Anvisa (National Health Surveillance Agency) has banned the production, marketing, distribution, advertising and use of the food supplement Soninho Perfeito Melatonin Kids produced by Mr Oemed Indústria Farmaceutica Ltda. The regulator ordered the product to be withdrawn from the market.

In a note, Anvisa said that melatonin, a hormone produced by the body, is not approved for use in dietary supplements intended for children and adolescents, and that the agency has not proven its safety for use in these age groups.

According to Anvisa, the product was advertised irregularly online with claims of therapeutic properties related to sleep, anxiety and overeating. Photo: Marcelo Camargo/Agência Brasil.

“Melatonin is also not approved for pregnant women or women who are breastfeeding (breastfeeding) and is only approved in supplement form intended for adults over 19 years of age at a concentration of 0.21 milligrams per day and with no claims for use,” it warns .

Irregular advertising

According to the agency, the product was also confirmed to be infrequently advertising the product online with claimed therapeutic properties related to sleep, anxiety, overeating, nighttime irritability, inflammation, supplements for autism spectrum disorders and cancer.

“None of these allegations are endorsed by Anvisa and are therefore irregular advertising,” Anvisa states.

In a statement, the regulator warns that there is no approval for melatonin supplements for sleep, mood and concentration. “Any advertisement or label containing such claims is illegal under Brazilian health law.”

Information

Information on substances approved for use in dietary supplements can be found in the Ingredients Approved for Use in Dietary Supplements section available on the Anvisa website.

This panel provides information such as the type of nutrient, bioactive compound, or enzyme approved for use in dietary supplements; minimum and maximum permitted quantity; the population and age range for which the product may be indicated; approved statements related to the substance’s role in the body; and warnings indicating conditions and limitations of use.

“All dietary supplements must have this identification on the (dietary supplement) label next to the product brand,” Anvisa stressed. “Do not buy products that are not properly identified or are of questionable origin,” he warns.

To view non-standard products that have been subject to preventive inspections accepted by Anvisa, visit the agency’s website. Report from no date+ I contacted Oemed Indústria Farmaceutica Ltda, but there has been no response yet.