Although the agency says it is unrelated to a current investigation of a multi-state Salmonella outbreak, the FDA is overseeing the recall and destruction of “a large volume” of kratom products.
Twenty states have reported 28 confirmed cases of Salmonella I 4,[5],12:b:- infections linked to consumption of dietary supplements containing kratom, according to previous announcements this week by both the Food and Drug Administration and the Centers for Disease Control and Prevention.
“This outbreak associated with kratom-containing capsules, teas and powders, underscores the risk that harmful bacteria may contaminate these products when not subjected to manufacturing controls to eliminate that risk, in addition to the overall safety concerns for kratom itself,” the FDA warned in a news release posted Wednesday.
Neither the company, Divinity Products Distribution, nor FDA had posted a recall notice on the kratom products as of this afternoon.
Kratom is a plant native to southeast Asia. It is consumed for its stimulant effects and as an opioid substitute, according to the CDC notice. It is typically brewed in a tea, chewed, smoked or ingested in capsules. Kratom may also be known as Thang, Kakuam, Thom, Ketom and Biak.
The FDA reports the company whose products are under voluntary recall is based in Grain Valley, MO, but local directories show it is in Blue Springs, MO. Both municipalities are in the Kansas City metro area. However, the phone number listed for the company has a St. Louis area code. The phone line was not answered this morning.
Recalled products include kratom dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity. The FDA did not provide any other details about the specific products, distribution channels or retailers that received the recalled products.
The FDA has not approved kratom for any uses in the United States. It has, in fact, been investigating contamination and health dangers associated with the substance since at least 2012, when it issued an Import Alert requiring that certain kratom products be held at U.S. borders and ports.
That Import Alert includes kratom from several companies in Indonesia, as well as companies in the United States that import kratom products.
Entities in the United States that are included on the Import Alert as of today are:
- Clayton Tannery in Texas
- Holly Chavez in Georgia
- Keith Poulos in Virginia
- Lunar Botanicals in Texas
- Mood & Mind in Florida
- Moon Botanicals in Texas
- Nathan John Watters in Florida
- Paul Sturgis in Florida.
Poison calls about kratom increased 10-fold in 5 years
Scott Gottlieb, FDA commissioner, this week repeated kratom warnings he articulated in a Feb. 6 statement about the ongoing threat and investigation into the substance.
“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,” Gottlieb said in FDA’s Wednesday news release.
“At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use. …
“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 …”
In November 2017, FDA reported that calls to U.S. poison control centers regarding kratom increased 10-fold from 2010 to 2015, with hundreds of calls made each year. The FDA is aware of reports of 44 deaths associated with the use of kratom-containing products. There have been reports of kratom being laced with other opioids like hydrocodone.
The CDC’s outbreak announcement Tuesday reported that no deaths have been confirmed in the current Salmonella outbreak linked to kratom products. The FDA did not report where or when the 44 deaths it has been investigating occurred.
Federal officials have seized hundreds of shipments of kratom in recent years from “international mail facilities” in the United States, Gottlieb said during an update on the FDA’s criminal investigations. He said more than 340 million packages of kratom products reach the U.S. every year.
Regarding the recall of the kratom products from Divinity Products Distribution, the FDA reported it is not aware of any recent reports of illnesses specifically associated with the brands sold by the company.
“… the agency asks health care professionals and consumers to report adverse events or quality problems associated with the use of Divinity Products Distribution’s products or any kratom product to the agency’s online Safety Reporting Portal.
“… a computational model developed by agency scientists, which — along with other scientific evidence evaluated by the agency — led to the FDA’s conclusion that compounds in kratom share the most structural similarities with controlled opioid analgesics, such as morphine derivatives, thus making kratom-containing products opioids.
“The agency has also been assessing peer-reviewed research and a growing number of adverse event reports associated with kratom use, including 44 reported deaths.”
(To sign up for a free subscription to Food Safety News, click here.)