Revibe, Inc. – FDA Warning Letter, Apr 30, 2018

The FDA issued a Warning Letter to Mr. Hanger, operating buykratombulkusa.com, after reviewing the website in April 2018. The FDA determined that numerous kratom products sold, including "50x Black Diamond Extract" and various "Bali Kratom" strains, are unapproved new drugs and misbranded drugs.

The products are deemed drugs under section 201(g)(1)(B) of the FD&C Act due to claims on the website establishing their intended use for diagnosing, curing, mitigating, treating, or preventing diseases. Examples of such claims include treating stress, anxiety, insomnia, various pains (e.g., back pain, arthritis, cancer pain), depression, opioid withdrawal, high blood pressure, diabetes, stroke-related ailments, and acting as an antioxidant and antibacterial.

These products are considered "new drugs" under section 201(p) because they are not generally recognized as safe and effective for their claimed uses. Their introduction into interstate commerce without FDA approval violates sections 301(d) and 505(a) of the FD&C Act. Furthermore, the products are misbranded under section 502(f)(1) because they are prescription drugs requiring professional supervision, and adequate directions for layperson use cannot be provided, violating section 301(a).

The FDA emphasized that the marketing of unapproved opioid addiction treatments poses a significant public