FDA Law Blog - FDA Broadens Arsenal in Fight Against Kratom

FDA Broadens Arsenal in Fight Against Kratom Posted: 06 Jan 2016 05:56 PM PST By Ricardo Carvajal – FDA announced the seizure of dietary supplements purportedly containing kratom, which the agency describes as “a botanical substance that could pose a risk to public health and have the potential for abuse.”  The seizure followed on the heels of an administrative detention – a preliminary step that enables FDA to restrict the movement of a product in commerce while the agency decides whether further action is warranted.  As an aside, the execution of administrative detention was made easier by the Food Safety Modernization Act, which lowered the standard for administrative detention from “credible evidence or information indicating” that a food “presents a threat of serious adverse health consequences or death,” to “reason to believe” that a food is adulterated or misbranded.  In the case of kratom, it is doubtful that FDA could have met the previous, higher standard because recalls of kratom have been classified as Class II (i.e., a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote). The government’s complaint for forfeiture alleges that the kratom supplements targeted by the seizure are adulterated because kratom is a new dietary ingredient for which a required premarket notification has not been submitted.  The complaint further alleges that the supplements are adulterated because there is inadequate information to provide reasonable assurance that kratom does not present a significant or unreasonable risk of illness or injury. As noted in FDA’s press release, FDA previously issued an import alert targeting kratom.  The recently announced seizure indicates that FDA also intends to go after products already on the domestic market.