FDA Takes Initiatives Against Kratom Products
Key Takeaways:
- The U.S. Food and Drug Administration (FDA) has ordered a recall and destruction of several kratom-based dietary supplements due to the plant’s association with serious health threats, including salmonella poisoning and opioid-like effects on the brain.
- Missouri-based company, Divinity Products Distribution, has agreed to recall and remove its kratom-infused products (sold under labels Botany Bay, Enhance Your Life, and Divinity) from the market.
- FDA Commissioner Dr. Scott Gottlieb stated that scientific data present in kratom qualifies it as an opioid and poses risks including addiction, abuse, overdose, and possible death. The FDA has found no scientific evidence suggesting kratom is safe or beneficial for any medicinal use.
- The FDA will continue to implement stringent measures against any kratom-based products for public health safety, including the enforcement of prohibitions and consumer warnings against its use.
- The FDA acknowledges that some individuals may use kratom to lessen dependency on more potent opioids, but maintains that there is no reliable evidence supporting kratom’s effectiveness for this use.
The directive by the U.S. Food and Drug Administration (FDA) detailing the recall and destruction of several kratom-rooted dietary supplements by the manufacturer has been made public.
Indigenous to Asia, kratom, the FDA reveals, poses serious health threats. The FDA’s recent declaration earlier this month categorizes this botanical as an opioid, affecting the human brain in a similar fashion. Adding to its notoriety, the plant has been implicated in 28 cases of salmonella poisoning, eight of which were confirmed users of the botanical.
Manufacturer Response
Divinity Products Distribution, a Missouri-based company, has pledged to recall and exterminate the kratom-infused products sold nationwide under the labels Botany Bay, Enhance Your Life, and Divinity. Confirming this, the FDA added that the company has assented to put an end to the sale of any product incorporating kratom.
The FDA is urging all manufacturers of akin products to recall them from the market, and has advised consumers with kratom inclusive products to cease usage and dispose of them.
The FDA Stance
“The vast amount of scientific data we’ve analyzed regarding kratom provides unequivocal evidence that the compounds present in kratom qualify as opioids. These are foreseeable to pose similar addiction risks as well as chances of abuse, overdose, and possibly death,” comments FDA Commissioner Dr. Scott Gottlieb.
Moreover, he noted, “Simultaneously, there’s no scientific evidence to suggest that kratom is safe or beneficial for any medicinal use.”
Dr. Gottlieb added that for public health safety, proactive measures against any kratom-rooted products will be relentlessly upheld by the FDA, alongside strict enforcement of the prohibition and consumer warnings against its use.
The American Kratom Association has taken umbrage at FDA’s decision to classify kratom as an opioid, condemning it as an abnormal misuse of science.
Possible use of Kratom
Dr. Gottlieb acknowledged that some individuals may resort to kratom usage to mitigate addiction to more potent opioids.
He stated, “We are aware that some patients are resorting to kratom usage in the belief that it can help alleviate their opioid dependency, but there’s no dependable evidence to validate kratom’s efficacy for this use.”
Future Steps
Dr. Gottlieb added that his organization “is spearheading new measures to promote secure and efficacious FDA-endorsed therapies in the market for opioid usage disorder treatment. Our recognition of the fact that patients suffering from opioid addiction require access to potent treatment options hence the creation of an efficient route for the development of such treatments is our high priority.”
More Information
American Addiction Centers provides more comprehensive details on the risks associated with kratom.
