8 Consequences of ACP Demands on Food Supplements
What the EU Market and Poland Can Adopt – and What They Cannot

The ACP's position paper, published on 14 July 2026 in Annals of Internal Medicine (Cline K, Beachy MW, Carr PW; doi: 10.7326/ANNALS-26-01119), is not the first initiative of this kind in the United States, but it is the first backed by such detailed clinical analysis of the harm caused by food supplements that have not undergone pre-market verification. The ACP calls on the US Congress to amend DSHEA (1994) so as to strengthen the FDA's pre- and post-market powers over dietary supplements. Industry reaction is divided: the Council for Responsible Nutrition (CRN) rejects universal pre-market approval, preferring the system envisaged by the Dietary Supplement Listing Act of 2026; the Natural Products Association (NPA) criticises the ACP's approach – in particular, it opposes the listing legislation (Dietary Supplement Listing Act), arguing that the FDA already has sufficient powers, and warns that the proposed register would serve as a 'procedural trap' for manufacturers. In the EU, the starting point is different: Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and Directive 2002/46/EC establish a framework that the United States lacks. The question is whether that framework is sufficient and what will happen if the European Commission concludes that it is not.

1. The ACP Demands Pre-Market Registration – the EU Already Has It in Part, but with Gaps

The ACP's principal demand is that manufacturers undergo premarket approval before a food supplement is placed on sale, together with strengthened post-market surveillance and evidence-based marketing. The ACP does not explicitly require proof of 'efficacy' in the clinical sense as a condition of market access; rather, it calls for a premarket safety review – a model closer to premarket review than to the full NDA procedure for medicinal products. In the United States, the Dietary Supplement Health and Education Act (DSHEA) of 1994 exempts food supplements from this requirement, which the ACP explicitly criticises, calling on Congress to amend the law. In the EU the situation is more complex: Article 10 of Directive 2002/46/EC authorises Member States to require notification to the competent national authority before a product is first placed on the market (in Poland this obligation derives from Article 29 of the Food Safety Act), and Regulation (EC) No 1924/2006 requires that health claims appear on an approved EFSA list. This means that a European manufacturer of a food supplement bearing the claim 'supports immunity' must use a claim from the register provided for in Article 13 or Article 14 of Regulation 1924/2006 – otherwise the manufacturer risks a decision by the Polish Chief Sanitary Inspectorate (GIS) ordering the withdrawal of the product from the market.

• Gap in the EU: notification does not require the submission of safety studies for ingredients that were on the market before 1997 ('grandfathering')
• New ingredients (novel food) are subject to Regulation (EU) 2015/2283 – pre-market verification is mandatory in this case
• What this means for manufacturers: if you are placing on the market a food supplement containing a botanical extract used before 1997, you notify but are not required to submit a full toxicological dossier – this may change when Directive 2002/46/EC is revised

The revision of Directive 2002/46/EC is officially on the European Commission's agenda – a discussion on reforming food supplement regulation has been under way for several years as part of the Farm to Fork Strategy objectives, although a concrete legislative timetable has not yet been confirmed. If the Commission moves in the direction advocated by the ACP for the FDA, manufacturers may expect an obligation to submit an abbreviated safety dossier with every notification – even for legacy ingredients.

2. Food Supplement Notification in Poland: A Procedure That Does Not Verify Efficacy – and the GIS Knows It

In Poland, notification of a food supplement is carried out through the GIS electronic information system pursuant to Article 29 of the Act of 25 August 2006 on food and nutrition safety. The GIS registers the notification but does not issue a marketing authorisation decision – the absence of an objection does not constitute acceptance of the product's composition or its health claims. Manufacturers frequently confuse the GIS's silence with product approval. This is an error that comes to light during inspections.

• The GIS may initiate proceedings at any time after notification if doubts arise regarding safety or health claims
• Penalty for failure to notify: a misdemeanour under Article 100(1) of the Act on food and nutrition safety – a fine of up to PLN 5,000. However, violations related to labelling, health claims, advertising, and promotion of food supplements (including use of unauthorised health claims) attract administrative penalties under Article 103 of the Act – up to 30 times the average monthly salary (over PLN 250,000 at current wage levels), imposed by the regional state sanitary inspector
• GIS inspection practice shows that the most common error is the use of health claims not included in Regulation (EC) No 432/2012 (the list of authorised claims under Article 13(1))

3. ACP Demands on Labelling Hit a Point That EFSA Has Already Flagged

The ACP advocates strengthening labelling requirements for food supplements, including enhanced information about the scope of FDA verification. It should be noted, however, that DSHEA already requires a disclaimer on structure/function claims, informing consumers that the product has not been evaluated by the FDA. It could not be confirmed from secondary sources that the ACP is proposing an entirely new warning beyond the existing system. In the EU, an analogous principle follows from Article 3, second subparagraph, point (e) of Regulation 1924/2006: a health claim must not suggest that the absence of a given ingredient poses a risk to health (Article 6 concerns the scientific substantiation of claims, not the rules for their formulation). In a series of scientific opinions issued by the EFSA NDA Panel under Article 13(1) between 2009 and 2011, it was explicitly stated that the majority of health claims submitted by manufacturers did not meet the evidentiary requirements – of approximately 44,000 submitted claims, consolidated to around 4,600, only 222 made it onto the authorised list in Regulation 432/2012.

