Longevity products: Supplements, cosmetics or medicinal products?

The market for preventive healthcare and longevity products is growing faster than many market participants' awareness of the regulations around it is. Nicotinamide mononucleotide (or NMN for short) against cell aging, resveratrol for healthy blood vessels, melatonin capsules, sprays and creams to promote sleep – products like these promise customers a longer and healthier life. 

But how should such products be categorised under the law? This question is key, because the category determines what requirements apply for admission to market, advertising, pricing and more. The line between a supplement, a cosmetic and a medicinal product requiring approval is fluid. Novel food law can also play a crucial role for supplements. Mistakes made here risk considerable financial losses.

Categorising longevity products under the law: Supplement, cosmetic or medicinal product?

Supplements are a subcategory of food in accordance with section 1 (1) German Nutritional Supplements Ordinance (NemV). "Food" refers to all substances or products that are intended or can reasonably be expected to be consumed by people in a processed, partially processed or unprocessed condition (section 2 (2) German Food and Feed Code (LFGB) in conjunction with Article 2 Regulation (EC) No 178/2002, "General Food Law Regulation"). They are distinguished by the fact that they supply the body with nutrients but do not directly heal the body or affect it medically. 

Cosmetics are any substance or mixture intended to be placed in contact with external parts of the human body or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours. (Article 2 (1) (a) Regulation (EU) 1223/2009, "Cosmetic Regulation")

Medicinal products by contrast are intended to be used as means of healing, alleviating or preventing human diseases in or on the human body (section 2 German Medicinal Products Act (AMG)) and/or have a pharmacological effect on the human body and typically require official approval before they can be placed on the market.

The distinction sounds clear, but in practice it is not.

The German Medicinal Products Act (AMG) recognises two relevant categories of medicinal products: functional medicinal products, which have actual pharmacological effects, and presented medicinal products, which are considered medicinal products if they are intended to heal or prevent diseases according to the data supplied by those bringing them to market. For longevity products, the latter type is particularly dangerous: Marketing a supplement or cosmetic product with claims like "protects against cell breakdown caused by aging" or "reduces inflammation" risks causing the product to be categorised as a medicinal product if it creates the impression among averagely well-informed consumers that the product can heal, alleviate or prevent diseases.

Novel food: An often-overlooked hurdle

Besides the distinction from medicinal products, there is another regulatory hurdle that can blindside providers of many preventive healthcare and longevity supplements: novel food law. The Novel Food Regulation ((EU) 2015/2283) requires individual approval for foodstuffs and ingredients that were not consumed in an appreciable volume in the EU before 1997 (see Article 3 (2) (a) and Article 6 Novel Food Regulation). 

For example, NMN has been categorised by courts in the past as a novel food (within the meaning of Article 3 (2) (a) Novel Food Regulation). To date no corresponding approval has been issued, meaning that supplements with NMN as an ingredient are currently not marketable in Germany (see for example Berlin II Regional Court, judgment dated 21 May 2025 – 97 O 44/24). Most recently in May 2026, the European authority for food security issued a positive report on the safety evaluation for a supplement containing NMN, but a novel food approval still has not been issued for NMN.

Supplements: When the dosage affects categorisation

Another critical factor is the dosage. From the perspective of public authorities, an unusually high dosage of certain ingredients can generally be an indicator that a product should be categorised as a medicinal product rather than as a foodstuff or cosmetic.

For example, many supplements in the preventive healthcare segment are offered in dosages far in excess of typical nutritional recommendations. This can be seen particularly clearly with melatonin: While high-dosage melatonin products are freely sold as supplements in some countries, in Germany melatonin is considered a medicinal product above certain dosages and requires a prescription (see for example Celle Higher Regional Court, judgment dated 2 February 2017 – 13 U 153/15). An online retailer that distributes high-dosage melatonin capsules in Germany without approval may be subject to criminal proceedings – even if the same product is available legally as a supplement abroad.

Ignoring these matters when developing a product and sales strategy risks not just an official ban from the market, but even consequences under civil and criminal law.

Distinguishing between products wrongly: Liability, warning and recall risks

Miscategorising a product is not just a formal error. Anyone who sells a product as a supplement or cosmetic which is legally to be categorised as a medicinal product is potentially committing a criminal offence, which in the worst-case scenario will be punished with prison time or a fine (see in particular section 96 no. 5 German Medicinal Products Act (AMG)). On top of that there is the risk of formal warnings under unfair competition law brought by competitors, officially ordered product recalls and, not least, significant reputational damage.

Other supply chain actors are not free of risk either: Retailers, importers and platform operators can equally be held responsible if, for example, they have neglected due diligence obligations – something that is often underestimated.

Review longevity products early and market them in compliance with the law

Categorising a product for aging healthily according to the regulatory regime – or other products in preventive healthcare and longevity – is not a job to be left to chance. It requires a structured review of the ingredients, dosage, planned communications and the target market – ideally before the product is developed or imported into the EU.

If this review is carried out early on, not only is the company spared liability risks, but the foundation is laid for a scalable, legally compliant market strategy in one of the most dynamic growth markets going for the coming years.