FDA WARNING_LETTER - Enzymology Research Center, Inc. - January 09, 2020

The FDA issued a Warning Letter to Mr. Aupperle on March 26, 2020, following an inspection of his facility in Miltona, Minnesota, from January 7-9, 2020. The inspection and subsequent review of product labels for (b)(4) and (b)(4) revealed that these products are marketed with claims establishing them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), due to their intended use in the cure, mitigation, treatment, or prevention of disease.

Specifically, the products are deemed "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their claimed uses. Introducing or delivering these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act.

Furthermore, (b)(4) and (b)(4) are considered misbranded under section 502(f)(1) of the Act because they lack adequate directions for use. As prescription drugs intended for conditions not amenable to self-diagnosis or treatment, they require supervision by a licensed practitioner, making it impossible to provide adequate directions for layperson use. The introduction or delivery of these misbranded drugs into interstate commerce violates section 301(a) of the Act.

The company'