Vinpocetine is Not a Dietary Ingredient, Say FDA
07 Sep 2016 --- A Food and Drug Administration (FDA) notice has requested comments on it’s tentative conclusion that vinpocetine is not a dietary ingredient, and it’s subsequent exclusion from the definition of a dietary supplement.
The basis for the conclusion is the FDA's view that, as a synthetic compound, vinpocetine does not fit the definition of a dietary ingredient under 201(ff)(1) of the the Federal Food, Drug, and Cosmetic Act, and that vinpocetine's history of drug research in the early to mid-1980s excludes it from the definition under 201(ff)(3).
According to FDA's Federal Register notice, "vinpocetine is a synthetic compound, derived from vincamine, an alkaloid found in the Vinca minor plant, or tabersonine, an alkaloid found in Voacanga seeds."
FDA maintains that it is not found in botanicals, but is a synthetic derivative of vincamine or tabersonine.
Vinpocetine is not approved as a drug in the US, but is currently sold as a dietary supplement often marketed for vasodilation and as a nootropic for the improvement of memory and cerebral metabolism.
Vinpocetine is however, used as a drug in Eastern Europe for the treatment of cerebrovascular disorders and age-related memory impairment. Research also suggests that it has potent anti-inflammatory properties that could aid in the treatment of Parkinson's disease and Alzheimer's disease.
The FDA acknowledges that several New Dietary Ingredient notifications have been filed for vinpocetine without comment by the Agency, and has advised companies manufacturing or marketing dietary supplements containing vinpocetine to read the notice.
FDA is accepting comments on its tentative conclusion.
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