US Fermented Food Regulations: Alcohol Limits, Acidified Foods, Labels and Claims

US fermented food regulations: who regulates what

There is no single US rulebook for fermented foods. FDA regulates most foods, including fermented ones. USDA’s Food Safety and Inspection Service (FSIS) covers meat, poultry and egg products under their own inspection Acts^[12], and the Alcohol and Tobacco Tax and Trade Bureau (TTB) covers alcohol beverages^[4]. States and localities license and inspect food businesses on top of that, and TTB itself reminds kombucha makers that state and local rules also apply^[4].

Which regime governs a product depends on what it is, how much alcohol it contains at any point, whether acid is added to a low-acid food, and how and to whom it is sold. A kombucha, a jar of kimchi and a probiotic yogurt can each sit under different rules, and two or three regimes often apply at once. Figure 1 gives the first-pass route and Figure 2 maps typical products to the regimes that usually apply.

This guide is general regulatory information, not legal advice. Classification depends on the exact formulation and process.

The 0.5% alcohol limit and when TTB steps in

Under federal law, kombucha that contains 0.5% or more alcohol by volume at any time, during production, when bottled or at any time after bottling, is an alcohol beverage subject to TTB regulations; kombucha that never reaches 0.5% must comply with FDA rules^[4]. The line is a legal boundary, not a style choice, and it applies to the product’s whole life, not only to the release test.

Once TTB rules apply, the product must be made on premises qualified by TTB under the Internal Revenue Code, meet the Code’s labelling, formula and tax requirements, and carry the government health warning required by the Alcoholic Beverage Labeling Act; if it also counts as a malt beverage under the Federal Alcohol Administration Act, FAA Act permit, labelling and advertising rules apply as well^[4]. FDA uses the same 0.5% figure from the other side: it expects dealcoholized wine to declare that it “contains less than 0.5 percent alcohol by volume”^[5].

Kombucha and in-bottle fermentation

Live kombucha can keep fermenting after it is packed, so alcohol can rise on the shelf, and TTB names that case specifically^[4]. Test finished product at release and again late in shelf life, including samples held at the warmest realistic storage temperature, and set an internal limit comfortably below 0.5% so the product does not drift across the line. FRL’s older note on kombucha labelling requirements summarises the industry’s voluntary labelling code.

Acidified and naturally fermented foods (21 CFR 114)

An acidified food is a low-acid food to which acid or acid foods are added, with a water activity above 0.85 and a finished equilibrium pH of 4.6 or below^[1]. Foods that are stored, distributed and retailed under refrigeration are excluded, as are acid foods with only small amounts of low-acid ingredients^[1]. Processors of acidified foods must register with FDA within 10 days of starting, file process information for each product^[2], and operate under a supervisor who has completed an FDA-approved school^[3].

Naturally fermented foods are treated differently. FDA’s inspection programme states that naturally fermented products are not acidified foods: a product salted or held in brine, fermented for one or more weeks and brought to pH 4.6 or below without added acid (acid added only to control the fermentation is allowed) falls outside Part 114; sauerkraut and some dill pickles are given as examples^[6]. A product that only reaches pH 4.6 because acid was added afterwards, or that is washed back above pH 4.6, is assessed as acidified or low-acid instead^[6].

Table 1. How fermentation, added acid and refrigeration decide the acidified-food position.

Separately, most facilities that must register with FDA also need a written food safety plan with a hazard analysis and preventive controls under 21 CFR Part 117, unless an exemption applies, for example for qualified (very small) facilities or for activities covered by juice or seafood HACCP^[7]. For the wider hurdles behind shelf-stable drinks, see our guide to hurdle technology for functional drinks.

Labelling live cultures and CFU

Fermented foods follow the same labelling rules as any food: statement of identity, ingredient list, allergen declaration, net quantity and nutrition labelling where it applies. Allergens deserve particular care because many fermented bases are milk, soy, wheat or fish; our report on the kimchi recall over undeclared anchovy shows what happens when a traditional ingredient is missed.

The only federal culture-count benchmark we found is in the yogurt standard. A yogurt may be labelled “contains live and active cultures” if it has at least 10⁷ CFU/g at manufacture with a reasonable expectation of 10⁶ CFU/g through its shelf life, and yogurt heat-treated after culturing must say “does not contain live and active cultures”^[8]. For other fermented foods there is no set figure, but any culture statement or CFU count must be truthful at the point of sale, which in practice means backed by stability data to the end of shelf life. Our explainer on what CFU means and how counts are labelled covers the counting methods.

