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The agency said in a statement last week that melatonin supplements should contain a warning that the product should not be consumed by pregnant women, nursing mothers, children, and those involved in activities requiring attention. constant.
Melatonin is a hormone produced naturally in the human brain, which helps the sleep-wake cycle (also called the “body clockâ€). This substance can be found in low concentration in foods, especially plants like strawberries, cherries, grapes, bananas, pineapples, oranges, etc. The compound can also be produced synthetically.
Already approved for use in several countries around the world as a dietary / dietary supplement with various conditions from us, ANVISA decided to evaluate the safety and efficacy of the compound due to the interest of consumers and enterprises.
This assessment led the Agency to note that, because of its presence in food and its well-characterized metabolic functions, melatonin meets the definition of a bioactive substance established in art. 3 of the resolution of the Collegial Council (RDC) 243, of 2018.
ANVISA noted that the health / benefit claims associated with the consumption of melatonin-based dietary supplements have not been approved.
The Agency also authorized 40 other new constituents of food supplements, including: eggshell membrane as a source of hyaluronic acid, glycosaminoglycans and collagen, orange extract (Citrus sinensis(L.) Osbeck) as a source of anthocyanins, turmeric rhizome extract as a source of curcumin, an isolated microorganism that may aid the immune response of the elderly to influenza vaccine, and a protease enzyme that may help gluten digestion.
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