FDA Seeks Comment on Tentative Conclusion that Vinpocetine Is not a Dietary Ingredient

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FDA Seeks Comment on Tentative Conclusion that Vinpocetine Is not a Dietary Ingredient

FDA maintains vinpocetine is a synthetic compound

Published: Tuesday, September 6, 2016

A Food and Drug Administration (FDA) notice scheduled to be published tomorrow in the Federal Register requests comments on the agency's tentative conclusion that vinpocetine is not a dietary ingredient and is excluded from the definition of a dietary supplement.

The basis for this conclusion is articulated as 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 vinpocetine's history of drug research in the early to mid-1980s excludes it from the definition under 201(ff)(3).

FDA acknowledges that several New Dietary Ingredient notifications have been filed for vinpocetine without comment by the Agency. Companies manufacturing or marketing dietary supplements containing vinpocetine should read this notice. FDA is accepting comments on its tentative conclusion.

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 U.S., 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 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.

View Federal Register notice >>

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