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A recent FDA investigation was instrumental in the enactment of a new law in Colorado making it a crime in that state for livestock exhibitors to give show animals illegal growth drugs. Violators are subject to a maximum punishment of 18 months in prison and a $100,000 fine.
Colorado Governor Roy Romer signed the law in May 1995, following events surrounding results of a competition at the Denver National Western Junior Livestock Show the preceding January. Both first- and second-place winners in the Junior Steers Class tested positive for clenbuterol, an illegal animal drug that promotes muscle growth.
Clenbuterol is approved in Canada and some European and South American countries to treat respiratory problems in horses, but no country has approved its use in food-producing animals. It is not approved for any use in the United States.
Agency surveillance at livestock shows over the last several years has found the drug continues to be used in animals entered for competition. These animals have often been slaughtered for food, with their meat ending up on dinner plates.
In 1990, 135 people in Spain became ill from eating beef liver that contained clenbuterol residues. The victims had symptoms that included fast heart rate, muscle tremors, headache, dizziness, nausea, fever, and chills. Later, there were reports of 22 illnesses in eight families in France.
The Denver investigation began when FDA Dallas district compliance officer Reynaldo Rodriguez called the agency's Denver office with a tip that some animals at the National Western Show might have been given clenbuterol.
On Jan. 25, 1995, FDA investigator Donald Bean collected eyeballs from the first- and second-place winners--Grand Champion and Reserve Grand Champion--in the classes Junior Steers, Swine, and Sheep. Testing by the agency's Denver laboratory showed the eyes from the steers contained clenbuterol. Denver sent the samples to the agency's Cincinnati Forensic Laboratory for confirmatory testing, which was obtained on Feb. 9.
FDA informed National Western officials that the two animals tested positive for clenbuterol, and they in turn informed the exhibitors and their parents.
"The kids that show animals in the junior livestock competitions are usually in FFA or 4-H," says John Vodneck, a compliance officer with FDA's Denver district. "A tremendous amount of money can be paid for these animals. At this show [the Denver National Western], the Grand Champion was sold at auction for $37,500 and the Reserve Champion for $12,000. In some shows it can go up to $150,000. The auctions are intended to be a way for rural youngsters to win money for college," he says.
National Western appointed a special committee to investigate the illegal use of clenbuterol in the winning steers. The committee began hearings in early March. On March 9, Bean testified about his sample collection, and other FDA officials described how the samples were screened and tested. Other experts provided information about clenbuterol (such as how long it stays in various organs) and about the validity of FDA's test method.
Following the testimony, the committee passed a resolution recommending that the purchase price of the animals be returned to the buyers.
"The hearing was to continue on March 15 and 16, but before it resumed, the exhibitors entered into an agreement with National Western," says Vodneck. "None of the exhibitors or their attorneys showed up for the hearings."
In a public statement and apology, the exhibitors said, "Although we initially disputed the accuracy of the [FDA] tests, we now acknowledge that the tests were accurate and that residues of clenbuterol were present in both steers. As the owners and exhibitors of those steers, we must take full responsibility for the presence of the drug in the steers."
In their agreement with National Western, the exhibitors stipulated the following:
Also, Vodneck says, some meat packers have written to show officials saying they will stop buying show animals unless reliable safeguards against drugs are instituted. One packer has a laboratory that screens for the drug.
Marian Segal is a member of FDA's public affairs staff.
More than 36,000 chocolate Ultra Diet Nutrition Bars, valued at more than $9,000, were destroyed last April 13 after FDA analysis found the bars contained significantly less riboflavin and vitamin C than the labels claimed.
FDA's Chicago district conducted a routine inspection March 2, 1994, of Dietary Enterprises, Ltd., also known as The Diet Store of Morton Grove, Ill., a distributor of weight-loss products. Agency investigators collected several samples of the Ultra Diet Nutrition Bars sold through Dietary Enterprises and sent them to FDA's Atlanta Center for Nutritional Analysis.
Laboratory analysis found that the bars, which were labeled as containing 33 percent of the U.S. Recommended Daily Allowance (RDA) for riboflavin, only contained 5.25 percent of the RDA. The label also stated that the bars contained 30 percent of the RDA of vitamin C, but they actually contained only from 1.2 to 2.45 percent of the RDA. In addition, the labels contained incorrect information--The Diet Store was listed as the product's distributor when, in fact, that firm does not appear in any local telephone directory.
