EU Directive 2002/46/EC, US DSHEA, UK Food Supplements Regulations, China Blue Hat registration, and novel food frameworks each impose different ingredient, labelling, claims, and pre-market requirements. TGC's specialist supplement compliance team handles multi-market labelling reviews, health claims authorisation, NDI notifications, Blue Hat registration management, and novel food applications so your products reach market legally and stay there.
EU botanical health claims
on hold since 2012 -
advertising
prohibited under April 2025 CJEU ruling
Source: CJEU Case C-386/23, April 2025
Food supplements occupy an unusually complex position in global trade. They sit at the intersection of food law, pharmaceutical regulation, and marketing compliance - and the rules governing which ingredients are permitted, which claims can be made, and how products must be labelled differ substantially between the EU, UK, US, China, and other major markets.
In the EU, over 1,500 botanical health claims have been in a prolonged on-hold state since 2012. On 30 April 2025, the Court of Justice of the European Union ruled that these claims cannot be used in advertising pending Commission authorisation - a ruling with immediate implications for any supplement business marketing products in the EU. In the US, New Dietary Ingredient (NDI) notifications must be submitted to the FDA at least 75 days before marketing - a requirement many foreign supplement manufacturers entering the US market for the first time have not fulfilled. In China, the Blue Hat registration system operates on timelines of two to three years, with eligibility requiring at least one year of commercial sales in the country of manufacture.
TGC provides specialist food supplement compliance support for manufacturers, importers, exporters, and brand owners operating across multiple markets. We combine deep regulatory expertise with practical supplement experience - covering pre-launch labelling review and ingredient verification through to health claims authorisation, NDI notification support, Blue Hat registration management, and novel food applications.
We provide Label Reviews for multi-market supplement labelling compliance, Expedited Compliance Audits for urgent gap assessments, and Full Product Compliance management for supplement brands entering multiple markets simultaneously.
From the EU's health claims deadlock and US DSHEA pre-market notification requirements to China's dual-track Blue Hat system and the UK's post-Brexit divergence, food supplement regulation is one of the most fragmented areas of global product compliance. Here is the current state by region.
The CJEU confirmed that the 2012 on-hold suspension does not permit continued use of botanical health claims. Directive 2002/46/EC and Regulation (EC) 1924/2006 govern ingredients and claims — only authorised claims on the EU register may be used, and botanical claims remain prohibited pending Commission action.
The UK Food Supplements Regulations 2003 remain the primary framework, but post-Brexit the UK health claims register, novel food pathways, and permitted substances list all diverge from EU equivalents — and the gap is widening.
DSHEA 1994 does not require pre-market FDA approval, but NDI notifications and 21 CFR Part 111 cGMP compliance apply to all manufacturers — including foreign suppliers. Updated NDI draft guidance was issued by the FDA in 2024.
Australia requires TGA ARTG listing before market entry; Canada requires a Product Licence (NPN) from Health Canada. All three markets operate independent pre-market authorisation frameworks with no EU or US equivalency pathway.
Unlike many regulatory areas, supplement compliance requirements are largely in force now — not clustered around future deadlines. These are the obligations your business needs covered today.
Claims errors, missing NDI notifications, and registration gaps don't require regulatory action to cause commercial damage — competitors, distributors, and retailers can trigger the same consequences.
EU botanical health claims prohibited following CJEU April 2025 ruling — any supplement brand using on-hold claims in EU advertising is now exposed to competitor cease and desist action
FDA pre-market notification window for New Dietary Ingredients — missing an NDI notification renders the product adulterated under US law, giving distributors grounds to delist immediately
combined commercial impact of EU claims challenge + US NDI gap for a single supplement brand — a loss a structured pre-launch regulatory review would have prevented entirely
A UK supplement brand launched into Germany using on-hold botanical claims — and simultaneously had an unnotified NDI ingredient in the US. See how both failures unfolded and what they cost.
A snapshot of the core regulatory obligations across the four largest target markets for supplement businesses. Full breakdown available in the linked guide below.
