Another kratom recall is underway, adding to the long list of such products recalled for Salmonella risks. The new recall follows a research report showing a 52-fold increase in kratom reports at poison control centers from 2011 to 2017.
The research report, published in the Journal of Clinical Toxicology, points to a 41-state Salmonella outbreak traced to kratom products as evidence of increasing problems with the substance. The outbreak from January 2017 through May 2018 included 199 lab-confirmed patients, with 50 people admitted to hospitals, according to the Centers for Disease Control and Prevention.
The CDC and the Food and Drug Administration wrapped up their outbreak investigation in May 2018, but both agencies continue to report an ongoing threat from kratom products, which include teas and powders that can be added to food. The CDC says more illnesses will likely be reported because a variety of kratom products continue to be sold and the FDA has documented widespread Salmonella contamination.
The latest company to pull kratom, Sunstone Organics of Springfield, OR, posted a short statement on its website and a more detailed notice with the FDA. The company did not include photographs of the products with either recall notice. Sunstone is offering consumers “replacements” if they have the recalled kratom in their possession.
Unspecified company officials said in the recall announcement on the Sunstone website that they “are implementing new safety protocols to prevent problems like this in the future.”
“It has been brought to our attention that two samples of kratom, White Vein Lot 119, and Maeng Da Lot 124A, were tested and found to be potentially contaminated by Salmonella,” according to the Sunstone website.
“We ask any customers who have these products to dispose of the product and return the packaging, with the Lot number visible, to the retail location where it was purchased for replacement.”
Sunstone distributed the recalled kratom products to retailers in Oregon, Washington, California and Nebraska, according to the recall notice posted with the FDA. The Sunstone website offers kratom products for sale, but the recall notices on the FDA and company websites do not address online sales.
The recalled products are not marked with expiration dates, according to the recall notice. Consumers can use the following information to determine whether they have the recalled Sunstone kratom products in their homes:
VIEW TABLE WITH INFORMATION HERE:
Company officials told the FDA that they had not received any reports of “adverse events” related to the recalled Sunstone Organics kratom products.
“Sunstone Organics is notifying its distributors and customers by visiting retail outlets on our distribution routes, phone calls to outlets we cannot visit, letters to all outlets, and a sign posted in all outlets notifying consumers, and is arranging for replacement of all recalled products. Consumers and retailers that have Sunstone Organics Kratom which is being recalled should stop using, discard or return to place of purchase,” according to the Sunstone recall notice posted with the FDA.
Consumers with questions can contact Sunstone Organics by phone at 541-972-3327 or by e-mail at email@example.com.
A plant indigenous to Southeast Asia, kratom has been gaining attention in the United States in recent years. It’s also been generating an increasing number of calls to poison control centers, many of which result in hospital treatment and admissions.
Poison control centers (PCCs) in the United States reported 1,807 “exposures” from 2011 through 2017, according to the report “Kratom exposures reported to United States poison control centers: 2011-2017” by Sara Post, Henry A. Spiller, Thitphalak Chounthirath and Gary A. Smith. They analyzed information from National Poison Data System for their report.
“The annual number of exposures increased by 52.5-fold, from 13 exposures in 2011 to 682 exposures in 2017,” according to the research report. “From 2011 through 2017, the annual exposure rate per million U.S. residents increased by 58.1-fold among adults, 41.7-fold among adolescents and 20.1-fold among children.”
Almost two-thirds of the 1,807 reports occurred in 2016-2017, the researchers reported. Among “first-ranked” kratom exposures, the data showed 32 percent resulted in admission to a health care facility, with and 51.9%52 percent having a “serious medical outcome.”
The researchers found there were 11 deaths associated with kratom exposure, including two that occurred after exposure to kratom only. Among kratom-only exposures, 86 percent resulted in one or more “clinical effects.” The most common clinical effects were agitation/irritability reported in 23 percent of people and tachycardia reported in 21 percent. There were seven neonatal exposures, including five infants who experienced withdrawal.
“Kratom is associated with a variety of serious medical outcomes, especially when used with other substances. More research is needed to define the human response to kratom,” according to the research report.
“Increased regulation of kratom products would help guarantee product quality and safety. Individuals who choose to use kratom should be educated about its potential risks, including the dangers of using it in combination with other substances.”
Companies’ marketing claims about kratom products often include descriptions of the substance as a way to self-manage withdrawal from opioids. Some marketing materials say people can use kratom to cure diabetes, lower blood pressure, treat cancer, and reduce neuron damage caused by strokes.
The FDA has not approved kratom for any uses. In late 2018 FDA Commissioner Scott Gottlieb renewed the agency’s previous warnings about kratom and reported a new threat. A stepped up testing program in response to the Salmonella outbreak revealed heavy metals, including lead and nickel, at dangerous levels in many kratom products.
Scientists at the Food and Drug Administration tested 26 kratom products as part of the follow-up sampling program.
“While the levels of the specific products we’ve tested so far are not likely to result in immediate acute heavy metal poisoning from a single use, some of these products included levels that, with chronic use, could cause some people to suffer from heavy metal poisoning,” Gottlieb said in the warning issued Nov. 27.
“We are concerned that there may be other kratom products on the market that also contain heavy metals. As a result of our analysis, we’re contacting companies marketing these kratom products to make them aware of the heavy metal testing results. And we are putting out this advisory to warn consumers so that they can take steps to protect their health.”
FDA has posted a list of recalls and Salmonella-positive kratom products at: https://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm597265.ht
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