Functional Beverage FDA Regulations: 10 Questions US Brands Ask Before Launch

Key terms used in this Q&A

Most delays in a functional drink project are regulatory, not technical: the wrong product category, an ingredient without a lawful status, or a claim that reads as a disease claim. Each answer below names the US rule that governs the point and links the official text. This page is educational, not legal advice; final sign-off sits with your regulatory advisor or counsel.

Table 1. Regulatory terms used in this Q&A

1. Is my functional beverage a conventional food or a dietary supplement?

Short answer: it depends on how the product is represented, not on the active ingredient alone. A drink sold and presented as a beverage is a conventional food; a liquid labelled and marketed as a dietary supplement follows the supplement rules. Decide this first, because it sets the label panel, the claims, the manufacturing standard and the ingredient route.^[1][2]

FDA’s 2014 guidance lists the factors it weighs: the product name, packaging (size, shape, colour and resemblance to ordinary drinks), serving size and recommended daily intake, composition, and marketing outside the label. A product sold in a soda-style can with an intake suggestion of several servings a day reads as a beverage, whatever the panel says.^[1]

Table 2. Conventional beverage versus liquid dietary supplement (US)

Our explainer on functional beverages vs functional foods covers the classification logic in the US and EU. For the formulation side, see how to formulate a functional beverage.

2. What can the label say about the drink's benefit?

Short answer: a label may describe how a nutrient or ingredient supports normal structure or function of the body, but it may not claim to diagnose, treat, mitigate, cure or prevent a disease. On a conventional beverage, a structure/function claim must derive from the drink’s nutritive value; a supplement may also claim non-nutritive effects.^[3][4]

• Disease claims: FDA defines a disease as damage to an organ, part, structure or system so that it does not function properly, or a state of health leading to that, such as hypertension. Wording like “lowers blood pressure in hypertension” or “relieves anxiety disorder” is a disease claim on either type of product.^[3]
• Structure/function claims: for example “supports normal hydration”, wording about normal function, backed by evidence for the dose in the drink.^[4]
• Health claims: a link between a substance and a disease or health-related condition, allowed only where FDA has authorised the claim and the food meets its conditions.^[5]

Which wording is open to you depends on your answer to Question 1. For a worked comparison of a claim term across markets, see our explainer on probiotic claims in the EU and US.

3. Do I need FDA approval or notification for a claim?

Short answer: not approval, but a supplement needs notification. A supplement making a structure/function claim must notify FDA no later than 30 days after first marketing and carry the FDA disclaimer. A conventional beverage needs neither. Health claims need no individual approval if they meet an authorised claim’s conditions; a new health claim needs an FDA petition.^[3][4][5][6]

• Supplement notification: the notice gives the firm, the claim text, the ingredient and the product name, and the signatory certifies that the firm has substantiation that the statement is truthful and not misleading.^[3]
• Disclaimer text (one claim): “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” A plural version applies to several claims.^[3]
• Conventional beverage: FDA does not require notification or a disclaimer for structure/function claims on conventional foods.^[4]
• New health claim: any interested person may petition FDA to issue a regulation for a health claim.^[6]

Either way, keep an evidence file for every claim, matched to the dose per serving in the finished drink.

4. Is my active ingredient allowed in a US beverage?

Short answer: each ingredient needs a lawful status for its intended use. In a conventional beverage that means an approved food additive or a GRAS use. In a supplement it means a dietary ingredient that was marketed before 15 October 1994 or one notified to FDA as a new dietary ingredient at least 75 days before marketing.^[2][7][9]

• GRAS: general recognition of safety must rest on the views of qualified experts, based on scientific procedures or on common use in food before 1958, under the intended conditions of use.^[7]
• Proposed change: on 11 August 2026 FDA proposed making GRAS notices mandatory for food substances purported to be GRAS (91 FR 51834, Docket FDA-2025-N-3262). Comments close on 9 December 2026. It is a proposal, not a final rule, but an ingredient resting on a self-determined GRAS conclusion should have a dossier ready to file.^[8]
• New dietary ingredients: the notification must give the basis on which the firm concluded the supplement will reasonably be expected to be safe.^[9]

A lawful supplement ingredient is not automatically lawful in a beverage, so if the classification in Question 1 changes, re-check every active.

