How to manage regulatory requirements when you are a start-up in the food supplement area ? Through this article, we have chosen to address the question that food supplement start-ups must ask themselves.
The aim of this article is not to go into details of French and European regulatory texts, which we had the opportunity to explore in previous articles.
In this text, we focus on the regulatory concerns faced by start-ups wishing to launch their food supplements brand. What am I allowed to do ? What should I not do ? What do regulation say for my sector ? How can I communicate on my product ? In which countries can I sell it ?
So, this article gives you some answers to solve one of the first questions asked by food supplement start-ups, namely : how to manage regulatory requirements ?
Food supplement regulation occurs at several levels for food supplement brands. To know how to manage regulation, we will detail the different stages where it occurs.
1/ The formulation of a food supplement
The ingredients used in the manufacturing of a food supplement (plants, vitamins, minerals, substances for nutritional and physiological purposes, probiotics, mushrooms, etc.) must be part of the official authorized list and their dosages must correspond to those authorized.
An formulation expert is responsible for verifying these conformities with the help of regulatory supports. This is the first regulatory control on the path leading to the marketing of the food supplement.
Please note that in France, brands are required to keep a scientific file justifying the dosages of the active ingredients (proof of effectiveness), aiming at ensuring effective dosages and not “marketing dosages” to the consumer.
2/ The development of the labeling
Labeling is also regulated. After the regulatory expertise (analysis of the formulation, technical and regulatory data sheets of the ingredients), a labeling guide is transmitted , including the mandatory information required by the regulations and the authorized claims (or claimed benefits).
The regulations govern the way in which brands can communicate about their formulas so as not to mislead the consumer. This is sometimes limiting in order to stand out from the competition, but compromises exist. Regulatory support allows brands to adjust their discourse to remain competitive while respecting regulations.
On the other hand, if the selected ingredients are the subject of a trademark registration and this is cited, it is necessary to ensure with the supplier that they comply with the requirements described in the trademark license.
Finally, in France and in several European countries, the affixing of the Triman logo and the info-sorting cartridge on packaging have been compulsory since March 9, 2023. This implies membership in a waste sorting organization such as CITEO. The visual elements affixed to the label make it possible to indicate to the consumer in a very pragmatic way which components of the packaging can be recycled.
3/ The regulation file for the authorities
Pre-market regulatory support generally concludes with the submission of the regulatory file, including labeling, to the competent authorities. In France, this is Direction Générale de l’Alimentation (DGAL, preceded by the DGCCRF).
Depending on the countries in which the brand markets its food supplements, regulation rules differ (EFSA at the European level ; FDA at the American level). Indeed, the positive and negative lists, as well as the dosages to be respected, vary ; The submission of the regulatory file may be optional if the company is previously declared as the establishment placing food supplements on the market.
Besides, in terms of labeling, the mandatory information can be organized in a completely different way. In addition, the official language of each country must be the one appearing first on the labeling. It is therefore important to take into consideration the marketing countries when developing the formulas.
4/ The manufacturing of a food supplement in France
French regulation requires at least that manufacturers of food supplements demonstrate a HACCP method (risk analysis and critical control points system). HACCP guarantees, in particular, the traceability of raw materials used in the composition of food supplements. Most French manufacturers go beyond this quality requirement and achieve ISO 22000 certification.
Each manufacturer has its strengths and weaknesses with regard to each manufacturing project. It is essential to know the industrial manufacturing park well to make the most appropriate choice.
5/ The website communication
Communication relayed on the internet follows the same rules as that authorized on labeling.
Furthermore, it is necessary to carefully choose the testimonies that appear there. In fact, only consumer testimonials can be highlighted, because those from health professionals are not authorized.
6/ Post-market surveillance
Once the food supplement is marketed, it is possible that some consumers may observe changes different from those claimed by the food supplement.
In France, if these changes have a harmful impact on the health of the consumer, these are undesirable effects which must be recorded : this is named nutrivigilance. A register of consumer returns must be kept and a nutrivigilance form must be communicated to the health authorities in order to alert and modify, if necessary, the product.
As you have understood, regulations are present throughout the life of a food supplement, from the very first steps. It is essential to take regulations into consideration from the beginning of the creation of a food supplement brand.
Finally, please note that Kares-up is an essential partner to support you throughout these stages by combining “obligations” and “innovation/differentiation” to assert your added value and your competitive advantages.
Raphaëlle DA COSTA
Founder of Kares-up
