Regulation of food supplements

The nutrition-health sector, driven by major public health challenges such as changing lifestyles and an ageing population, continues to expand. This sector, which brings together different markets such as functional foods, dietetic products, clinical nutrition and dietary supplements, is attracting increasing interest from consumers.

The constantly growing dietary supplements market is supported by numerous new products and innovations. In addition to high-performance innovations in buoyant health and well-being segments such as stress, sleep and digestion, manufacturers have invested heavily in communication to stimulate this market.

The craze for well-being and better living is not the only reason for the strength of the dietary supplements market. In fact, the development of self-medication, growing awareness of the link between diet and health, and longer life expectancy are all factors contributing to the positive evolution of this market. According to Synadiet, sales of the dietary supplements market in France are estimated at 1.92 billion euros in 2018, with a clear advantage for pharmacies, which account for just over half of sales.

Food supplements are strictly regulated in France and the EU. Nevertheless, this regulatory environment can be complex and restrictive.

Legally, food supplements fall into the category of foodstuffs, and are therefore considered to be foodstuffs. It must not only comply with legislation specific to food supplements, but also with general food legislation, also known as "horizontal" regulations (food safety, traceability, novel foods, nutritional and health claims, consumer information, etc.).

Food supplements were first defined at European level in Directive 2002/46/EC, which lays down requirements for these products. This directive, which has to be transposed into national law, gives rise to specific local requirements in each of the 28 member states of the European Union.

This directive, while laudable in its existence, only partially harmonizes the marketing of food supplements. Thus, the legislation of each Member State must be taken into account, as marketing procedures are specific to each one.

For example, a dietary supplement marketed in one Member State may be classified as a medicinal product in another, or even prohibited in a third. Furthermore, if a company wishes to include as many active ingredients as possible in the composition of a dietary supplement it plans to market in France, it can take advantage of a skilful combination of multiple national specificities.

At the same time, dietary supplements can raise issues of demarcation between food and drugs. Depending...