FDA WARNING_LETTER - Canna Companion LLC

The FDA issued a Warning Letter to Canna Companion, LLC, regarding their product "Canna Companion," marketed on their website www.cannaforpets.com and Facebook page. The FDA determined the product is an unapproved new animal drug under section 201(g)(1)(B) of the FD&C Act because it is intended for use in the mitigation, treatment, or prevention of disease in animals.

Violations include claims on their website such as "Reduce cancer-associated symptoms," "Aid in decreasing severity of dementia," "Reduce bronchial spasms in asthmatics," and "Inhibits cancer cell growth." Facebook posts also indicated drug intent, referencing the product's use for "spinal arthritis & a type of cancer called adenocarcinoma" and for "lymphoma patients."

As a new animal drug, Canna Companion requires an approved new animal drug application, conditionally approved application, or index listing, which it lacks. Therefore, the product is considered unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act. Introducing an adulterated drug into interstate commerce is prohibited by section 301(a).

Canna Companion, LLC must respond within fifteen working days, detailing specific corrective actions taken, steps to prevent recurrence, and providing supporting documentation. If unable to comply within the timeframe, they must state the reason for delay and a new completion date.