What this means for manufacturers in Poland: using a health claim rejected by EFSA, even if it appears in documentation submitted before 2012, is unlawful. The GIS treats such claims as misleading to consumers within the meaning of Article 7 of Regulation (EU) No 1169/2011 on the provision of food information to consumers. A decision ordering the withdrawal of a product batch or a change of labelling may be issued to a manufacturer without prior warning.

graph TD
    A[Formulation of food supplement composition] --> B{Novel food ingredient?}
    B -- YES --> C[Novel food authorisation application\nReg. EU 2015/2283\nTimeline: 18-36 months]
    B -- NO --> D{Health claim?}
    D -- YES --> E[Only claims from the register\nReg. EC 432/2012\nor Art. 14 Reg. 1924/2006]
    D -- NO --> F[Notification to GIS\nArt. 29 Act on food and nutrition safety]
    E --> F
    C --> F
    F --> G[Placement on the market]
    G --> H[GIS inspection - at any time]
    H --> I{Violation?}
    I -- YES --> J[GIS decision:\nwithdrawal / relabelling\nAdmin. penalty up to 30x\naverage monthly salary\nover PLN 250,000]
    I -- NO --> K[Product remains on the market]
    
    style C fill:#ff9999
    style J fill:#ff9999
    style E fill:#ffcc99
    style K fill:#99ff99

4. The Adverse Event Reporting Model from the United States: A Gap That the ACP Wants to Close – and That Poland Cannot Fill

One of the ACP's key demands is the expansion of the adverse event reporting system for food supplements. In the United States, the FDA operates the CFSAN Adverse Event Reporting System (CAERS), but reporting is voluntary for both consumers and manufacturers – the ACP calls on Congress to make it mandatory. In the EU, the Rapid Alert System for Food and Feed (RASFF) covers food supplements but focuses on safety hazards (contaminants, unauthorised ingredients) rather than adverse events arising from use in accordance with the intended purpose.

• Polish food law does not impose an obligation on manufacturers to report serious adverse events related to food supplements – this is a systemic gap. Article 29a of the Act on food and nutrition safety (in its current wording) regulates the consequences of placing a product on the market without the required notification, not adverse event reporting. The obligation to report adverse reactions (pharmacovigilance) applies to medicinal products, not foodstuffs
• This gap is precisely one of the ACP's main arguments: the absence of systematic collection of data on supplement side effects makes population-level risk assessment impossible. Poland has no equivalent of the CAERS system for dietary supplements
• RASFF notifications concerning Polish food supplements in the period 2021–2023 related primarily to: unauthorised sildenafil analogues in 'sexual performance' supplements, excessively high doses of vitamin D3, and heavy metal contamination in herbal supplements
• What this means for manufacturers: the absence of a statutory obligation does not relieve manufacturers of civil liability for unsafe products. Implementing an internal adverse event monitoring system is good practice and may also reduce the risk of a RASFF alert – which is public and immediately visible to commercial partners throughout the EU

5. Hemp in Food Supplements: The ACP Is Silent, the EU Is Straddling the Fence, Poland Is on the Edge

The ACP does not address hemp directly, but its general demand for pre-market ingredient verification strikes directly at CBD-containing products. In the EU, CBD isolate (cannabidiol derived from hemp) is treated as novel food under Regulation (EU) 2015/2283 – this was confirmed by the European Commission in its 2019 catalogue. This means that every product containing CBD (capsules, drops, food supplements) requires a novel food authorisation before being placed on the EU market. Without that authorisation, the product is unlawful.

GIS inspection practice shows that a significant proportion of Polish CBD-containing food supplements on the market between 2020 and 2023 did not hold the requisite novel food authorisation. The GIS issued decisions ordering the withdrawal of such products, but enforcement was uneven. Manufacturers who nonetheless sell CBD-containing food supplements without a novel food authorisation face a withdrawal decision and an administrative penalty under Article 103 of the Act on food and nutrition safety of up to 30 times the average monthly salary (over PLN 250,000 at current wage levels) – and, in the case of products harmful to health, criminal liability – in particular, the product may be classified as a medicinal product without a marketing authorisation (Article 129 of the Pharmaceutical Law Act) or be subject to sanctions under Article 103 of the Act on food and nutrition safety.

