Deputy Felipe Carreras (PSB-PE) stated that he believes in the swift approval of the proposals that expand health control and sanctions for fraud and misleading advertising regarding dietary supplements. The three bills (PL 5229/25, 5319/25, and 6000/25), recommended by the working group he coordinated in the Chamber of Deputies, already have urgent approval and are therefore ready for a vote in the Plenary. In addition to criminalization and increased fines for irregularities, the proposals focus on food security.

The congressman argued that the regulation of this sector cannot be limited solely to the resolutions of Anvisa (Brazilian Health Regulatory Agency), as is currently the case.

“There is no national law on this matter.” There is an RDC, which is a resolution from the board of directors of Anvisa (National Health Surveillance Agency of Brazil). Recently, we had a serious problem with a brand of milk, with a batch that caused gastrointestinal symptoms in children. That batch was withdrawn from the market. Do you know what penalty that big company received? None. Today, the problem with the mineral water has been reported, where a batch is being withdrawn because it contains bacteria. “Maybe it will only receive an administrative sanction,” he complained.

Felipe Carreras is expected to be the rapporteur for the proposals related to the health control of dietary supplements in the full House. The deputy recalled that in the working group’s hearings, all involved sectors were heard, from companies to doctors and nutritionists.

The Natural Products Committee of the Exporters Association (ADEX) reiterated the importance of promoting the creation of a Health Registry for Food Supplements, as outlined in Bill No. 6435/2023-CR, approved by the Health Commission of Congress in April 2025 and currently pending debate in the Plenary.

The initiative seeks to establish a specific regulatory framework for this category, under the authority of the General Directorate of Environmental Health and Food Safety (DIGESA in Spanish), thru the implementation of a Sanitary Regulation.

He indicated that having differentiated regulation will provide greater legal certainty to companies, strengthen the competitiveness of the sector, and align national legislation with global standards and the guidelines promoted by the Pacific Alliance.

The National Health Surveillance Agency (ANVISA in Portuguese) has updated Normative Instruction IN 28/2018 to include new limits and detail the changes in the labeling of dietary supplements that contain turmeric (also known as açafrão) in their composition.

The update was motivated by the identification—within the context of post-marketing surveillance—of a potential risk of liver damage associated with the use of supplements and medications containing turmeric (Curcuma longa) or curcuminoids. In March, Anvisa issued a pharmacovigilance alert to warn users of these products about the associated risks.

The three main points of the regulatory update:

• Mandatory inclusion of the following warning on supplement labels: “This product should not be consumed by pregnant women, breastfeeding women, children, people with liver or biliary diseases, or gastric ulcers.” People with illnesses or who are taking medications should consult their doctor.

• The limits for curcumin consumption should be calculated by adding its three main components (total curcuminoids).

• Inclusion of tetrahydrocurcuminoids in the list of permitted ingredients, with restrictions on mixing this new component with the natural extract of the plant in the same product to avoid overloading the body with this substance.

The Working Group of the Chamber of Deputies, responsible for analyzing the marketing of dietary supplements, approved a report proposing an urgent reform of the sector. The document recommends the expedited processing of three bills aimed at increasing health control and sanctions related to fraud and misleading advertising.

The bills in question are: PL 5229/25, by Pedro Paulo (PSD-RJ); PL 5319/25, by Tabata Amaral (PSB-SP); and PL 6000/25, by Mário Heringer (PDT-MG). The coordinator of the group, Deputy Felipe Carreras (PSB-PE), highlighted the seriousness of the current situation, stating that “the scenario of total insecurity regarding the consumption of dietary supplements in Brazil demands urgent measures.”

Currently, most supplements do not require health registration, according to Anvisa’s resolution (Resolution 240/18), which is based on prior notification, assuming the manufacturer’s good faith. The current sanctions, according to Law 6.437/77, are limited to fines and batch withdrawals, which are insufficient to address serious frauds, such as ingredient adulteration and the use of prohibited substances.