Gaia Ethnobotanical LLC, of Jacksonville, Florida, is voluntarily recalling all of its kratom powder products with lot number 0102031800 and batch number 031800, owing to potential Salmonella contamination.
The recall covers 27 kratom products the company manufactured, processed, packed, or held from March 18, 2018, to March 30, 2018. The product was packaged in plastic bags containing 1 oz, 250 g, and 1 kg. All recalled products are listed in a company news release posted June 21 on the US Food and Drug Administration (FDA) website.
The products were distributed to 40 states via the Internet. Through sample testing, the FDA found that the products were contaminated with Salmonella, the company said.
As a result of the FDA’s findings, the company said it has “implemented standard operating procedures and sterilization processes in accordance to FDA guidelines.”
Gaia is notifying its customers of the recall by email and/or telephone. Consumers are advised to return the recalled products to the company or immediately discard them. For more information on the recall, contact the company at firstname.lastname@example.org or by phone at 702-996-8523.
Ongoing Kratom Crackdown
Kratom is derived from the leaves from the kratom tree (Mitragyna speciosa), which is native to Thailand, Indonesia, and Papua New Guinea. The botanical’s popularity has been increasing in the United States, with users claiming it helps treat pain, anxiety, depression, and, more recently, opioid withdrawal.
In April, as reported by Medscape Medical News, the FDA issued a mandatory recall of all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several products were found to contain Salmonella.
In May, as part of the FDA’s ongoing efforts to crack down on kratom and to alert the public to the risks of using kratom products, the agency sent warning letters to three companies for illegally selling unapproved kratom products, which the companies claimed could treat opioid addiction and withdrawal and a host of other problems.
The letters were sent to Front Range Kratom, of Aurora, Colorado; Kratom Spot, of Irvine, California; and Revibe Inc, of Kansas City, Missouri, as reported by Medscape Medical News.
There are no FDA-approved uses for kratom, and the agency has advised against using kratom or its psychoactive compounds mitragynine and 7-hydroxymitragynine in any form and from any manufacturer.
Kratom has been linked to more than 40 deaths. Earlier this year, an analysis of the substance by FDA scientists found that its compounds act like prescription-strength opioids, as reported by Medscape Medical News.
The scientific data and adverse event reports have “clearly revealed” that compounds in kratom make it “not just a plant — it’s an opioid,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
“Claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous,” he added.