“Gluten-free” claims also have a fermented-food rule. Where no scientifically valid method can test the finished fermented or hydrolyzed food for gluten, the manufacturer must keep records showing the food was gluten-free before fermentation and that gluten cross-contact has been evaluated and controlled^[13].

Formulator’s note. Write the claim from the stability data, not the formula sheet. If the count at expiry cannot support “live and active cultures” or a CFU figure, change the wording or the dose before you print the pack; relabelling after launch costs far more than one extra stability pull.

The survival work behind a label count is covered in our guide to formulating live culture foods and drinks, and our live-culture survival trial worked example shows a count study in a fermented beverage.

Health and structure/function claims

US food claims fall into a few defined types^[9]. A health claim links a food or food substance to reduced risk of a disease. It needs an FDA regulation, an authoritative-statement notification, or, for a qualified health claim, an FDA letter of enforcement discretion with set qualifying wording^[9][10]. One qualified health claim already covers a fermented food: in March 2024 FDA said it would not object to claims that eating at least 2 cups (3 servings) of yogurt a week may reduce the risk of type 2 diabetes, worded to show the evidence is limited^[11].

A structure/function claim describes an effect on normal body structure or function. On a conventional food it needs no FDA notification or disclaimer, but it must be truthful and not misleading, and FDA says such claims on conventional foods focus on effects derived from nutritive value^[14]. Dietary supplements are different: the firm must notify FDA no later than 30 days after first marketing the claim and carry the standard disclaimer^[15]. In the EU, health claims must be authorised under Regulation (EC) No 1924/2006, so US wording cannot be reused without review^[16]. For the word “probiotic” itself and the supplement route, see our explainer on probiotic claims in the EU and US.

Table 2. Claim types and their position under US rules.

State cottage food laws and interstate sale

Most states have cottage food laws that let small producers sell certain low-risk foods made in a home kitchen, usually directly to consumers, with lighter licensing. Product lists and sales limits vary by state, and acidified, refrigerated and other time- and temperature-controlled foods are often excluded, so check your state agriculture or health department before you start.

Federal registration depends on the type of business. Retail food establishments, restaurants and farms do not have to register with FDA, but a facility that manufactures, processes, packs or holds food for US consumption generally does^[12]. Selling through distributors or retailers, or moving beyond direct sales, usually means a licensed commercial kitchen or co-packer, FDA facility registration and the federal rules above. Our guide to FDA food facility registration sets out the steps.

A compliance checklist for a US launch

1. Classify the product: conventional food, dietary supplement, alcohol beverage, meat or poultry product, or acidified food (Figure 1).
2. Measure alcohol through shelf life; if it can reach 0.5% ABV at any time, plan for TTB^[4].
3. Decide whether Part 114 applies; if it does, register, file the process and train a supervisor^[1][2][3].
4. Write the hazard analysis and preventive controls, or confirm your exemption^[7].
5. Set live-culture wording and any CFU figure only from stability data to expiry^[8].
6. Review every claim against the health-claim and structure/function rules; notify FDA only if the product is a supplement^[9][15].
7. Confirm state licensing, cottage-law fit, FDA facility registration and your route to interstate sale^[12].

Conclusion

US fermented food regulations turn on a few early decisions: whether alcohol can ever reach 0.5%, whether acid is added to a low-acid food or the product is naturally fermented, what the label says about live cultures, and which claims you make. Classify first, test alcohol and counts through shelf life, and write every culture and health statement from data.

For brands & formulators

Food Research Lab’s microbiome solutions team develops fermented and live-culture foods and drinks with the US route built in from the first prototype: product classification, alcohol and pH control in the formulation, live-culture survival and label-count planning. Alcohol, pH and viability testing is run or arranged through accredited partner laboratories. We work from Chennai, India, for brands launching in the US.

Our regulatory and scientific research team reviews labels and claims against FDA rules, and our new food product development service takes the formula to pilot scale. You can also contact us with your product and target market.

