FDA Label Claims: Definitions and Compliance Considerations

For food manufacturers, product labeling represents both a regulatory responsibility and a powerful tool for brand differentiation. Label claims help consumers make informed purchasing decisions while allowing brands to highlight the unique nutritional or functional benefits of their products.  

These claims are tightly regulated by the U.S. Food and Drug Administration (FDA), requiring strict adherence to defined standards, substantiation protocols, and disclosure rules. A deep understanding of these requirements is essential to crafting claims that not only comply with federal regulations but also reinforce brand credibility and competitive positioning.  

This article provides an overview of FDA-regulated label claims and outlines the main criteria used for enforcement.  

Types of FDA Label Claims 

Nutrient Content Claims (NCCs)

Nutrient Content Claims (NCCs) are statements that characterize the level of a nutrient in a food product. These claims are regulated by the FDA and must meet specific criteria depending on the type of claim. 

• Absolute NCCs are defined by regulation and must meet fixed thresholds. (e.g., "low sodium" must contain ≤140 mg per RACC and "high fiber" must contain ≥5 g per RACC). 

• Relative NCCs compare the nutrient level in a product to a reference food and include: 

• • The percentage or fraction of modification (e.g., "40% less fat") 

• • The reference food (e.g., "than regular potato chips") 

• • A quantitative comparison (e.g., "contains 4g less fat") 
• Implied NCCs suggest nutrient levels by symbols, graphics, or ingredients (e.g., a heart symbol may imply cardiovascular benefits or “contains oat bran” implies a good source of fiber). 

All NCCs must be assessed based on the Reference Amount Customarily Consumed (RACC), and in some cases, per 50g or 100g portions depending on product type. Products with small RACCs (<30g or 2 tbsp) must be assessed using a 50g portion. Meal/main dish products require assessment per 100g. 

General Assessment Criteria: 

• "Good Source" requires ≥10% DV per RACC. 

• "Excellent Source" requires ≥20% DV per RACC. 

• Claims must not be more than twice the size of the product name and must not be unduly prominent. 
• If a product exceeds thresholds for total fat, saturated fat, cholesterol, or sodium, a General Disclosure Statement (GDS) must be placed adjacent to the claim. 

Regulatory Nuances: 

Antioxidants 

Antioxidant claims must be based on nutrients with recognized antioxidant activity and listed in the Nutrition Facts Panel, where applicable. The FDA recognizes vitamins A, C, and E as antioxidants. Claims involving other nutrients like zinc or selenium require scientific substantiation of antioxidant activity. Claims like "rich in antioxidants" must be supported by evidence and include qualifying language. 

Example: "Rich in antioxidants including vitamin C and E" 

Fiber 

Fiber claims are popular but must be carefully constructed. Unless the product is low-fat, a fiber claim must be accompanied by a total fat disclaimer ("contains X grams total fat per serving"). 

Example: "Good source of fiber contains six grams total fat per serving" 

Protein 

Protein claims are subject to additional scrutiny due to the need to assess protein quality. They must include %DV calculated from Protein Digestibility Corrected Amino Acid Score (PDCAAS) in the Nutrition Facts Panel. 

Example: "High in protein – 15g per serving (25% DV)" 

Health Claims

Health claims describe the relationship between a substance and reduced risk of a disease or health-related condition. They must be supported by significant scientific evidence that is available to the public and avoid implying treatment or cure. Manufacturers must take care to use phrasing that reflects risk reduction and not disease prevention. 

• Authorized health claims are Codified in 21 CFR (accepted by the FDA) and based on significant scientific agreement (SSA). 

• • "Adequate calcium throughout life may reduce the risk of osteoporosis." 

• Authoritative statement health claims are allowed when supported by certain scientific bodies rather than the FDA doing an independent investigation. 

• • “Diets rich in fruits and vegetables may reduce the risk of some types of cancer.” 

• Qualified health claims are permitted when the evidence is limited but credible. They must include qualifying language that clearly communicate the level of scientific support. 
  • “Some scientific evidence suggests... but the FDA has determined that evidence is limited and not conclusive.” 

Regulatory Nuances: 

• Symbols such as hearts or checkmarks used in conjunction with health claims must be accompanied by the full claim text to avoid implying drug-like effects. 

Structure/Function Claims

These claims describe the role of a nutrient or ingredient in maintaining normal body structure or function (such as “fiber helps support digestive health”). They do not reference disease risk reduction and are commonly used in dietary supplements. These types of claims must be substantiated by competent and reliable scientific evidence, but still many also require a disclaimer: "This statement has not been evaluated by the FDA..." 

Regulatory Nuances: 

• Cannot imply treatment or improvement of abnormal conditions. 
• Must identify the nutrient or ingredient responsible for the claimed effect. 

Drug Claims

Statements that imply curing or treating a disease are considered drug claims and are strictly prohibited on food labels. 

Other Claims 

Organic 

Organic claims are regulated by the USDA National Organic Program. Products labeled “Made with Organic” must contain at least 70% organic ingredients and list the certifying agent. Those labeled “Organic” must contain at least 95% organic ingredients and may use the USDA Organic seal. Products labeled “100% Organic” must have all ingredients certified organic. 

Natural 

Natural claims are not formally defined by the FDA. Historically, the term has been interpreted to mean nothing artificial or synthetic, including color additives. Because of this ambiguity, use of the term “natural” should be cautious and substantiated to avoid misleading consumers. 

Claims stating “No Artificial Flavors/Colors” must be based on the definitions of artificial and natural flavors. These claims must be accurate and not misleading, especially when natural flavors do not match the named flavor of the product. Color claims must be carefully reviewed, as even naturally sourced colors can be synthetically produced. 

Precautionary Allergen Labeling (PAL) 

PAL includes statements such as “Made in a facility that also processes peanuts.” These must not conflict with explicit absence claims like “Peanut Free.” Allergen-free claims must be substantiated and consistent with manufacturing practices. 

Non-GMO 

Non-GMO claims are permitted by the FDA as voluntary labeling. These claims must be truthful and not misleading. Products that cannot be genetically modified should not carry non-GMO claims unless clearly qualified. 

Gluten-Free 

Gluten-free claims must meet the FDA definition of less than 20 parts per million (ppm) of gluten. Products making this claim cannot contain any gluten-containing ingredients. Claims like “naturally gluten-free” may be misleading and should be avoided. 

Plant-Based, Vegan, & Vegetarian 

These claims are not formally defined by the FDA but must be substantiated by ingredient sourcing and processing. Vegan claims must exclude all animal-derived ingredients and byproducts. Symbols and icons used to denote these claims must be clear and not misleading. 

Eurofins: Your Trusted Partner in Quality and Compliance  

Maintaining compliance with FDA label claim regulations is integral to both operational excellence and consumer confidence. Each type of claim—from nutrient content to health-related statements—requires precise formulation, accurate documentation, and careful alignment with FDA definitions and thresholds. Failure to meet these standards can lead to costly relabeling, enforcement actions, or erosion of brand trust.  

As consumer demand for transparency, health-focused products, and sustainability continues to rise, proactive compliance with FDA labeling requirements not only protects against risk but also strengthens brand credibility in a competitive marketplace. 

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