Let our US food label compliance consulting services help you grow your business by taking the hassle out of food labelling and food safety compliance with the Canadian Food Inspection Agency the US Food & Drug Administration, the US Departments of Agriculture and the European Food Safety Authority
Successfully selling food products in the United States requires strict adherence to FDA food labeling regulations. The US market is both lucrative and unforgiving—FDA enforcement protects American consumers, and non-compliant labels can result in detained shipments, warning letters, and costly recalls. Whether you’re a domestic manufacturer or importing into the US, our US food label compliance services will help your understanding and implementing FDA requirements to ensure market success.
At FTC International, our regulatory specialists bring deep expertise in FDA food labeling regulations, helping you navigate the complex requirements of the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, and the Nutrition Labeling and Education Act. We translate regulatory language into practical guidance that protects your business and ensures your labels meet FDA standards.
The FDA’s authority over food labeling stems from multiple legislative acts and decades of regulatory development. The requirements are comprehensive, covering everything from how you identify your product to how you format nutritional information.
Key FDA Labeling Requirements Include:
Getting these elements right requires more than reading the regulations—it requires understanding how FDA interprets and enforces them in practice.
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The Nutrition Facts panel is arguably the most scrutinized element of US food labels. Following FDA’s modernized nutrition labeling rules (implemented in 2020), the formatting requirements are specific and inflexible.
Critical Nutrition Facts Requirements:
Serving Size Accuracy: Serving sizes must be based on FDA’s Reference Amounts Customarily Consumed (RACCs), not arbitrary portions. FDA provides specific RACCs for over 150 food categories. Using incorrect serving sizes is one of the most common compliance violations.
Mandatory Nutrients: Your Nutrition Facts panel must include total calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium—in the precise format and sequence specified by FDA.
Updated Daily Values: FDA updated Daily Values (DVs) for nutrients in 2020. Your labels must use current DVs, not outdated reference values. This affects the percentage calculations displayed on your panel.
Formatting Specifications: Font sizes, bolding, indentation, and spacing must follow FDA’s detailed formatting requirements. FDA provides precise specifications for every element, from the thickness of dividing lines to the minimum font height.
Dual Column Labeling: Products that could reasonably be consumed in one sitting or in multiple servings may require dual column formats showing “per serving” and “per container” information.
Our team ensures your Nutrition Facts panels meet all these requirements, properly formatted and calculated. We verify serving sizes against FDA RACCs, confirm nutrient calculations, validate Daily Value percentages, and ensure formatting complies with FDA specifications down to the millimeter.
FDA requires complete transparency in ingredient listing. Every ingredient must be declared by its common or usual name in descending order by weight at the time of manufacture.
Ingredient List Compliance Considerations:
Characterizing Ingredients: Certain ingredients must be declared by their characterizing component (e.g., “sugar” not “sucrose” unless specifically refined sugar). FDA provides guidance on accepted common names.
Sub-Ingredients: When an ingredient itself contains multiple components, those sub-ingredients must often be declared in parentheses following the ingredient name. The requirement varies based on the ingredient and its function.
Incidental Additives: Some additives present at insignificant levels and with no functional purpose in the finished product may be exempt from declaration, but these exemptions are narrow and specific.
Color Additives: Certified color additives must be declared by specific names (e.g., “FD&C Yellow No. 5”). Natural colors have different declaration requirements.
Percentage Declarations: When products make characterizing claims (e.g., “made with real fruit”), FDA may require percentage declarations for certain ingredients.
We review your complete ingredient list for FDA compliance, ensuring proper names, correct order, appropriate sub-ingredient declarations, and compliant formatting.
The Food Allergen Labeling and Consumer Protection Act (FALCPA) requires clear identification of major food allergens. This is a critical area where mistakes can have serious consequences for allergic consumers.
The Eight Major US Allergens:
FDA-Compliant Allergen Declaration Methods:
FDA allows two approaches to allergen declaration. First, you may identify allergens within the ingredient list using parenthetical statements (e.g., “whey (milk)”). Second, you may use a “Contains” statement immediately after or adjacent to the ingredient list (e.g., “Contains: Milk, Eggs, Wheat”).
