The FDA maintains that it "can question the basis for an impartial GRAS conclusion, whether or not notified or not," or even when the discover is withdrawn. Their clinical reviewer reached an identical conclusion, and additionally observed that "a number of consumers who were being handled for seizures experienced a rise in the variety of seizures whereas consuming Prevagen." The assessment concluded: "There are quite a few adverse events reported pertaining to this ingredient which signifies a critical security hazard." The report was sent to Robert Durkin, who was the Acting Director of DDSP at the time, on July 14, and was obtained by WIRED through FOIA. By that point, the corporate had received nicely over 4,000 experiences from prospects who mentioned they experienced health issues after using its products since they first went on sale, in keeping with the paperwork WIRED obtained from the FDA. Internal emails exchanged by FDA employees that year, obtained by WIRED by FOIA, indicate that by then, a "synthetically produced product being marketed in the form of a shake" was underneath investigation by the FDA as a potential unapproved food additive. Electrons like being in pairs and when they split up, they grow to be unstable.
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