Ecuador – Draft revised standard on dietary supplements

The Ecuadorian Standardization Service (INEN in Spanish) has published a draft revision of NTE INEN 2983 (1st Revision) Complementos/ suplementos nutricionales. Requirements. This standard establishes the requirements for nutritional complements/supplements. This standard does not apply to foods for special diets.

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Guatemala – Update to the standard on health registration of dietary supplements published

The Ministry of Health published the update of Rule 14 version 2/2022 on sanitary registration of dietary supplements.
The purpose of this Technical Standard is to regulate the conditions and requirements through which the Department of Regulation and Control of Pharmaceutical and Related Products, hereinafter referred to as the Department, will grant the Sanitary Registration of dietary supplements.

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;

The Americas – Peru: DIGEMID updates the vitamins, minerals and other nutrients allowed in the manufacture of dietetic products (dietary supplements)

Through Resolution No. 025-2022-DIGEMID-DG-MINS, the General Directorate of Medicines, Supplies and Drugs (DIGEMID in Spanish), approved the list of vitamins, minerals and other nutrients allowed in the manufacture of dietary products.
This new Resolution supersedes Directorial Resolution No. 177-2013-DIGEMID-DG-MINSA dated August 22, 2013.

The Americas – ANMAT banned the sale of seven dietary supplements “dangerous to health”.

The National Administration of Medicines, Food and Medical Technology (ANMAT) banned the use, distribution and commercialization throughout the country of a series of supplements promoted for “focus, concentration and memory” in capsules, powders and drops.
Provision 2105/2022 published this Tuesday in the Official Gazette indicates that these are the products “Newmind – Noopept – GVS -111 powder; Newmind – F-Phenibut powder; PURENOOTROPICS Noopept capsules; PURENOOTROPICS Noopept powder; NOOPEPT sublingual, PURE NOOTROPICS; B-12 sublingual PURENOOTROPICS; and PURENOOTROPICS BACOGNIZE Bacopa Monnier”.