For the first time ever the FDA has ordered a company to recall products, with the dubious honor going to Triangle Pharmanaturals LLC. The Las Vegas company refused to pull its kratom products after state and federal tests showed Salmonella contamination.
The recall order from the Food and Drug Administration comes amidst an ongoing outbreak of Salmonella infections that has sickened at least 87 people in 35 states. At least four different serotypes of Salmonella have been confirmed.
Of the people for whom complete information is available, 73 percent report consuming kratom products of various brands before they became sick. Several unidentified brands are implicated, according to the FDA and Centers for Disease Control and Prevention.
“The FDA is advising consumers to discard the products that are part of the mandatory recall, which include, but are not limited to: 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,” according to an agency statement issued Tuesday.
Employees at Triangle Pharmanaturals would not discuss the FDA’s findings with the agency and did not respond to multiple news media seeking comment. The company also denied FDA access to its records, according to a statement from the agency. As of Tuesday night, the Triangle Pharmanaturals page on Facebook appeared to have been disabled.
The Salmonella found in the CDC, dietary supplements, FDA, herbal supplements, kratom, kratom outtbreak, products did not match any of the confirmed outbreak strains. However, FDA and CDC officials say additional victims are likely to be identified and their infections could be a match.
Outbreak cases that occurred after Feb. 20 might not yet be reported to the CDC because of the time it takes between when a person becomes ill with Salmonella and when the illness is reported. At any rate, many strains of Salmonella, including the one found in the Triangle products, can cause serious food poisoning infections.
Federal officials are concerned that Triangle Pharmanaturals may manufacture, process, pack and/or hold additional brands of products containing kratom, including powder and encapsulated powder forms. All Triangle kratom products are under recall regardless of the brand or form, even if they are not specifically identified in the FDA’s list.
Several other companies have already recalled numerous kratom products after tests showed Salmonella contamination, some of them with the outbreak strains. The companies initiated those recalls in cooperation with FDA.
‘Imminent health risk’ prompted FDA action
The FDA has only had the power to mandate a recall since January 2011 when President Obama signed the Food Safety Modernization Act into law. Since then the federal agency has flexed its recall muscles with two other companies — Kasel Associates for pet treats and OxyElite Pro for dietary supplements.
Those two companies’ owners agreed to voluntarily recall their products after FDA notified them that it intended to begin mandatory recall proceedings, officially known as a Notice of Opportunity to Initiate a Voluntary Recall.
“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,” said FDA Commissioner Scott Gottlieb in the statement Tuesday.
“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. Our first approach is to encourage voluntary compliance, but when we have a company like this one, which refuses to cooperate, is violating the law and is endangering consumers, we will pursue all avenues of enforcement under our authority.”
Before imposing the mandatory recall order, FDA officials collected and tested samples of Triangle Pharmanaturals’ kratom products, according to agency documents. Four of the samples tested positive for Salmonella bacteria.
Prior to the FDA testing, the Oregon Public Health Division collected and tested samples sold at the retail location Torched Illusions in Tigard, OR. Two of those samples showed Salmonella contamination.
On March 30, the FDA issued Triangle Pharmanaturals a “Notification of Opportunity to Initiate a Voluntary Recall.” It informed the company that the agency could order it to cease distribution and notify applicable parties within 24 hours if the company did not conduct a voluntary recall.
On March 31, the FDA ordered the company to cease distribution of the products. The federal agency gave Triangle Pharmanaturals the opportunity to request an informal hearing.
“The company did not respond within the timeframe specified, therefore waiving its opportunity for an informal hearing, and the agency ultimately issued the mandatory recall order in the interest of public safety,” according to FDA documents.
The FDA has not approved kratom for any uses in the United States. The so-called supplement forms of the mitragyna speciosa plant, commonly known as kratom, are often marketed as a pain medication. The plant grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea.
Federal and state public health officials urge consumers to avoid kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine, in any form and from any manufacturer.
“There is strong evidence that kratom affects the same opioid brain receptors as morphine and appears to have properties that expose people who consume kratom to the risks of addiction, abuse and dependence,” according to the FDA.”
The agency also remains concerned about the use of kratom 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.
Advice to consumers
Anyone who has consumed any products containing kratom and developed symptoms of Salmonella infection should seek medical attention and tell their doctors about the possible exposure to the bacteria.
Symptoms of a Salmonella infection, called salmonellosis, typically start 6 to 72 hours after exposure to Salmonella bacteria. However, in some people it takes two weeks for symptoms to develop.
Symptoms include fever, chills, diarrhea, abdominal cramps, headache, nausea and vomiting. These symptoms usually last for four to seven days. Anyone can become sick with a Salmonella infection, but infants, children, seniors and those with weakened immune systems are at higher risk of serious illness.
It is possible for some people to be infected with the bacteria and not get sick or show any symptoms, but they are still be able to spread the infection to others.
“If consumers have one or more of these products in their homes, they should discard them immediately. As a precaution, kratom no longer stored in its original packaging should be discarded and the containers used to store it should be thoroughly washed and sanitized,” the FDA advised in its statement Tuesday.
To prevent cross-contamination, consumers should wash their hands, as well as work surfaces and utensils, thoroughly after contact with any kratom products. Food should not be prepared in the potentially contaminated area until it has been sanitized.
(To sign up for a free subscription to Food Safety News, click here.)© Food Safety News