Herbal supplements New regulatory requirements

The agri-food industry has undergone unprecedented change over the last century. via the introduction of an increasing number of refined products. Deprived of the nutrients naturally present in raw foods, these mass-produced processed products have given rise to numerous cases of dietary imbalance. Examples include salt, which once refined no longer contains minerals such as magnesium or calcium, or cereals, which are stripped of their husks and germ and lose their natural fibre, vitamin B and vitamin E content.

Against this backdrop, a new product has emerged on the market: dietary supplements.

According to decree no. 2006-352 of March 20, 2006 on dietary supplements, "dietary supplements" means foodstuffs whose purpose is to supplement the normal diet and which constitute a concentrated source of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, i.e. forms of presentation such as capsules, pastilles, tablets, pills and other similar forms, as well as sachets of powder, ampoules of liquid, dropper bottles and other similar forms of liquid or powder preparations intended to be taken in measured units of small quantity.  ».

This definition clearly broadens the use of dietary supplements, from a foodstuff intended to supplement nutritional deficiencies to a product with physiological effects, blurring the boundary between food and medicine for the consumer. This is why legislation had to provide the closest possible framework for this new product, both in terms of indications of use intended for consumers and the special precautions to be taken by manufacturers, particularly in the case of the use of plants described in the Order of June 24, 2014 establishing the list of plants, other than mushrooms, authorized in food supplements and the conditions of their use.

In addition to providing a socio-economic overview of the herbal food supplement sector, this article details the various regulatory aspects that must be met by this commodity. It also discusses the reference systems available to professionals in the field, and explains the botanical concepts essential to the implementation of appropriate quality control.

A glossary of the elements used and a table of acronyms are presented at the end of the article.