Brazil – ANVISA publishes updated guide to questions and answers on dietary supplements

The eighth edition of the Dietary Supplement Q&A document has 178 questions and answers with updated guidance on the regulatory framework for dietary supplements. In this edition, the following topics have been added or updated from the last edition:

a) introduction and other answers throughout the document with the exclusion of individual hyperlinks redirecting to the texts of the standards and the inclusion of the hyperlink to Food Topics Library;
b) Questions 5 and 6, which clarify the regulatory framework for food supplements and its updates;
c) Question No. 14, which informs on the second version of the Guide for the Instruction of the Procedure for the Request for Evaluation of Probiotics for Use in Foods;
d) Question No. 23, which clarifies the food supplements indicated for sublingual administration.
e) Question No. 37, with new wording on food supplements intended for children;
f) Question No. 40, updating the list of substances considered as doping substances by the World Anti-Doping Agency;
g) Question No. 41, with update of DRC No. 632/2022, which deals with trans fats in food; h) Question No. 41, with update of DRC No. 632/2022, which deals with trans fats in food;
h) Question No. 42, updating the rule on the admissibility of foreign pharmaceutical codes;
i) Question No. 45, on the documentation to be submitted for approval of bidding documents by Anvisa;
j) Question No. 49, on the nutritional value and compliance with the maximum limits of food supplements;
k) Question No. 51, with information on compliance with the deadline for the submission of contributions to Guide No. 16/2018, which deals with the determination of expiration dates of foodstuffs;
l) Question No. 55, on the main changes in the lists of constituents, limits of use, declarations and supplementary labeling of food supplements made by IN No. 102/2021;