Kratom Action Presents Regulatory Puzzle For FDA
This article was originally published in The Tan Sheet
The agency is seizing imports of kratom but industry seeks to clarify whether the substance, which in large doses can have narcotic effects, can be used in dietary supplements. Because FDA acknowledges kratom is a dietary ingredient, a ban as used for ephedra action may be up for consideration.
You may also be interested in...
"Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids," says Commissioner Scott Gottlieb.
DEA says more kratom was seized from US firms in the first half of 2016 than in any previous year, but the seizures came two years after FDA imposed an import alert to stop shipments and three years after the agency stumbled out of the gate in determining whether the ingredient could be used in supplements.
The seizure targets some 90,000 bottles of RelaKzpro brand products marketed by Dordoniz Natural Products in Illinois, the home state of Sen. Dick Durbin, who is critical of FDA's supplement market enforcement and plans legislation for tighter regulation.