The Natural Products Association has asked FDA to extend the comment period deadline concerning the regulatory status of vinpocetine until September 6, 2017.
- 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. From a regulatory standpoint, 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. In recent years, however, vinpocetine has been the subject of some controversy. FDA took note and, as previously covered on this blog, on September 7, 2016, FDA requested public comment (by November 7, 2016) on the regulatory status of vinpocetine. In requesting public comment, the Agency stated that it has “tentatively concluded” that vinpocetine is not eligible to be marketed as a dietary ingredient.
- Earlier this month, the Natural Products Association requested that FDA extend the comment period deadline to September 6, 2017, noting that industry will need this “time to conduct additional research, as well as identify the extent to which these changes might impact manufacturers, distributors and consumers” of these products.
- Given the somewhat unusual, but not unprecedented move by the Agency in revisiting the regulatory status of vinpocetine, coupled with its widespread use (in as much as 350 brands according to the Natural Medicines Comprehensive Database), it would not be surprising if FDA extended the comment period. However, it remains to be seen whether the Agency will agree to grant the substantial amount of additional time NPA requested.