5. Can I add caffeine to a functional beverage?

Short answer: yes, but the GRAS listing in 21 CFR 182.1180 covers caffeine only in cola-type beverages, at up to 0.02 percent. Use in other drink types, or at higher levels, needs its own lawful basis, such as a documented GRAS conclusion. FDA has no regulation specific to energy drinks, so the general ingredient rules apply.^[10][11]

• Scale of the listing: 0.02 percent is roughly 200 mg per litre, or about 70 mg in a 12 fl oz (360 mL) serving (our conversion, assuming a density close to water).^[10]
• FDA reference points: FDA cites 400 mg a day as an amount not generally associated with negative effects in healthy adults, and reports energy drinks at about 54 to 328 mg per 16 fl oz.^[11]
• Labelling: caffeine added as an ingredient must appear in the ingredient list. Declaring the amount per serving is voluntary, though many brands do.^[11]

Set the dose per serving and per container together with the classification, the label statements and any advice for sensitive groups, and confirm the basis with your regulatory advisor before you lock the formula.

6. Which rules decide how a shelf-stable drink must be processed?

Short answer: the drink’s pH, water activity, container and process put it in a regulatory class. A low-acid drink heat-processed in a sealed container falls under Part 113; an acidified drink under Part 114. Both need the processing plant to register with FDA and file each scheduled process before packing the product.^{[12][13][14][15]}

Table 3. Shelf-stable classes and the governing rule (US)

• Timing: register the establishment (Form FDA 2541) no later than 10 days after first processing, and file the scheduled process for each product and container size no later than 60 days after registration and before packing a new product.^[14][15]
• Filing is not approval: FDA states that filing process information does not constitute approval.^[14]
• Scheduled process: it must control pH and the other critical factors as established by a competent processing authority.^[12]

Our hurdle technology guide for functional drinks explains how pH, water activity and preservatives combine. For low-acid drinks that need a validated heat process, see pilot retort trials and our note on retort-processed beverages.

7. Does a juice-based functional drink need juice HACCP?

Short answer: the juice in it does. Part 120 applies to any juice sold as such or used as an ingredient in beverages, including purées and concentrates. The HACCP plan must deliver at least a 5-log reduction of the most resistant pathogen likely to occur in the juice, for the product’s shelf life.^[16][17]

• Exemptions from the 5-log requirement: processors already subject to Part 113 or Part 114, and processors that use a single thermal step sufficient to make the juice shelf-stable, provided the process is documented in the hazard analysis.^[17]
• Single facility: the reduction treatment and final packaging must take place in one facility operating under CGMP.^[17]
• Label: a beverage that purports to contain fruit or vegetable juice must declare the percentage of juice.^[24]

If you buy a juice concentrate, ask the supplier which HACCP plan covers it and agree in writing who holds the pathogen-reduction step for your finished drink.

8. Which facility and manufacturing rules apply?

Short answer: the plant must be registered with FDA as a food facility before it starts making food for US consumption, and must renew every even-numbered year between 1 October and 31 December. A conventional beverage follows Part 117 (CGMP and preventive controls); a liquid supplement follows Part 111 (supplement CGMP).^[18][19][20]

• Supplements: a facility making a supplement in compliance with Part 111 is exempt from the Part 117 preventive-controls subparts for that product.^[19]
• Low-acid canned drinks: activities that comply with Part 113 are exempt from the Part 117 preventive-controls subparts for the microbiological hazards Part 113 regulates; other hazards still need controls.^[19]
• Contract manufacturing: confirm in writing which standard the line is audited to (Part 117, Part 111, and Part 113 or 114 where relevant) and who holds the registration and process filings.

Our guide to FDA food facility registration for a US launch covers registration, the 2026 renewal window and the import rules for foreign plants.

