Melatonin
In the US, melatonin is sold as a dietary supplement and is not regulated as a food additive. In the EU, it is regulated as a medicinal product and only authorized for an EFSA health claim at 1 mg before bed.
What it is
A hormone naturally produced by the pineal gland that regulates the sleep-wake cycle.
Used as a dietary supplement for sleep; not authorized as a food additive in the EU.
Why it's flagged
- Hormonal effects
- Drowsiness
- Pediatric use cautioned by AAP
What regulators actually say
"A cause and effect relationship has been established between consumption of melatonin (1 mg per serving) and reduction of sleep onset latency."
"Melatonin appears to be safe when used short-term, but less is known about long-term safety, especially in children."
Regulatory status
United States — FDA
Sold as dietary supplement; not GRAS as food additive
European Union — EFSA
Authorized health claim at 1 mg/serving (Reg 432/2012); regulated as medicinal in many EU states
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