Maker of ‘Raw Form Organics’ refuses to cooperate with FDA over salmonella recall
The FDA issued a press release yesterday to update the public on the status of three organic supplements sold by Triangle Pharmanaturals LLC.
Today, the U.S. Food and Drug Administration announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.
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. The FDA understands that Triangle Pharmanaturals may manufacture, process, pack and/or hold additional brands of food products containing powdered kratom, including powder and encapsulated powder forms.
“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, M.D. “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.”
Mitragyna speciosa, commonly known as kratom, is a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Importantly, the FDA advises consumers to avoid kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine, in any form and from any manufacturer. The agency also has received concerning reports about the safety of kratom, including deaths associated with its use. 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. The agency also 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.
In this instance, two samples of kratom products manufactured by Triangle Pharmanaturals of Las Vegas, Nevada, sold through the retail location Torched Illusions in Tigard, Oregon and collected by the Oregon Public Health Division, tested positive for salmonella, as did four additional samples of various types of kratom product associated with the firm collected by the FDA. Adding to the concerns, in the course of investigating a multi-state 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.
Opinions on the use of kratom supplements is mixed. According to Science Based Medicine (SBM):
Because kratom is a botanical, it is legally classified as a dietary supplement in the U.S. However, the Dietary Supplement Health & Education Act (DSHEA) requires any supplement ingredient that wasn’t in use before 1994 to meet a minimal demonstration of potential safety. Manufacturers are supposed to submit information to the FDA showing a history of use or other evidence of safety, establishing that their product is reasonably expected to be safe under normal conditions of use.
So far no such evidence has been presented to the FDA.
Had kratom made it onto the expansive U.S. dietary supplement market prior to 1994, there would be little the FDA could do to get it off the market. The burden would have been on the FDA to prove kratom is unsafe before it could be banned. The fact that it was used in Southeast Asia (as opposed to the U.S.) in a tea prior to 1994 is sufficient in the eyes of at least one lawyer on the payroll of the supplement industry to argue that it should be allowed into the U.S. and sold as a dietary supplement, potential for abuse and ill effects be damned.
On the other hand, if kratom were purified and the active ingredient(s) isolated and manufactured, (as is the case with, for example, morphine), it would have to go through the FDA’s new drug process, including randomized controlled clinical trials to establish its safety and efficacy in humans. The drug would require a prescription, and extensive literature including information on side effects, dosing, and interactions with other substances would be available for both the prescriber and the patient. Such is the fiction established by DSHEA that botanicals are somehow not drugs, even when they are taken explicitly for medicinal purposes.
Given its status as a dietary supplements, warning about risks are not mandated to appear on the label.
The number of kratom poisonings has been increasing, along with its popularity, over the past few years. Compared to the 16,000 annual deaths the CDC says come from opioid deaths, it is possible that kratom could be an alternative to opioids as the American Council for Science and Health details in a risk/benefit analysis.
Unfortunately without a science based approach to regulation, something the supplement industry is pushing back against, kratom simply remains a threat.
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