Updates on Melatonin & Ashwagandha

Updates on Melatonin & Ashwagandha

Happy Thursday!

Here’s your weekly must-read update from Rosapharma - contact us with any questions or feedback.


Melatonin - Germany

The German Federal Institute for Risk Assessment (BfR) has expressed concerns about the widespread use of food supplements containing melatonin, which are marketed as sleep aids and come in various forms. These supplements are sometimes taken without medical supervision and may contain dosages similar to or higher than approved medicinal products containing melatonin.?The long-term health risks associated with these supplements remain unclear, especially for certain groups such as children, pregnant women, nursing mothers, those with liver or kidney problems, and people at risk for diabetes or with autoimmune diseases or epilepsy.

The BfR report emphasizes that even low doses (1 mg or less) of melatonin may cause side effects like drowsiness, headaches, reduced alertness, low blood pressure, and nightmares. Additionally, melatonin may interact with certain medications, such as anti-hypertensives and anticoagulants.

We have been informed that the European Commission does NOT currently prioritize melatonin in discussions regarding potential 'Article 8' procedures.


Ashwagandha - Germany

The German Federal Institute for Risk Assessment (BfR) has issued a warning regarding potential health risks associated with Ashwagandha supplements. The BfR recommends that children, pregnant and nursing mothers, and individuals with liver disease avoid products containing Ashwagandha.?

Due to insufficient data, they also advise caution for the general population when considering these supplements.


Ashwagandha - The Netherlands

The Dutch Authorities have added Ashwagandha, Tabernanthe iboga, and Huperzia serrata to the list of banned substances.

This decision follows advice from the RIVM (Dutch Institute for Public Health and the Environment), which recommended against using products containing these herbs. Consequently, the Dutch Ministry of Health, Welfare, and Sport has officially prohibited these substances.


We will keep you briefed as new information becomes available.


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