA food facility registration required with the biennial renewal dates. A bakery that sells more to walk-in customers than to businesses is likely a retail food establishment, a listed exemption.

Before you start

The checker asks: What does the facility do; What kind of facility is it; Where is it located. Have your supplier paperwork, specification sheet and draft listing copy open, because each answer maps to a specific rule quoted below.

The result gives a verdict, the reasons behind it with the rule text it relied on, and next steps. Where your answers leave a real gap, it says "check" instead of guessing. Nothing you type leaves your browser, so you can try different answers to see how the verdict changes.

What the official source says

• Who registers (21 CFR 1.225): owners, operators or agents in charge of domestic or foreign facilities that make, pack or hold food for US consumption must register unless exempt under 1.226; domestic facilities must register even if food never enters interstate commerce.
• Exemptions (21 CFR 1.226): farms, retail food establishments, restaurants, certain nonprofit food establishments, fishing vessels (within limits), facilities regulated exclusively by USDA under the meat, poultry or egg products laws, and foreign facilities whose food gets further processed or packaged at another foreign facility.
• Retail food establishment (21 CFR 1.227): one whose primary function is selling directly to consumers, which is the case when annual sales to consumers exceed annual sales to all other buyers.
• Timing (21 CFR 1.230): register before the facility begins handling food for US consumption; renew every other year from 1 October to 31 December of each even-numbered year.
• US agent and UFI: foreign facilities must designate a US agent who lives or has a place of business in the US, not a mailbox or answering service; registrations since 1 October 2020 need a Unique Facility Identifier. Source: 21 CFR Part 1 Subpart H and FDA registration page.

All sources retrieved October 2026. Not covered: does not register you, decide state licensing or cottage food law, cover Prior Notice for imports, labeling, or the FSMA rules that follow registration. Registration is done on FDA's own system. Rules change; the linked page governs.