FDA Nets Maker of Unapproved Fish Drugs
A Washington state company has the dubious distinction of being the first firm involved in a criminal case brought by FDA for selling unapproved drugs for use in raising food fish. The case resulted in fines for the firm and its officers and a prison sentence for its president.
Freshwater fish raised in "fish farms" for human consumption have become an important segment of the aquaculture industry. The industry also has become a marketplace in its own right for specialized foods, nutritional supplements, and medications for fish, some of which are regulated by FDA. (See "Aquaculture, They're Growing Food Under Water" in the November 1981 FDA Consumer.)
Argent Chemical Laboratories, Inc., Redmond, Wash., has been making, packaging and distributing drugs, pesticides and other chemicals for the aquaculture industry for more than 10 years. Its sales and distribution have expanded, particularly into the Far East and South America. Growth resulted in a move to new facilities and addition of a distribution center in Mississippi, closer to the "catfish farming" industry in the southeastern United States.
Argent has been regular stop for FDA investigators, who found the company had ignored warnings to correct violations of good manufacturing practices and to stop selling unapproved new animal drugs for use in food fish. These included nitrofurazone, an antibacterial drug for fish that is suspected of causing cancer in humans; tricaine methane sulfonate, used to anesthetize fish before transporting or handling them; chloramphenicol, a very dangerous antibacterial drug that can cause potentially lethal aplastic anemia in humans and is not approved for any aquaculture use; and malachite green, used to control parasite infestations among fish kept in close confinement. Malachite green may cause cancer in humans.