Thus, through the Provision 8770/2021published today in the Official Gazette, the administration communicated the measure on the Peruvian product, which was marketed through virtual platforms. In the recitals, the ANMAT argued that the product was prohibited for “lack health records of establishment (RNE) and product (RNPA), resulting in being an illegal product”.
ANMAT banned an “anti-cancer” supplement
In the official Provision, the national administration detailed that the actions began from a consultation of the College of Pharmacists of the province of Buenos Aires before the INational Food Institute (INAL) in relation to the product: “Graviola, Prodenza Life brand. Anticancer, 100% original, 90 Caps., Prepared by Laboratorios Agroindustrias Amazonas SAC, RUC: 20433175558, Mz. or Lt. 34 Asoc. Sr. de los Milagros Lima 31, Sanitary registration: N7407114N, DIGESA RSA: NAARAA EXP. 12/2026, 100% natural Peruvian product.”
According to the administration’s investigations, the aforementioned product is in “violation of article 4 of Law No. 18284, article 4 of Annex II of Decree No. 2126/71, and articles 13 and 155 of the Food Code Argentine (CAA)” because it lacks the National Establishment Registry (RNE) and National Food Product Registry (RNPA). These regulatory breaches result in the supplement being classified as a “illegal product“.
In detail, the Peruvian supplement was marketed on virtual platforms where it is described as ” 100% natural, antibacterial, antifungal and antiparasitic.” Furthermore, in its description, it also “helps with joint problems, parasites, diabetes, cancer and hypertension.”
Given this, the ANMAT decreed: “because it is a product that cannot be reliably and clearly identified as produced, processed and/or divided in a specific establishment, It may not be produced in any part of the country, nor marketed or sold in the territory.”.
ANMAT prohibited the sale of a brand of blood pressure monitors
In recent days, the national administration also prohibited the sale and use of a series of ALP-K2 brand blood pressure monitors. The measure was taken due to irregularities in its documentation and origin.
Blood pressure monitors are essential devices for measuring blood pressure, and their correct operation is essential to ensure accurate diagnoses.
The beginning of the investigation dates back to July 2024, when members of the ANMAT carried out a routine inspection at the company Health Products SRLlocated in San Miguel de Tucumán. During the procedure, the authorities found 12 ALP-K2 blood pressure monitors that did not comply with legal requirements basics.
Among the multiple violations detected, the products did not include a user manual in Spanishsomething that is mandatory according to current regulations. The manufacturer or importer of the blood pressure monitors was also not clearly identified, which raised questions about their legitimacy, production and origin.
The inspected company presented a purchase invoice indicating that the blood pressure monitors had been acquired through Trinidad Insumos SRL. However, when attempting to verify this information, ANMAT discovered that Trinidad Insumos was no longer operating at the registered address, and it was not possible to confirm the origin of the productsfor which its sale and use was decreed.
Source: Ambito
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