The Complete 2026 Guide to US FDA Food and Supplement Compliance

Selling foods or dietary supplements in the US means navigating FDA regulation and FTC advertising standards. FDA regulates ingredients, manufacturing, and labels post-market. FTC regulates health claims in all advertising channels.

DSHEA and supplement classification

DSHEA (1994) defines dietary supplements as products taken by mouth to supplement the diet, containing vitamins, minerals, herbs, amino acids, enzymes, or similar. Disease claims make a product a drug. Structure/function claims like 'supports immune health' are permitted with the required disclaimer and FDA notification within 30 days of first marketing.

New Dietary Ingredients (NDI)

Ingredients marketed before October 15, 1994 are grandfathered. Post-1994 ingredients require pre-market notification to FDA with safety evidence. NDI notification is the most commonly missed requirement by foreign brands entering the US. Check your ingredient list against the FDA NDI database before launch.

The drug/supplement boundary

A product crosses into drug territory via disease claims or cumulative marketing that implies disease treatment. 'Reduces inflammation' is likely a drug claim. 'Supports a healthy inflammatory response' is a structure/function claim. FDA evaluates the totality of claims across all marketing, not just the label, including PDPs, Amazon listings, and influencer posts.

Labelling requirements

Supplement Facts panel is required under 21 CFR 101.36. Format errors (wrong column order, incorrect rounding, missing elements) trigger enforcement. Required disclaimer: 'This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.' Identity, net quantity, and responsible party must appear on label. Major allergens declared per FALCPA.

Current Good Manufacturing Practices (cGMP)

21 CFR Part 111 applies to all supplement manufacturers including foreign facilities exporting to the US. FDA inspects foreign facilities and posts warning letters publicly. Key requirements: identity testing of incoming ingredients, manufacturing controls, in-process and finished product testing, batch records, and complaint handling.

FTC advertising substantiation

FTC requires 'competent and reliable scientific evidence' for health claims in advertising. Influencer posts, Amazon listings, PDPs, and paid ads are all subject to FTC standards. A permissible label claim can become an FTC violation if amplified in advertising to imply disease treatment. FTC actively enforces against both brands and influencers.

Amazon and retailer compliance

Amazon requires FDA facility registration number, cGMP documentation, ingredient documentation for novel ingredients, and clean labelling. Listing suspension follows failure to provide documentation on request. Major retailers (Target, Whole Foods) layer additional requirements on top of FDA baseline.

What changed in 2025 to 2026

FDA proposed and in some cases finalized updates to NDI notification requirements, enhanced enforcement on structure/function claims approaching disease claim territory, and increased warning letters for cannabinoid-adjacent and novel botanical ingredients. FTC continued focusing on influencer marketing disclosure requirements.

Common failures for foreign brands

In order of frequency: no NDI notification for novel ingredients; structure/function claims without required disclaimer or FDA notification; incorrect allergen declaration format under FALCPA; cGMP non-compliance at the manufacturing facility; drug claims in digital advertising or influencer posts; Supplement Facts panel format errors.

Taama covers US FDA compliance including NDI screening, structure/function claim review, Supplement Facts panel compliance, and dossier completeness. See our US coverage