Failed NDIs, FDA's Opioid Concerns Don't Stop Kratom Supplement Sales
This article was originally published in The Rose Sheet
Executive Summary
Proponents say the herbal ingredient extracted from a plant in the coffee family and available in powders, capsules or pills and beverages has been used in the US since long before the October 1994 grandfather date for ingredients to be eligible for use in supplements without being notified to FDA as new. But FDA wants NDI notifications, and the four submitted so far have been incomplete or did not show safety for intended use in a supplement.