Carbadox

An Iowa businessman was recently sentenced after pleading guilty to illegally selling adulterated and misbranded animal drugs.

Gary L. Grimsman, president of Cingar Diversified, Inc., Carroll, Iowa, was sentenced to 90 days in jail and three years' probation, and was fined $20,000 last July 14 in the U.S. District Court for the Northern District of Iowa. He had pleaded guilty March 7 to illegally selling 50 kilograms of dimetridazole, an unapproved animal drug.

FDA's Kansas City district office first learned of Grimsman's activities in January 1986 while the district's bulk animal drugs work group was investigating Jeffrey Engel, owner of Custom Feed Blenders, Fort Dodge, Iowa, and Ardean Veldcamp, owner of Selltics, Co., Edgerton, Minn.

"Engel was more or less the kingpin," acting compliance officer Peter Gruman said. "Once we were able to nail him down, he gave us additional information that pointed us in other directions," including to Grimsman.

"When you're investigating one person, you often come across names of others," he explained. "It's like we were investigating a 28-headed monster, all at the same time."

FDA's investigation found that "from mid-1984 through 1988, Grimsman purchased more than $600,000 worth of black market animal drugs from individuals who smuggled or otherwise unlawfully imported these drugs into the United States," according to court documents.

"The drugs originated in Europe or China," Gruman said. "They would either come in smuggled across the border from Canada...or they would come through U.S. ports declared as something other than what they actually were."

Grimsman bought from Engel and Veldcamp bulk quantities of drugs--primarily antibiotics, including dimetridazole, furazolidone and carbadox. He stripped off the labels or covered them with black paint to prevent FDA from being able to identify the drugs or trace them back to their original manufacturers. He would then repack and resell the bulk drugs or mix them with other ingredients and sell the finished product for a substantial profit to veterinarians in Iowa and South Dakota.

Neither dimetridazole nor furazolidone are approved for use in the United States because they pose a substantial public health risk and have not been proven safe and effective for use in food-producing animals. Carbadox is approved, but Pfizer Inc.'s animal health division is the only U.S. drug firm with FDA approval to handle carbadox in its bulk form.

FDA banned dimetridazole July 31, 1987, because of evidence that it may cause cancer in humans, and residues in meat, milk and eggs would pose a significant threat to human health. FDA banned furazolidone Jan. 31, 1992, because it was found to cause cancer in animals.

Bulk carbadox, if handled improperly, also poses a risk because it is explosive during handling and use, it fumes are toxic to the lungs, and it may cause chromosomal changes in animals and humans.

The bulk drugs Grimsman sold were adulterated and misbranded because they are unapproved new animal drugs. In addition, none was labeled with the required accurate instructions for use and name and place of business of the manufacturer, packer or distributor.

As a result of FDA's investigation, a six-count indictment was filed against Grimsman on Sept. 16, 1992, charging him with conspiracy to defraud FDA and introducing into interstate commerce adulterated or misbranded animal drugs.

On Oct. 14, 1992, Grimsman was arraigned. He pleaded not guilty. After substantial negotiating, however, Grimsman pleaded guilty March 7, 1994, to a single count of illegally selling dimetridazole.

Engel had earlier been found guilty for his role in the scheme and was sentenced in the U.S. District Court for the District of Nebraska to three years in jail with all but six months suspended, fined $10,000, and ordered to perform 1,500 hours of community service.

Veldcamp was also found guilty and was sentenced in the U.S. District Court for the District of South Dakota to one year in jail and fined $25,000. His prison sentence was suspended.

FDA has not determined that anyone was injured after eating the meat, milk or eggs from animals treated with any of these drugs.

COPYRIGHT 1994 U.S. Government Printing Office
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