| Permits, notices and registration (TTB; 27 CFR 25.61, 24.105, 24.106 and 19.71) | A brewery can't start brewing until TTB approves the brewery and its brewer's notice. A bonded winery applies on TTB F 5120.25, and anyone producing or blending wine of 7% alcohol by volume or more needs a basic permit. A distilled spirits plant registers with TTB and obtains an operating permit and/or a basic permit. | Outside both programs: an SQF or FSSC 22000 certificate isn't a TTB permit, notice or registration |
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| Formulas and label approval (TTB; 27 CFR 4.50, 5.21 and 7.21) | TTB requires some products to have an approved formula, which covers ingredients and production process, before the COLA application. Wine of 7% alcohol by volume or more, distilled spirits and malt beverages need a certificate of label approval (COLA) before bottling, subject to TTB's exemptions for products not sold in interstate commerce and, for malt beverages, the state-law conditions in 7.21(b). | SQF 2.3.1 Product Formulation and Realization; 2.3.2.7 labels accurate, legal and approved; 2.6.1 Product Identification, Mandatory; FSSC 22000 2.5.2 product labeling |
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| Required label statements (TTB; 27 CFR part 16, 4.32, 5.63 and 7.63) | Drinks of 0.5% alcohol by volume or more carry the government health warning statement. Labels also declare sulfites when sulfur dioxide or a sulfiting agent is detected at 10 parts per million or more (measured as total sulfur dioxide), FD&C Yellow No. 5, and cochineal extract or carmine. Malt beverage and distilled spirits labels add "PHENYLKETONURICS: CONTAINS PHENYLALANINE" when the product contains aspartame. | SQF 2.3.2.7 labels accurate, legal and approved; 2.6.1 Product Identification, Mandatory; 2.4.4 product testing, such as for sulfites and alcohol content; FSSC 22000 2.5.2 |
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| Allergen and gluten statements (TTB; 27 CFR 4.32a, 5.82 and 7.82; TTB Ruling 2020-2) | On TTB-labeled drinks, major food allergen statements are voluntary today, but if you declare one, you must declare all the major food allergens used in production. TTB proposed mandatory allergen labeling on January 17, 2025, including fining and processing agents that are or contain major food allergens, such as egg white, isinglass (fish) and casein (milk); comments closed August 15, 2025, and TTB hadn't published a final rule as of October 2026. "Gluten-free" claims must meet FDA's gluten-free standard, and a product fermented from grains containing gluten may say it was "[processed, treated or crafted] to remove gluten" only with TTB's qualifying statement and a description of the gluten-removal method filed with the label application. Drinks under FDA labeling follow FDA's allergen labeling law (21 U.S.C. 343(w)), which also covers allergens in processing aids. | SQF 2.8.1 Allergen Management, Mandatory; FSSC 22000 2.5.6 and 2.5.2 |
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| Food facility registration (FDA; 21 CFR 1.225 and 1.230) | TTB says manufacturers and processors of alcohol must register with FDA under the Bioterrorism Act. Exemptions include farms, retail food establishments and restaurants (1.226). Registrations are renewed between October 1 and December 31 of each even-numbered year, such as 2026. | SQF 2.4.1 Food Legislation, Mandatory; certification isn't FDA registration |
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| Good manufacturing practices and preventive controls (FDA; 21 CFR Part 117) | Makers of alcoholic beverages follow FDA's current good manufacturing practices (subpart B). The preventive controls and supply-chain program requirements (subparts C and G) don't apply to alcoholic beverages at a facility that needs a TTB permit, registration or notice approval and must register with FDA (117.5(i)(1)). Other food at that facility gets this exemption only if it's in prepackaged form that prevents direct human contact and makes up no more than 5% of the facility's sales (117.5(i)(2)), so non-alcoholic products you make, such as non-alcoholic beer or kombucha under 0.5%, may be subject to subparts C and G unless another exemption applies, such as the one for qualified facilities (117.5(a)). | SQF 2.4.2 Good Manufacturing Practices and 2.4.3 Food Safety Plan, Mandatory; FSSC 22000 ISO 22000 clause 8.2 (prerequisite programs) and 8.5 (hazard control) |
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| Food and color additives (FDA) | A food, including an alcoholic beverage, is adulterated if it contains an unapproved food or color additive. In 2010, FDA warned four companies that the caffeine added to their alcoholic malt beverages was an "unsafe food additive." | SQF 2.3.1 Product Formulation and Realization; 2.4.1 Food Legislation, Mandatory; FSSC 22000 ISO 22000 clause 8.5.2 hazard analysis |
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| Spent grain and other by-products for animal food (FDA; 21 CFR 507.12 and 117.95) | A facility that follows FDA's human food good manufacturing practices and doesn't further process the by-product isn't subject to the rest of FDA's animal food rule (Part 507) for it, but must hold and distribute it under 21 CFR 507.28 and 117.95: protected from contamination, in containers and vehicles examined before use, and labeled with its common or usual name. FDA says brewers supplying wet spent grains would not need additional preventive controls or good manufacturing practice regulations, "except to prevent physical and chemical contamination when holding and distributing the by-product"; drying, pelleting or heat-treating it for feed requires good manufacturing practices for that processing and, unless the facility is a qualified facility or otherwise exempt, a hazard analysis to decide whether any hazard needs a preventive control. | Covered by FDA's rules rather than a specific SQF or FSSC 22000 clause; feed manufacturing is SQF FSC 34 |
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| Imported alcohol and ingredients (FDA's Foreign Supplier Verification Program; 21 CFR 1.501(e)) | The Foreign Supplier Verification Program (FSVP) doesn't apply to alcoholic beverages imported from a foreign supplier that would need a TTB permit, registration or approval if it were in the United States and is required to register with FDA, or to raw materials and other ingredients imported for use in alcoholic beverages when the importer uses them in its own registered facility and meets the rule's other conditions. | SQF 2.3.4 Approved Supplier Program, Mandatory; FSSC 22000 2.5.1 management of purchased materials |
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| Sanitary transportation (FDA; 21 CFR Part 1, subpart O) | FDA says the rule doesn't apply to food fully enclosed by a container that doesn't need temperature control, which "essentially excludes packaged beverage alcohol products," but transportation operations for beverage alcohol can otherwise be covered, such as bulk shipments. | SQF 11.6.5 Loading, Transport, and Unloading Practices; FSSC 22000 prerequisite programs (ISO/TS 22002-1) |
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| Recalls (FDA–TTB memorandum of understanding 225-25-015) | Under the agreement that took effect June 30, 2025, TTB has primary responsibility for issuing recall notices and monitoring voluntary recalls of adulterated wine, distilled spirits and malt beverages covered by the FAA Act, with FDA providing health hazard evaluations, and FDA has primary recall responsibility for drinks generally outside TTB's labeling authority, such as wine under 7% alcohol by volume and beer made without both malted barley and hops. FDA keeps its authority over adulterated and misbranded alcoholic beverages, and TTB reminds industry members of their reporting obligations through FDA's Reportable Food Registry. | SQF 2.6.3 Product Withdrawal and Recall, Mandatory (tested at least once a year); FSSC 22000 ISO 22000 clause 8.9.5 withdrawal/recall |
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