Recently, FDA took administrative action by detaining at the border a product containing kratom, a plant material that may have the potential for abuse and potential serious health consequences. Then the Department of Justice filed a complaint in US District Court on behalf of the FDA “alleging, among other things, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements containing kratom are adulterated under the FD&C Act.” The announcement of the seizure conducted by US Marshalls can be found here in a news release from FDA.
The FDA first expressed concern about the substance in February 2014 and issued an import alert (here) wherein the FDA noted that, while meeting the definition of a dietary supplement under the Act, kratom was a new dietary ingredient, which was first marketed after the grandfather date of October 15, 1994, thus requiring notice to the Agency prior to marketing demonstrating that the dietary ingredient was safe. This was not done by anyone and, according to the news release “[I]n fact, the scientific literature disclosed serious concerns regarding the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms. In the absence of a history of use or other evidence of safety establishing that kratom will reasonably be expected to be safe as a dietary ingredient, kratom and kratom-containing dietary supplements and bulk dietary ingredients are adulterated under section 402(f)(1)(B) of the Act [21 U.S.C. 342(f)(1)(B)], because they contain a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.”
The FDA must remain diligent to protect the American consumers from potentially dangerous products. We have posted multiple times (here, here, here, and here) regarding the continuing discussions about both the safety and efficacy of dietary supplements and, as the Agency moves into the new year, perhaps we will see additional enforcement action and potentially a public debate relative to the entire dietary supplement issue.