Supplements from lab to label: the compliance checklist

Market entry in the EU hinges on early classification, rigorous ingredient due diligence, a defensible claims strategy, precise labelling, compliant distribution and structured post‑market surveillance. This insight outlines the principal regulatory requirements under EU law and highlights relevant German specifics.

Concept and classification

EU law treats medicinal products and foods (including supplements) as distinct and mutually exclusive categories for a given intended use. Overlap is not permitted for the same product presentation. Therefore, product classification determines the regulatory route. Format, composition and overall presentation are decisive factors.

If a product meets the definition of a medicinal product by presentation or by function, medicinal rules prevail and exclude food regimes. Therefore, it must be ensured that the foods or supplements do not contain ingredients with pharmacological effects and would therefore be classified as medicinal products. Claims and imagery that suggest prevention, treatment or cure of disease may create a “presentation medicinal product” which, at least in Germany, triggers the application of the German Medicinal Products Act (Arzneimittelgesetz) with pre‑authorisation and strict advertising rules. A food law route, on the other hand, requires a food presentation without any medicinal cues.

Supplements and relevant sub-categories

Food supplements are a subcategory of foods and are governed by Directive 2002/46/EC and respective national implementing rules. The Directive defines supplements as concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in dose form (e.g. capsules or tablets). Only the vitamin and mineral substances listed in Annex II to the directive may be used in supplements. Maximum levels for vitamins and minerals are not yet harmonised at EU level. In Germany, the Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung) issues guidance values that authorities frequently apply. In Germany, while supplements (with the exception of novel foods) do not need to be reviewed or approved by an authority, the first placing on the market of a supplement must be notified to the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit) under section 5 of the German Food Supplement Regulation (Nahrungsergänzungsmittelverordnung – “NemV”).

Furthermore, supplements may be or contain novel foods. Such novel foods, meaning foods that were not consumed to a significant degree in the EU before 15 May 1997, fall under Regulation (EU) 2015/2283 (Novel Food Regulation). Covered categories include, among others, micro‑organisms, fungi, algae, plants, animals or their parts (including insect preparations), synthetic foods and foods from cell or tissue cultures.

Novel foods require pre‑market authorisation, which is why only authorised novel foods may be used in and as supplements. Approved items are added to the Union List, a positive list of approved foods, with specific conditions of use, specifications and labelling requirements. Parts of the dossier are published, so technical choices and IP strategy should align with transparency requirements.

Ingredient due diligence and safety

For foods, including supplements and novel foods, proactive auditing of the supply chain is advisable. Each ingredient must be permitted in the intended food category and market, and identity, purity and contaminant controls should be verified accordingly. Allergen status, applicable maximum levels, potential interactions and implications for vulnerable consumer groups require careful review. Against this background, the implementation of a food safety management system is expected.

Labelling and presentation

For foods, including supplements and novel foods, Regulation (EU) No 1169/2011 on the provision of food information to consumers applies.

Mandatory particulars include, among others, a list of ingredients, allergen indication, quantitative ingredient declaration and date of minimum durability. Products offered online must present this mandatory information before purchase.

For supplements, the German NemV, in particular section 4 thereof, adds several requirements, including the use of the sales designation “Food supplement” (Nahrungsergänzungsmittel), the indication of the recommended daily dose and a warning not to exceed it, as well as statements that supplements do not replace a varied, balanced diet and should be kept out of reach of young children.

Marketing and influencer content

Marketing must not reclassify a food as a medicinal product by presentation. In particular, influencer content raises specific risks where disease claims, exaggerated effects or undisclosed advertising appear; liability for misleading advertising typically sits with the advertiser in addition to the content creator.

Furthermore, the presentation of a supplement as a medicinal product in advertising will subject such supplement to the German Act on Advertising of Medicinal Products (Heilmittelwerbegesetz – “HWG”) which restricts disease‑related communications and sets strict rules for medicinal advertising to the public. Consequences include prohibitions on claims of prevention, treatment or cure to lay audiences. Labelling, pack design and online copy should be aligned to avoid HWG scope and the associated advertising restrictions.

Across EU food law, certain communications are categorically prohibited, in particular misleading information (including false effect claims), attribution of characteristics for preventing, treating or curing human diseases, exploitation of illness and discouragement of consumers from consulting a doctor.

Contracts with agencies and influencers should assign responsibilities for claim vetting, internal review and approvals, training, and notice‑and‑takedown.

As already discussed in our previous insight, Regulation (EC) No 1924/2006 (Health Claims Regulation) governs nutrition and health claims in labelling and marketing. Health claims, which link a food or component to a health effect, may only be used if authorised and only in accordance with their conditions of use; non‑specific claims must be accompanied by an authorised specific health claim relevant to the stated effect. Moreover, nutrition claims must meet precise criteria – accordingly, ongoing review against updates of the EU Register is advisable.

Post‑market surveillance and governance

In order to remain compliant, ongoing monitoring is essential. Companies should track adverse effects associated with their supplements, record consumer complaints and monitor for emerging patterns to ensure early identification of issues. Periodic audits of labels, product information and marketing materials help maintain alignment with evolving rules.

Conclusion

Maintaining regulatory compliance for food supplements is not a one-off exercise but a continuous process that demands cross-functional coordination from product development through to post-market surveillance. Accurate classification at the outset, early engagement with the applicable regulatory frameworks, robust safety and substantiation files, compliant labelling, duly authorised claims, careful product positioning, controlled marketing collaborations and disciplined post-market oversight together form a defensible pathway from lab to label – and beyond.

Companies entering or operating in the EU market – and in Germany in particular – are well advised to establish a structured compliance framework early on. This includes integrating regulatory review into the product development cycle, maintaining living substantiation files, implementing clear escalation and recall protocols, and ensuring that all consumer-facing communications, whether on-pack, online or via influencer channels, are subject to systematic legal sign-off.

Given the pace of regulatory development at both EU and national level, periodic compliance audits and horizon scanning are essential to safeguard market access and mitigate enforcement risk.