Cistanche tubulosa
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This is Novel in UK and EU and not approved.
The European Food Safety Authority (EFSA) concluded that the safety of a water extract of Cistanche tubulosa stems as a novel food ingredient has not been established. EFSA's Panel on Nutrition, Novel Foods and Food Allergens (NDA) raised safety concerns due to adverse events reported in clinical trials, including severe events like cerebral haemorrhage and epilepsy. Consequently, the European Commission terminated the procedure for authorizing the extract as a novel food. This was in 2021, no further applications have been made.