The U.S. Food and Drug Administration (FDA) today announced that Alpharma, a subsidiary of Pfizer Inc., will voluntarily suspend U.S. sales of the animal drug 3-Nitro (Roxarsone), an FDA-approved product used by poultry producers since 1944.
A recent FDA study of broiler chickens using a new analytical detection method revealed low levels of inorganic arsenic in edible tissue. Scientists from the FDA’s Center for Veterinary Medicine and the Center for Food Safety and Applied Nutrition developed this detection method. Inorganic arsenic, a known carcinogen, was found at higher levels in the livers of 100 chickens treated with 3-Nitro compared with untreated chickens. FDA officials stress that the levels of inorganic arsenic detected were very low and do not pose a health risk.
“FDA detected increased levels of inorganic arsenic in the livers of chickens treated with 3-Nitro, raising concerns of a very low but completely avoidable exposure to a carcinogen,” says Michael R. Taylor, FDA deputy commissioner for foods. “We are pleased to announce that the company is cooperating with us to protect the public health.”
Arsenic is in the environment as a naturally occurring substance or as a contaminant and is found in water, air, soil and food. Published scientific reports have indicated that organic arsenic, a less toxic form of arsenic and the form present in 3-Nitro could transform into inorganic arsenic.
Alpharma’s plan provides for continued sales of 3-Nitro for 30 days from today. The company stated that allowing sales for this period will provide time for animal producers to transition to other treatment strategies and will help ensure that animal health and welfare needs are met. The company is working with the FDA to examine all relevant scientific data regarding the use of 3-Nitro in animals.
Combined with other animal drugs, 3-Nitro has been used by some in the poultry industry to help control coccidiosis, a parasitic disease that affects the intestinal tracts of animals. It has also been used for weight gain, feed efficiency and improved pigmentation.
FDA has consulted with the U.S. Department of Agriculture and is working with Alpharma to minimize the impact on the animal agriculture industry as 3-Nitro is suspended from the market.