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FDA Continues Removal of Kratom Products / Restates Concerns Over Usage and Abuse

February 22, 2018
Risks associated with kratom-containing products continue to present public health risk

A PPM Brief

On February 21, 2018, FDA announced the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured by Divinity Products Distribution (Grain Valley, MO), distributed under the brand names Botany Bay, Enhance Your Life, and Divinity. The company, in cooperation with FDA, has also agreed to stop selling all kratom-containing products.1

Based on recent research showing the risks involved with using kratom, the FDA has also encouraged all companies involved in the selling of kratom-containing products for consumption to make similar attempts to take the products off the market, and notify the FDA of any evidence for evaluation and regulatory purposes. The FDA continues to urge consumers to not use any kratom-containing products and dispose of any in their possession.

“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death,” said FDA Commissioner Scott Gottlieb, MD, in the statement. “We’ll continue to affirm the risks associated with kratom, warn consumers against its use and take aggressive enforcement action against kratom-containing products. We appreciate the cooperation of companies currently marketing any kratom product for human consumption to take swift action to remove these products from circulation to protect the public.” 

Over concerns of the safety and potential misuse and abuse of kratom, the FDA recently published findings of a study2 that looked at the prevalent molecular compounds of kratom in order to see how kratom interacts with the body and affects the brain. Evidence suggests that these compounds share similar characteristics of opioid analgesics such as morphine derivatives, among other similar findings. Included in the statement was an update on the number of reported deaths involving kratom (44), as well as numerous suggestions for physicians to take alternative treatments for opioid withdrawal conditions and related symptoms.

To date, FDA has shown no evidence that kratom or compounds associated with it will reasonably be expected to be as safe as a dietary ingredient, nor are there currently any FDA-approved therapeutic uses for kratom.1 Due to its safety risk, FDA urges consumers not to take kratom for medical conditions, especially as an alternative to prescription opioids.1

“We know that some patients are using kratom because they believe it can help treat their opioid dependency, but there’s no reliable evidence to support kratom’s effectiveness for this use; and we’re deeply committed to making sure patients have access to safe, effective treatment options,” Dr. Gottlieb added.

This statement comes on the heels of numerous reports of seizures3 of kratom-containing products within the past few years by US Marshals, including a January 2016 report4 of a seizure of nearly 90,000 bottles of kratom-containing dietary supplements manufactured by Dordoniz Natural Products, LLC (South Beloit, IL) under the brand name RelaKzpro.

 FDA is currently monitoring an active nationwide outbreak of a rare type of salmonella5 associated with kratom products. The agency has also been cracking down on packaging and labeling of products to prevent abuse and misuse. Read more in our Abuse-Deterrent Pain Scan.

 

UPDATE 2/26/18: FDA sent a letter to a representative of Industrial Chemicals, LLC (Salt Lake City, UT), notifying the company of its inaccurate and misleading statements about the legal status of one of its products, Mitrasafe, which purports to be a 99% purity extract of mitragynine, one of the active compounds in kratom. Click here to learn more.

UPDATE 4/9/18: Club 13 (St. Augustine, FL) is recalling various gram pouches and capsule bottles of its kratom-containing product, called "Maeng Da Red," over a potential salmonella contamination. Click here to learn more.

UPDATE 5/22/18: FDA has issued warning letters to three marketers and distributors of kratom products: Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California and Revibe, Inc., of Kansas City, Missouri for illegally selling unapproved kratom-containing drug products. Click here to learn more.

Last updated on: May 22, 2018
Continue Reading:
Warning Over Kratom: What's the Real Impact for Pain Practitioners?
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