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Melatonin, a hormone that regulates sleep-wake cycles, has gained significant popularity as a dietary supplement for improving sleep quality and managing circadian rhythm disorders. The regulatory status of melatonin varies widely across the globe, reflecting differences in public health policies, scientific assessments of safety and efficacy, and cultural attitudes towards supplements. This article explores the regulatory frameworks governing the use of melatonin in major health supplement markets, including the United States, the European Union, Canada, Australia, China, Japan, and Singapore.
United States
In the United States, melatonin is regulated as a dietary supplement under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This means that melatonin can be marketed without pre-approval from the Food and Drug Administration (FDA), provided it is not marketed as a prevention, treatment or cure for any specific disease. As per CDC, the usage of melatonin by U.S. adults has quintupled in the past two decades, with about 2% of adults nationwide estimated to use the supplement now.
Furthermore, as per CDC, nearly 11,000 U.S. children ended up in the emergency room from 2019 to 2022 after taking melatonin without supervision. Researchers tested 25 melatonin products and found the majority of them were mislabeled. Some were found to contain over 300% more melatonin than what was listed on the bottle. Based on the status quo, the Council for Responsible Nutrition (CRN) issued new voluntary labeling guidelines for melatonin supplements in March 2024.
Allowed Use: Melatonin is widely available over-the-counter (OTC) as a dietary supplement.
Supervision: Manufacturers must ensure that their products are safe with non-misleading claims. According to the supervision process, the FDA does not approve dietary supplements before they reach the market, but it can take action against any adulterated or misbranded products after they are sold.
Usage Requirements: There are no specific dosage limits mandated by the FDA, but products must be labeled with the recommended dosage and any relevant warnings.
European Union
The regulatory landscape in the EU is more stringent. Melatonin is classified differently across member states, so its availability and regulation can vary.
Allowed Use: In some EU countries, such as France, Spain and Italy, melatonin is available as a dietary supplement, but in the rest of EU, such as Denmark and Czech, it is only classified as a medicinal product.
Supervision: The European Food Safety Authority (EFSA) has approved health claims for melatonin relating to sleep onset and reducing the effects of jet lag, but these claims are subject to strict guidelines. While some countries (e.g., Germany and Finland) allow low-dose melatonin supplements to be sold OTC, higher doses generally require a prescription due to concerns about potential side effects and interactions with other medications.
Usage Requirements: Products must comply with the EU Food Supplements Directive (2002/46/EC) and specific national regulations. The labeling must include information on the safe use of the product.
Canada
In Canada, melatonin was first licensed in 2005 as a natural health product (NHP) ingredient, which aims to help promote regular sleep cycles in adults. Numerous melatonin health products are available on the Canadian market in various dosage forms including capsules, tablets, gummies, and sublingual tablets. No melatonin products are currently licensed in Canada for use in children and adolescents under the age of 18.
Allowed Use: Melatonin is allowed for use as a natural health product.
Supervision: Health Canada classifies melatonin under the Natural Health Products Regulations (NHPR). Products must be licensed and gain Natural Product Number (NPN).
Usage Requirements: Canada has industry guidelines for the preparation of Product Licence Applications (PLAs) and labels for NHP market authorization. Please refer to Melatonin – Sublingual [monograph] and Melatonin – Oral [monograph].
Australia
In Australia, the regulation of melatonin is relatively strict compared to some other countries.
Allowed Use: Melatonin is primarily available as a prescription medication.
Supervision: The Therapeutic Goods Administration (TGA) regulates melatonin as a Schedule 4 prescription-only medicine. However, people over 55 are allowed to purchase melatonin products without prescription.
Usage Requirements: Melatonin can be prescribed for short-term treatment of primary insomnia in people aged 55 years and older. Usage is controlled and monitored through prescriptions, with strict labeling and dosage guidelines.
China
China approves the melatonin as an ingredient for health supplements. According to the data from the Special Food Information Inquiry Platform, China approved the registration of 115 melatonin supplement products from 2017 to 2020. Since 2021, domestically-produced melatonin supplements have been eligible for filing, which is another market entry channel much more relaxed compared to registration. Up to now, a total of 771 Chinese melatonin supplements have obtained filing approval.
Allowed Use: Melatonin is available as an ingredient used in health supplements.
Supervision: China SAMR oversees the regulation of health supplements. Products must be registered or filed and meet safety and efficacy standards.
Usage Requirements: Health Food Raw Material Directory - Melatonin provides specific guidelines on the use of melatonin in health supplements.
Japan
In Japan, melatonin is treated with caution. The manufacture and sale of hormone supplements, including melatonin, is prohibited.
Allowed Use: Melatonin is not available as an OTC supplement and is generally considered a drug.
Supervision: The Pharmaceuticals and Medical Devices Agency (PMDA) regulates melatonin as a pharmaceutical product. It requires rigorous testing and approval processes before it can be marketed.
Usage Requirements: Melatonin can only be obtained via prescription for specific medical conditions related to sleep disorders. It is subject to strict controls and monitoring.
Singapore
Singapore maintains a highly regulated environment for health supplements, including melatonin.
Allowed Use: Melatonin is available as a health supplement but closely monitored.
Supervision: The Health Sciences Authority (HSA) oversees the regulation of health supplements. They can be imported and sold without a license from HSA, and are not subject to pre-market approval.
Usage Requirements: Health supplements, including melatonin supplements, shall comply with the Health Supplement Guidelines released by HSA, which specifies the usage requirements for health supplements, including requirements for safety and quality, labeling, claims, licensing, etc.
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