9. What must the label panel and ingredient statement show?

Short answer: the panel follows Question 1: Nutrition Facts for a conventional beverage, Supplement Facts for a supplement. Both need a complete ingredient statement and a declaration of any of the nine major food allergens. For beverages, the reference serving is 12 fl oz (360 mL), which decides how a bottle must be labelled.^{[21][22][23][25]}

• Serving size: carbonated and non-carbonated beverages have a reference amount of 360 mL; juices, nectars and fruit drinks 240 mL.^[23]
• Single-serving rule: a container holding less than 200 percent of the reference amount is labelled as one serving, so a 20 fl oz bottle of a functional soda is one serving. From 200 to 300 percent, a second column for the whole package is required.^[21]
• Allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame became the ninth major allergen on 1 January 2023 under the FASTER Act.^[25]
• Juice content: if the drink looks, tastes or is named like it contains juice, declare the percentage juice.^[24]

Check each added ingredient, such as plant protein, botanical extracts and flavour carriers, for an allergen source. Undeclared allergens are a leading cause of US food recalls; see our undeclared allergen recall review.

10. Who signs off on regulatory status, and what does FRL cover?

Short answer: the brand owns the regulatory decision, with its regulatory advisor or counsel giving final sign-off, and a competent processing authority setting any Part 113 or Part 114 scheduled process. FRL works alongside them, planning the formula, claims and label against FDA rules from the start so the recipe, label and process stay aligned.

• Brief we need: drink type and pack, target market, each active and its dose per serving, the claim you want to make, and the shelf life and storage you are aiming for.
• What we provide: classification and claim mapping, ingredient-status checks, label and Nutrition or Supplement Facts drafts, and a testing plan.
• Testing: pH, water activity, microbiological and stability testing, which we run or arrange through accredited partner laboratories.

For brands & formulators

Most US functional drink launches that stall trip on one of these ten questions: a beverage that was really sold like a supplement, a claim that crossed into disease, an active without a GRAS basis, or a shelf-stable process that was never filed. FRL’s beverage formulation team works through them in that order:

• Classification: conventional beverage or liquid supplement, decided from the name, pack, serving and marketing plan before formulation.
• Ingredient and claim map: the lawful status of each active, the dose per serving and the claim wording it can support.
• Process class: pH and water activity targets that fix the Part 113, 114 or 120 route, with heat-process work through pilot retort trials where needed.
• Label file: Nutrition or Supplement Facts, ingredient and allergen statements, reviewed by our regulatory and scientific research team.

Send us your brief through the beverage formulation service, or contact us.

In this series

• Functional beverage development cost guide: what each development stage involves and what drives the budget.
• How to formulate a functional beverage: the pillar guide, from target profile to shelf-stable batch.
• Hurdle technology for functional drinks: how pH, water activity and preservatives keep a drink stable.
• Heat-stable plant beverage development: a plant-based drink taken from brief to batch.
• Functional beverage FDA regulations: 10 questions (you are here): classification, claims, ingredients, processing and labels.
• Beverage formulation services: FRL’s service page for functional drink development.

