Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Kratom Action Presents Regulatory Puzzle For FDA

This article was originally published in The Tan Sheet

Executive Summary

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...



FDA's Opioid Label For Kratom Called Misbranding By Marketers

"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.

Kratom In Supplements Reaches Dead End On DEA Direct Regulatory Path

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.

FDA Kicks Off Kratom Enforcement With $400,000 Seizure In Illinois

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.

Related Content

Topics

UsernamePublicRestriction

Register

PS106642

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel