Food supplement regulation does not cluster around a single deadline. Unlike consumer product labelling, where a new regulation comes into force and businesses have a transition period to comply, supplement compliance is a continuous state — with requirements largely active at the point of market entry, and changes arriving through court rulings, amended permitted lists, and updated guidance as much as through new legislation.
2025 brought two significant developments: the CJEU April 2025 ruling on botanical health claims, which has immediate practical implications for any supplement brand advertising in the EU, and the continued divergence of the UK regulatory framework from its EU equivalent. The US NDI notification requirement remains one of the most commonly missed obligations for foreign supplement manufacturers entering the American market. China's Blue Hat system continues to present the most significant timeline challenge for brands targeting domestic retail.
Here is the current state of supplement regulation in each major market.
European Union — Supplements Directive and Health Claims
CJEU Botanical Health Claims Ruling — Case C-386/23
On 30 April 2025, the Court of Justice of the European Union issued its ruling in Case C-386/23 (Novel Nutriology v Verband Sozialer Wettbewerb). The Court confirmed that health claims on food products containing botanical substances cannot be used in advertising until formally authorised by the European Commission. Over 1,500 botanical health claims have been in a suspended on-hold state since 2012, while the Commission sought a revised scientific assessment framework. The CJEU ruling confirmed that this on-hold status does not constitute transitional permission to use the claims — the prohibition applies during the entire period of suspension.
The practical implication is immediate. Any supplement business using botanical health claims in EU-facing labelling, digital advertising, e-commerce product descriptions, or marketing materials must review and remove non-authorised claims. In Germany specifically, Abmahnung (cease and desist) procedures from trade associations and competitor businesses are a well-established enforcement channel under unfair competition law (UWG) — giving well-resourced competitors a direct legal mechanism to challenge non-compliant advertising without waiting for regulatory enforcement. The Commission has not published a timeline for resolving the on-hold status.
EU Food Supplements Directive — Directive 2002/46/EC
Directive 2002/46/EC is the core EU framework for food supplements, harmonising rules on the vitamins and minerals that may be used. Only substances listed in Annexes I and II of the Directive (and its implementing measures) may be used as sources of vitamins and minerals in supplements marketed in the EU. Labelling requirements include: the term "food supplement" on the label; names of the nutrient or substance categories; recommended daily dose with a warning not to exceed it; a statement that supplements should not be used as a substitute for a varied diet; and the name and address of the EU-established manufacturer or seller. Ingredient notification requirements are administered at member state level — most EU countries require pre-market notification to the national competent authority.
EU Health Claims — Regulation (EC) 1924/2006
Regulation (EC) 1924/2006 governs all nutrition and health claims on foods and food supplements sold in the EU. Health claims must be substantiated by scientific evidence and authorised by the European Commission before use. Authorised claims are published on the EU Register of Authorised Nutrition and Health Claims, and cover vitamins, minerals, and other non-botanical nutrients. Botanical claims remain prohibited pending Commission resolution of the on-hold list. Novel food ingredients used in supplements must also be assessed under Novel Food Regulation (EU) 2015/2283 if they were not consumed to any significant degree in the EU before 15 May 1997.
United Kingdom — Post-Brexit Divergence
UK Permitted Vitamins and Minerals List — Independent from EU Annex II
From 10 August 2024, the UK amended its permitted vitamins and minerals list under the Food Supplements and Food for Specific Groups (Miscellaneous Amendments) Regulations 2024. The UK now operates an independent permitted substances schedule rather than automatically mirroring EU Annex updates. This means that ingredient forms permitted under EU Directive 2002/46/EC Annex II may not automatically be permitted in the UK, and vice versa. Supplement businesses operating in both markets must verify ingredient compliance against both the EU Annexes and the UK permitted list separately. The Food Standards Agency provides the current UK permitted forms list.
UK Food Supplements (England) Regulations 2003
The Food Supplements (England) Regulations 2003 — with equivalent instruments in Scotland, Wales, and Northern Ireland — is the primary UK framework, implementing requirements broadly equivalent to EU Directive 2002/46/EC. Unlike most EU member states, the UK does not require pre-market notification before placing a food supplement on the market. Products must comply at point of sale, with the Food Standards Agency as the oversight body. The MHRA continues to act as the borderline authority between supplements and medicines in the UK.
UK Health Claims Register and MHRA Borderline Products
The UK maintains a separate nutrition and health claims register, retaining the claims that were on the EU authorised list at the point of Brexit. The CJEU April 2025 ruling does not bind UK courts, but UK law applies equivalent substantiation requirements — botanical claims not on the UK authorised register remain prohibited. Businesses operating in both EU and UK markets must maintain parallel regulatory assessments, as equivalent does not mean identical.
United States — DSHEA and FDA Regulation
New Dietary Ingredient (NDI) Notifications — 75-Day Pre-Market Window
Any dietary ingredient not marketed in the US in a dietary supplement before 15 October 1994 is a New Dietary Ingredient and requires a pre-market notification to the FDA at least 75 days before first marketing. The notification must include the ingredient's history of use, safety evidence, and proposed conditions of use. The obligation applies to the ingredient in its specific form, concentration, and intended use — a novel extract or concentrated form of an otherwise common ingredient may still require an NDI notification even if the underlying substance is well known. Failure to submit a required notification renders the supplement adulterated under US law (DSHEA), creating liability for both the manufacturer and the US importer. The FDA issued updated draft guidance on NDI submissions in 2024.
cGMP Requirements — 21 CFR Part 111
Current Good Manufacturing Practice requirements for dietary supplements are codified at 21 CFR Part 111 and apply to all manufacturers, packagers, labelers, and holders of US dietary supplements — including foreign manufacturers. Key requirements include written quality control procedures, identity and purity testing of components, and batch production records. FDA inspections of supplement facilities assess cGMP compliance — violations can result in warning letters, import alerts, or consent decrees. Foreign manufacturers are subject to the same requirements as domestic manufacturers and may be inspected by the FDA at their overseas facilities.
Structure/Function Claims — 21 CFR 101.93
Structure/function claims such as "supports immune health" are permitted on US dietary supplements without FDA pre-approval, but must be substantiated by adequate evidence, must include the required disclaimer ("This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."), and must be notified to the FDA within 30 days of first marketing under 21 CFR 101.93. Disease claims are prohibited and will cause the product to be reclassified as an unapproved drug.
China, Australia and Canada — Key Non-EU/US Markets
China — Blue Hat Health Food Registration and Filing
China regulates health food products through a dual-track system administered by SAMR (State Administration for Market Regulation). The registration pathway applies to products making specific health function claims from China's list of 27 approved functions — and requires clinical data, with typical timelines of 2 to 3 years. The filing pathway is available for products using standard approved ingredients (vitamins, minerals, CoQ10, fish oil) and typically takes 6 to 12 months. Both pathways require at least one year of commercial sales in the country of manufacture before the application. Products approved under either pathway carry the Blue Hat logo, mandatory for domestic retail and e-commerce channels. Cross-border e-commerce sales do not require Blue Hat certification and are commonly used as an interim route while registration is in progress. Approved registrations have a five-year validity period and must be renewed before expiry — approvals from 2020–2022 are entering their renewal window.
Australia — TGA Complementary Medicines Framework
In Australia, food supplements are regulated as complementary medicines by the Therapeutic Goods Administration (TGA) and must be included in the Australian Register of Therapeutic Goods (ARTG) before sale. The framework offers three pathways: Listed medicines (low-risk, self-certification); Assessed Listed medicines (pre-market TGA review of efficacy evidence); and Registered complementary medicines (full TGA evaluation). The TGA updated its Permissible Ingredients Determination in March 2024 and June 2024, adding new ingredients and revising existing approvals. Products using ingredients outside the permissible list require TGA pre-approval.
Canada — Natural Health Products Regulations
Canada classifies dietary supplements as Natural Health Products under the Natural Health Products Regulations (SOR/2003-196), administered by Health Canada. Unlike the US, Canada requires pre-market authorisation — a Product Licence must be obtained before market entry. Approved products receive an NPN (Natural Product Number) which must appear on the label. Health Canada proposed amendments to the NHP framework in its 2024–2026 Forward Regulatory Plan aiming to modernise the risk-based review process, with specific effective dates not yet finalised as of early 2026.
What This Means for Supplement Businesses
The pattern across all markets is consistent: supplement compliance does not have a grace period. Obligations apply at the point of market entry, and — unlike pharmaceutical drug regulation — the consequences of non-compliance are frequently triggered by commercial actors (competitors, distributors, retailers) rather than regulatory authorities alone.
The CJEU April 2025 ruling on botanical claims is the most significant recent development for EU market access. Any supplement brand that was treating the on-hold status of botanical claims as implicit permission to use those claims must now treat those claims as prohibited and review its labelling and advertising materials accordingly.
For US market entry, the NDI notification requirement remains the most commonly missed obligation for foreign supplement manufacturers. The 75-day window must be observed before first marketing — not first sale, and not registration. The obligation applies even if the product has been sold in other markets for years.
For China, the practical implication of the Blue Hat registration timeline is that brands targeting domestic retail must begin the process before they have finalised formulation. The one-year in-market sales history requirement means that a product launching in its home market today cannot apply for Blue Hat registration until at least 2026 — and registration will not be complete until 2028–2029 at the earliest under the standard pathway.
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