Anvisa bans children’s supplement Perfect Soninho (Perfect Sleep) with melatonin.

The use of melatonin in food supplements for children and adolescents is not authorized.

The banning of the food supplement Soninho Perfeito Melatonina Kids, manufactured by MR Oemed Indústria Farmacêutica Ltda. (CNPJ: 32784492/0001-40), covers manufacturing, circulation, distribution, advertising, and use. The decision was made official on 8/23/2023 through Resolution – RE 3148, with data from August 22, 2023.

This Anvisa determination confirms the fact that melatonin is not authorized for use in food supplements intended for children and adolescents. The lack of evidence proving its safety for these age groups, following the standards established by Anvisa, was justified in this measure. In addition, it is worth noting that melatonin is not allowed for pregnant and lactating women. Its use is approved exclusively for adults over 19 years old, with a daily concentration of 0.21 mg, without specific specifications for use.

Consequently, Anvisa authorized the circulation of this supplement in the market and ordered its collection. This action aims to ensure the safety of public health and compliance with regulatory standards. Stay informed about Anvisa’s guidelines for protecting your health and well-being.

Irregular Disclosure of Soninho Perfeito Melatonina Kids

In the online analysis, non-compliant disclosure practices were also identified for the Soninho Perfect Melatonina Kids supplement. These practices include therapeutic discussions covering several areas, such as sleep, anxiety, binge eating, nighttime irritability, inflammation, supplementation for autism spectrum disorder, and cancer, among others. It is worth mentioning that none of this information received approval from Anvisa, making the examples clear of irregular advertising.

The Brazilian Health Regulatory Agency emphatically warns that there is no authorization for any restrictions related to sleep, mood, concentration, and other similar ones when it comes to food supplements containing melatonin. Any type of advertisement or product description that mentions these claims is considered non-compliant with health legislation in force in Brazil. It is critical to heed these guidelines to maintain legal compliance and public safety.

How can I consult information about approved substances and conditions of use of food supplements?

Information on substances approved for food supplements can be consulted on the Anvisa panel “Authorized Constituents for Use in Food Supplements”, available on the Internet at this link.

In this panel, it is possible to obtain information about food supplements, such as:

• The type of nutrient, bioactive substance, or enzyme approved for use in food supplements.
• The minimum and maximum quantity authorized.
• The population group and age range for which the product can be indicated.
• Approved claims relating to the role of the substance in the body.
• Warnings with information on usage conditions and restrictions.

If you have any questions, please contact Anvisa through the service channels available at Fala.BR – Integrated Ombudsman and Access to Information Platform (cgu.gov.br).

Identification of Food Supplements: A Practical Guide

Identifying a food supplement is crucial for making a conscious choice of products that promote your well-being. The first tip: look closely at the label. All food supplements must bear the clear identification “Food Supplement” next to the product brand.

Especially when shopping online, companies are obliged to provide information provided to the consumer. This includes essential supplier data, such as company name, CNPJ, physical and electronic address, as well as key information about the product, such as name, brand, composition, usage restrictions, and other details.

Avoid purchasing products without proper identification or from dubious sources. Always give priority to products that comply with the relevant standards.

To verify products that have undergone preventive actions by Anvisa, access our list of irregular products.

Stay tuned

Recently, Anvisa issued an alert to highlight the risks associated with the consumption of food supplements containing melatonin.

This warning emphasizes that melatonin supplements must have a clear warning, stating that they are not suitable for pregnant women, nursing mothers, children, and people involved in activities that require constant attention.

For additional details, see  GGMON ALERT 05/2022 (NUTRIVIGILANCE) – RISKS ASSOCIATED WITH THE CONSUMPTION OF DIETARY SUPPLEMENTS CONTAINING MELATONIN.