FDA WARNING_LETTER - Omni Consumer Products LLC d/b/a YoKratom - July 05, 2022

On June 30, 2022, the FDA and FTC issued a Warning Letter to Ben Harrison of 1650 Pennystone Trl, Myrtle Beach, SC, regarding products sold on yokratom.com. The agencies reviewed the website in May and June 2022 and determined that "Red Maeng Da Kratom," "Red Borneo Kratom," "Red Bali Kratom," "White Maeng Da Kratom," and "White Borneo Kratom" powder and capsule products are unapproved new drugs.

The FDA asserts these kratom products are drugs under section 201(g)(1) of the FD&C Act because they are marketed for treating opioid addiction and withdrawal symptoms, which are unapproved uses. The claims on the website establish the intended use as drugs, making them "new drugs" under section 201(p) of the FD&C Act. Introducing or delivering these unapproved new drugs into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act. The letter emphasizes the public health threat posed by unproven opioid addiction treatments, which could delay or replace FDA-approved therapies.

The FTC also states that advertising products to prevent, treat, or cure human disease, including addiction, requires competent and reliable scientific evidence, which is lacking for kratom. Violations of the FTC Act can result in injunctions and civil penalties up