We help manufacturers of food supplements, dietetic foods, foods for special medical purposes and borderline products – i.e., products on the borderline between the product categories food, medical device and medicinal product – with our technical expertise.
Food supplements and foods for special medical purposes (FSMP) are subject to a wide range of laws and regulations. We stay on top of matters, verify the marketability of product formulations and ingredients, and advise manufacturers when it comes to borderline issues. We make sure that food supplements meet the regulatory requirements and check their packaging and labelling requirements. If our clients ever face the prospect of regulatory action or challenges from competitors, we are there to stand by them with experience and regulatory expertise.
The marketability of foods for special medical purposes (FSMP) and especially of supplementary balanced diets (SBD) is ensured through Regulations (EU) 609/2013 and (EU) 2016/128. However, the new regulations also entail several new provisions. For example, distributors must now frequently provide an FSMP dossier/SBD dossier in accordance with corresponding EFSA guidance. Diapharm is there to provide advice and assistance with this task as well.