- On February 21, FDA issued a press release announcing the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity
- The manufacturer of the products, Divinity Products Distribution, has also agreed to stop selling all products containing kratom
- As discussed previously in this blog, FDA has used its administrative detention power followed by seizure against large volumes of kratom containing dietary supplements
- In its current press release, FDA stressed the potential dangers of kratom as having opioid-like properties and indicated that there are no FDA-approved therapeutic uses of kratom
- FDA urged all manufacturers of kratom containing supplements to cease marketing and to submit New Dietary Ingredient Notifications to FDA for kratom prior to marketing
Clients who are interested in pursuing appropriate regulatory status for their dietary ingredients or dietary supplements are invited to contact Mel Drozen at email@example.com or 202-434-4222 for assistance.