9 Differences in Supplement Oversight: USA vs EU
What an Inspector Will Find Before a Court Does

Oversight of food supplements is, in 2026, a topic that has ceased to be academic. The number of RASFF alerts relating to food supplements has exceeded 400 per year in recent years, and the FDA issued more than 50 Warning Letters to supplement manufacturers in 2023 alone. Below are nine points that explain how these systems work in practice, not in theory.

1. In the USA, a supplement enters the market without FDA approval – but that does not mean there is no oversight

The fundamental systemic difference: in the United States, dietary supplements are regulated by the Dietary Supplement Health and Education Act of 1994 (DSHEA). A manufacturer does not submit an application for product approval before placing it on the market. The burden of proof lies with the FDA – the agency must demonstrate that a product is unsafe in order to withdraw it. This is a reversal of the burden of proof compared to the European model. The practical consequence: the FDA concentrates its oversight at the post-market stage. Inspectors primarily check compliance with Current Good Manufacturing Practices (cGMP) – 21 CFR Part 111 – that is, production documentation, ingredient identity, microbiological purity, and heavy metal content. Failure to implement cGMP is a violation that in itself justifies a Warning Letter, regardless of whether the product has caused harm to anyone.

• 21 CFR Part 111 – mandatory cGMP for food supplements since 2010; lack of documentation = automatic grounds for a Warning Letter
• New ingredients (New Dietary Ingredients, NDI) introduced after 15 October 1994 require FDA notification 75 days before market entry – this is the only procedure comparable to the European notification process
• FDA Dietary Supplement Ingredient Advisory List (updated since 2019) – ingredients on the list are not automatically prohibited, but signal that the agency is analysing the risk; the presence of an ingredient from this list in a product exported to the USA is a red flag for any lawyer
• What this means for manufacturers: a product can be legally sold in the USA for years before the FDA takes action – but when it does, the consequences are immediate and public

2. In the EU, the notification obligation precedes market entry – and it is not a formality

In the European Union, food supplements are regulated primarily by Directive 2002/46/EC and, in Poland, by the Act of 25 August 2006 on food and nutrition safety. Before placing a food supplement on the Polish market, the manufacturer or importer is obliged to notify the Polish Chief Sanitary Inspectorate (GIS) – this is a mandatory information obligation under Article 29 of the Act. GIS does not approve the product, but the notification creates a formal record. The absence of notification is itself a violation subject to administrative penalties.

In practice, the notification process also forces the manufacturer to verify the composition against the positive lists of vitamins and minerals (Annex I and II to Directive 2002/46/EC) and against national regulations on maximum and minimum levels. In Poland, these are set out in the Regulation of the Minister of Health of 9 October 2007 on the composition and labelling of food supplements. Any ingredient not covered by these lists requires a separate legal analysis – and in many cases, a novel food assessment under Regulation (EU) 2015/2283.

• Notification to GIS is mandatory before first placing the product on the Polish market – not after
• GIS does not issue an approval decision; the notification is acknowledged, not validated
• Ingredients outside the positive lists of vitamins and minerals require individual legal assessment – and may require a novel food authorisation under Regulation (EU) 2015/2283
• Other EU Member States have their own notification systems – a GIS notification does not authorise sale in Germany, France or Italy

3. Health claims: two separate registers, two separate legal regimes

In the USA, the FDA distinguishes between several categories of health claims: authorised health claims (based on significant scientific agreement), qualified health claims (lower standard of evidence, with mandatory disclaimer), and structure/function claims (no FDA pre-approval required, but notification within 30 days of first marketing). The FTC, not the FDA, oversees advertising – and applies its own standard of "competent and reliable scientific evidence".

In the EU, Regulation (EC) No 1924/2006 creates a single, closed system. Every health claim used on a label or in advertising must appear in the EU Register of Nutrition and Health Claims. The register contains authorised claims (Article 13 – general function claims, and Article 14 – claims relating to disease risk reduction and children's development) and rejected claims. A claim not in the register is prohibited. There is no equivalent of the American qualified health claim with a disclaimer.

