FDA WARNING_LETTER - homero corp - March 31, 2020

The FDA issued a Warning Letter to Mr. Johnson on April 20, 2020, following a March 2020 review of his websites, naturescbdoil.com and facebook.com/naturescbdoil/. The FDA determined that the company sells various human and animal products containing cannabidiol (CBD), making unapproved drug claims and violating several sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, the FDA cited the following violations: * **Unapproved New Drugs (Human):** CBD-containing products for humans are promoted with claims indicating intended use for disease treatment (e.g., opioid addiction, Alzheimer's, cancer, asthma), making them unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act. * **Misbranded Drugs (Human):** These human CBD products are also misbranded under section 502(f)(1) of the FD&C Act due to inadequate directions for use, as the conditions they claim to treat are not amenable to self-diagnosis and treatment. * **Prohibited Act and Adulterated Human Foods:** CBD edible products ("CBD Froggies," "CBD Gummies") are considered adulterated under section 402(a)(2)(C)(i) and violate section 301(ll) of the FD&C