The approval of Melatonin as an acceptable ingredient in food Supplements occurred through the amendment of Normative Instruction (IN) No. 28/2018, which approves the list of constituents authorized for use in food supplements.
The National Health Surveillance Agency (ANVISA) of Brazil approved the use of the substance melatonin for the formulation of food supplements, intended exclusively for people aged 19 years or older and for the maximum daily consumption of 0.21 mg.
The approval occurred through the amendment of Normative Instruction (IN) No. 28/2018, which approves the list of constituents authorized for use in food supplements.
Another 40 new food supplement constituents were also authorized, including: eggshell membrane as a source of hyaluronic acid, glycosaminoglycans and collagen, extract of moro orange (Citrus sinensis (L.) Osbeck) as a source of anthocyanins, extract of turmeric rhizomes as a source of curcumin, an isolated microorganism that can help the immune response of the elderly to the influenza vaccine, and a protease enzyme that can aid in the digestion of gluten.
What is melatonin?
Melatonin is a hormone naturally produced in the human brain that aids in the sleep-wake cycle (also called the “biological clock”). This substance can be found in small concentrations in foods, including strawberries, cherries, tomatoes, olives, cereals, wines, meats, cow’s milk, and other food products. Melatonin can also be produced synthetically.
After Anvisa’s decision, melatonin may be available, without prescription, as a food supplement, a category of products intended to supplement the diet of healthy people with substances present in food, including nutrients and bioactive substances, where melatonin fits.
The substance in question is already used in several countries as a food supplement and as a medicine, with varying conditions of use. Due to the interest of consumers and the productive sector in the access and supply of products containing this substance, Anvisa has proactively evaluated the safety and efficacy of the constituent.
Claims and WARNING
Melatonin supplements must contain a warning that the product should not be consumed by pregnant and lactating women, children and people involved in activities that require constant attention.
In addition, people with illnesses or taking medication should consult their physician before consuming the substance.
No benefit claims associated with the consumption of melatonin-based food supplements were approved.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.