FDA WARNING_LETTER - Jackson Health & Wellness Clinic - February 28, 2023

The FDA issued Warning Letter #646556 to Mr. Miller on February 3, 2023, following reviews of www.drmillersclinic.com/landing/ and www.drmillersclinic.com/index.html in October 2022 and January 2023. The FDA determined that products sold, including Dr. Miller’s Holy Tea, Super Holy Tea, Ultimate Tea, Be Free Spring Clean Herbal Detox (pills and tea), and Youthin Fatburners, are unapproved new drugs and misbranded drugs.

The claims on the websites, including personal testimonials, establish the products' intent for use in the cure, mitigation, treatment, or prevention of disease, classifying them as drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. Since these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under section 201(p) of the Act [21 U.S.C. 321(p)], requiring prior FDA approval for interstate commerce introduction.

Furthermore, Dr. Miller’s Holy Tea, Super Holy Tea, Ultimate Tea, and Youthin Fatburners are misbranded under section 502(f)(1) of the Act [21 U.S.C