Many manufacturers use both methods for extra clarity, though only one is required. Regardless of method, the declaration must be clear, conspicuous, and use the specific allergen source names required by FDA.
Cross-Contact Considerations:
“May contain” or “processed in a facility” statements are voluntary and not regulated by FALCPA. However, if you use these advisory statements, they should be accurate and not used as a substitute for good manufacturing practices to prevent cross-contact.
Our allergen review ensures all major allergens are properly declared, declarations use FDA-compliant language, and advisory statements (if used) are appropriately worded.
FDA strictly regulates claims on food labels. What seems like harmless marketing language may actually trigger FDA regulatory requirements or constitute prohibited claims.
Types of FDA-Regulated Claims:
Nutrient Content Claims: Claims like “low fat,” “high fiber,” or “good source of calcium” have specific regulatory definitions. You cannot use these terms unless your product meets FDA’s precise criteria for that claim.
Health Claims: These relate a food or ingredient to reduced risk of disease (e.g., “diets high in calcium may reduce risk of osteoporosis”). FDA authorizes specific health claims through regulation or qualified health claim letters. Unauthorized health claims are prohibited.
Structure/Function Claims: These describe how a nutrient affects normal structure or function of the body (e.g., “calcium builds strong bones”). While these claims don’t require FDA pre-approval, they must be truthful, non-misleading, and substantiated.
Implied Claims: Be careful with claims that might imply nutritional or health benefits. Terms like “natural,” “healthy,” and even imagery can constitute implied claims subject to FDA regulation.
Organic Claims: USDA regulates organic claims under the National Organic Program, but FDA enforces truthfulness in labeling. Organic claims require certification and compliance with USDA organic standards.
We help you identify which claims are permissible for your products, ensure claimed benefits are properly substantiated, and recommend compliant claim language that supports your marketing while meeting FDA requirements.
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The net quantity statement tells consumers how much product they’re purchasing. FDA has specific requirements for how this information must be presented.
Net Quantity Requirements:
Dual Declaration: Most products require both metric (grams, milliliters) and US customary (ounces, fluid ounces) units. The US customary unit typically appears first, though some products permit metric-first declarations.
Placement and Prominence: The net quantity must appear in the bottom 30% of the Principal Display Panel (PDP) with specified minimum letter heights based on PDP size.
Descriptor Requirements: Use appropriate descriptors: weight for solid or semi-solid products, volume for liquids, count for discrete items. Specific products have special requirements (e.g., aerosols declare net weight excluding propellant).
Accuracy Standards: FDA allows specific tolerances for net quantity variations. Your declared amount should account for reasonable production variations and settling.
The Principal Display Panel (PDP)—typically the front of your package—must include certain mandatory elements in specific formats.
PDP Mandatory Elements:
Statement of Identity: The name of your product must be presented in bold type on the PDP, using the product’s common or usual name or an appropriate descriptive name. If FDA has a standard of identity for your product category (like “mayonnaise” or “ice cream”), you must use that exact name.
Brand and Variety: While brand names are not mandatory, if you use them they cannot be misleading. Variety or flavor designations should accurately reflect the product’s characteristics.
Vignettes and Images: Visual representations on the PDP must not be misleading. If you show strawberries on your “strawberry flavored” yogurt, FDA expects actual strawberries in the product or appropriate qualification of the imagery.
Prominence and Conspicuousness: Required elements must be prominent and conspicuous, meaning reasonably likely to be read under normal purchase conditions. Tiny text or poor contrast can constitute violations.
Certain product categories have additional or modified labeling requirements:
Dietary Supplements: Subject to FDA’s dietary supplement labeling requirements under DSHEA, including Supplement Facts panels, structure/function claim disclaimers, and specific ingredient listing requirements.
Infant Formula: Highly regulated with mandatory nutrient specifications, required age designations, and special statements regarding the importance of breast milk.
Beverages: Particularly beverages making health claims or containing specific ingredients face heightened scrutiny and specific labeling requirements.
Meat and Poultry: While primarily regulated by USDA, products containing meat or poultry in combination with other ingredients may fall under shared USDA-FDA jurisdiction.
Irradiated Foods: Must include the radura symbol and specific statements regarding irradiation treatment.
Importing food products into the United States adds another layer of requirements beyond standard FDA labeling regulations.
