FDA WARNING_LETTER - Front Range Kratom

The FDA issued a Warning Letter to Front Range Kratom following a review of their website (www.frontrangekratom.com) and social media (Facebook, Twitter) in April 2018. The FDA determined that Front Range Kratom sells various kratom products, including powders and capsules, with unapproved drug claims.

The core violations are that these kratom products are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA cited sections 505(a) and 301(d) for unapproved new drugs and section 502 for misbranded drugs.

The FDA determined these products are drugs because claims on the company's website and social media establish their intended use for diagnosing, curing, mitigating, treating, or preventing disease, specifically opioid addiction and withdrawal symptoms, pain, and other conditions. Examples of claims include "help people get through some of the post acute withdrawl [sic] symptoms they get when they come off of their pain medications" and "Kratom Is the Cure for the Opioid Epidemic."

As "new drugs," they lack general recognition of safety and effectiveness and require prior FDA approval, which they do not have. Furthermore, they are considered prescription drugs due to potential harmful effects and the need for professional supervision, making them misbranded under section 502(f)(1) because adequate directions for layperson