Do you need to register with FDA, and which federal rules apply to a jam business?

If you make jam in a licensed kitchen and most of your sales go to shops, distributors or other businesses, you almost certainly need to register that kitchen with FDA as a food facility, renew every even-numbered year between October 1 and December 31, and follow FDA's current good manufacturing practices in 21 CFR Part 117. A cottage kitchen in a private home does not register, and a business that sells mostly straight to consumers may qualify as a retail food establishment, which is exempt. Fruit jam is not an acidified food, so the separate canning registration applies only to products such as pepper jelly. This page sorts out which rules reach you.

Four questions that decide it

Work through these in order. Each answer comes from the regulation text; your facts may change the answer, so confirm with FDA when your status depends on it.

1. Whether your kitchen is a "facility" at all

FDA's registration rule covers facilities that manufacture, process, pack or hold food for people in the United States. A private home is not a facility under the definitions in 21 CFR 1.227, which is why NC State Extension lists home processors working under cottage food laws among the operations that do not register [1][2]. If you are still making jam under your state's cottage food law, you can stop here for registration, though state rules still apply.

2. Whether you are a retail food establishment

21 CFR 1.226(c) exempts "Retail food establishments" from registration [3]. The definition does the work: a retail food establishment "sells food products directly to consumers as its primary function," and that is measured by money. Your primary function is retail 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." Businesses do not count as consumers [1].

The test is annual and by dollars, so a good wholesale year can tip you over. The regulation's list of direct sales channels (farmers markets, roadside stands, internet orders and so on) is written for establishments located on farms [1]. A licensed kitchen that is not on a farm uses the general test above. FDA's 2016 rule, published at 81 FR 45912, settles the online question for it: answering commenters who wanted mail, catalog and internet orders left out, FDA said the statute "does not specify that direct-to-consumer sales be face-to-face" [20]. Jars sold to consumers at a market or through your own web store count on the direct side.

3. When and how to register

Register "before your facility begins to manufacture, process, pack, or hold food" (21 CFR 1.230(a)), and renew between October 1 and December 31 of every even-numbered year (1.230(b)) [4]. The 2026 renewal window is open now and closes December 31, 2026.

1. Get a unique facility identifier first. Registrations must include a UFI that FDA accepts; FDA recognizes the DUNS number [5]. NC State notes that a DUNS number is free and can take up to 30 days to arrive [2].
2. Register online through FDA's registration system. NC State notes that paper registration needs a prior FDA waiver [2].
3. Update within 60 days of changes such as a new owner [2].

FDA enforces renewal. A January 9, 2026 warning letter cited a small food maker because its facility "failed to renew your registration for the 2024 bi-annual renewal year" [6].

4. Whether you make anything acidified

Standard fruit jam, jelly and preserves are excluded from FDA's acidified foods rule by name: 21 CFR 114.3(b) excludes "jams, jellies, preserves" [7]. Penn State Extension adds the condition that matters: Part 114 does not apply to jams "unless they contain significant low-acid ingredients" [8]. Pepper jelly is the common case, and this book treats it as an acidified food for sale until a process authority says otherwise. An acidified product brings a second FDA registration (Form 2541, the food canning establishment registration) and a process filing for each product and jar size, explained on process authorities and scheduled processes.

The federal rules that reach a licensed jam maker

Label rules have their own pages: what a jam label must say and do you need a Nutrition Facts panel.

Good manufacturing practices in a jam kitchen

Part 117 Subpart B is the rule an inspector walks through your kitchen with. Its sections cover personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, and warehousing and distribution [12]. In a jam kitchen that comes down to things you can check on any production day:

• Hand washing, clean outer clothing, hair restraint, and sick workers kept off the line.
• Cleaned and sanitized kettles, funnels, ladles and fillers, with a cleaning schedule you can show.
• Fruit inspected and sorted, and moldy fruit discarded before it reaches the kettle.
• Jars and lids stored off the floor and protected from dust.
• Allergen separation if you make anything with nuts (some conserves) on the same equipment.
• Pests kept out, and the evidence that you do.

Qualified facility status and the written food safety plan

A registered facility must also meet the preventive controls rule, which requires a written food safety plan unless the facility is a "qualified facility" [10]. For most small jam makers that means a "very small business," with average annual sales of human food under $1,000,000 adjusted for inflation over the previous three years. FDA's cut-off for 2025 is $1,409,899, and the 2023 to 2025 average is $1,372,952 [13]. A second route covers businesses whose direct sales to qualified end users exceed their other sales and whose sales are under $500,000 adjusted ($704,950 for 2025) [13][14].

You have to claim qualified status: you file an attestation on Form FDA 3942a [15], and Minnesota's guidance adds that you resubmit every two years in the October 1 to December 31 renewal window of even-numbered years [14]. A qualified facility still follows Subpart B and the training requirement; it is excused from the hazard analysis, the written plan and the supply chain program [14]. Check FDA's cut-off page each year, since the figures move.

The traceability rule: probably not your fruit

FDA's food traceability rule (FSMA section 204) adds detailed records for foods on its Food Traceability List. The produce entries are fresh cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes and tropical tree fruits, plus fresh-cut fruits and fresh-cut vegetables [16]. Whole fresh berries, stone fruit, apples and grapes are not on that list. Two cases deserve a second look:

• Fresh peppers are listed. A pepper jelly maker who buys fresh peppers is receiving a listed food.
• Fresh-cut fruit is listed, so buying pre-cut fruit (diced mango, for example) brings it in.