• A health claim approved by the FDA has no legal status in the EU – and vice versa
• In the EU, even a claim that is scientifically accurate but not in the register is prohibited
• Structure/function claims used in the USA (e.g. "supports immune function") require verification against the EU register before use on European labelling
• In 2026, the European Commission is reviewing the register – some claims previously on hold may be finally rejected

4. Advertising oversight: FTC in the USA, UOKiK and GIS in Poland

In the USA, the Federal Trade Commission (FTC) is the primary authority overseeing advertising of food supplements. The FTC applies the standard of "competent and reliable scientific evidence" – in practice, this means well-designed human clinical trials. Testimonials, before-and-after photos, and celebrity endorsements are permitted but subject to strict disclosure requirements (the FTC's Endorsement Guides, updated in 2023). The FTC has the power to impose civil penalties of up to USD 50,120 per violation per day.

In Poland, advertising oversight is divided between the Office of Competition and Consumer Protection (UOKiK) – which handles unfair commercial practices and misleading advertising – and the State Sanitary Inspectorate (Sanepid/GIS), which monitors compliance with food law requirements, including the prohibition on attributing medicinal properties to food supplements. The Advertising Council (Rada Reklamy) operates a self-regulatory system, but its decisions are not legally binding.

• In the USA, the FTC can act against advertising independently of the FDA – a product may be legally compliant but its advertising unlawful
• In Poland, attributing medicinal properties to a food supplement (e.g. "treats", "cures", "heals") is a violation of Article 7 of Regulation (EC) No 1924/2006 and Article 46 of the Act on food and nutrition safety
• UOKiK has the power to impose fines of up to 10% of annual turnover for unfair commercial practices
• Online advertising (social media, influencer marketing) is subject to the same rules as traditional advertising – in both jurisdictions

5. Novel food: a European concept with no direct American equivalent

Regulation (EU) 2015/2283 on novel food applies to foods and food ingredients that were not used for human consumption to a significant degree within the EU before 15 May 1997. If an ingredient meets this criterion, it requires authorisation from the European Commission before it can be placed on the market – regardless of whether it is safe or widely used elsewhere in the world.

In the USA, there is no direct equivalent of the novel food concept. New ingredients for dietary supplements are subject to the NDI notification procedure (see point 1), but the threshold for what constitutes a "new" ingredient is different, and the procedure is less burdensome than the EU novel food authorisation process. Many ingredients freely available in the USA – including certain botanical extracts and isolated compounds – require novel food authorisation in the EU.

• The novel food register is publicly available at: ec.europa.eu/food/safety/novel_food
• An ingredient's absence from the register does not mean it is authorised – it may simply not yet have been assessed
• The novel food authorisation procedure takes on average 18–24 months and requires a full safety dossier submitted to EFSA
• In 2026, the European Commission is updating the novel food catalogue – several botanical extracts previously in a legal grey area are being formally classified

6. What an inspector checks: cGMP in the USA vs official food controls in the EU

An FDA inspection of a supplement manufacturer focuses primarily on 21 CFR Part 111 compliance. Inspectors verify: batch production records, raw material specifications and certificates of analysis, identity testing for each ingredient, finished product testing (potency, purity, contaminants), complaint handling procedures, and recall procedures. A Form 483 (Inspectional Observations) is issued at the end of the inspection listing all observed deficiencies – this is not yet a Warning Letter, but failure to respond adequately leads to one.

In Poland, official food controls are conducted by the State Sanitary Inspectorate (Sanepid) under Regulation (EC) No 882/2004 (now replaced by Regulation (EU) 2017/625). Inspectors check: GIS notification status, labelling compliance (mandatory particulars under Regulation (EU) No 1169/2011 and the Regulation of the Minister of Health of 9 October 2007), composition against declared values, microbiological safety, and the absence of prohibited substances. Inspectors may collect samples for laboratory analysis – results that deviate from declared values are grounds for a withdrawal decision.

