The US and EU take fundamentally opposite approaches to supplement regulation — and understanding the difference is critical before you try to sell in both markets. The US is largely 'post-market' (sell first, prove safety later), while the EU is increasingly 'pre-market' (prove it's safe before you sell). Here's exactly how they differ.
US (FDA/DSHEA): No pre-market approval required for most supplements. Manufacturers must notify the FDA within 30 days of first marketing a new dietary ingredient (NDI) introduced after 1994, but most established ingredients need no approval at all. The burden is on the FDA to prove a product is unsafe after it's on the market.
EU: More complex. Vitamins and minerals on the EU positive list can be used freely. Botanicals have no harmonised EU list, so national rules apply. Novel ingredients require Novel Food authorisation under EU 2015/2283 before they can be sold — a process that takes 18–24 months and costs €100,000+.
US: Three types of claims are permitted: structure/function claims (e.g. 'Calcium builds strong bones'), nutrient content claims, and FDA-authorised health claims. Structure/function claims require 30-day notification to FDA but are relatively easy to use. Disease claims are prohibited.
EU: Only claims on the EU Register of Authorised Claims (Regulation 1924/2006) are permitted — and only if the product meets the nutrient profile conditions. The approved phrase must be used exactly as listed. This is far stricter than the US system and catches many brands off guard.
US: FDA Dietary Supplement GMPs (21 CFR Part 111) require finished product testing, identity testing of every ingredient, and documented manufacturing procedures. Third-party certification (NSF, USP, Informed Sport) is not required but strongly preferred by retailers.
EU: No single harmonised GMP standard for supplements, but pharmaceutical-grade GMP is increasingly expected by retailers and required by some national authorities. ISO 22000 and FSSC 22000 are common frameworks used.
US: Supplement Facts panel (not Nutrition Facts), net weight in US customary units, structured ingredient list with daily value percentages where applicable. Disclaimers for structure/function claims must appear on label and in immediate packaging.
EU: Labels must use the official language of the country of sale. Nutrition declaration per 100g/100ml and per serving. No equivalent of the Supplement Facts panel — ingredients listed in descending order by weight. Allergen declarations must follow EU format (bold, listed in ingredient list).
US: FDA maintains a list of prohibited or restricted ingredients. Some stimulants (DMAA, ephedra alkaloids) are prohibited. CBD remains in a regulatory grey area. Otherwise the list is relatively short.
EU: Banned ingredient lists are longer and vary by country. DMAA, DMHA, many stimulant compounds, high-dose melatonin, and several botanicals are prohibited in multiple EU markets. Novel ingredients not yet authorised under EU law are also effectively banned.
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