FDA Regulations for US Snack Brands

Every foreign facility that manufactures, processes, packs, or holds snack foods for US consumption must be registered with the FDA under FSMA Section 415. Registration is free and done through FDA's online system. Facilities must re-register biennially. Unregistered foreign facilities cannot legally export food to the US — FDA uses this as a first-line screening tool.

FSMA's Preventive Controls for Human Food rule (21 CFR Part 117) requires facilities to have a written Food Safety Plan including: hazard analysis, preventive controls, recall plan, and supply chain program. Foreign snack manufacturers must comply with these rules or have their US importer implement a Foreign Supplier Verification Program (FSVP) on their behalf.

The FDA's updated Nutrition Facts panel (mandatory since January 2020 for large manufacturers, January 2021 for all) introduced important changes that catch international brands off guard: (1) Added Sugars must be declared separately from Total Sugars. (2) Calories are displayed in a larger font. (3) Vitamin D and Potassium are now required; Vitamins A and C are no longer required. (4) Serving sizes must reflect amounts 'customarily consumed' — reference amounts were updated for many snack categories.

International brands often try to use EU or Australian nutrition panels without conversion — this is non-compliant. The US Nutrition Facts format, units (grams, milligrams, % Daily Value based on 2,000 calorie diet), and mandatory nutrients differ from EU, Canadian, and Australian formats.

The Food Allergen Labeling and Consumer Protection Act (FALCPA) requires that labels declare the presence of the nine major food allergens: milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, soybeans, and sesame (added in 2023 under the FASTER Act). This applies to any ingredient containing protein from these allergens.

Declaration can be either in the ingredient list ('milk') or in a separate 'Contains' statement ('Contains: Milk, Wheat, Sesame'). Cross-contact statements ('May contain traces of nuts') are voluntary but have specific requirements if used. The FASTER Act's addition of sesame in January 2023 is a recent change that many international brands producing in shared facilities have had to address.

Health claims on snack packages — 'high protein,' 'low sugar,' 'heart healthy,' 'good source of fiber' — are regulated by both the FDA (truthfulness and compliance with nutrient content claim definitions) and the FTC (unfair or deceptive advertising). 'High protein' requires meeting FDA's threshold for protein content per serving. 'Heart healthy' requires compliance with FDA's specific nutrient requirements for soluble fiber or saturated fat levels.

Unauthorized health claims can result in FDA warning letters and FTC enforcement. The FTC has taken action against snack brands making unsubstantiated claims about satiety, energy, weight management, and cognitive benefits. Structure/function claims (common in supplement-enhanced snacks) must be carefully reviewed against FDA guidelines.

The FDA has not officially defined 'natural' for food labeling purposes, but has issued guidance that food labeled 'natural' should not contain added color, artificial flavors, or synthetic substances. The FTC requires that 'natural' claims be substantiated and not misleading. 'No artificial preservatives,' 'no artificial colors,' and 'no artificial flavors' claims are acceptable if accurate.

'Clean label' is a marketing term with no regulatory definition — brands can use it freely but should be prepared to defend it against consumer class action lawsuits (a growing US litigation risk for food brands making vague 'clean' claims that don't align with actual ingredient lists).