FDA WARNING_LETTER - Vital Health & Wellness - August 30, 2021

The FDA inspected Vi-tal Health & Wellness's tea processing facility in Trenton, TN, on August 23 and 30, 2021. The inspection and subsequent review of the company's website (www.vitalhealthandwellness.net) and product label for "Vi-tal Health & Wellness brand Dr. Miller’s Holistic Premium Holy Tea" revealed that the product is marketed with claims that establish it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)].

The product label and website make claims indicating the tea is intended for the cure, mitigation, treatment, or prevention of diseases, such as "MAY BE BENEFICIAL FOR:… ACID REFLUX…HIGH BLOOD PRESSURE." Specific ingredient claims on the website, including those for Persimmon leaves, Holy thistle, Malva leaves, Marshmallow leaves, Blessed thistle, Papaya, Ginger, and Chamomile, describe medicinal uses for various ailments, including anti-hypertensive properties, liver disorders, gastrointestinal issues, and cancer prevention.

Because these claims classify the product as a drug, and it is not generally recognized as safe and effective for these uses, it is considered a "new drug" under section 201(p) of the Act [21 U.S.C.