Functional & Health Claims on Non-Alcoholic Drinks

The FDA permits "structure/function" claims on food and beverage products — statements like "supports relaxation" or "promotes mental clarity" — provided the claim is truthful, substantiated, and accompanied by a mandatory disclaimer. Claims that imply the product diagnoses, treats, cures, or prevents a specific disease are prohibited for foods and can reclassify your beverage as an unapproved drug. For EU brands entering the US, this distinction is the single most important regulatory difference in how functional beverages may be marketed.

This content is general information, not legal advice. Claims on food and beverage products are highly fact-specific. Verify all proposed label language with qualified regulatory counsel and consult FDA.gov before printing. Regulatory violations in this area can result in Warning Letters, injunctions, and mandatory recalls.

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Key Takeaways

• Structure/function claims (e.g., "supports focus") are permitted with substantiation and a required disclaimer.
• Disease claims (e.g., "reduces anxiety disorder") are prohibited for food/beverage and trigger drug classification.
• Adaptogens, nootropics, and botanicals are not uniformly GRAS — ingredient status must be confirmed for each specific compound and use level.
• CBD in beverages remains a gray zone as of 2026 — FDA has not issued a final rule permitting its use as a food ingredient.
• EU-approved health claims (under EFSA Regulation 1924/2006) do not transfer to US labels. US claims require independent substantiation.

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The US Claims Framework for Beverages: Three Categories

The FDA distinguishes three types of health-related claims that can appear on food/beverage products. Understanding which category your proposed language falls into is the threshold question before any label is printed.

Category 1 — Nutrient Content Claims

These are factual claims about the presence or level of a nutrient or substance in the product. They have FDA-defined thresholds.

Examples: "sugar-free," "low calorie," "high in vitamin C," "zero sodium."

The FDA defines each term precisely in 21 CFR Part 101. "Sugar-free" means less than 0.5 g sugars per reference amount and per labeled serving. Using these terms without meeting the regulatory definition is a labeling violation.

EU–US gap: EU nutrient content claim terms (from Regulation 1924/2006) differ from FDA definitions. "Low sugar" in the EU does not carry the same threshold as "low sugar" in the US. All nutrient content claim language must be reviewed against US definitions — not EU equivalents.

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Category 2 — Structure/Function Claims

These are claims that describe the role of a nutrient or ingredient in affecting the normal structure or function of the body. They are the primary vehicle for functional beverage marketing in the US.

Permitted examples:

• "Supports relaxation"
• "Promotes mental clarity and focus"
• "Helps maintain healthy energy levels"
• "Supports the body's natural stress response"

Requirements for structure/function claims on food/beverages:

1. The claim must be truthful and not misleading.
2. The claim must be substantiated — the brand must have competent and reliable scientific evidence supporting the claim at the use level in the product.
3. The mandatory disclaimer must appear on the label: "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."
4. The disclaimer must appear prominently, immediately adjacent to the claim, in type size that is at least one-sixteenth of an inch.

Note on food vs. dietary supplement: Dietary supplements (sold in capsule, tablet, or powder form) have a more formalized structure/function claim notification process — the brand must notify the FDA within 30 days of first marketing. For conventional foods and beverages, the notification requirement does not apply — but the substantiation and disclaimer requirements do.

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Category 3 — Disease Claims (Prohibited for Foods)

A disease claim explicitly or implicitly links the product to the diagnosis, cure, mitigation, treatment, or prevention of a specific disease or health condition. Disease claims on food/beverage products are prohibited — making a disease claim reclassifies the product as a drug, triggering full drug approval requirements.

Prohibited examples (for food/beverage context):

• "Reduces anxiety" (anxiety disorder = disease)
• "Lowers blood pressure" (hypertension = disease)
• "Helps manage blood sugar in diabetics" (diabetes = disease)
• "Prevents cancer"
• "Treats insomnia"

The line between a permitted structure/function claim and a prohibited disease claim can be narrow. "Supports healthy sleep" is generally a structure/function claim; "treats insomnia" is a disease claim. The context in which a claim is made — including off-label marketing materials, social media, and influencer content — is also considered by the FDA.

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Adaptogens: What the FDA Says (and Doesn't)

Adaptogenic ingredients — ashwagandha (Withania somnifera), rhodiola rosea, lion's mane mushroom, holy basil, eleuthero, and others — are standard components of European and Asian functional beverages entering the US market. Their regulatory status in US food/beverage products involves two distinct questions:

Question 1: Is the ingredient GRAS for use in a beverage?

