The four largest markets for food supplements — the EU, UK, US, and China — each operate a distinct regulatory framework with different underlying philosophies. The EU and UK use positive lists of permitted ingredient forms and require pre-authorisation of health claims. The US operates on a post-market model where most ingredients are permitted without pre-approval, but NDI notifications are required for ingredients introduced after 1994. China requires mandatory pre-market registration or filing for domestic retail sales. The table below sets out the core obligations side by side.
Core Regulatory Comparison
| Requirement | EU | UK | US (DSHEA / FDA) | China (Blue Hat) |
|---|---|---|---|---|
| Primary legislation | Directive 2002/46/EC (supplements); Regulation (EC) 1924/2006 (health claims); Novel Food Regulation (EU) 2015/2283 | Food Supplements (England) Regulations 2003 and equivalents; UK Nutrition and Health Claims Regulations 2007 | Dietary Supplement Health and Education Act (DSHEA) 1994; Federal Food, Drug, and Cosmetic Act | Food Safety Law of China; SAMR Measures on Supervision and Administration of Health Food |
| Ingredient permissions | Positive list — vitamins and minerals in Annexes I and II of Directive 2002/46/EC only; novel ingredients require Novel Food authorisation under Regulation (EU) 2015/2283 | UK positive list — diverged from EU Annex II from 10 August 2024; novel ingredients require UK Novel Food authorisation; separate from EU pathway | No positive list — broad range of dietary ingredients permitted; post-1994 ingredients require NDI notification to FDA at least 75 days before first marketing | Approved ingredient directories for filing pathway; non-listed or novel ingredients require full registration pathway with clinical safety data |
| Health claims | Pre-authorisation required under Regulation 1924/2006; only claims on EU authorised register permitted; botanical claims prohibited pending Commission evaluation following CJEU ruling April 2025 (Case C-386/23) | Separate UK authorised claims register (retained EU claims at Brexit); botanical claims require substantiation equivalent to EU standard; CJEU ruling does not bind UK courts but equivalent prohibition applies | Structure/function claims permitted without pre-approval but require substantiation, required disclaimer, and 30-day FDA notification under 21 CFR 101.93; disease claims prohibited and cause reclassification as drug | Health function claims limited to 27 approved categories via registration pathway; products on filing pathway may not make specific function claims |
| Pre-market requirements | No EU-level pre-market approval; national notification to member state competent authority required in most EU countries before or at time of market entry | No UK pre-market notification required; products must comply at point of sale; FSA oversight body | No FDA pre-approval required for ingredients in US food supply pre-October 1994; NDI notification required for newer ingredients (75-day pre-market window) | Blue Hat registration (2–3 years) or filing (6–12 months) required before domestic retail, pharmacy, or domestic e-commerce sales; 1 year in-market commercial sales history in country of manufacture required before application |
| Manufacturing standards | EU food hygiene rules (Regulation 852/2004); no specific EU-level supplement GMP — national standards vary by member state | UK retained food hygiene framework; no supplement-specific GMP regulation; MHRA GMP standards apply if product is classified as a borderline medicine | 21 CFR Part 111 — comprehensive cGMP regulation for dietary supplements; applies to all manufacturers including foreign facilities supplying the US market | Specific GMP requirements under Chinese national supplement manufacturing standards (GB 17405-2010); required for both registration and filing pathways |
| Labelling requirements | Term "food supplement" required; recommended daily dose + do not exceed warning; nutrient reference value (NRV) percentages; full ingredient list; EU-based responsible person name and address; best-before date | Equivalent to EU requirements with UK-specific format guidance from FSA; products must use the term "food supplement" in English | Supplement Facts panel (21 CFR Part 101); net quantity; ingredient list; manufacturer contact details; required structure/function disclaimer if applicable; country of origin may be required | Chinese-language label mandatory; approved health function claim wording; Blue Hat symbol; product registration or filing number; manufacturer and importer details; storage conditions |
| Key 2025–2027 change | CJEU April 2025 ruling prohibits all 1,500+ on-hold botanical claims; Commission resolution timeline not announced; competitor-initiated enforcement via trade associations now active | Permitted substances list updated August 2024 and operating independently of EU; novel food and health claims registers diverging progressively from EU equivalents | Updated NDI draft guidance issued by FDA in 2024; cGMP enforcement for foreign supplement manufacturers ongoing; structure/function claim substantiation standards under review | Blue Hat approvals granted 2020–2022 entering 5-year renewal window from 2025–2027; cross-border e-commerce regulatory framework under ongoing review by SAMR |
Key Differences in Regulatory Philosophy
The fundamental difference between the EU/UK approach and the US approach is the treatment of ingredients. In the EU and UK, only ingredients on approved lists may be used in supplements. In the US, any ingredient that is reasonably expected to be safe may be used — the burden is on the FDA to demonstrate that a product is unsafe, not on the manufacturer to demonstrate pre-market approval. The NDI notification requirement is the exception to this model: it is the closest the US comes to pre-market oversight for dietary ingredients.
China operates the most restrictive access model for domestic retail: without Blue Hat approval, a product cannot be sold through domestic retail, pharmacy, or domestic e-commerce channels, regardless of its approval status in any other market. The two-to-three year registration timeline and the one-year in-market prerequisite make China market entry planning a multi-year exercise.
Australia operates a licensing model closer to pharmaceutical regulation than food regulation: every complementary medicine product must be listed on the ARTG before sale. The self-certification pathway for low-risk products makes this manageable, but it remains a pre-market obligation with no equivalency to approvals from other markets.
Health Claims: The Most Complex Dimension
Health claims are where the regulatory complexity of supplement markets is most acute. In the EU, the situation as of 2025 is that the authorised claims register covers vitamins, minerals, and a limited range of non-botanical nutrients — and the 1,500+ botanical claims that have been on hold since 2012 are now explicitly prohibited in advertising. The practical effect is that the EU authorised claims register is significantly narrower than many supplement brands assume.
In the UK, the starting point is the same authorised list as existed at the point of Brexit — but the register is now maintained independently, and the UK has not automatically adopted subsequent EU register updates. The MHRA borderline guidance adds an additional layer of complexity: a product making claims that are too close to medicinal claims may be reclassified as a medicine, triggering a completely different regulatory pathway including a marketing authorisation requirement.
In the US, the structure/function claims system is the most permissive of the major markets — but the required disclaimer and 30-day FDA notification obligation are routinely overlooked by non-US supplement manufacturers entering the market.
Planning for Multi-Market Entry
Supplement businesses targeting all four markets simultaneously face a fundamental sequencing challenge. EU and UK market entry can be relatively rapid if ingredients are on the permitted list and labelling is correctly structured. US market entry requires NDI review and — if NDI notifications are required — a 75-day pre-market window. China market entry, if domestic retail is the objective, requires initiating the Blue Hat process two to three years before the planned launch date. Australia requires ARTG listing before any sale.
The most common planning error is treating China as a later phase of market entry that can be initiated after EU and US sales are established. The one-year in-market prerequisite means that China planning must begin at the same time as initial market entry, not after it.
Planning multi-market supplement entry?
TGC provides multi-market supplement compliance reviews covering ingredient permissions, health claims, labelling, NDI status, novel food classification, and Blue Hat pathway assessment — across all your target markets simultaneously.
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