In theory and since February, the melatonin, a hormone made by a region of the brain that works against sleeping troubles, should no longer be dispensed except in pharmacies and on medical prescription. But in practice, nothing could be simpler than finding it on the Internet or in stores.
Three years ago, the Ministry of Health reminded all health stakeholders in a decree that melatonin, in all its forms, was a substance potentially dangerous to health. The Council of State had been seized by industrialists dissatisfied with this decision.
But if the National Health Security Agency (ANSES) affirmed that the dose necessary to consider melatonin as a drug was 2 mg, the Council of State confirmed the position adopted by the ministry last February, it is that is to say to restrict its delivery.
“Serious side effects”
On the side of the Medicines Agency (ANSM), the verdict is just as clear: “in general, any product containing a substance on the lists of poisonous substances is subject to the conditions of the regulation of poisonous substances, in particularly as regards the modalities of prescription and delivery of products containing them “. As melatonin is on list II of poisonous substances, it is subject to these special provisions “whatever the form in which it is presented”.
The administrative court also noted that it emerges “in particular from the extracts from the national pharmacovigilance database produced by the Minister, that the absorption of melatonin can lead to serious undesirable effects” (arterial hypertension, anxiety, back pain, dizziness, drowsiness, reduced visual acuity, etc.). The General Directorate of Competition, Consumption and Fraud Control (DGCCRF) was seized, “so that controls are carried out”, we explain to the office of Marisol Touraine, Minister of Health.