• In the USA, the most common cGMP violations found during inspections: lack of identity testing for raw materials, incomplete batch records, inadequate out-of-specification procedures
• In Poland, the most common labelling violations: missing mandatory particulars, unauthorised health claims, misleading net quantity declarations
• Both systems allow for unannounced inspections – there is no obligation to notify the manufacturer in advance
• In the EU, RASFF (Rapid Alert System for Food and Feed) enables cross-border information exchange – a product withdrawn in one Member State may trigger controls in others

7. Penalties: Warning Letters and Import Alerts in the USA vs administrative decisions in the EU

In the USA, the FDA's enforcement toolkit includes: Warning Letters (public, no immediate financial penalty but with serious commercial consequences), Import Alerts (automatic detention of goods at the border), injunctions (court orders to cease manufacturing or distribution), seizures (physical confiscation of products), and criminal prosecution (in cases of intentional violations). The FTC can impose civil penalties directly. State attorneys general also have independent enforcement powers.

In Poland and the EU, the primary enforcement tools are administrative decisions: orders to withdraw products from the market, prohibitions on placing products on the market, and financial penalties. Under the Act on food and nutrition safety, GIS/Sanepid can impose fines of up to PLN 5,000 per violation (Article 103). UOKiK can impose fines of up to 10% of annual turnover. In cases of serious violations affecting consumer safety, criminal liability under the Polish Penal Code may also apply.

• An FDA Warning Letter is published within days of being issued – distributors and retailers monitor the FDA database and may suspend orders immediately
• An Import Alert can remain in force for years – removal requires a formal petition to the FDA with evidence of corrective action
• In the EU, a product withdrawal decision in one Member State is notified through RASFF and may lead to parallel actions in other Member States
• Financial penalties in Poland are relatively low compared to the USA – but reputational damage and market withdrawal costs are comparable

8. Prohibited and restricted ingredients: the lists are not the same

The lists of prohibited and restricted ingredients differ significantly between the two jurisdictions. In the EU, the key reference points are: Annex III to Regulation (EC) No 1925/2006 (substances prohibited or subject to conditions when added to food), the novel food register, and national lists of prohibited substances. In the USA, the FDA's Dietary Supplement Ingredient Advisory List and the list of substances subject to Import Alerts are the primary references.

Practically significant differences in 2026 include: melatonin (medicinal product in Poland, freely available dietary supplement in the USA); certain Ayurvedic and traditional Chinese medicine botanicals (novel food status in the EU, no equivalent restriction in the USA); DMAA and related stimulants (subject to FDA Warning Letters but still present in the US market, prohibited in the EU); and high-dose vitamins and minerals (subject to maximum level regulations in the EU, no equivalent federal limits in the USA).

• An ingredient that is legal in the USA is not automatically legal in the EU – and vice versa
• Melatonin above 0.5 mg per daily dose is classified as a medicinal product in Poland – selling it as a food supplement is unlawful
• Botanical extracts standardised to specific active compounds may require novel food authorisation in the EU even if the whole plant has a history of use
• In 2026, the European Commission is finalising maximum levels for vitamins and minerals in food supplements under Directive 2002/46/EC – this will affect products currently on the market

9. What a manufacturer operating in both markets should do in 2026

Operating simultaneously in the US and EU supplement markets requires treating them as two separate compliance programmes, not one. The practical minimum for 2026 includes: maintaining cGMP-compliant manufacturing documentation that satisfies both 21 CFR Part 111 and EU food safety requirements; conducting ingredient-by-ingredient legal analysis for each jurisdiction before finalising formulations; maintaining separate label versions for each market with jurisdiction-specific health claims; establishing a monitoring system for regulatory changes (FDA Advisory List updates, EU novel food catalogue updates, RASFF alerts); and having a documented response procedure for Warning Letters, inspection findings, and RASFF notifications.