6. Upper Safe Intake Levels (ULs): The Lack of EU Harmonisation Is a Time Bomb

The ACP identifies the lack of control over doses of active ingredients as one of the main food supplement safety problems. In the EU, Directive 2002/46/EC provides for the establishment of maximum amounts of vitamins and minerals in food supplements (Article 5), but the European Commission has to date not issued an implementing regulation setting those limits at EU level. This means that each Member State applies its own thresholds – or none at all.

• Germany: BfR recommends a maximum of 20 µg (800 IU) of vitamin D per day in food supplements (proposed maximum levels, Höchstmengenvorschläge, 2021) – this is a scientific recommendation, not a binding legal provision
• Poland: the GIS uses non-binding EFSA scientific opinions on tolerable upper intake levels (ULs) as a reference point in inspections – but there is no national provision expressly setting limits
• Practical risk: a food supplement lawfully sold in Poland (e.g. 4,000 IU of vitamin D3) may be detained at the border or withdrawn from the market in Germany – and vice versa
• What this means for exporters: before entering the market of another EU Member State, check the national guidelines of the relevant food safety authority, not just EU legislation

graph LR
    subgraph USA_DSHEA [USA - Current Position under DSHEA]
        A1[No pre-market registration]
        A2[Structure/function claims - unrestricted]
        A3[Adverse event reporting - voluntary]
    end
    
    subgraph ACP_Postulaty [ACP Demands]
        B1[Pre-market registration]
        B2[Mandatory premarket safety review]
        B3[Mandatory ADR reporting]
        B4[Strengthened labelling requirements]
    end
    
    subgraph UE_Prawo [EU - Applicable Law]
        C1[Pre-market notification\nDir. 2002/46/EC]
        C2[Claims only from the register\nReg. 1924/2006]
        C3[Novel food - full dossier\nReg. 2015/2283]
        C4[RASFF - safety alerts]
    end
    
    B1 -.->|EU already has - partially| C1
    B2 -.->|EU has for novel food| C3
    B3 -.->|EU has RASFF, not ADR| C4
    
    style USA_DSHEA fill:#ffeeee
    style ACP_Postulaty fill:#fff3e0
    style UE_Prawo fill:#e8f5e9

7. Food Supplement Advertising: This Is Where the Gap Between the United States and the EU Is Greatest – and It May Narrow

The ACP criticises food supplement advertising in the United States as virtually unrestricted – DSHEA allows manufacturers to make broad 'structure/function' claims without proving efficacy. In the EU, Regulation 1924/2006 is considerably more restrictive: only claims from the authorised register are permitted, and every claim must be linked to a specific substance and a specific dose. Despite this, online advertising of food supplements in Poland routinely violates these rules.

GIS inspection practice shows that the most common violations in food supplement advertising are: attribution of medicinal properties (e.g. 'heals joints', 'lowers blood pressure'), use of health claims not drawn from the register established by Regulation 432/2012, and indirect suggestions that a food supplement replaces a medicinal product. The last of these violations carries the most serious legal consequences – Article 7(3) of Regulation 1169/2011 prohibits attributing to foodstuffs properties of preventing or treating disease. The sanction is a GIS decision ordering removal of the advertisement. Where the advertisement attributes medicinal properties to a food supplement, the product may be classified as a medicinal product without a marketing authorisation – which opens up sanctions under Article 129 of the Pharmaceutical Law Act or an administrative penalty under Article 103 of the Act on food and nutrition safety.

8. Revision of Directive 2002/46/EC: A Timeline That Manufacturers Should Have in Their Calendars

Independently of the debate in the United States, the European Commission has been discussing a revision of the legal framework for food supplements for years. Directive 2002/46/EC provides in Article 5 for the establishment of harmonised maximum levels of vitamins and minerals, but the Commission has not yet adopted the necessary implementing regulation — national limits therefore apply. Any legislative proposal, if it is ever tabled and adopted by the European Parliament and the Council, would enter into force with the transitional period of 18–24 months that is typical for EU legislation.

• Likely directions of change according to Commission consultation documents: harmonisation of maximum doses of vitamins and minerals, expansion of the list of regulated botanical ingredients, strengthened notification requirements (possible safety dossier obligation)
• What this means for manufacturers today: companies planning reformulation or the introduction of new product lines should factor in a scenario of tightened requirements when designing their product composition – reverting to lower doses after new rules enter into force is a costly exercise in relabelling and documentation
• For lawyers serving the industry: monitoring the legislative process at Commission level (DG SANTE) and actively participating in public consultations is the only way to have a real influence on the shape of future legislation

The ACP's position strengthens the hand of those factions in the European Parliament and among national regulators that have for years been advocating stricter controls on food supplements. It is not a direct source of law for the EU, but the clinical arguments raised by the ACP – data on supplement-related hospitalisations, drug interactions, and misleading health claims – will be cited in the European legislative process. Manufacturers and lawyers who familiarise themselves with this position now will know what arguments to expect from the regulator's side.