The US Food and Drug Administration (FDA) has 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.
Failure of Triangle Pharmanaturals to comply with the agency’s request for a voluntary recall prompted the mandatory recall by the FDA. It marks the first time the FDA has issued a mandatory recall order to protect Americans from contaminated food products.
Imminent Health Risk
“This action is based on the imminent health risk posed by the contamination of this product with Salmonella and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions,” FDA Commissioner Scott Gottlieb, MD, said in a statement released April 3.
“We continue to have serious concerns about the safety of any kratom-containing product, and we are pursuing these concerns separately. But the action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen,” said Gottlieb.
According to the FDA, two samples of kratom products manufactured by Triangle Pharmanaturals, of Las Vegas, Nevada, tested positive for Salmonella. The products were sold through the retail location Torched Illusions in Tigard, Oregon, and were collected by the Oregon Public Health Division. Four other samples of various types of kratom product associated Triangle Pharmanaturals also tested positive for Salmonella.
The FDA advises consumers to discard products that are part of the mandatory recall. Those products include, but are not limited to, Raw Form Organics Maeng Da Kratom Emerald Green, Ivory White, and Ruby Red. The FDA notes that Triangle Pharmanaturals may manufacture, process, pack, or hold additional brands of food products containing powdered kratom, including powder and encapsulated powder forms.
On March 30, the FDA asked Triangle Pharmanaturals to initiate a voluntary recall of their kratom products, but the company failed to comply with the request. The FDA then ordered the company to cease distributing the products and provided the company opportunity to request an informal hearing. The company did not respond within the time frame specified, thereby waiving its opportunity for an informal hearing, and the agency issued the mandatory recall order.
This is the third time that the FDA has invoked its mandatory recall authority, but it is the first time the agency has ordered a mandatory recall because a company opted not to comply with a voluntary recall request.
“Adding to the concerns, in the course of investigating a multistate outbreak of Salmonella infections linked to kratom products in conjunction with local officials, FDA investigators were denied access to the company’s records relating to potentially affected products, and Triangle employees refused attempts to discuss the agency’s findings,” the FDA notes.
As of March 16, at least 87 people in 35 states have become sick with salmonellosis after consuming kratom, as reported by Medscape Medical News.
Kratom Linked to Deaths
Kratom is derived from the leaves from the kratom tree (Mitragyna speciosa), which is native to Thailand, Indonesia, and Papua New Guinea. Its popularity is increasing in the United States, with users claiming the botanical helps treat pain, anxiety, depression, and, more recently, opioid withdrawal.
The FDA has advised against using kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine, in any form and from any manufacturer.
In February, the FDA said kratom has been linked to more than 40 deaths and noted that an analysis by FDA scientists found that compounds in kratom act like prescription-strength opioids.
The FDA says it “remains concerned about the use of kratom as an alternative to FDA-approved pain medications or to treat opioid withdrawal symptoms, as neither kratom nor its compounds have been proven safe and effective for any use and should not be used to treat any medical conditions.”
For more Medscape Psychiatry news, join us on Facebook and Twitter.
Tidak ada komentar:
Posting Komentar