Prior to 2018, The Food supplement category in Brazil was non-existent. It was not until the National Health Surveillance Agency (ANVISA)’s released Resolutions RDC No. 242/2018 and 243/2018, there have been significant changes in the framing of the product as a medicine or food supplement.
The food supplement category was created in Brazil in 2018 to ensure the population’s access to safe and quality products. However, we can still observe confusion at the moment of framing and registering the product. Many people still have questions, such as: does the product fall into the category of medicine or food supplement?
Previously, foods for athletes, pregnant women, vitamin and mineral supplements were framed in other food groups or even as specific medicines. However, with the creation of the Food Supplement category, more appropriate rules were defined for food supplements, including minimum and maximum limits, indicated populations, authorized constituents, and scientifically proven claims.
In the past, to differentiate a supplement that was classified as food from a supplement that was classified as medicine, Anvisa relied on the Recommended Daily Intake (RDI). With the publication of RDC No. 242/2018 and RDC No. 243/2018 specific for Food Supplements, the RDI values are no longer used to define the supplement category.
Food supplements are exempt from sanitary registration and must follow the provisions of Resolution No. 23/2000 for their regularization with the Sanitary Surveillance. On the other hand, food supplements that contain enzymes or probiotics must have, obligatorily, the sanitary registration.
Food Supplement x Specific Medicine
A food supplement is a product for oral ingestion, presented in pharmaceutical forms, intended to supplement the diet of healthy individuals with nutrients, bioactive substances, enzymes or probiotics, alone or in combination.
Food supplements are not medicines, and therefore are not intended to treat, prevent or cure diseases. Supplements are intended for healthy people. Their purpose is to provide nutrients, bioactive substances, enzymes, or probiotics in addition to the diet.
Specific medicines are pharmaceutical products, technically obtained or elaborated, with prophylactic, curative or palliative purposes, that do not fit in the categories of new, generic, similar, biological, phytotherapic or notified medicines, and whose active substance(s), regardless of nature or origin, are not subject to bioequivalence test against a comparator product. Also, medicines based on vitamins and/or minerals and/or amino acids and/or proteins, isolated or associated, for oral use, with well-established therapeutic indications is classified as Specific medicines.
Under no circumstances a food supplement can be claimed to prevent, treat or cure diseases. This type of claim is restricted to medicines and must be proven by other means.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.