Do not call it probiotics

Marketing products and services in the Life Sciences field is not a simple task. In addition to the general marketing law rules that apply to all goods and services, there is a rich array of special regulations to consider, for example regarding medicinal products and foods.

One field of business in which many actors have become very aware of this is that of probiotic food supplements. Although large parts of the consumer base think of these supplements simply as “probiotics,” the word (in most cases) does not appear on product packaging in Sweden. Instead, it often says “lactic acid bacteria” or similar. This stems from the European Commission’s position that the word “probiotics” in itself is what is termed as a  health claim under Regulation 1924/2006 on nutrition and health claims made on foods. The regulation provides that the only claims regarding a food’s health effects that are permissible are those that are authorised in accordance with the regulation and included in the EU Register of nutrition and health claims.

Since “probiotics” is not listed in the register, and since the European Commission, in its Guidance document on the implementation of the regulation (dated 2007), has stated that the word probiotics in itself implies a health benefit — that is, it constitutes a health claim — the European Commission is of the view that probiotics may not be used as a designation for foods containing lactic acid bacteria. The Swedish Food Agency has aligned itself with the European Commission’s assessment.

The Swedish position is not unproblematic. Although “probiotics” is a well-known concept that many consumers have become familiar with, manufacturers of probiotic supplements cannot communicate to the consumer that the product is precisely what the consumer thinks of as “probiotics.” This is illustrated by a question in 2022 from the Swedish industry organisation Svensk Egenvård, that asked the Swedish Food Agency whether probiotics could constitute a ”category name”, i.e. mandatory information in labelling that describes what characterises food supplements. In its response, the Swedish National Food Agency said that it considers that even if ”probiotics” were to be used as a category name, it would still represent a health claim. Therefore, as long as there is no approved health claim about probiotic microorganisms, the word cannot be used in either the labelling or the marketing of food supplements. See, in this regard, the following article here.

Since the EU guidelines stating that “probiotics” should be interpreted as a health claim are not binding, several EU countries have developed their own guidelines on how the term probiotics may be used. However, in Sweden the tougher EU position is, for the time being, adhered to. It remains to be seen whether the less strict approach in other parts of the EU may also affect the Swedish view on marketing these good bacteria.