The warning letters were sent to companies that Gottlieb characterized as “two more unscrupulous vendors” of the ingredient. The major concern is the recommendation by some markers of the ingredient for its as treatment for the symptoms of opioid withdrawal, a medical condition reserved for drug treatment.
Claims are, simply put, illegal
“Simply, selling these unapproved kratom products with claims that they can treat opioid withdrawal and addiction and other serious medical conditions is a violation of federal law,” Dr Gottlieb said.
He also said that, claims language aside, the agency has an issue with kratom itself.
“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. And its use has been on the rise and is of concern to the FDA. 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.,” he wrote.
“Due to the rise in opium costs and the discovery that kratom could relieve opium withdrawals, many users turned to kratom as a means to cure their addiction.”
“It has been long reported that kratom has been used to treat a myriad of ailments including but not limited to: diarrhea, depression, diabetes, obesity, high blood pressure, stomach parasites, diverticulitis, anxiety, alcoholism, and opiate withdrawal.”
Letters sidestep ingredient’s status
Attorney Justin Prochnow, a shareholder in the firm Greenberg Traurig, said while Gottlieb’s commentary mentions the uncertain legal status of the botanical, the warning letters do not. The warning letters focus exclusively on the recommendation of kratom as an opioid withdrawal medication.
“These letters didn’t take issue with kratom as an ingredient per se,” Prochnow said. “But just because they don’t mention that doesn’t mean that FDA is signing off on kratom as a legal ingredient.”
“Other than that, there’s not much to say other than FDA sending out these letters is not terribly surprising,” he said.
Kratom group takes stand against impermissible health claims
The American Kratom Association has taken issue with FDA’s assertion that kratom is unsafe and has an addictive potential in and of itself. The organization has campaigned hard both at the national level and before state legislatures to fight efforts to restrict the use of and access to the botanical.
But earlier this summer, in response to a multi-state kratom contamination episode, the AKA announced a Good Manufacturing Practices policy for members. In speaking at a trade show event in Las Vegas in July where the effort was announced, AKA chairman Dave Herman had this to say:
“These strict baseline recommendations for GMP Standards for the manufacturing and distribution of kratom products are essential in protecting the safety of consumers, and will send the clear message to the FDA and federal and state legislators that we are committed to removing adulterated or contaminated kratom products from the marketplace, and we will not allow impermissible health claims to be made by any credible kratom vendor.”