The National Health Surveillance Agency (Anvisa) ordered the seizure and prohibited the sale of irregular products this Monday (17). The measures affect the Newfit dietary supplement, Mounja Gummy and all Shark Pro brand supplements. The agency also ordered the seizure of a counterfeit batch of the drug Trodelvy.
Anvisa prohibits the manufacture and sale of irregularly produced food supplements
The National Health Surveillance Agency (Anvisa) ordered the seizure and prohibited the sale of irregular products this Monday (17). The measures affect the Newfit dietary supplement, Mounja Gummy and all Shark Pro brand supplements. The...
Newfit had substances not reported on the label In the case of the Newfit food supplement, an analysis carried out by the Chemistry Laboratory of the State University of Campinas (Unicamp) identified the presence of sibutramine, fluoxetine and furosemide, substances that were not declared in the product's composition. The test also showed that five...
- The test also showed that five ingredients reported on the label were not found in the analysis: chlorella, spirulina, turmeric extract, psyllium and chromium.
- Anvisa considered the results indicative of adulteration.
- The product is under the responsibility of the company Romario Barbosa Bueno 41858909821, RBB Top New.
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Newfit had substances not reported on the label
In the case of the Newfit food supplement, an analysis carried out by the Chemistry Laboratory of the State University of Campinas (Unicamp) identified the presence of sibutramine, fluoxetine and furosemide, substances that were not declared in the product's composition.
The test also showed that five ingredients reported on the label were not found in the analysis: chlorella, spirulina, turmeric extract, psyllium and chromium. Anvisa considered the results indicative of adulteration.
The product is under the responsibility of the company Romario Barbosa Bueno 41858909821, RBB Top New. The determination provides for the seizure and prohibition of the manufacture, sale, distribution, dissemination and use of the products affected by the measure.
Mounja Gummy was not regularized at Anvisa
Another affected product is Mounja Gummy, manufactured by Bela Blue Beauty Ltda. According to Anvisa, the supplement has no registration, notification or registration with the agency.
With the decision, the product must be seized and cannot be manufactured, sold, distributed, imported or disclosed.
Anvisa suspends Shark Pro supplements
Anvisa also ordered the recall and suspended the manufacture, sale, distribution, advertising and use of all Shark Pro brand food supplements, in all batches. The products are the responsibility of RCA Labs.
The decision was taken after an inspection by the Capivari Health Surveillance, in São Paulo, identified flaws in good manufacturing practices.
Among the irregularities highlighted are the lack of quality control of raw materials, inadequate storage, lack of preventive maintenance records for equipment, lack of stability studies and lack of regularization of some products. Problems were also found with allergen information and possible cross-contamination on labels.
Trodelvy batch is considered counterfeit
The measures released by Anvisa also include batch 10008808 of the drug Trodelvy.
Gilead Sciences Farmacêutica do Brasil Ltda., holder of the drug registration, informed the agency that it does not recognize the batch, which was classified as counterfeit. Therefore, Anvisa ordered its seizure.
The determination is specific to batch 10008808 and does not represent a ban on the Trodelvy drug as a whole.
Anvisa prohibits teas that promise the effect of Mounjaro
According to the agency, the items do not have health registration and are prohibited from being manufactured, distributed, sold, disclosed or used. They are produced by an unknown company.