FDA Requests Comments on Regulatory Status of Vinpocetine
FDA has requested comments on its “tentative conclusion” that vinpocetine is not eligible for use as a dietary ingredient.
Vinpocetine is a semisynthetic derivative of the vinca alkaloid vincamine, an extract from the lesser periwinkle plant. Dietary supplements containing vinpocetine as a dietary ingredient have been on the market for roughly 20 years, although not without some controversy. For example, in late 2015, Senator Claire McCaskill (D-MO) called for the FDA to suspend sales of supplements containing vinpocetine, noting that “the law governing dietary supplements prohibits the inclusion of synthesized ingredients like those found in prescription drugs.”
On September 7, 2016, FDA requested public comment (by November 7, 2016) on the regulatory status of vinpocetine. 81 Fed. Reg. 61700. The Agency has “tentatively concluded” that vinpocetine is not eligible to be marketed as a dietary ingredient. FDA’s request is highly unusual because the Agency had previously accepted five 75-day New Dietary Ingredient Notifications (NDINs) for vinpocetine and did not raise any concerns about the ingredient’s status when evaluating those submissions. It is not clear what specifically triggered FDA’s decision to reevaluate the status of vinpocetine at this time.
FDA’s request for comments on the status of vinpocetine is not unprecedented. In 2005, FDA published a similar request for comments on the status of pyridoxamine as part of the Agency’s evaluation of a Citizen Petition concerning the ingredient. 70 Fed. Reg. 69976 (November 18, 2005). FDA ultimately concluded (in January 2009) that products containing pyridoxamine are not dietary supplements. The Citizen Petition and FDA’s response can be found in Docket No. FDA-2005-P-0259 at www.regulations.gov. It remains to be seen whether vinpocetine will endure the same fate as pyridoxamine, although it may be very difficult for proponents of vinpocetine to overturn FDA’s “tentative” conclusion.