FDA WARNING_LETTER - Cali Botanicals, LLC - June 25, 2019

The FDA issued a Warning Letter to Cali Botanicals, LLC, following a March 2019 review of their website (www.calibotanicals.com) and social media (Facebook, Twitter). The FDA determined that Cali Botanicals sells various kratom products, including powders, capsules, and tinctures, which are marketed as unapproved new drugs and misbranded drugs.

The products are deemed "drugs" under section 201(g)(1) of the FD&C Act due to claims on their website and social media suggesting intended use for diagnosing, curing, mitigating, treating, or preventing diseases, specifically opioid addiction and withdrawal symptoms, and affecting body structure/function. Examples of claims include "Kratom Benefits," "Red Veins" (blog), and social media posts discussing opioid withdrawal.

These kratom products are considered "new drugs" under section 201(p) of the FD&C Act because they are not generally recognized as safe and effective for their intended uses. Since no FDA-approved applications exist, their introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.

Furthermore, the products are misbranded under section 502(f)(1) of the FD&C Act because they lack adequate directions for use by a layperson, as they are intended for conditions requiring professional supervision. This violates section 301