| Requirement | EU | UK | US (DSHEA / FDA) | China (Blue Hat) |
|---|---|---|---|---|
| Ingredient permissions | Positive list — vitamins and minerals in Annexes I and II only; novel ingredients require Novel Food authorisation | Independent UK positive list (diverged from EU Annex II from August 2024); separate novel food pathway | No positive list — broad range permitted; post-1994 ingredients require NDI notification 75 days pre-market | Approved ingredient directories for filing; non-listed ingredients require registration with clinical data |
| Health claims | Pre-authorisation required; botanical claims prohibited following CJEU ruling April 2025 | Separate UK authorised register; botanical claims equally prohibited pending substantiation | Structure/function claims permitted with disclaimer + 30-day FDA notification; disease claims prohibited | Claims limited to 27 approved function categories; filing pathway products cannot make specific function claims |
| Pre-market requirements | No EU-level pre-market approval; national notification to member state competent authority required in most countries | No UK pre-market notification required; FSA oversight at point of sale | No FDA pre-approval for pre-1994 ingredients; NDI notification required for newer ingredients (75-day window) | Blue Hat registration (2–3 years) or filing (6–12 months) required before domestic retail; 1 year in-market history prerequisite |
| Key 2025–2027 change | CJEU April 2025 ruling prohibits on-hold botanical claims; Commission resolution timeline not announced | UK permitted substances list updated August 2024; novel food and claims registers operating fully independently | Updated NDI draft guidance 2024; FDA enforcement of cGMP for foreign manufacturers ongoing | Blue Hat approvals granted 2020–2022 enter 5-year renewal window 2025–2027; cross-border e-commerce framework under review |
Our supplement compliance work spans the full product lifecycle - from pre-launch ingredient verification and labelling review through to health claims authorisation, NDI notifications, Blue Hat registration management, and ongoing regulatory monitoring across multiple markets.
We review food supplement labels against EU Directive 2002/46/EC, UK Food Supplements Regulations 2003, US 21 CFR Part 101 (Supplement Facts panel), China Blue Hat labelling rules, and Australian TGA requirements — covering permitted ingredient forms, dose declarations, mandatory warnings, health claim compliance, and multi-language requirements simultaneously across all target markets.
We assess your supplement's intended claims against the EU authorised register and UK Nutrition and Health Claims Register, identifying which claims are authorised, which are on hold, and which are prohibited. Following the CJEU April 2025 ruling on botanical claims, we advise on EU labelling exposure and recommend compliant alternatives — including claim substitution with authorised equivalents or reformulation of marketing materials.
We conduct ingredient date-of-introduction reviews, prepare and submit NDI dossiers within the 75-day pre-market window, and advise on structure/function claim substantiation and required disclaimer wording under 21 CFR 101.93. We also support the 30-day FDA notification requirement for new structure/function claims and advise on the boundary between permissible claims and prohibited disease claims.
We manage the full Blue Hat registration or filing process — from pathway determination and eligibility assessment (including the one-year in-market prerequisite) through dossier preparation, submission, and SAMR liaison. We advise on Chinese-language label preparation, function claim alignment with China's 27 approved categories, and interim market access strategies via cross-border e-commerce while registration is in progress.
We advise on novel food status determinations — distinguishing ingredients with a history of third-country use (potentially eligible for traditional food notification) from those requiring a full safety dossier — and support application preparation under Novel Food Regulation (EU) 2015/2283 and the equivalent UK Novel Food framework.
When a market entry deadline is approaching, a competitor has challenged your claims, or an ingredient change has raised novel food or NDI questions, TGC's expedited audit delivers a prioritised assessment of your supplement's compliance status across all target markets — with a clear remediation roadmap delivered within days.
These are the compliance situations we encounter most frequently when supplement businesses come to TGC - often following a costly market disruption that a structured regulatory review would have prevented.
Non-compliant advertising exposed to competitor cease and desist action under German unfair competition law — without waiting for regulatory enforcement.
Products sold in the US without required NDI notifications are adulterated under DSHEA — giving distributors and retailers grounds to delist without FDA action.
A label built for one market creates compliance gaps in every other — EU NRV percentages, US Daily Values, China's Chinese-language label, and Australian ARTG number all differ.
Registration takes 2–3 years and requires 1 year of in-market sales history — brands that start late miss launch windows by 12 months or more.
A novel concentration or delivery format of a well-known ingredient can trigger Novel Food requirements — without a formal determination, brands risk enforcement or retail delisting.
Permitted substances, novel food pathways, and health claims registers now diverge independently — businesses treating EU and UK compliance as equivalent are increasingly exposed.
Answers to the questions we hear most often from supplement manufacturers, importers, and brand owners navigating multi-market regulatory requirements.
Directive 2002/46/EC requires that food supplements sold to consumers in the EU carry the term "food supplement" on the label; the names of the nutrient or substance categories characterising the product; the recommended daily dose in a suitable format; a warning not to exceed the recommended daily dose; a statement that food supplements should not be used as a substitute for a varied diet; and a statement that products should be kept out of the reach of young children. The name or address of the manufacturer, packer, or seller established within the EU is required, along with a best-before date and net quantity.
In addition, ingredient forms used must be drawn from those permitted under Annexes I and II of the Directive. Nutrition and health claims on supplements are regulated separately under Regulation (EC) 1924/2006 - only claims on the authorised register may be used, and botanical health claims are currently prohibited in advertising following the CJEU April 2025 ruling. Member states may impose additional notification requirements at national level. Source: EUR-Lex, Directive 2002/46/EC.
