FDA WARNING_LETTER - Fishman Chemical of North Carolina, LLC - April 16, 2020

The FDA issued a Warning Letter to Dr. Fishman on April 15, 2020, following a review of the website http://www.fishchemical.com in April 2020. The FDA observed the website offering Chloroquine Phosphate for sale in the United States.

The Chloroquine Phosphate product is deemed an adulterated drug under Section 301(a) of the FD&C Act [21 U.S.C. § 321(a)]. It is classified as a drug under Section 201(g)(1)(B) of the FD&C Act [21 U.S.C. §321(g)(1)(B)] due to its intended use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals, specifically tropical fish. Website claims establishing intended uses include: "Chloroquine is used as a bacteriacide, an algaecide and as an antimalarial," and "It is superior in the fight against ICH, slimness of the skin and flukes and can be used as both a treatment and a preventative."

Since the product is intended for use in fish, a "minor species," it is considered a new animal drug under Section 201(v) of the FD&C Act [21 U.S.C. § 321(v)]. To be legally marketed, a