On Aug. 4, when FDA investigators returned to Dietary Enterprises, they found that all the adulterated and misbranded products had been sold. FDA considered the products adulterated and misbranded because the bars contained significantly less riboflavin and vitamin C than were listed on the label, the product's labeling was false and misleading, and the nutrition information, ingredients statement, and name and place of business of the distributor were not prominently placed on the label.
Investigators again inspected the firm on Aug. 23, and again collected Ultra Diet Nutrition Bar samples. Laboratory analysis again found the products lacking significant amounts of riboflavin and vitamin C. At FDA's request, Illinois embargoed the lot.
On Nov. 3, 1994, also at the agency's request, the U.S. District Court for the Northern District of Illinois Eastern Division ordered a U.S. marshal to seize 601 cases of Ultra Diet Nutrition Bars stored in Dietary Enterprises' offices.
When Dietary Enterprises failed to claim the bars, the U.S. attorney entered a default decree of condemnation on Dec. 28, 1994, and on April 13, 1995, the products were destroyed in a local landfill.
--Kevin L. Ropp
Endangered species are protected under the Convention on International Trade in Endangered Species (CITES), a treaty signed by most countries, including the United States and Bangladesh.
Investigation by FDA, Customs, and the U.S. Fish and Wildlife Service revealed that Flag Imports, Inc., of Secaucus, N.J., altered labeling and invoices to defraud the government, never obtained permission from Bangladesh to export the protected frog legs, and often imported seafood contaminated with Salmonella bacteria. Following seizure of the shipments in 1993, U.S. District Judge John Lifland in Newark, N.J., on June 30, 1995, ordered the products condemned and forfeited for destruction.
Customs and FDA had been keeping a wary eye on Flag Imports since 1990, when routine examination of sampling worksheets by FDA investigator John Moore of the agency's New York district office revealed the firm was falsifying invoices.
The investigation, in fact, led to a 138-count conviction in 1993 of Flag's president, Thekkedajh Menon. (See "Importer Sentenced in Tainted Seafood Case," in the September 1993 FDA Consumer.) Menon appealed, arguing that the convictions were based on a law that required proof of intent to deprive the United States of revenue, and that this had not been proven. Agreeing with Menon, an appeals court reversed all but one conviction. The court upheld Menon's conviction for fraudulently re-importing contaminated shrimp previously rejected by FDA.
Flag's first two shipments of shrimp and concealed frog legs arrived at Port Elizabeth, N.J., on May 30, 1992. Invoices and labeling identified the contents as Sony Brand black tiger shrimp from Sundarban Sea Food Industries, Ltd., Bangladesh. A third shipment arrived at Oakland, Calif., on June 6, and was sent on to Port Newark, N.J., where it arrived June 15.
Also, on June 6, Customs notified FDA that a routine examination of the Port Elizabeth shipments found frog legs concealed in the middle cartons. FDA automatically detains imported frog legs for Salmonella testing.
In addition, Bangladesh bans exportation of Rana tigerina frog legs for ecological reasons. A firm wanting to export them would need a CITES certificate from that country, authorizing their export. Flag did not have CITES certificates for any of its shipments.
On July 2, the Fish and Wildlife Service seized the shipments under its administrative authority, and moved them to a South Plainfield, N.J., warehouse. A Fish and Wildlife Service forensic herpetologist (expert on reptiles and amphibians) identified the frog legs as Rana tigerina.
FDA sampled the shipments, and agency testing revealed Salmonella in both the frog legs and the shrimp.
On Jan. 13, 1993, a complaint for seizure, condemnation and forfeiture of the goods was filed in federal court under the Endangered Species Act (ESA), the Lacey Act, and the Federal Food, Drug, and Cosmetic (FD&C) Act, and U.S. marshals seized the shipments.
On May 31, 1994, in cooperation with FDA and the Fish and Wildlife Service, the U.S. Attorney's Office in Newark sought a summary judgment of condemnation, forfeiture and destruction of the three shipments of shrimp and frog legs.
Judge Lifland ruled that the shipments violated the ESA because Flag had no CITES certificates to authorize exporting the protected frog legs. Because the shrimp was used to conceal the illegally imported frog legs, Lifland ruled it forfeited under the ESA as well.
Lifland found that the government had probable cause to believe the three shipments violated the Lacey Act Amendments' prohibition against false labeling of imported fish and wildlife.
Flag argued that under Section 801(a) of the FD&C Act, it had the right to export, rather than forfeit, the shipments. Lifland ruled that even if the section might confer this right, "such a right would not prevail in the face of condemnation and forfeiture under the ESA and the Lacey Act."
