In a rare move, the top administrator at the FDA on Tuesday posted a statement about warning letters the agency sent this past week. The comments from Commissioner Scott Gottlieb renewed FDA’s warnings to consumers about teas and other products containing kratom.
Such products, made with the leaves from a plant that is native to Thailand, Malaysia, Indonesia and Papua New Guinea, have been in the forefront of public health concerns in the United States for the past few years. The Food and Drug Administration says the two companies cited in the Sept. 4 warning letters, as well as many others, have consistently made illegal health claims on the labels of their kratom products.
Also, public health officials documented that a multi-state Salmonella outbreak from January 2017 through May this year was traced to multiple brands of kratom.
The kratom labeling in question violates federal law, the FDA commissioner said, because producers and sellers have not secured approval for their teas and other kratom products they say can be used as medications. The products have not even received “GRAS” status, which means “generally recognized as safe.”
Kratom product labels make a variety of claims, including that it can be used as a treatment for opioid independence and withdrawal. The substance itself, however, it is believed to contain opioids.
“While it is important to generate more evidence, there is evidence that certain substances found in kratom are opioids and data suggest that one or more may have a potential for abuse,” Gottlieb said. “… We’re not alone in our concern about the opioids found in kratom — it’s already illegal or controlled in several other countries including Australia, Denmark, Germany, Malaysia and Thailand. The substance is also banned in a number of states and municipalities in the U.S.”
Gottlieb said the FDA’s Sept. 4 warning letters went to “unscrupulous” internet vendors Chillin Mix Kratom and Mitra Distributing, for marketing kratom products with scientifically unsubstantiated claims. Those claims involve using kratom as a treatment for ailments including, but not limited to, diarrhea, depression, diabetes, obesity, high blood pressure, stomach parasites, diverticulitis, anxiety and alcoholism.
A list of recalled kratom products is available on the FDA website. Earlier this year the agency imposed a mandatory recall on one company that refused to pull its kratom products after Salmonella was found.
Outbreak and additional concerns
The CDC has joined the Food and Drug Administration, state and local officials across the country in monitoring illnesses linked to kratom products.
A Salmonella outbreak traced to multiple kratom products sickened at least 199 people from 41 states, according to the Centers for Disease Control and Prevention. Of those patients with the information available, almost 40 percent required hospitalization and three-fourths reported consuming teas, powders and capsule forms of kratom powder before becoming sick.
The CDC declared the 17-month outbreak over in May, but said additional illnesses are possible because people likely have unused portions of the kratom products in their homes.
“At this time, CDC recommends that people not consume kratom in any form,” according to the initial outbreak statement posted in February this year.
The FDA’s outbreak investigational activities have concluded, according to a June 29 post by the agency. “… but the FDA continues to address the issue of Salmonella in kratom.”
Out of 66 samples analyzed through April 19 as part of the FDA’s investigation into the outbreak, 33 were positive for one or more strains of Salmonella. The CDC reported 85 different DNA fingerprints of Salmonella bacteria were identified in samples of kratom products.
“Traceback was particularly challenging in this outbreak because kratom enters the market through channels that are atypical for foods, such as through personal importation or false declaration of product at the port of entry into the U.S.,” the FDA reported.
“The FDA has not been able to confirm that growers or processors of kratom are using Good Manufacturing Practices (GMPs) or otherwise taking steps to ensure that their products are not contaminated with Salmonella. … The FDA reminds consumers that raw products contaminated with Salmonella can make people sick if they consume them, and can also cross-contaminate surrounding surfaces and possibly expose others to Salmonella.”
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