On 30 April 2025, the Court of Justice of the European Union ruled in Case C-386/23 (Novel Nutriology v Verband Sozialer Wettbewerb) that health claims on food products containing botanical substances cannot be used in advertising until the European Commission formally authorises them. The ruling arose from a German unfair competition challenge. The Court confirmed that the on-hold status of over 1,500 botanical health claims - maintained since 2012 while the Commission sought a revised scientific framework - does not constitute permission to use those claims. The prohibition applies during the entire period of suspension.
The practical consequence is that supplement businesses marketing products in the EU with botanical health claims on their labels, in digital advertising, or on e-commerce product pages must review and remove non-authorised botanical claims. German trade associations and competitor businesses have a direct legal mechanism to challenge non-compliant advertising through cease and desist procedures under unfair competition law. The Commission has not announced a timeline for resolving the on-hold status. Source: EUR-Lex, CJEU Case C-386/23.
Under DSHEA 1994, a New Dietary Ingredient is any dietary ingredient that was not marketed in a US dietary supplement before 15 October 1994. Manufacturers or distributors who wish to market a dietary supplement containing an NDI must submit a pre-market notification to the FDA at least 75 days before introducing the product to market. The notification must contain the basis on which the manufacturer or distributor has concluded that the NDI or the supplement containing it will reasonably be expected to be safe. The FDA does not approve NDI notifications but may issue a response letter if safety evidence is considered inadequate. Source: US FDA, NDI Notification Process.
Ingredients that were in the food supply in their chemically unaltered form before October 1994 are exempt from the NDI notification requirement. The exemption applies to the specific ingredient form and conditions of use - a novel extract or concentrated form of an otherwise common ingredient may still require an NDI notification. The FDA issued updated draft guidance on NDI submissions in 2024. Failure to submit a required notification renders the supplement adulterated under the Federal Food, Drug, and Cosmetic Act, creating legal liability for both the manufacturer and the US importer.
China's health food framework, administered by SAMR, operates on two pathways. The registration pathway is required for products making specific health function claims from China's list of 27 approved functions - it requires clinical data and takes approximately 2 to 3 years. The filing pathway is available for products using only vitamins, minerals, and nutrients from approved directories or approved functional raw materials (such as CoQ10, melatonin, and fish oil) - it takes 6 to 12 months. Both pathways require that the product has been sold commercially in its country of manufacture for at least one year before the application. Source: CIRS Group, China Health Food Registration.
Products approved under either pathway carry the Blue Hat logo, which is mandatory for domestic retail, pharmacy, and domestic e-commerce sales in China. Cross-border e-commerce into China operates under a separate regulatory framework and does not require Blue Hat certification - it is commonly used as an interim market entry route while a domestic registration is in progress. Approved registrations have a five-year validity period and must be renewed before expiry.
The UK and EU food supplement frameworks have been diverging since Brexit. The most significant recent change is the UK permitted vitamins and minerals list, updated in August 2024 to operate independently of EU Annex II - meaning that ingredient forms permitted in the EU may not automatically be permitted in the UK. The UK Food Standards Agency does not require pre-market notification before placing a supplement on the UK market, unlike most EU member states, which operate national notification systems with their own competent authorities. Source: Food Standards Agency, Food Supplements Guidance.
The UK maintains a separate nutrition and health claims register. The CJEU April 2025 ruling on botanical claims does not bind UK courts, but UK law applies equivalent substantiation requirements - botanical claims that are not on the UK authorised register are not permitted. The MHRA continues to act as the borderline authority between supplements and medicines in the UK, applying the medicinal product definition under UK law. Businesses operating in both EU and UK markets must maintain parallel regulatory assessments, as equivalent does not mean identical.
Current Good Manufacturing Practice requirements for dietary supplements in the US are codified at 21 CFR Part 111. These regulations apply to all manufacturers, packagers, labelers, and holders of US dietary supplements - including foreign manufacturers whose products are imported. Key requirements include: written quality control procedures; component identity and purity testing before production use; batch production records; controls to prevent contamination, mix-ups, and errors; and sample retention from each batch.
The regulations require that dietary supplements are manufactured consistently and meet established specifications for identity, purity, strength, and composition. FDA inspections of supplement facilities assess cGMP compliance - violations can result in warning letters, consent decrees, product seizures, or import alerts that prevent a manufacturer's products from entering the US. Foreign manufacturers are subject to the same requirements as domestic manufacturers and may be inspected by the FDA at their overseas facilities. Maintaining a current cGMP-compliant quality system is a prerequisite for sustainable US market access.
Supplement compliance requires expertise across food law, pharmaceutical borderline classification, health claims science, and market-specific pre-market authorisation systems — simultaneously.
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Talk to a TGC specialist about your product, your target markets, and your deadlines. We will tell you exactly where the risks are and what it takes to resolve them - before they become a problem at the border, in a retailer's compliance review, or in a competitor's cease and desist letter.
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