FDA Study: Kratom Capsules Well-Tolerated

A preliminary report from an ongoing FDA clinical study found that kratom capsules, even in very high doses in a short period of time, are well-tolerated by participants.

The FDA recently concluded a pilot study that aimed to assess the abuse potential of kratom, which has been a concern for the FDA. However, the preliminary results suggest that kratom, in leaf form, is well tolerated.

The "single-ascending dose" (SAD) study was announced in a presentation by an FDA representative at a scientific symposium held at the University of Florida in Orlando in February. It involved 40 healthy participants with no history of substance abuse. They were given single ascending doses of kratom in capsule form, starting from 1 gram and going up to 12 grams to be consumed in a five minute period. Researchers monitored vital signs such as blood pressure, pulse, respiratory rate, and body temperature. The results showed no significant adverse events, even at higher doses.

Important to note that in this study, participants only consumed plain leaf kratom, closer to the traditional substance consumed for centuries in Southeast Asia. Other kratom-based products, like highly concentrated liquid extracts and 7-hydroxymitragynine based products would likely have different results.

The FDA considers kratom a new dietary ingredient and has issued safety warnings about kratom-based products. Previous FDA studies on kratom have been based on poorly screened, online reports alone and were heavily criticized by experts. Others have accused FDA of relying on old science, and of having a bias against dietary supplements in general.

FDA press officer Lauren-Jei McCarthy told the Arizona Mirror, “While there’s no date to provide at this time, we expect to publish the final study results of the FDA’s single ascending dose (SAD) study in the near future."