Food Supplement Compliance Deadlines: The 2025–2026 Enforcement Calendar

30 April 2025 — EU Botanical Health Claims Prohibition Enforced

The Court of Justice of the EU issued its ruling in Case C-386/23 (Novel Nutriology v Verband Sozialer Wettbewerb) on 30 April 2025. The Court confirmed that health claims on foods containing botanical substances cannot be used while they remain on the Commission's on-hold list — the on-hold status does not constitute permission to use the claims during the suspension period.

Over 1,500 botanical health claims have been suspended since 2012 while EFSA sought a revised assessment framework. The ruling means any supplement business using botanical health claims in EU-facing labelling, e-commerce descriptions, or digital advertising must remove or replace non-authorised claims immediately. In Germany, Abmahnung (cease and desist) proceedings from trade associations and competitors are a well-established enforcement channel that operates independently of regulatory action. Affected categories include herbal extracts (valerian, echinacea, St John's wort, turmeric, ginseng), adaptogens, and botanical immunity products. The Commission has not published a timeline for resolving the on-hold status.

2002 (ongoing) — EU Food Supplements Directive 2002/46/EC

Directive 2002/46/EC is the core EU framework, harmonising rules on vitamins and minerals that may be used in supplements. Only substances listed in Annexes I and II (and implementing measures) may be used. Labelling must include the term "food supplement," the names and quantities of nutrient categories, recommended daily dose with a not-to-exceed warning, and a statement that supplements should not substitute a varied diet. Most EU member states require pre-market notification to the national competent authority before a supplement can be placed on the market.

August 2024 — UK Permitted Substances List Updated, Now Independent from EU Annex II

From August 2024, the UK operates an independent permitted vitamins and minerals list under the Food Supplements and Food for Specific Groups (Miscellaneous Amendments) Regulations, rather than automatically tracking EU Annex updates. Ingredient forms permitted under EU Directive 2002/46/EC Annex II may not be permitted in Great Britain, and vice versa. Supplement businesses operating in both markets must audit ingredient compliance against both frameworks separately. Northern Ireland continues to follow EU regulations under the Windsor Framework, meaning dual-market brands may require separate GB and NI labelling programmes. Maximum permitted levels for several nutrients now reflect GB-specific risk assessments that diverge from EU NRVs.

2003 (ongoing) — UK Food Supplements (England) Regulations

The primary UK framework — with equivalent instruments in Scotland, Wales, and Northern Ireland — implements 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. The MHRA continues to act as the borderline authority between supplements and medicines in the UK, and products making therapeutic claims risk reclassification as medicines requiring a marketing authorisation.

75-Day Pre-Market Window — US NDI Notification Required

Under DSHEA 1994, any dietary ingredient first marketed in the US after 15 October 1994 is a New Dietary Ingredient. A manufacturer or distributor must submit an NDI notification to the FDA at least 75 calendar days before introducing such a product to interstate commerce. The obligation applies to the ingredient in its specific form and concentration — a standardised extract of a familiar botanical can still qualify as a New Dietary Ingredient if that specific form was not commercially sold in the US before October 1994.

FDA enforcement of NDI requirements has accelerated significantly. Between 2021 and 2025, the FDA issued over 200 warning letters specifically citing NDI non-compliance. Novel categories under active scrutiny include NAD+ precursors (NMN, NR), certain peptide compounds, and high-concentration botanical extracts not previously commercialised at those levels. Products shipped without a required notification are adulterated under the FD&C Act — a designation that creates liability for US distributors regardless of whether the FDA has taken enforcement action. Documentation required includes history of use or other safety evidence, manufacturing information, ingredient identity specifications, and the basis for the safety conclusion.

In Force Since 2010 — US cGMP Manufacturing Standards (21 CFR Part 111)

All dietary supplement manufacturers, packagers, labellers, and holders distributing products in the US must comply with FDA's Current Good Manufacturing Practice regulations under 21 CFR Part 111. These rules have been fully in force for all facility sizes since 2010, but FDA inspections and Warning Letters for cGMP violations have increased materially since 2022. The most common deficiencies cited include failure to establish product specifications for identity, purity, strength, and composition; insufficient incoming component testing; incomplete batch production records; absence of reserve samples; and failure to qualify contract manufacturers through audits or certificates of analysis. Warning Letters are published on the FDA website and remain visible indefinitely — and in several cases cGMP failures have resulted in injunctions or criminal charges.

24–36 Months — China Blue Hat (保健食品) SAMR Pre-Market Registration

Any product sold as a 保健食品 (health food / dietary supplement) in China must obtain SAMR (State Administration for Market Regulation) registration and display the Blue Hat (蓝帽子) logo before placement on the Chinese market. There is no alternative route. Imported health foods register directly with SAMR's national system — a process that typically takes 24–36 months from submission to approval, and longer where SAMR requests additional data or product modifications.

Only health functions from SAMR's approved list of 27 permitted functions may be claimed. Functions outside this list cannot be approved regardless of supporting evidence. Documentation requirements include product formulation with raw material specifications, safety and efficacy testing conducted in CNAS-accredited Chinese laboratories, stability testing, a GMP certificate from the country of manufacture, a Chinese labelling draft, and legal representative authorisation documents. A 2–3 year registration window means brands targeting China must begin their application at least 2–3 years before target commercial launch — and laboratory testing delays frequently extend this to 4+ years.

Mid-2024 — Australia TGA ARTG Listing and Updated Batch Testing Requirements

In Australia, most food supplements are regulated as Listed Medicines (AUST L) under the Therapeutic Goods Act 1989 and must be entered on the Australian Register of Therapeutic Goods (ARTG) before being supplied. All ingredients must appear on the TGA's Permitted Ingredients List (PIL). The TGA updated the PIL in 2023 and 2024 to reflect new safety data, removing several previously permitted concentrations and botanical species — products listed under prior requirements may now have non-compliant ingredient specifications. Listed medicines may only use indications from the TGA's permitted indications list; claims beyond this scope require the Registered Medicine pathway.

In mid-2024, the TGA tightened batch release and finished product testing requirements. Sponsors must now hold current evidence of testing for each batch held for supply — not just at time of listing. Random TGA audits of Listed Medicine sponsors can result in ARTG cancellation, mandatory recall, and financial penalties up to AUD $2.22 million per contravention. Brands that listed products before the 2024 update and have not reviewed their quality documentation may now be non-compliant.