Import Compliance Considerations:
FDA Prior Notice: Electronic prior notice must be submitted before food products arrive at US ports. Labeling discrepancies discovered during this process can delay clearance.
Country of Origin: Imported products must declare country of origin. While not always required on the label itself, it’s often good practice to include it.
FSIS Requirements: Products containing even small amounts of meat or poultry require USDA FSIS import inspection and compliance with FSIS labeling regulations.
English Language: FDA requires all required label information to appear in English. Additional languages may be included but cannot replace English declarations.
Our experience reviewing thousands of food labels has revealed common pitfalls:
Incorrect Serving Sizes: Using serving sizes that don’t align with FDA RACCs is pervasive. Manufacturers sometimes choose aspirational or marketing-driven serving sizes that don’t comply.
Outdated Nutrition Facts Formats: Some companies still use the pre-2020 Nutrition Facts format. The old format is no longer compliant.
Allergen Declaration Errors: Failing to identify allergen sources in sufficient detail (e.g., listing “natural flavors” without identifying milk-derived components), or using non-compliant allergen statement formats.
Unauthorized Claims: Using terms like “healthy,” “natural,” or “lightly sweetened” without understanding FDA’s specific requirements and definitions for these claims.
Inadequate Manufacturer Information: Omitting required manufacturer/distributor information or failing to include the required “manufactured for” or “distributed by” designations.
Formatting Errors: Nutrition Facts panels with incorrect font sizes, improper bolding, missing lines, or other formatting deviations from FDA specifications.
FDA conducts regular inspections of food facilities and import screening at US ports of entry. Non-compliant labels trigger various enforcement actions:
Warning Letters: FDA issues warning letters for significant violations, which become public record and can damage brand reputation.
Import Detention: Products with non-compliant labels may be refused entry, requiring relabeling before release or potentially requiring destruction or return to origin.
Recalls: Serious labeling violations—particularly those affecting allergen declaration or misleading health claims—can trigger mandatory recalls with devastating financial and reputational consequences.
Legal Action: While less common, FDA can pursue criminal prosecution for egregious or willful violations.
The good news: most FDA labeling violations are entirely preventable with proper review before printing.
When you engage FTC International for US food label compliance review, you receive comprehensive evaluation and actionable recommendations:
We Review:
You Receive:
FDA food labeling requirements evolve through new regulations, guidance documents, and warning letter enforcement patterns. We monitor these developments continuously:
Recent FDA Developments:
Our team stays current with FDA regulatory updates, ensuring our clients receive guidance based on the latest requirements and enforcement trends.
Professional FDA compliance review protects your business investment:
Cost of Compliance Review: $500-2,000 per product (complexity dependent)
Cost of Non-Compliance:
The return on investment is clear: prevention costs far less than correction.
Whether you’re launching your first product in the US market or reformulating existing products, our FDA expertise ensures your labels meet current regulatory requirements.
Our clients include:
We provide practical, business-oriented regulatory guidance that protects your compliance while supporting your marketing objectives.
Looking to expand beyond the US market? Explore our other food label compliance services:
Ready to ensure your food labels meet FDA requirements? Contact FTC International today to discuss your US labeling needs. Our FDA specialists are ready to help you navigate US food labeling regulations with confidence.
Protect your business, your brand, and your consumers with expert FDA compliance guidance. Let us review your labels before you print—prevention is always more affordable than correction.
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Deep Regulatory Expertise
Walter Dullemond has worked in food ingredient technology and regulatory affairs since 1987—that’s 37 years of hands-on experience. He’s developed thousands of products and navigated regulatory requirements across Canada, US, Asia, and Europe.
Eva Savova joined FTC in 2004 and specializes in regulatory compliance for labeling and nutrition. Eva’s a food label consulting expert. Her background in chemistry combined with economics gives her a unique perspective on balancing compliance with commercial viability.
We’ve Seen It All
Over 25 years, we’ve worked with:
Multi-Market Knowledge
Most consultants specialize in one market. We work across Canada, US, and EU regularly, which is invaluable if you’re:
We understand the nuances between jurisdictions and can help you create labels that work across multiple markets (or explain why you need different labels for each).
We Prevent Expensive Mistakes
Our fees are typically a fraction of what you’d pay for:
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