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FDA warns firms marketing unapproved chloroquine products

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FDA is concerned consumers may mistake unapproved chloroquine phosphate animal drugs for FDA-approved human drugs.

The U.S. Food & Drug Administration’s Center for Veterinary Medicine (CVM) issued warning letters April 16 to Fishman Chemical of North Carolina LLC and Dr. G’s Marine Aquaculture, which distribute chloroquine phosphate products intended to treat disease in aquarium fish.

CVM said in order to be marketed legally, animal drug products must have an approved new animal drug application, a conditionally approved new animal drug application or a listing on the "Index of Legally Marketed Unapproved New Animal Drugs for Minor Species."

Chloroquine phosphate intended to treat disease in aquarium fish has not been approved, conditionally approved or indexed, CVM said, so it is, therefore, an adulterated drug under the Federal Food, Drug & Cosmetic (FD&C) Act. Animal feed containing chloroquine phosphate to treat aquarium fish is also an adulterated drug under the FD&C Act, while food containing chloroquine phosphate to treat aquarium fish is an adulterated food, CVM said. Introduction of an adulterated drug or food into interstate commerce is a violation of the FD&C Act.

FDA approval, conditional approval or index listing of animal drugs is important because, through these processes, FDA reviews data on the drug products to ensure that there is adequate evidence to demonstrate that the drugs are safe, properly manufactured and accurately labeled, CVM explained. Effectiveness of animal drugs must also be demonstrated for approval and index listing.

FDA is further concerned that consumers may mistake unapproved chloroquine phosphate animal drugs for FDA-approved human drugs used to treat malaria and other conditions. The human drug chloroquine phosphate is currently under study as a potential treatment for COVID-19. CVM added that although neither product identified in today’s warning letters made claims about use in people, the agency is aware of one person in the U.S. who died after he and his wife reportedly took unapproved chloroquine phosphate intended for fish in an attempt to prevent COVID-19; his wife also became very ill.

Products marketed for veterinary use, “for research only” or otherwise not for human consumption have not been evaluated for safety or effectiveness in humans, CVM emphasized.

People should not take any form of chloroquine unless it has been prescribed by a licensed health care provider. Chloroquine products also should not be given to pets or livestock unless prescribed by a veterinarian, CVM said.

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