In this series

• Stanford fermented food study explained: what the 2021 Cell trial showed about fermented foods, the microbiome and inflammation markers.
• Fermentation scale-up for foods and drinks: from bench fermentation to plant.
• Formulating live culture foods and drinks: strain, dose, matrix and survival (the cluster guide).
• US fermented food regulations: alcohol, acidified foods, labels and claims (you are here).
• Live-culture survival trial in a fermented beverage: a worked example of a shelf-life count study.
• Fermented foods and drinks Q&A: common formulation, regulation and shelf-life questions.
• Microbiome solutions: develop your fermented product with FRL.

1. U.S. Food and Drug Administration. (2026). 21 CFR Part 114: Acidified foods (§114.3 definitions). Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-114 (cited for the acidified-food definition, pH 4.6, a_w above 0.85 and the refrigeration exclusion)
2. U.S. Food and Drug Administration. (2026). 21 CFR 108.25: Acidified foods. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-108/subpart-B/section-108.25 (cited for registration within 10 days and process filing)
3. U.S. Food and Drug Administration. (2026). 21 CFR 114.10: Personnel. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-114#114.10 (cited for supervision by a person trained at an FDA-approved school)
4. Alcohol and Tobacco Tax and Trade Bureau. (n.d.). Kombucha. https://www.ttb.gov/kombucha (cited for the 0.5% ABV threshold at any time, qualified premises, IRC labelling, formula and tax, ABLA health warning, FAA Act rules for malt beverages, and state rules)
5. U.S. Food and Drug Administration. (n.d.). CPG Sec. 510.400: Dealcoholized wine and malt beverages, labeling. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-510400-dealcoholized-wine-and-malt-beverages-labeling (cited for the “less than 0.5 percent alcohol by volume” declaration)
6. U.S. Food and Drug Administration. (2024, corrected 2025). Compliance Program 7303.070: Acidified and low-acid canned foods program, import and domestic. https://www.fda.gov/media/182173/download (cited for naturally fermented foods not being acidified foods, and for washed or high-pH fermented products)
7. U.S. Food and Drug Administration. (2026). 21 CFR Part 117: Current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food (§117.5 exemptions). Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117 (cited for food safety plans and exemptions for qualified facilities and juice/seafood HACCP activities)
8. U.S. Food and Drug Administration. (2026). 21 CFR 131.200: Yogurt, paragraph (f). Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-131/subpart-B/section-131.200 (cited for “contains live and active cultures” at 10⁷ CFU/g at manufacture and 10⁶ CFU/g through shelf life, and the heat-treated statement)
9. U.S. Food and Drug Administration. (n.d.). Label claims for conventional foods and dietary supplements. https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/label-claims-conventional-foods-and-dietary-supplements (cited for health claim routes: NLEA regulation, FDAMA notification, qualified health claims)
10. U.S. Food and Drug Administration. (n.d.). Qualified health claims. https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/qualified-health-claims (cited for letters of enforcement discretion with qualifying language)
11. U.S. Food and Drug Administration. (2024, March 1). FDA announces qualified health claim for yogurt and reduced risk of type 2 diabetes. https://www.fda.gov/food/hfp-constituent-updates/fda-announces-qualified-health-claim-yogurt-and-reduced-risk-type-2-diabetes (cited for the yogurt qualified health claim, 2 cups or 3 servings a week, limited evidence)
12. U.S. Food and Drug Administration. (2026). 21 CFR 1.226: Who does not have to register under this subpart? Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-H/section-1.226 (cited for registration exemptions for retail food establishments, restaurants and farms, and for USDA-only meat, poultry and egg product facilities)
13. U.S. Food and Drug Administration. (2026). 21 CFR 101.91: Gluten-free labeling of food, paragraph (c). Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-F/section-101.91 (cited for record-keeping for fermented or hydrolyzed foods labelled gluten-free)
14. U.S. Food and Drug Administration. (n.d.). Structure/function claims. https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/structurefunction-claims (cited for structure/function claims on conventional foods: nutritive value, no notification or disclaimer; disease claims reserved to drugs)
15. U.S. Food and Drug Administration. (2026). 21 CFR 101.93: Certain types of statements for dietary supplements. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-F/section-101.93 (cited for notification no later than 30 days after first marketing and the disclaimer)
16. European Parliament and Council. (2006). Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. EUR-Lex. https://eur-lex.europa.eu/eli/reg/2006/1924/oj (cited for authorisation of health claims in the EU)