FDA WARNING_LETTER - Desert Defense, LLC - February 21, 2023

The FDA issued a Warning Letter to Rogue Research, LLC, concerning the marketing of unapproved new animal drug products, including "Desert Defense Original Formula, Yeast, Fungal & Mold Support, and SuperBo Wellness Formula." The FDA reviewed the firm's websites (www.desert-defense.com and www.rogueresearch.com/) and social media (https://www.facebook.com/Desert.Defense.Valley.Fever/) in November and December 2022.

The FDA determined that "Desert Defense" products are drugs under section 201(g)(1)(B) of the FD&C Act because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. Claims observed on the websites and social media, such as "A First Line of Defense Against Valley Fever for Your Dog" and "boost your dogs natural defenses against the unique host of fungal, parasitic, viral, and bacterial pathogens," demonstrate these intended uses.

These products are considered new animal drugs under section 201(v) of the FD&C Act, as they are not generally recognized as safe and effective for their intended uses. 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. Consequently, the products are deemed unsafe under section 51