The National Agency for Health Supervision (ANVISA) has ordered the seizure and ban on the production, sale, and distribution of several products deemed illegal. The measures, announced on August 17, concern the supplement Newfit, the product Mounja Gummy and all food supplements marketed under the brand Shark Pro.
Anvisa has also ordered the seizure of a Counterfeit batch of the drug Trodelvy, specifying that the measure concerns only that batch and not the medicine as a whole.
Newfit: Undeclared Substances Found
The most relevant case concerns the food supplement Newfit, subjected to analysis by the Chemistry Laboratory of the State University of Campinas (Unicamp).
The tests revealed the presence of sibutramine, fluoxetine and furosemide, pharmacological substances that were not indicated on the product label.
The analysis also revealed the absence of five ingredients that were, however, declared in the composition: chlorella, spirulina, turmeric extract, psyllium and chromium.
According to Anvisa, the discrepancy between what is declared on the label and what is actually detected in the laboratory constitutes an indicative element of product adulteration.
The Newfit is attributed to the company Romario Barbosa Bueno 41858909821, RBB Top New. The health authority then ordered the seizure and prohibited the manufacturing, marketing, distribution, advertising and use of the products concerned.
Mounja Gummy without health authorization
A second provision concerns the Mounja Gummy, produced by the company Bela Blue Beauty Ltda.
In this case, the problem concerns the lack of regularization at Anvisa. According to the authority, the product It has no registration, notification or authorization required by Brazilian health regulations.
The provision therefore establishes the seizure of the product and prohibits its production, sales, distribution, import and advertising.
Shark Pro: Serious deficiencies in production processes
Anvisa has also ordered the withdrawal from the market and suspension of production, sale, distribution, advertising and use of all food supplements of the Shark Pro brand, regardless of the lot.
The products are the responsibility of the company RCA Labs.
The decision came after an inspection conducted by the Health Supervision of the municipality of Capivari, in the State of São Paulo, during which numerous violations of good manufacturing practices were reportedly found.
Among the irregularities identified are:
- lack of adequate controls on the quality of raw materials;
- non-compliant storage conditions;
- lack of records relating to preventive maintenance of equipment;
- lack of product stability studies;
- failure to regulate some supplements;
- incomplete or incorrect information regarding allergens;
- risk of cross-contamination.
The combination of irregularities led the health authority to order the recall of the products and the suspension of activities relating to the entire Shark Pro line.
Trodelvy: a counterfeit batch seized
Finally, the measures include the batch 10008808 of the drug Trodelvy, product used in oncology.
The company Gilead Sciences Farmacêutica do Brasil Ltda., the holder of the registration of the medicine in Brazil, has communicated to Anvisa that do not recognize the lot in question.
The product was therefore classified as counterfeit and the health authority ordered its seizure.
Anvisa has however underlined an important aspect: the provision concerns exclusively lot 10008808 And does not constitute a general ban on the marketing of Trodelvy.
A new call to consumer attention
The measures once again highlight the risks associated with purchasing and using supplements without proper authorization or produced outside of the necessary health controls.
The presence of undeclared pharmacologically active substances, as emerged in the case of Newfit, can in fact transform a product presented as a simple supplement into a potential source of health risks, especially when the consumer is not aware of the real composition.
In Brazil, Anvisa therefore recommends verifying the legality of products subject to health surveillance and paying particular attention to those marketed through unofficial channels or with claims not supported by the relevant health authorization.
Source: Anvisa / Agência Nacional de Vigilância Sanitária;