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The FDA maintains that it "can question the basis for an impartial GRAS conclusion, whether notified or not," or even if the notice is withdrawn. Their clinical reviewer reached an analogous conclusion, and additionally noticed that "a number of consumers who have been being treated for seizures experienced a rise within the variety of seizures whereas consuming Prevagen." The evaluation concluded: "There are quite a few adverse occasions reported pertaining to this ingredient which indicates a serious safety hazard." The report was despatched to Robert Durkin, who was the Acting Director of DDSP on the time, on July 14, and was obtained by WIRED via FOIA. By that time, the corporate had acquired properly over 4,000 studies from prospects who mentioned they experienced health points after using its products since they first went on sale, according to the documents WIRED obtained from the FDA. Internal emails exchanged by FDA workers that yr, obtained by WIRED through FOIA, point out that by then, a "synthetically produced product being marketed within the form of a shake" was under investigation by the FDA as a possible unapproved food additive. Electrons like being in pairs and once they split up, they change into unstable.
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