Do I need to register my facility with FDA?

If you make hot sauce in a commercial kitchen and sell it to stores, distributors or anyone other than the final consumer, almost certainly yes. Section 415 of the Federal Food, Drug, and Cosmetic Act requires food facilities to register with FDA before they start, and to renew every even-numbered year between October 1 and December 31, so the 2026 window is open right now. The main exception for small makers is the retail food establishment: a business whose direct-to-consumer food sales are larger than its sales to everyone else. This registration is separate from the acidified food (FCE) registration on Form 2541. Many sauce makers need both, and FDA has cited makers for having one and not the other.

Two FDA registrations, side by side

Sauce makers mix these up constantly. They come from different laws, use different systems and lapse on different schedules.

FDA's acidified foods filing page lists its own forms and systems and does not explain how they relate to facility registration [5]. NC State Extension describes them as two steps: facility registration under the Bioterrorism Act, and registration as an acidified or low-acid canned food manufacturer on Form 2541 [6]. Registering in one system does not register you in the other. The FCE side is covered on FCE registration and process filing.

The retail food establishment exemption, from the regulation

21 CFR 1.226 lists the facilities that do not have to register. Paragraph (c) is three words: "Retail food establishments;" [1]. The definition in 1.227 does the work [7]:

A retail food establishment "means an establishment that sells food products directly to consumers as its primary function." It "includes facilities that manufacture, process, pack, or hold food if the establishment's primary function is to sell from that establishment food, including food that it manufactures, processes, packs, or holds, directly to consumers."

The test for "primary function" is a dollar comparison: a retail food establishment's primary function is selling to consumers "if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers." And "The term “consumers” does not include businesses." [7]

For an establishment located on a farm or operated by a farm business, the definition counts sales at "a roadside stand", a "farmers' market", a "community supported agriculture program", and "other such direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order," including online farmers markets and online grocery delivery, plus "religious or other organization bazaars; and State and local fairs" [7]. That list of channels is written for farm establishments. A sauce maker working from a licensed kitchen that is not on a farm uses the general test: the primary function must be to sell "from that establishment" directly to consumers, measured by the yearly dollar comparison [7]. FDA addressed online sales in its 2016 rule, published at 81 FR 45912. Commenters asked it to leave mail, catalog and internet orders out of the count, and FDA answered that the statute "does not specify that direct-to-consumer sales be face-to-face" [11]. Sales to consumers at a market booth or through your own web store count on the direct side; sales to stores and distributors do not.

How the test plays out

These examples apply the regulation's text. Your own situation may have facts that change the answer; confirm with FDA.

The test is annual and by dollar value, so a business can cross it in a good year. Watch the ratio as wholesale grows.

Under 1.227, "The private residence of an individual is not a facility" [7], which is why NC State lists home processors working under cottage food laws among operations that do not register [6].

The in-state question

You may read that FDA registration is not needed if you sell only within your state. The regulations do not say that. NC State Extension states that registration is required before a commercial facility starts operating "even if the product will not enter interstate commerce" [6]. The acidified food rule in 108.25(c)(1) applies to a commercial processor that begins making acidified foods in any state [3]. The retail exemption turns on who buys your sauce, not where they live. If you believe your operation falls outside either rule, get the answer from FDA in writing (LACF@FDA.HHS.GOV for the acidified foods side) [5] and from your state agriculture department.

Registering and renewing

1. Get a unique facility identifier. Since October 1, 2020, registrations must include "the facility's UFI recognized as acceptable by FDA" (1.232(a)(2)) [4]. FDA recognizes the DUNS number from Dun & Bradstreet as the acceptable UFI [8]. NC State notes DUNS numbers are free and "It can take up to thirty (30) days" to receive one, with a fee for expedited service [6]. Start here, because it is the slow step.
2. Create an account and register online. Registration and renewal go through FDA's Unified Registration and Listing System (FURLS); NC State notes that fax or mail needs a prior FDA waiver [6].
3. Give the required contacts and assurance. The registration must include the owner, operator or agent's email address, an emergency contact, and "an assurance that FDA will be permitted to inspect the facility" [4].
4. Renew between October 1 and December 31 of every even-numbered year [2]. For 2026 that is October 1 to December 31, 2026. NC State notes an abbreviated renewal is available if nothing has changed [6].
5. Update within 60 days of changes, including a change of ownership, according to NC State [6].

FDA enforces the renewal. Its January 9, 2026 warning letter to an Arkansas pickled egg maker stated that "your facility has failed to renew your registration for the 2024 bi-annual renewal year" and cited it as a prohibited act [9]. FDA's March 2024 letter to a Massachusetts sauce and chowder maker found the facility subject to registration and not registered, and gave it 30 working days to register [10].

What registration does not settle

Registering a facility does not file your sauce's process, license you with your state or exempt you from food safety rules. A registered facility may also be subject to FDA's preventive controls rule; do I need a written food safety plan covers that, including the qualified facility threshold. State licensing is on what licenses a hot sauce business needs.

Registering your acidified sauce separately

If your sauce is an acidified food, the facility registration above is only half the federal paperwork. FCE registration and process filing covers Form 2541, Form 2541e and their 10-day and 60-day deadlines.

References

1. Legal Information Institute, Cornell Law School, 21 CFR 1.226 Who does not have to register under this subpart?, accessed October 22, 2026. https://www.law.cornell.edu/cfr/text/21/1.226
2. Legal Information Institute, Cornell Law School, 21 CFR 1.230 When must you register or submit a registration renewal?, accessed October 22, 2026. https://www.law.cornell.edu/cfr/text/21/1.230
3. U.S. Food and Drug Administration, 21 CFR 108.25 Acidified foods, eCFR, up to date as of October 20, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-108/subpart-B/section-108.25
4. Legal Information Institute, Cornell Law School, 21 CFR 1.232 What information is required in the registration?, accessed October 22, 2026. https://www.law.cornell.edu/cfr/text/21/1.232
5. U.S. Food and Drug Administration, Establishment Registration and Process Filing for Acidified and Low-Acid Canned Foods (LACF), content current as of May 29, 2025. https://www.fda.gov/food/registration-food-facilities-and-other-submissions/establishment-registration-process-filing-acidified-and-low-acid-canned-foods-lacf
6. Johnston, L. and Nicholas, K., FDA Food Processing Facility Registration, NC State Extension, September 6, 2022. https://content.ces.ncsu.edu/fda-food-processing-facility-registration
7. Legal Information Institute, Cornell Law School, 21 CFR 1.227 What definitions apply to this subpart?, accessed October 22, 2026. https://www.law.cornell.edu/cfr/text/21/1.227
8. U.S. Food and Drug Administration, FDA Extends Flexibility on Unique Facility Identifier Requirement for Food Facility Registration, Constituent Update, March 30, 2021. https://www.fda.gov/food/hfp-constituent-updates/fda-extends-flexibility-unique-facility-identifier-requirement-food-facility-registration-through
9. U.S. Food and Drug Administration, Warning Letter to Christopher Dale Butler, CMS 720334, January 9, 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/christopher-dale-butler-720334-01092026
10. U.S. Food and Drug Administration, Warning Letter to F1 Foods Inc. dba Flavor First Foods Inc., CMS 668515, March 14, 2024. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/f1-foods-inc-dba-flavor-first-foods-inc-668515-03142024
11. U.S. Food and Drug Administration, Amendments to Registration of Food Facilities, final rule, 81 FR 45912, July 14, 2016. https://www.federalregister.gov/documents/2016/07/14/2016-16531/amendments-to-registration-of-food-facilities