Claim

A food label claim is a statement about a food product or recipe that communicates a verifiable fact — such as "low sodium" or "heart-healthy." BetterMenu evaluates five categories of claims against FDA thresholds and equivalent standards from Health Canada, Food Standards Australia New Zealand, and the UK Food Standards Agency.

Claims fall into one of the following categories:

• Nutrient Content Claim
• Health Claim (Authorized or Qualified)
• Structure/Function Claim
• Food Source Claim (e.g. Organic, Non-GMO)
• Lifestyle Claim (e.g. Vegan, Gluten-Free)

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graph TD
  A[Food Label Claim] --> B[Nutrient Content Claim]
  A --> C[Health Claim]
  A --> D[Structure/Function Claim]
  A --> E[Food Source Claim]
  A --> F[Lifestyle Claim]
  C --> G[Authorized — meets SSA standard]
  C --> H[Qualified — limited scientific evidence]
  B --> I[Examples: low fat, high fiber, reduced sodium]
  E --> J[Examples: USDA Organic, Non-GMO]

What is a Nutrient Content Claim?

A Nutrient Content Claim characterizes the level of a nutrient in a food using terms such as "free," "low," "reduced," "high," "good source of," or "light." Under 21 CFR Part 101, Subpart D — Specific Requirements for Nutrient Content Claims, the FDA defines precise numerical thresholds that a product must meet before using any of these descriptors on its label. The governing general framework appears at 21 CFR 101.13 — Nutrient Content Claims: General Principles. A claim is considered a nutrient content claim when it explicitly names a nutrient or implicitly characterizes it through comparative language. Products failing to meet the established thresholds may not carry the claim regardless of how the statement is phrased. These requirements apply to conventional foods and dietary supplements sold in the United States.

Common FDA-defined thresholds under 21 CFR 101.13 and the relevant subpart sections include:

BetterMenu evaluates nutrient data returned by the API against these regulatory thresholds and surfaces applicable claims for each ingredient, recipe, or product.

How does the FDA regulate nutrient content claims in the United States?

The FDA administers nutrient content claim requirements under 21 CFR Part 101, Subpart D. The general principles at 21 CFR 101.13 establish that claims must be made in accordance with an authorizing regulation, must not be false or misleading, and must comply with the reference amount customarily consumed (RACC) framework. Implied nutrient content claims — statements, symbols, or vignettes that characterize a nutrient level without naming it — are subject to the same standards. For a complete list of authorized terms and their thresholds, see FDA Label Claims for Conventional Foods and Dietary Supplements.

Which global authorities regulate nutrient content claims outside the US?

What is a Health Claim?

A Health Claim describes a relationship between a food, a food component, or a dietary supplement ingredient and a reduced risk of a disease or health-related condition. The general regulatory framework is established at 21 CFR 101.14 — Health Claims: General Requirements. Unlike nutrient content claims, which describe nutrient levels, health claims assert a physiological relationship — for example, "Diets low in sodium may reduce the risk of high blood pressure." Under 21 CFR 101.14, a health claim must meet three core criteria: the substance must be associated with a disease or health-related condition for which the general U.S. population is at risk, the food bearing the claim must be a "good source" of the relevant substance before fortification, and the claim must be complete, truthful, and not misleading.

What are authorized health claims under the Significant Scientific Agreement standard?

Authorized health claims are those that the FDA has reviewed and found to meet the Significant Scientific Agreement (SSA) standard — meaning the totality of publicly available scientific evidence supports the relationship. These claims are authorized through a formal rulemaking process and codified in 21 CFR Part 101, Subpart E. Examples include the relationship between dietary saturated fat and cholesterol and the risk of coronary heart disease (21 CFR 101.75), and between dietary fiber and cancer risk (21 CFR 101.76). A complete registry of SSA-standard authorized claims is maintained at FDA Authorized Health Claims: Significant Scientific Agreement Standard.

What are qualified health claims and when are they permitted?

Qualified health claims are permitted where the scientific evidence is supportive but does not meet the SSA standard. The FDA issues enforcement discretion letters for these claims, which must be accompanied by qualifying language that conveys the limited nature of the evidence — for example, "Some evidence suggests... however, FDA has determined that this evidence is limited and not conclusive." Qualified claims do not appear in the CFR; they are governed by FDA guidance and individual letters of enforcement discretion. The FDA maintains a list of qualified health claims for conventional foods and dietary supplements.

Which global authorities regulate health claims outside the US?

What is a Structure/Function Claim?

A structure/function claim describes the role of a nutrient or dietary ingredient in maintaining normal structure or function of the body. These claims do not assert a relationship to a disease or health condition — that distinction separates them from health claims. An example of a permitted structure/function claim is "Calcium builds strong bones." Structure/function claims for conventional foods are not subject to FDA pre-authorization, but they must be truthful and non-misleading under the Federal Food, Drug, and Cosmetic Act. For dietary supplements, 21 CFR 101.93 requires that manufacturers notify the FDA within 30 days of marketing a product bearing a structure/function claim, and the label must carry a disclaimer stating that the claim has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease. The boundary between a structure/function claim and a health claim can be narrow; when a statement implies disease risk reduction, it is treated as a health claim and falls under 21 CFR 101.14.

What is a Food Source Claim?

Food source claims communicate the origin, production method, or certification status of a food or its ingredients. The most regulated food source claim in the United States is the USDA Organic designation. Under the USDA National Organic Program (NOP), agricultural products labeled "organic" must be produced in accordance with the NOP regulations codified at 7 CFR Part 205. Products containing 95% or more organically produced ingredients (excluding water and salt) may display the USDA Organic seal. Products containing 70–94% organic ingredients may state "Made with organic [ingredient]" but may not display the USDA seal. Products with less than 70% organic ingredients may list organic ingredients only in the ingredient statement. Certifying agents accredited by the USDA verify compliance before a producer may use the organic designation on labels or in labeling.

Non-GMO claims are not federally mandated but are governed by voluntary standards, most notably the Non-GMO Project Verified program. The USDA also administers a voluntary Bioengineered Food Disclosure Standard (7 CFR Part 66), which requires disclosure of bioengineered food ingredients on most packaged foods — a related but distinct regulatory obligation from non-GMO marketing claims.

How do food source claim standards vary by jurisdiction?

Food manufacturers use organic and related certifications voluntarily to communicate production standards to consumers. The use of these claims on packaging must accurately reflect the certification status granted by an accredited body and must not be applied to products that have not completed the required certification process.

Where can I find the official regulatory sources for food label claims?

• 21 CFR 101.13 — Nutrient Content Claims: General Principles (eCFR)
• 21 CFR Part 101, Subpart D — Specific Requirements for Nutrient Content Claims (eCFR)
• 21 CFR 101.14 — Health Claims: General Requirements (eCFR)
• 21 CFR Part 101, Subpart E — Specific Requirements for Health Claims (eCFR)
• FDA Authorized Health Claims — Significant Scientific Agreement Standard
• FDA Label Claims for Conventional Foods and Dietary Supplements
• USDA National Organic Program
• 7 CFR Part 205 — National Organic Program Regulations (eCFR)