The Brazilian Federal Health Agency ("Anvisa") approved new regulations concerning food supplements. Resolutions No. 239, 240, 241, 242 and 243 and Ordinance No. 28/2018 ("Legal Framework") aim at bringing more information to consumers and restraining the use of scientific allegations without proper evidence.
The Legal Framework relates to the growth of the market of food supplements and the need to guarantee the quality of such products through nutritional and health control.
Among the main changes brought by the Legal Framework, we highlight the following:
- Definition of food supplements, their respective functions, maximums limits and conditions of use;
- Specific labeling requirements for such products, such as the indication of the population group, quantity and frequency of consumption for each of the population groups, a prominent warning of "This product is not a drug" etc.;
- List of ingredients that are sources of nutrients, bioactive substances or enzymes, food additives and technology adjuvants authorized to be used as supplements;
- List of health benefits claims that may be written on the packaging of supplements.
Such changes impact food supplements' business in that they may affect the formulation of the products themselves (due to need of quality and safety analysis), as well as packaging and labeling of such products.
Products that are already on the market will have a period of five years to comply with the new rules, while new products will have to adapt immediately.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.