FDA WARNING_LETTER - Clarke Pharmaceutical Manufacturing, Inc. - February 09, 2021

The FDA issued a Warning Letter to Dr. Lewis Clarke M.D. and M. Christopher Clarke of Clarke Pharmaceuticals on February 2, 2021, following a review of their website (www.clarkepharmaceuticals.com) and YouTube channel in December 2020 and January 2021. The FDA determined that five products—"OsteoBLAST®," "Cell Block #19," "High Potency Vitamin D3," "Neupanex®," and "Natural Progesterone Skin Cream"—are unapproved new drugs and misbranded.

The products are deemed drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) due to claims on their website and YouTube videos indicating their intent for disease treatment, prevention, or to affect body structure/function. Specifically, "Cell Block #19" is cited for COVID-19 related claims.

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their claimed uses. Marketing them without prior FDA approval violates sections 301(d) and 505(a) of the Act. Furthermore, they are misbranded under section 502(f)(1) of the Act because they lack adequate directions for use by a layperson, as their intended uses require supervision