The FDA has ordered a herbal supplements company to pull its kratom products from the market after the agency linked the substance to a nationwide salmonella outbreak.
Kratom is sometimes used as an alternative to opioids, has been the culprit in nearly 90 cases of salmonella in recent months.
The FDA asked that several companies voluntarily recall their products, but one, Triangle Pharmanaturals refused to do so, prompting the FDA to issue its first-ever mandatory recall for a contaminated food today.
In a separate investigation following several deaths linked to the substance, the FDA also warned that kratom is chemically similar to an opioid, and is now urging customers to avoid kratom on both grounds.
The FDA took a rare step today, ordering the recall of kratom made by Triangle Pharmanaturals after the company refused to cooperate with regulators (file image)
Kratom is made from the eponymous plant, a native species to Southeast Asia where it has historically been used as a stimulant – not unlike chewing tobacco – in low doses, or to treat pain by inducing eurphoria a higher doses.
However, due to its opioid-like effects, the plant’s use has been outlawed in several countries in the region.
Kratom has made its way onto the expansive American herbal supplement market, and is widely sold online for around $20.
It is often advertised as a legal substitute with similar effects to opioids, but in February, the FDA published a notice that their extensive studies had found that it has no medical benefits – a use that the substance is not approved for – and suggested that it should be considered an opioid itself.
Less than two weeks later, kratom found itself in hot water again, as the Centers for Disease Control and Prevention (CDC) issued a warning that it had traced salmonella outbreaks in 20 states to kratom product-consumption.
Now, various brands of kratom supplements have been linked to a total of almost 90 cases of salmonella, across 35 states, according to federal figures.
Salmonella bacteria most commonly grow on poultry, meat and eggs that come into contact with fecal matter from sick humans or animals.
But in recent years, it has been found in a number of herbs, spices and other plant-based food products.
Nearly 30 cases of the bacterial infection have involved such serious fever, cramps, malegenix pills diarrhea and nausea that sufferers have been hospitalized for the potentially life-threatening illness, according to the Centers for Disease Control and Prevention.
State and federal officials detected salmonella in a half-dozen samples of Triangle’s products. But the company refused to allow FDA inspectors to access the company’s records or discuss the contamination issue, according to an agency statement.
On March 30, the FDA wrote to Triangle Pharmanaturals, asking that it voluntarily recall a number of its products, including Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, and Raw Form Organics Maeng Da Kratom Ruby Red, within 24 hours.
But the company’s products did not budge, nor did Triangle respond or accept its opportunity for a hearing with the FDA.
So, for the first time ever, the agency issued a formal order that Triangle recall its kratom today.
‘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,’ said FDA Commissioner Scott Gottlieb in a statement.
Calls and an email to the company were not immediately returned Tuesday morning.
This week’s action marks the first time the FDA has ever formally ordered a food recall. Congress gave the FDA that authority in 2011 after a series of high-profile food outbreaks involving peanut butter, spinach and other grocery staples.