FDA WARNING_LETTER - Dr. G's Marine Aquaculture, Inc. - April 16, 2020

The FDA issued a Warning Letter to Ms. Ninoua-Gonzalez regarding the sale of "Dr. G’s Anti-Parasitic Caviar" on http://www.drgsmarineaquaculture.com. The FDA reviewed the website in April 2020 and determined the product is adulterated.

The product is classified as a new animal drug under Section 201(g)(1)(B) and 201(v) of the FD&C Act due to claims such as "Treats Ich, Brooklynella, Uronema, Crypto, Oodinium and many more Ornamental Fish Parasites" and "Effective new treatment for several forms of marine and freshwater Parasites." It is intended for use in fish, a "minor species."

The product is adulterated because it is an unapproved new animal drug, lacking required FDA approval, conditional approval, or index listing under sections 512, 571, or 572 of the FD&C Act. The product's labeling indicates it "provides the Anti-Parasitic efficiency of Chloroquine," which is also an unapproved new animal drug for ornamental fish.

Furthermore, if the product is considered an "animal feed" (Section 201(w)) containing unsafe chloroquine, it is an unsafe animal feed under Section 512(a)(2) and an adulterated drug under Section 501(