1. U.S. Food and Drug Administration. (2014). Guidance for industry: Distinguishing liquid dietary supplements from beverages. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-distinguishing-liquid-dietary-supplements-beverages (cited for the factors FDA weighs: name, packaging, serving size, recommended intake, composition and marketing).
2. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321 (definitions), sections 201(s) and 201(ff). Legal Information Institute, Cornell Law School. https://www.law.cornell.edu/uscode/text/21/321 (cited for the dietary supplement definition, including “not represented for use as a conventional food”, and the food additive definition that excludes GRAS substances); and 21 U.S.C. § 350b(d), https://www.law.cornell.edu/uscode/text/21/350b (cited for the new dietary ingredient definition: not marketed in the US before 15 October 1994).
3. U.S. Food and Drug Administration. (2026). 21 CFR 101.93: Certain types of statements for dietary supplements. Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-101.93 (cited for the 30-day notification, its content and substantiation certification, the disclaimer text and the definition of disease claims).
4. U.S. Food and Drug Administration. (2024). Structure/function claims. https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/structurefunction-claims (cited for nutritive-value claims on conventional foods, and no notification or disclaimer for conventional foods).
5. U.S. Food and Drug Administration. (2026). 21 CFR 101.14: Health claims: general requirements. Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-101.14 (cited for the health claim definition and conditions; specific authorised claims are in Subpart E).
6. U.S. Food and Drug Administration. (2026). 21 CFR 101.70: Petitions for health claims. Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-101.70 (cited for the petition route for a new health claim).
7. U.S. Food and Drug Administration. (2026). 21 CFR 170.30: Eligibility for classification as generally recognized as safe (GRAS). Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-170.30 (cited for the basis of GRAS status: qualified experts, scientific procedures or common use before 1958).
8. U.S. Food and Drug Administration. (2026, August 11). Substances generally recognized as safe [Proposed rule]. Federal Register, 91, 51834 (Docket No. FDA-2025-N-3262). https://www.federalregister.gov/documents/2026/08/11/2026-16296/substances-generally-recognized-as-safe (cited for the proposal to make GRAS notices mandatory and the 9 December 2026 comment deadline).
9. U.S. Food and Drug Administration. (2026). 21 CFR 190.6: Requirement for premarket notification. Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-190.6 (cited for the new dietary ingredient notification at least 75 days before marketing and its safety basis).
10. U.S. Food and Drug Administration. (2026). 21 CFR 182.1180: Caffeine. Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-182.1180 (cited for GRAS status in cola-type beverages at a tolerance of 0.02 percent).
11. U.S. Food and Drug Administration. (2024). Spilling the beans: How much caffeine is too much? [Consumer update]. https://www.fda.gov/consumers/consumer-updates/spilling-beans-how-much-caffeine-too-much (cited for 400 mg a day in healthy adults, 54 to 328 mg per 16 fl oz in energy drinks, no energy-drink-specific regulation, and listing added caffeine as an ingredient).
12. U.S. Food and Drug Administration. (2026). 21 CFR 114.3: Definitions (acidified foods). Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-114.3 (cited for the acid food and acidified food definitions, the carbonated-beverage and refrigeration exclusions and the scheduled process definition).
13. U.S. Food and Drug Administration. (2026). 21 CFR 113.3: Definitions (thermally processed low-acid foods packaged in hermetically sealed containers). Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-113.3 (cited for the low-acid food definition: pH above 4.6, water activity above 0.85, alcoholic beverages excluded).
14. U.S. Food and Drug Administration. (2026). 21 CFR 108.25: Acidified foods. Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-108.25 (cited for establishment registration within 10 days, process filing within 60 days and before packing, and that filing is not approval).
15. U.S. Food and Drug Administration. (2026). 21 CFR 108.35: Thermal processing of low-acid foods packaged in hermetically sealed containers. Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-108.35 (cited for registration and process filing for low-acid canned foods).
16. U.S. Food and Drug Administration. (2026). 21 CFR 120.1: Applicability (juice HACCP). Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-120.1 (cited for juice sold as such or used as an ingredient in beverages, and the juice definition).
17. U.S. Food and Drug Administration. (2026). 21 CFR 120.24: Process controls (juice HACCP). Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-120.24 (cited for the 5-log reduction, its exemptions and the single-facility requirement).
18. U.S. Food and Drug Administration. (2026). 21 CFR 1.230: When must you register or renew your registration?. Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-1.230 (cited for registration before operating and renewal between 1 October and 31 December of each even-numbered year (Part 1, Subpart H)).
19. U.S. Food and Drug Administration. (2026). 21 CFR 117.5: Exemptions (Current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food). Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-117.5 (cited for the Part 117 framework and the exemptions for Part 111 supplements and Part 113 microbiological hazards).
20. U.S. Food and Drug Administration. (2026). 21 CFR Part 111: Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111 (cited for supplement CGMP).
21. U.S. Food and Drug Administration. (2026). 21 CFR 101.9: Nutrition labeling of food. Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-101.9 (cited for the Nutrition Facts panel, the single-serving rule below 200 percent of the reference amount and the dual column from 200 to 300 percent).
22. U.S. Food and Drug Administration. (2026). 21 CFR 101.36: Nutrition labeling of dietary supplements. Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-101.36 (cited for the Supplement Facts panel).
23. U.S. Food and Drug Administration. (2026). 21 CFR 101.12: Reference amounts customarily consumed per eating occasion. Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-101.12 (cited for the 360 mL reference amount for beverages and 240 mL for juices).
24. U.S. Food and Drug Administration. (2026). 21 CFR 101.30: Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice. Electronic Code of Federal Regulations, retrieved 5 November 2026. https://www.ecfr.gov/current/title-21/section-101.30 (cited for the percentage juice declaration).
25. U.S. Food and Drug Administration. (2026). Food allergies. https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/food-allergies (cited for the nine major food allergens, FALCPA and sesame from 1 January 2023 under the FASTER Act).