Omni Consumer Products LLC d/b/a YoKratom Warning Letter Details

Summary

Omni Consumer Products LLC, operating as YoKratom, was cited for marketing unapproved kratom powder and capsule products (Red Maeng Da, Red Borneo, Red Bali, White Maeng Da, and White Borneo varieties) as drugs in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The company made disease claims on its website, specifically marketing the products for treatment and mitigation of opioid addiction and withdrawal symptoms, without FDA approval or evidence of safety and efficacy. The FDA emphasized this violation posed a significant public health threat given the ongoing opioid crisis, as consumers might forgo proven FDA-approved addiction treatments in favor of these unproven products.