2023-12-12 18:15:00
The National Health Surveillance Agency (Anvisa) recently announced the ban on the food supplement Soninho Perfeito Melatonin Kids, manufactured by the company Mr Oemed Indústria Farmacêutica Ltda. The decision covers the manufacturing, marketing, distribution, advertising and use of the product, with the requirement for immediate withdrawal from the market.
The measure was taken due to the presence of melatonin, a hormone produced naturally by the body, which is not authorized for use in dietary supplements intended for children and adolescents.
Anvisa highlighted that there is no proof of safety in the use of melatonin for these age groups, in addition to highlighting the lack of authorization for pregnant and lactating women. Melatonin is only approved in supplements intended for adults over 19 years of age, with a specific concentration of 0.21 milligrams per day, and without claims of use for prohibited age groups.
Irregular disclosure on the internet
The agency also identified the practice of irregularly advertising the product on the internet, with therapeutic claims related to sleep, anxiety, binge eating, nocturnal irritability, inflammation, supplementation for autism spectrum disorder and cancer. None of these allegations were approved by Anvisa, characterizing the advertising as irregular.
The note released by Anvisa emphasizes that there is no approval of melatonin-based dietary supplements to improve sleep, mood or concentration. Any advertisement or label that makes such claims is considered irregular according to Brazilian health legislation.
The regulatory agency also advised consumers to consult the panel “Constituents Authorized for Use in Food Supplements” on the Anvisa website for information on substances approved for this purpose. The panel provides details such as the type of nutrient, authorized bioactive substance or enzyme, permitted quantity, population group and age group indicated, approved claims and warnings about conditions and restrictions of use.
Anvisa ended the statement by reinforcing the importance of checking the identification on the label of all dietary supplements, recommending that consumers avoid purchasing products without proper identification or of questionable origin.
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