Prevagen Fda Warning Letter. The letter also noted that the product did not satisfy the definition of a dietary supplement because the only dietary ingredient on the label — "synthetically. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
At the time, Prevagen was marketed as a treatment for Alzheimer's disease and head injury, claims only.
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Prevagen also has drawn fire from the U. In that same letter, it is stated that the clinical studies conducted on Prevagen didn't report side effects like fainting, irregular heartbeat. The letter also noted that the product did not satisfy the definition of a dietary supplement because the only dietary ingredient on the label — "synthetically.
