Washington, D.C.—FDA issued a statement warning women of childbearing age about use of vinpocetine, due to a recent report from the National Institute of Health’s National Toxicology Program that found that consumption of vinpocetine may cause a miscarriage or harm fetal development.
The statement advises pregnant women and women who could become pregnant against taking vinpocetine, and advises manufacturers of vinpocetine to ensure that their product labels provide proper safety warnings.
On September 6, 2016, FDA reached the tentative conclusion that vinpocetine does not meet the definition of a dietary ingredient. It maintained this conclusion following a two month-long public comment period.
In May, the Natural Products Association (NPA) wrote a letter to FDA requesting the withdrawal of that particular administrative proceeding, noting that vinpocetine has been acknowledged as an NDI five separate times, each time earning an “acknowledgement without comment” letter from FDA. In that letter, NPA noted that FDA has not found any safety issues with vinpocetine, and failed to submit an Economic Impact Analysis.
NPA, following the release of FDA’s more recent statement, sent out a press release in which Daniel Fabricant, Ph.D., president and CEO of NPA, said: “This is a red herring for the FDA to ban vinpocetine. This latest report has nothing to do with the FDA’s 2016 notice that it reached a tentative conclusion that vinpocetine is not a dietary ingredient. The FDA is grasping at straws in an attempt to ban this safe and legal product.”
NPA’s release noted that a study conducted in 2013 found no evidence that vinpocetine causes miscarriages or harms fetal development.