GNC Vincamine New Dietary Ingredient Safety Notice To Be Resubmitted
This article was originally published in The Tan Sheet
Executive Summary
General Nutrition Corporation plans to resubmit its new dietary ingredient premarket notification to FDA for a derivative of vinca minor (periwinkle) called vincamine.
You may also be interested in...
Jarrow Formulas' Vinpocetine Claim Cited In FDA "Courtesy" Letter
Jarrow Formulas' Vinpocetine 5 mg is cited by FDA in a Sept. 8 "courtesy" letter for making a structure/ function claim referring to "brain metabolism."
GNC Vincamine Supplement Cleared For Short-Term Adult Use
A dietary supplement providing up to 20 mg of vincamine per day is reasonably expected to be safe when consumed by healthy adults for up to six months, FDA says in a letter to GNC recently made available by the agency.
Structure/function claims certification signature required by FDA in final rule.
STRUCTURE/FUNCTION CLAIMS CERTIFICATION SIGNATURE REQUIRED by FDA in a Sept. 23 final rule on the notification procedures for statements on dietary supplements. The agency "is requiring that the notification be signed by a responsible individual," and that the "individual certify the accuracy of the information presented in the notice, for efficient enforcement" of the law. Under the Dietary Supplement Health & Education Act, marketers must notify FDA that they are using a structure/function claim 30 days after first marketing the product.