FDA WARNING_LETTER - health & wellness center international one, l.l.c. - November 03, 2020

On December 2, 2020, the FDA and FTC issued a Warning Letter to Health & Wellness Center International One, L.L.C. dba Hotze Vitamins, specifically Dr. Steven F. Hotze, MD, for selling unapproved and misbranded products related to COVID-19. The agencies reviewed the company's websites (www.hotzehwc.com, www.hotzevitamins.com) and social media (Facebook, Twitter) on September 10 and November 3, 2020.

The products "Dr. Hotze’s Immune Pak with Vitamins A, B, C, D, Zinc and Probiotics," "Dr. Hotze’s Kids Immune Pak," and "Dr. Hotze’s Teen Immune Pak" were offered for sale with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA determined these products are unapproved new drugs under section 505(a) and misbranded drugs under section 502 of the FD&C Act, violating sections 301(a) and (d).

Examples of violative claims included statements about boosting the immune system against coronavirus, and ingredients like Vitamin B6, probiotics, Vitamin A, and zinc enhancing immune function and protecting against respiratory infections.

The letter demands immediate cessation of sales of these unapproved products for COVID-19 related uses. The company must