(CNN) The US Food and Drug Administration has rejected a submission from Phoenix Biotechnology Inc. to market oleandrin as a dietary supplement ingredient, citing "significant concerns" about the safety evidence the company presented. The extract comes from the Nerium oleander plant; the raw oleander plant is highly toxic and consuming it can be fatal. There are no peer-reviewed, published studies on the impact of oleandrin on Covid-19, and there's no public evidence it has been studied in patients with Covid-19. On June 2, Phoenix Biotechnology submitted oleandrin to the FDA as a new ingredient in dietary supplements, describing the dosage and saying it's intended only for adults. If a dietary supplement contains a new ingredient, manufacturers must notify the FDA, and the agency will review it for safety -- not effectiveness -- and determine whether it may be marketed as a dietary supplement.

Source: CNN September 04, 2020 21:33 UTC