The Agency stated in a release last week that melatonin supplements should contain a warning that the product should not be consumed by pregnant women, nursing mothers, children and people involved in activities that require constant attention.
Melatonin is a hormone produced naturally in the human brain, which aids in the sleep-wake cycle (also called the “biological clock”). This substance can be found in small concentrations in foods, notably plants such as strawberry, cherry, grape, banana, pineapple, orange, etc. The compound can also be produced synthetically .
Already approved for use in several countries around the world as a food/ dietary supplement with varying conditions of us, ANVISA decided to evaluated the safety and efficacy of the compound due to consumer interest and businesses.
That assessment led to the Agency to note that, since it is found in food and has well-characterized metabolic functions, melatonin meets the definition of a bioactive substance established in art. 3 of the Resolution of the Collegiate Board (RDC) 243, of 2018.
ANVISA noted that 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, rhizome extract of turmeric as a source of curcumin, an isolated microorganism that can aid the immune response of the elderly to influenza vaccine, and a protease enzyme that can aid in the digestion of gluten.