FDA WARNING_LETTER - AniCell Biotech, LLC - September 13, 2017

On July 3, 2018, the FDA issued a Warning Letter to AniCell Biotech following an inspection from September 11-13, 2017, and a review of their website. The FDA determined that AniCell Biotech is marketing unapproved new animal drugs.

The company's cell-based, regenerative therapy products, including "CanisCell Treatments for Dogs," "CanisCell AniMatrix," and "CanisCell StemWrap," are intended for use in the mitigation, treatment, or prevention of disease in animals, classifying them as drugs under section 201(g)(1)(B) of the FD&C Act. Website statements indicated uses for orthopedic, bone, muscle, ligament, tendon, and eye issues, as well as wound management.

These products are considered "new animal drugs" under section 201(v) of the FD&C Act because they are not generally recognized as safe and effective by experts. Since they lack an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, they are deemed unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act.

AniCell Biotech must notify the FDA in writing within fifteen working days of receipt of the letter,