FDA WARNING_LETTER - Coenzyme A, Inc. dba Coenzyme-A Technologies, Inc. - September 26, 2017

The FDA issued a Warning Letter to Mr. Skouras following an inspection of his facility in Lynnwood, Washington, from September 13-26, 2017. The FDA reviewed product labeling and the website www.coenzyme-a.com, determining that the product Coenzyme-A is marketed with claims establishing it as a drug under section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (the Act).

The claims, found on the website, suggest the product is intended for the cure, mitigation, treatment, or prevention of diseases such as cardiovascular/diabetic disorders, depression, anxiety, respiratory infection, cardiac instability, neurological disorders, arthritis, multiple sclerosis, Parkinson's, Alzheimer's, adult-onset diabetes, cancer, atherosclerosis, obesity, chronic fatigue syndrome (CFS), and toxic poisoning. These claims include statements about fatty acid metabolism, cholesterol/triglyceride levels, DNA/RNA repair, stress/anxiety coping, and immune system strengthening. Citations to scientific publications on the website are also considered evidence of intended drug use.

Coenzyme-A is deemed a "new drug" under section 201(p) of the Act because it is not generally recognized as safe and effective for these uses, requiring prior FDA approval. Furthermore, the product is misbranded under section 502(f)(1) of the Act because it lacks adequate directions