Cooking can change your obligations. FDA's exemption in 21 CFR 1.1305(d) covers listed food that receives a kill step, with conditions and written agreements in the supply chain [16], and UF/IFAS notes that foods undergoing a validated kill step "may be exempt from some traceability requirements" [17]. Whether your cook qualifies is a question for FDA or a food safety specialist, and worth asking before you rely on it.

Compliance timing: the original compliance date was January 20, 2026. FDA proposed in August 2025 to extend it by 30 months, to July 20, 2028, and Congress has since directed FDA not to enforce the rule before that date, which FDA says it intends to follow; FDA's page, current as of October 8, 2026, shows the extension as proposed rather than final [19]. Extension sources describe the same date as an extension (UF/IFAS, June 2026) [17] and as a proposal (NC State, May 2026) [18], and both readings fit FDA's page. Plan on July 20, 2028, and check FDA's traceability page before you build records around it. The records themselves, where the rule applies, must be kept two years and provided to FDA as a sortable spreadsheet within 24 hours of a request [17].

Who to ask

For registration and Part 117 questions, FDA's Technical Assistance Network and FDA small business representatives answer directly; Penn State recommends contacting an FDA Small Business Representative when you are unsure which rules apply [8]. For acidified products, write to LACF@FDA.HHS.GOV. Your state agency inspects most small plants and can tell you which version of the rules it applies.

Where this leads: the records you will keep

Every rule above ends in paperwork: training logs, cleaning schedules, receiving and shipping records, and lot codes that tie them together. What to keep and for how long is on records, lot tracing and recalls.

References

1. eCFR, 21 CFR 1.227, What definitions apply to this subpart?, up to date as of October 20, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-H/subject-group-ECFRef316bd359c83c7/section-1.227
2. NC State Extension, Johnston and Nicholas, *FDA Food Processing Facility Registration*, September 6, 2022. https://content.ces.ncsu.edu/fda-food-processing-facility-registration
3. eCFR, 21 CFR 1.226, Who does not have to register under this subpart?, up to date as of October 20, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-H/subject-group-ECFRef316bd359c83c7/section-1.226
4. eCFR, 21 CFR 1.230, When must you register or submit a registration renewal?, up to date as of October 20, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-H/subject-group-ECFRcbf7d701d6722a5/section-1.230
5. US 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
6. US 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
7. Legal Information Institute, Cornell Law School, 21 CFR 114.3, Definitions, accessed October 2026. https://www.law.cornell.edu/cfr/text/21/114.3
8. Penn State Extension, LaBorde, *Food for Profit: Commercial Production of Jams, Jellies and Fruit Butters*, updated May 24, 2024. https://extension.psu.edu/food-for-profit-commercial-production-of-jams-jellies-and-fruit-butters
9. Legal Information Institute, Cornell Law School, 21 CFR 117.4, Qualifications of individuals who manufacture, process, pack, or hold food, accessed October 2026. https://www.law.cornell.edu/cfr/text/21/117.4
10. US Food and Drug Administration, *FSMA Final Rule for Preventive Controls for Human Food*, content current August 11, 2026. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food
11. Legal Information Institute, Cornell Law School, 21 CFR Part 1, Subpart J, Establishment, Maintenance, and Availability of Records, accessed October 2026. https://www.law.cornell.edu/cfr/text/21/part-1/subpart-J
12. Tennessee Department of Agriculture, *Good Manufacturing Practices: 21 CFR 117*, accessed October 2026. https://tn.gov/agriculture/consumers/food-safety/ag-farms-food-manufacturing-and-warehousing/ag-businesses-federal-regulations/ag-businesses-good-manufacturing-practices.html
13. US Food and Drug Administration, *FSMA Inflation Adjusted Cut Offs*, accessed October 2026. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-inflation-adjusted-cut-offs
14. Minnesota Department of Agriculture, *Qualified Facility Guidance*, March 2, 2023. https://www.mda.state.mn.us/sites/default/files/docs/2023-05/Qualified%20Facility%20Guidance_03022023.pdf
15. US Food and Drug Administration, *Qualified Facility Attestation*, content current September 29, 2026. https://www.fda.gov/food/registration-food-facilities-and-other-submissions/qualified-facility-attestation
16. US Food and Drug Administration, *What You Need to Know About the Food Traceability Rule: Coverage and Exemptions for Produce Farms*, June 2023. https://fda.gov/media/169509/download
17. UF/IFAS Extension, Farzad and Brown, *Food Traceability Rule: Part 2, Definitions and Acronyms* (FSHN26-6/FS477), June 16, 2026. https://ask.ifas.ufl.edu/publication/FS477
18. NC State Extension Food Business, *FDA FSMA 204 Food Traceability Rule: July 20, 2028*, updated May 14, 2026. https://foodbusiness.ces.ncsu.edu/news/fda-fsma-204-food-traceability-rule-july-20-2028/
19. US Food and Drug Administration, *FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods*, content current as of October 8, 2026. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods
20. 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