[REVISION HISTORY]

Brazil ANVISA expands product safety enforcement

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2026-10-19 18:06 UTC → 2026-10-21 00:52 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. Throughout July, enforcement targeted contaminated mineral water, energy drinks, and illegal weight-loss pens containing the experimental drug retatrutide. In August, enforcement expanded to prohibit salt products from Quanqton and 12 cleaning products, including brands such as Oxypur and Yta Clean. Dietary supplements from Newfit and SharkPro were also banned. Parallel to these actions, Brazil has seen a surge in the smuggling of weight-loss medications like semaglutide and tirzepatide. The value of seized weight-loss pens by the Federal Revenue rose from R$ 4 million in early 2025 to over R$ 80 million in the first half of 2026, driven by price discrepancies with Paraguay. In response, ANVISA and Paraguay’s Dinavisa have strengthened cooperation, and ANVISA has introduced Normative Instruction 469 to fast-track generic semaglutide registrations. Recent enforcement includes seizing United Labz products and suspending Unilever manufacturing in Vinhedo due to Good Manufacturing Practice failures. In September, ANVISA ~~has also prohibited unregistered hormone implants from MC Legacy Lab~~ issued Resolution RE nº 3.626/2026 to ban the import, storage, distribution, sale, advertising, and ~~seized batches~~ use of ~~Dysport and Keytruda due to counterfeiting.~~ T36, a Paraguayan weight-loss medication produced by Laboratorios Catedral that contains tirzepatide. The agency also reiterated its prohibition on the sale of GLP-1 receptor agonists via the website Go Pharma. In October, the agency targeted ~~illegal sales~~ counterfeit medications, specifically confirming that a lot of ~~tirzepatide~~ Dysport (botulinum toxin) is counterfeit due to incorrect expiration dates and ~~retatrutide on various websites.~~ packaging discrepancies.

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