[REVISION HISTORY]

Anvisa regulatory actions in Brazil

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2026-10-28 18:46 UTC → 2026-10-28 21:18 UTC · added ~~removed~~

The Brazilian Health Regulatory Agency (Anvisa) has implemented several bans and recalls targeting various consumer goods due to safety and regulatory concerns. In the dietary supplement sector, Anvisa reinforced a prohibition on ashwagandha, noting its popularity on social media despite the herb not being on the list of authorized ingredients. The agency cited a severe international case of liver failure and brain damage linked to the product. Recent enforcement actions have targeted specific food and supplement items. Anvisa ordered ABB Gelateria Ltda to recall Bentô Gelatos Magnésio + Inositol Relief 3.0 popsicles because the formula contains melatonin and inositol; while these substances are authorized for supplements, their safety for use in popsicles has not been assessed. Consequently, the agency suspended the manufacture, sale, distribution, advertising, and consumption of the product. Bentô Gelatos stated it is complying with the resolution and noted the product was not yet part of its active menu. Additionally, the agency ordered a recall for Equaliv's Body Strong Protein (cocoa flavor), manufactured by Althaia S.A. Indústria Farmacêutica. The supplement contains Peptistrong, a hydrolyzed fava bean protein that lacks a safety assessment for use in food products. Anvisa also noted this supplement made irregular therapeutic claims regarding muscle mass support for users of GLP-1 medications and the prevention of sarcopenia. Further regulatory actions include the suspension of KF Embutidos smoked pork sausage after microbiological analysis detected Listeria monocytogenes in a specific batch, prompting a voluntary recall by manufacturer Fábrica de Embutidos Zanetti. Anvisa also suspended advertising for Glifit and Glicofit dietary supplements by Vita Nutriom Saúde & Bem Estar Ltda, citing deceptive claims regarding insulin sensitivity and glucose regulation.

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