Furthermore, Lifland stated that even if Section 801(a) applied, FDA would still be justified under the FD&C Act in requesting seizure, condemnation and forfeiture of the products because of the circumstances of the case.
"Shrimp was used," he wrote, "in what can only be described as a deliberate attempt to conceal Rana tigerina frog legs. It does not seem too cynical a position to hold that the FDA would be reasonable in believing on this basis that re-import of the res [the seized shipments] was likely." He added, "The history of Flag Imports gives credence to this conclusion."
Lifland condemned the shipments and ordered them forfeited for destruction. He also ordered that the government is entitled under the FD&C Act to costs, fees, and storage and other proper expenses.
--Dixie Farley
Bruce Weiss, 35, of Staten Island, N.Y., was sentenced March 28, 1995, in U.S. District Court, Eastern District of New York, to 12 months in prison and three years of supervised release. He was also fined $50 and ordered to pay $60,000 restitution. Weiss began his jail sentence in June.
On Aug. 24, 1993, an agent from the Department of Veterans Affairs' Office of the Inspector General (VA OIG) contacted FDA's Office of Criminal Investigations (OCI) in New York to enlist cooperation in an investigation of drug thefts from the Brooklyn VA Medical Center. The VA had been tipped off to Weiss' activities by an informant. At the same time, the medical center notified the Federal Bureau of Investigation, and the three agencies subsequently conducted a joint investigation of the thefts.
According to OCI, an eight-week FBI surveillance of Weiss, beginning in October 1993, revealed that Weiss often carried "things" under his jacket as he walked out of the hospital during lunch hour and after work. He would glance furtively to the left and right, open the car trunk, and throw things into it or the back seat. A couple times after driving away, he would turn a corner two or three times, circling as though checking to see if he was being followed.
Surveillance photos also showed Weiss going into pharmacies carrying things under his jacket and leaving empty-handed. According to the investigating agents, this evidence--although circumstantial--was highly suspicious.
At around this same time, the VA OIG conducted audits of the hospital and found approximately $500,000 worth of drugs missing due to thefts, pilferage or waste.
In February 1994, agents from the VA OIG, the FBI, and FDA OCI decided to approach one of the pharmacists Weiss visited. The pharmacist admitted that he dealt with Weiss, that he knew Weiss was a government employee, and that Weiss brought him drugs that were stolen from the VA. He said he bought the drugs from Weiss, paying half the average wholesale price. The drugs were valued at $50,000 to $60,000. He said he met with Weiss approximately 25 to 35 times from January 1992 to March 1994, when he purchased the stolen drugs.
The pharmacist surrendered to the agents drugs he had purchased from Weiss. They were the same kinds of drugs as those in the VA's inventory.
Meanwhile, OCI and VA OIG agents interviewed VA employees and local retail pharmacies. They talked with other pharmacy technicians Weiss socialized with and worked with in the supply areas. All those interviewed denied participating in any of Weiss' activities or seeing anything illegal.
Early in June 1994, agents from OCI, VA OIG, and the FBI went to see Weiss at his residence. They told him they were conducting a three-agency investigation into thefts at VA pharmacies and that they would like to speak to him about his activities.
At the request of the agents, Weiss went to the FBI office to be interviewed. The agents hoped he would cooperate with their investigation, but he refused. Weiss admitted to stealing for personal use small quantities of creams and lotions, which he valued at about $30,000. However, during another interview at the U.S. attorney's office, with his attorney present, Weiss admitted to stealing drugs worth $65,000. Every time Weiss was interviewed, he upped the value of the stolen drugs.
On June 14, 1994, the Department of Justice filed a criminal complaint charging Weiss with theft of government property, and on June 21, he was arrested. He was indicted by a federal grand jury on Aug. 19.
On Oct. 28, Weiss pleaded guilty and was to be sentenced, yet he challenged the $60,000 estimated value of the items he was charged with stealing. Also, his attorney maintained that Weiss had cooperated fully with the investigation and appealed to the judge to consider this in sentencing.
The prosecution, however, pointed out that Weiss continually set conditions on his cooperation, and that the government considered the $60,000 estimate to be very conservative, since it was based on only one of the five pharmacies Weiss admitted to dealing with.
The judge sentenced Weiss to 12 months in jail.
There have been no reports of theft at the Brooklyn VA Medical Center since the Weiss investigation.
--Marian Segal