• A single global label is almost never compliant with both US and EU requirements simultaneously
• cGMP documentation prepared for FDA inspections provides a strong foundation for EU official food controls – but requires supplementation with EU-specific records
• Regulatory monitoring should be assigned to a named responsible person – not treated as an ad hoc task
• Legal counsel with jurisdiction-specific expertise in both US and EU food law is not a luxury for a manufacturer operating in both markets – it is a compliance requirement

FAQ – Frequently Asked Questions

Does notifying GIS in Poland protect me from a Sanitary Inspectorate inspection?

No. Notification to the Polish Chief Sanitary Inspectorate (GIS) (legal basis: Article 29 of the Act of 25 August 2006 on food and nutrition safety) is purely an information obligation – GIS acknowledges the notification but does not verify or approve the product. The State Sanitary Inspectorate (Sanepid) has the right to inspect a product at any point after it has been placed on the market and may issue a decision ordering its withdrawal if a breach of regulations is found. Notification is a necessary condition for lawful sale, but it is not sufficient on its own.

Can I use a health claim approved by the FDA on the label of a product sold in the EU?

No. The health claim approval systems in the USA and the EU are entirely independent of one another. In the EU, Regulation (EC) No 1924/2006 applies, which requires every health claim to appear in the EU Register of Nutrition and Health Claims – inclusion in the register is preceded by a scientific opinion from EFSA. A health claim approved by the FDA (e.g. a qualified health claim) has no legal status in the EU, and placing it on a label constitutes a breach of Article 10 of Regulation (EC) No 1924/2006.

What is an FDA Warning Letter and what are its consequences for an exporter from Poland?

A Warning Letter is an administrative letter sent by the FDA to a manufacturer or importer when violations of federal food and supplement regulations are identified. The letter itself does not impose a financial penalty, but it is immediately published in the FDA's public database. For an exporter from Poland, the practical consequences include: suspension of sales by distributors and e-commerce platforms that monitor this database, the risk of being placed on an Import Alert (goods detained at the US border without individual inspection), and the initiation of legal proceedings by the FDA if no effective response is provided. Failure to respond within the timeframe specified in the letter (usually 15 working days) is treated by the FDA as confirmation of the violation.

Which food supplement ingredients are prohibited in the EU but permitted in the USA?

The differences are numerous and relate primarily to substances listed in Annex III to Regulation (EC) No 1925/2006 (substances prohibited or subject to risk assessment when added to food) and substances classified as medicinal products in the EU under Directive 2001/83/EC. Examples: melatonin – in Poland available exclusively as a medicinal product (under pharmaceutical law provisions), in the USA permitted as a dietary supplement without dosage restrictions; DMAA (1,3-dimethylamylamine) – prohibited in the EU and Australia, formally subject to FDA action in the USA (a series of Warning Letters since 2012), but still found in pre-workout products on the American market. Before introducing an ingredient into a product sold in both jurisdictions, a separate legal analysis for each jurisdiction is required.

Who in Poland imposes penalties on food supplement manufacturers – GIS, Sanepid or UOKiK?

Competences are divided. The State Sanitary Inspectorate (Sanepid), operating under the supervision of the Polish Chief Sanitary Inspectorate (GIS), conducts official food controls and issues administrative decisions concerning food supplements – orders to withdraw from the market, prohibitions on placing products on the market, and financial penalties under the Act of 25 August 2006 on food and nutrition safety. The Office of Competition and Consumer Protection (UOKiK) intervenes exclusively in matters concerning unfair market practices and the protection of collective consumer interests (legal basis: the Act of 23 August 2007 on counteracting unfair market practices) – for example, in cases of advertising that misleads consumers about a product's properties. The Trade Inspection Authority may inspect sales conditions and labelling at retail points of sale.