Food supplement

A food supplement is a foodstuff the purpose of which is to supplement the normal diet and which is a concentrated source of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, such as capsules, tablets, sachets of powder or ampoules. The definition is laid down by Directive 2002/46/EC, transposed into French law by a 2006 decree. Food supplements fall under food law, and any therapeutic claim is prohibited for them.

Placing on the market

A food supplement is not subject to prior authorisation. Placing it on the French market requires a notification to the authority responsible for competition, consumer affairs and fraud control, through an online procedure, and the authority may object to its marketing. The vitamins and minerals that may be used appear on harmonised lists, while plants and other substances are still largely governed by national rules, with a mutual recognition mechanism for products lawfully marketed in another Member State. An ingredient without a significant history of consumption in the Union before 1997 falls under Regulation (EU) 2015/2283 on novel foods.

Claims

Nutrition and health claims are governed by Regulation (EC) No 1924/2006, which permits only claims that have been authorised and entered in a Union register. Any claim attributing to the product the property of preventing, treating or curing a human disease is prohibited. A therapeutic presentation exposes the product to reclassification as a medicinal product by presentation, following the logic of borderline products, with the penalties attached to breach of the pharmaceutical monopoly and to placing on the market without authorisation.

Intellectual property in food supplements

Food supplement compositions and their manufacturing processes are patentable under the ordinary conditions, but protecting a new use of a known substance runs into a difficulty. The second medical use claim format presupposes a therapeutic use, which the supplement cannot claim in its commercial communication, whereas a non-therapeutic use must establish its novelty through a distinct technical effect. The sector also relies heavily on the trade mark, on the secrecy of formulations and on parasitism actions against imitations of packaging.

Key points

A food supplement is a foodstuff that is notified rather than authorised and may not claim any therapeutic effect. Its claims must be among those authorised at Union level. The list of ingredients should be checked against national rules and novel food status, and claims should be reviewed before any campaign, since an overly medical presentation exposes the product to reclassification as a medicinal product.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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