ANMAT prohibits products claiming to contain retatrutide nationwide

ANMAT has prohibited the use, commercialization, publication, and distribution throughout the national territory and on electronic sales platforms of all batches, sizes, and presentations of any product for human administration that claims to contain “retatrutide” or “retatrutida” as an ingredient. The decision was formalized through Provision 6140/2026 (DI-2026-6140-APN-ANMAT#MS), signed in the City of Buenos Aires on September 22, 2026, and published in the Official Gazette on September 24, 2026, in its First Section.

The regulation bears the signature of the national sub-administrator Gabriel Leonardo Barbagallo and was issued within the framework of File No. EX-2026-80354354-APN-DVPS#ANMAT, based on Law No. 16,463 and Decree No. 1490/1992. The agency framed the measure under subsections ñ), i), and l) of Article 8 of said regulation, which empowers it to adopt preventive and corrective measures to protect the health of the population against risk factors linked to the quality and safety of the products under its jurisdiction.

A substance in clinical research without authorized specialties

According to the recitals, there are no medicinal specialties marketed in the Argentine Republic that contain this substance, as it is an ingredient currently in the clinical research stage for its potential effects in patients suffering from type II diabetes and inadequate glycemic control.

The prohibition applies to any product that claims to contain “retatrutide” or “retatrutida” until it is authorized by ANMAT, with one single exception: cases of clinical research expressly authorized by the National Administration itself.

The agency justified the sanitary measure on the grounds that the products involved lack the registrations required to prove their legitimate manufacture and oversight in accordance with applicable regulations.

Complaint, regional alerts, and judicial proceedings

The proceedings were initiated following a complaint received by email at the Directorate of Evaluation and Management of Health Product Monitoring, which reported two web links through which products claiming to contain “retatrutide,” among others, were being offered.

The file also records international precedents:

• Brazil’s National Health Surveillance Agency, ANVISA, published alerts regarding products containing “retatrutide.”
• Paraguay’s National Surveillance Agency, DINAVISA, did the same.

The Marketing Chain Oversight Service of the Directorate of Evaluation and Management of Health Product Monitoring suggested, through NO-2026-80512378-APN-DEYGMPS#ANMAT, publishing an alert on the agency’s website to warn the population, and expanding the complaint before the Federal Criminal and Correctional Court of Lomas de Zamora No. 2, presided over by Dr. Armella, Luis Antonio, with Secretariat No. 4 presided over by Dr. García Lira, Nicolás.

That case was registered under internal number 1329-71-000.265/2026, captioned “complaint a.n.m.a.t. – gm distributor”. The complaint was formalized by the Directorate of Legal Affairs of ANMAT through the Argentine Federal Police, Health Crimes Division, in accordance with provision PV-2026-84049998-APN-DAJ#ANMAT.

Deadlines and scope of the measure

Article 2 of the provision establishes that the act exhausts the administrative route regarding the prohibition. Against the measure, the interested party may file, at their option:

• A motion for reconsideration, within twenty (20) administrative business days.
• An administrative appeal (recurso de alzada), within thirty (30) administrative business days.
• A judicial action, within one hundred and eighty (180) judicial business days.

All deadlines are computed from the day following the notification of the act, in accordance with the Administrative Procedures Regulations (Decree No. 1759/72, T.O. 2017) and Article 25 of Law No. 19,549.

The provision orders the communication of the prohibition to the jurisdictional health authorities, the National Directorate of Regulatory Management and Control of the Undersecretariat for Consumer Defense and Fair Trade, the Directorate of Evaluation and Management of Health Product Monitoring, and the Directorate of Technical Information Management, and the referral of the proceedings to the Summary Coordination office.

The impact of the measure is direct for patients with type II diabetes seeking therapeutic alternatives and for online buyers: ANMAT not only blocks the sale and advertising of these products nationwide but also warns that these are dangerous offers to health, lacking registration support or sanitary control, and activates an ongoing criminal investigation.

Source: Official Gazette of the Argentine Republic, September 24, 2026, First Section (official reference: ANMAT Provision 6140/2026).