FDA WARNING_LETTER - Red Pill Medical Inc. - November 25, 2019

The FDA issued a Warning Letter to Red Pill Medical, LLC, after reviewing their websites and social media in September and October 2019, identifying numerous violations related to their cannabidiol (CBD) products. The agency determined that the firm is illegally marketing several human CBD products, including “Red Pill Formula 1” and “Pain Relief CBD Bath Bombs,” as unapproved new drugs (FD&C Act sections 505(a), 301(d), 201(p)) and misbranded drugs (section 502(f)(1)) due to lack of adequate directions for use. These products cannot be dietary supplements (section 201(ff)) because CBD is an active ingredient in an approved drug or subject to clinical investigations. The “Red Pill CBD Pet” product was cited as an unapproved new animal drug (sections 512(a), 201(v)) and adulterated (section 501(a)(5)) because it lacks FDA approval and is not generally recognized as safe and effective for animals. Moreover, marketing any CBD product as animal food is a prohibited act (section 301(ll)) and results in adulterated animal food (sections 409, 402(a)(2)(C)(i)) as CBD is not Generally Recognized As Safe (GRAS) for animal consumption. Red Pill Medical must promptly correct these violations and respond to the FDA in writing within fifteen working days, outlining specific corrective actions and preventative measures. Failure to comply could result in legal action, including product seizure and injunction.