[REVISION HISTORY]

Brazil ANVISA expands product safety enforcement

Updated 16 times since CLSTR started tracking revisions of this situation.

What changed

2026-08-29 11:50 UTC → 2026-08-29 11:50 UTC · added ~~removed~~

Since May 2026, Brazil’s National Health Surveillance Agency (ANVISA) has intensified enforcement of sanitary rules for pharmaceuticals, cosmetics, and consumer goods. Early actions included suspending batches of statins, dexamethasone, enalapril, and the oncology drug Halaven; recalling infant formula, injectable antibiotics, and saline solution due to contamination or quality defects. In June, the agency prohibited unregistered herbal drugs, banned formaldehyde and glioxilic acid in hair-straightening products, and seized illegal e-cigarettes. ANVISA also suspended the Voy obesity-treatment platform and recalled various supplements. Regulatory focus expanded to include medical supply storage standards and new cosmetic ingredient restrictions. Throughout July, enforcement targeted contaminated mineral water, energy drinks, and illegal weight-loss pens containing the experimental drug retatrutida. In August, enforcement expanded significantly. ANVISA prohibited six salt products from Quanqton for clandestine manufacturing and deceptive health claims, and banned 12 cleaning products—including brands such as Oxypur and Yta Clean—due to a lack of sanitary regulation. The agency also targeted unregistered weight-loss products, including Chá Sarapião by Natural Ervas Produtos Naturais Ltda. (Farmagon) and various items marketed as Milagroso Ervas or Mounfor X ~~Emagrecedor.~~ Emagrecedor, prompting PROCON/SC to monitor markets. Additionally, dietary supplements from Newfit and SharkPro were banned; laboratory analysis found Newfit products contained undeclared substances like sibutramine, fluoxetine, and ~~furosemide.~~ furosemide, while SharkPro faced recalls due to manufacturing violations. Parallel to these actions, Brazil has seen a surge in the importation and smuggling of weight-loss medications, specifically GLP-1 agonists like semaglutide and tirzepatide. ~~To strengthen oversight, ANVISA issued a new resolution~~ Official data shows imports grew by 85% in late August redefining quality control rules for public and private laboratories. Laboratories must now maintain valid sanitary licenses, employ qualified technical managers, and adopt quality management systems aligned with the ABNT NBR ISO/IEC 17025 standard. Laboratories testing medicines and vaccines are required to follow World Health Organization (WHO) best practices and share data with ANVISA. Facilities have one year to adapt first seven months of 2026, reaching US$ 1.512 billion. The value of seized weight-loss pens by the Federal Revenue rose from R$ 4 million in early 2025 to ~~these expanded biosafety and monitoring requirements.~~ over R$ 80 million in the first half of 2026.

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