The Ministry of Health issues CIRCULAR MS-DRPIS-UR-0890-2024 on request for scientific justification or technical support for dietary supplements.

The scientific justification is made in the following cases:

1. For all cases of dietary supplements containing hemp and its derivatives; according to Article 16 of the “Regulation to Law No. 10113, Law of Cannabis for medicinal and therapeutic use and Hemp for food and industrial use of March 02, 2022, Regulation of hemp for food and industrial use”, published by Executive Decree No. 43689-MP-MAG-S of September 7, 2022.
2. For all cases of dietary supplements that include Health Claims that do not appear in Annex G and that must be evaluated by the health authority; according to Article 7.4 of the “Central American Technical Regulation RTCA 67.01.60:10 Nutritional labeling of pre-packaged food products for human consumption for the population from 3 years of age”, published by Executive Decree No. 37100-COMEX-MEIC-S of February 20, 2012.

Bill 5742/23 establishes a prison sentence of one to five years, in addition to a fine, for whoever falsely advertises dietary supplements. Under analysis in the Chamber of Deputies, the text inserts the penalty in the Penal Code.

The proposal also determines that the labels of the supplements must inform that the product has no therapeutic or pharmacological action and that it is not indicated for the treatment, prevention or cure of diseases.

Currently, whoever advertises products contrary to health legislation is subject to suspension of sales and a fine. According to the legislation, the fine varies from R$ 2,000, for minor infractions, to R$ 1.5 million, for very serious infractions.

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.

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.