Side effects prompt French authorities to issue melatonin supplement warning

Posted 10 May 2018

French authorities are urging certain populations to avoid consuming food supplements containing melatonin after incidences of adverse effects were reported to the country’s nutrivigilance scheme.

The National Agency for Sanitary, Food, Environmental and Occupational Safety (ANSES) in France said pregnant and breastfeeding women should not consume melatonin in the form of a food supplement.

“Given the variability in the status of melatonin and the regulatory limits governing its use within the European Union, the Agency has questions about the place of melatonin on the market in food supplement form at doses comparable to those of the medicinal product,” ANSES stated.

“In the absence of sufficient data on the safety of daily consumption of 2 milligrams (mg) of melatonin it believes it necessary for a harmonised regulatory framework to be defined at European level on the basis of safety studies conducted for doses below 2 mg.”

90 reported cases

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