A National Health Surveillance Agency (Anvisa) ordered the suspension of commercialization of the Sublingual Melatonin in Passion Fruit Flavor Dropsmanufactured by the company Vita BE Cosméticos LTDA.
The measure includes the recall of the product and the prohibition of sale, distribution, manufacture, import, advertising and use throughout the country.
According to Anvisa, the decision was motivated by irregularities in the composition of the sublingual. The product was formulated with an ingredient that has not been evaluated for safety for sublingual use, that is, when the substance is administered under the tongue to be absorbed directly through the mucosa, without initially passing through the digestive system.
Melatonin is a hormone naturally produced by the body and is related to the regulation of the sleep-wake cycle. In Brazil, commercialization is permitted in the food supplement category, as long as it follows specific rules established by Anvisa. These rules include composition limits, quality standards and restrictions on claims made in advertising.
In addition to the formulation problem, the agency identified that the product’s advertising contained unapproved claims, such as the promise of regulating sleep, preventing insomnia and balancing the body.
According to health regulations, dietary supplements cannot make therapeutic claims that are not expressly authorized, as this could mislead the consumer, bringing the product closer to the medicine category without it having undergone the same rigorous evaluations.
With the determination, it must be removed from the market, and consumers are advised to stop using it. The measure is preventive in nature and aims to protect the health of the population, ensuring that only products that meet health standards can be sold in the country.
Anvisa also reinforces that supervision of dietary supplements is continuous and that companies must prove the safety of the ingredients used, especially when they involve different forms of administration, such as the sublingual route.