GRAS (Generally Recognized As Safe) status is the gateway requirement for any ingredient used in a conventional food or beverage. An ingredient must either be:

• Subject to a completed GRAS determination (self-affirmed or FDA-notified), or
• Otherwise approved by the FDA for use in food

GRAS status for adaptogens is not uniform:

• Ashwagandha (KSM-66 extract): Several manufacturers have self-affirmed GRAS for specific extract types and use levels. However, GRAS status is brand/extract/use-level specific — it does not apply universally to "ashwagandha."
• Rhodiola rosea: Self-affirmed GRAS exists for some preparations, but not all; use levels matter.
• Lion's mane mushroom: GRAS status varies by extract form and preparation method.
• Eleuthero (Siberian ginseng): Used in food for decades; generally accepted, but formal GRAS documentation is advisable.

The EU-US gap: An ingredient authorized under EFSA Opinion for use in EU food or beverages does not carry automatic GRAS status in the US. EU authorization and US GRAS are parallel systems with no legal equivalence. Every novel or botanical ingredient in your EU formula needs a fresh GRAS assessment for the US market.

Question 2: What claims can you make about the adaptogen?

Even if the ingredient is GRAS, your claim language must fit within the structure/function framework. "Ashwagandha supports the body's natural stress response" is generally a structure/function claim. "Ashwagandha reduces cortisol levels in patients with chronic stress disorder" is approaching disease claim territory.

Campden BRI's technical guidance for exporting food and drink to the USA identifies adaptogen ingredient status as one of the most frequent regulatory gaps for EU beverage brands targeting the US market.

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Nootropics and Cognitive Function Claims

Nootropic beverages — products marketed for mental clarity, focus, memory, or cognitive performance — are an active and scrutinized category. The FDA has issued Warning Letters to beverage brands that used cognitive enhancement claims that crossed into disease claim territory (e.g., claims about dementia prevention or ADHD treatment).

Generally permissible claim language (structure/function):

• "Promotes focus and concentration"
• "Supports mental clarity"
• "Helps maintain cognitive performance"

Higher-risk claim language (approaching disease claim territory):

• "Improves memory impairment"
• "Helps with ADHD"
• "Supports brain health in aging populations" (if context implies disease prevention)

Common nootropic ingredients and their US status:

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CBD Beverages: Still a Gray Zone in 2026

CBD (cannabidiol) in food and beverages remains one of the most unsettled areas of US food law. As of the date of this article, the FDA has not issued a final rule definitively permitting CBD as a food ingredient. The agency has stated that CBD is subject to the drug exclusion clause of the FD&C Act (because it was approved as a drug — Epidiolex — before being used as a food ingredient).

In practice, many CBD beverages are sold in US states that have adopted permissive state-level rules, and federal enforcement has been limited. But this creates legal uncertainty that affects:

• The ability to make any structure/function claim about CBD's effects.
• Interstate commerce risk.
• Retailer and distributor compliance requirements (many major retailers still refuse CBD food/beverage products).

If your EU formula contains CBD: assume it cannot be marketed in a US food/beverage product under current federal law without significant regulatory risk. Reformulation for the US market is likely necessary. Consult specialized cannabis/CBD regulatory counsel. This is general information, not legal advice — verify with FDA.gov.

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The Mandatory Disclaimer: Don't Print Without It

Every structure/function claim on a food/beverage product must carry this exact language, prominently displayed:

"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."

It must appear:

• Immediately adjacent to the claim (not buried in fine print on the back panel while the claim is on the front).
• In a type size at least one-sixteenth of an inch.
• Prominently and conspicuously.

Many brands include this disclaimer on the information panel. If claims appear on the principal display panel, the disclaimer should also appear there.

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In Our Own US Launches

In working with EU functional beverage brands on US market entry, the most common claims issue we encounter is the direct translation of EU health claims into US marketing copy. An EU brand with EFSA-approved claims for reduced tiredness or improved cognitive function cannot carry those same approved claims on a US label. The EU approval is irrelevant to the FDA. We always recommend a fresh claims audit with US regulatory counsel before finalizing any label or marketing asset that includes functional language.

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Related Reading

• Labeling & Compliance for Non-Alcoholic Beverages in the US
• FDA Labeling Requirements for Imported Beverages: A Checklist
• Allergens, Ingredients & GRAS: Reformulating an EU Recipe for the US
• FDA vs. TTB — Who Regulates Non-Alcoholic Beverages?

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About the Author

Written by Nick Bodkins, co-founder of Avenor, the US market-entry partner for overseas non-alcoholic beverage brands. Nick previously founded Boisson, the largest US non-alcoholic retail and e-commerce platform. Connect on LinkedIn.