On Wednesday, September 16, the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária) (Anvisa) banned the circulation in Brazil of T36, a brand of tirzepatide manufactured in Paraguay and popularly known as a “weight-loss pen.” The product did not hold sanitary registration in the country, but it was already being imported and marketed through social media advertisements.
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Banning Scope
Under the regulation, the following activities are strictly prohibited: storage, commercialization, distribution, export, import, advertising, transportation, and use of the medication. This means the ban extends beyond domestic sales in Brazil, it also covers the common practice among patients of crossing the border to purchase the product in Paraguay and bringing it back for personal use.
Lack of Sanitary Registration
Anvisa’s justification is the lack of sanitary registration, a mandatory requirement for any medication to circulate in the country. This registration certifies that the product has undergone safety and efficacy evaluations. Without sanitary registration, these products lack origin and batch traceability, making it practically impossible to verify the source of potential complications.
Analysis:
Weight-loss pens have become extremely popular across Brazil. High prices have not prevented consumption across different social classes. However, this has stimulated the proliferation of alternative, and often illegal, ways to obtain such drugs to control weight. Besides the theft and robbery of pens from the most famous brands offered in the official network of drugstores, there have also been contraband of various kinds of pens and the production of parallel brands, some of good standard, others not. In the end, for the consumers, the risk is the same: damage to health. Anvisa’s control is essential to protect people from eventual contamination by uncontrolled products; therefore, a ban by the agency should be taken seriously. The best behavior here is avoiding the acquisition of T36 and the disposal of any box previously acquired. Furthermore, consumers must really pay attention to the origin and brand of pens, to avoid drugs that may have been counterfeit, contrabanded, or stolen, since even official products that were not well preserved can harm people’s health.
