U.S.
Food and Drug Administration
FDA Consumer magazine
January-February 2003
Table of Contents
By Carol Lewis
State agriculture officials twice refused to give Steven Fawcett a license to manufacture human food products at his Whitehall, Wis., animal feed plant after determining that his operating procedures didn't meet required standards. But that didn't stop the company president from producing what proved to be an illicit human food product that contained an animal feed supplement.
Fawcett authorized the purchase and use of inactivated yeast--an animal feed supplement--in the production of a variety of imitation cheese slices. According to Food and Drug Administration investigators, Fawcett bought the supplement and manufactured the food product through two companies--Whitehall Specialties, Inc., a plant that manufactures cheese products for human consumption, and WaCon Corporation, a subsidiary of DMV USA, Inc., an animal feed manufacturer.
Documents filed in the U.S. District Court for the Western District of Wisconsin show that WaCon initially contacted the state's agriculture department in December 1993 to obtain guidance for building a human food-grade plant to produce dry yeast products. The company was already producing these products for the animal feed industry.
In order to operate as a human food-grade plant, WaCon was required by Wisconsin law to obtain a license. State agriculture officials inspected the WaCon facility located in Whitehall, Wis., a short time after the application. The inspection revealed manufacturing deficiencies at the plant that would prevent the production of human food products. Without a license, the facility was legally limited to animal food production.
The Wisconsin Department of Agriculture (WDA) conducted another pre-licensing inspection of the plant in March 1995. The WDA again denied WaCon's request for a human food-grade license. Consequently, all products coming out of WaCon could only be used for animal feed purposes.
Even though Fawcett knew that WaCon did not have a human food-grade license, he authorized Whitehall to purchase from WaCon over 1,700 pounds of inactivated yeast to be used as a flavor enhancer in the production of 500,000 pounds of imitation cheese slices between April 1994 and June 1995. Subsequently, according to court documents, WaCon employees were instructed by WaCon's parent company, DMV, to remove any reference to animal feed from the yeast, thereby mislabeling the product so that it could be sold to a human food manufacturer.
Whitehall then sold the adulterated and misbranded product to companies throughout the United States. Unsuspecting food manufacturers from overseas also bought several shipments of the yeast product.
CPC, a food manufacturer in the United Kingdom, was approached by DMV as a potential customer for their yeast products, which were being misrepresented as approved for human food purposes. CPC never questioned WaCon's credibility, and purchased seven shipments, totaling more than 315,000 pounds of yeast products, mislabeled as human food grade product. According to court documents, CPC admitted that had they known that DMV and WaCon lacked the proper food licenses, they would not have purchased the product.
According to the agent who handled the case, it appeared that Fawcett was approached by DMV officials to try WaCon products in Whitehall's cheese products to see how they worked.
The case originated after state food safety inspectors conducted a random inspection of Whitehall in November 1995. The inspectors, who were aware that WaCon did not possess a human food license, determined that Whitehall was using an animal feed-grade product from an adjacent WaCon facility in its production of human food products.
The WDA requested investigative assistance from the FDA's Office of Criminal Investigations' Chicago field office in April 1996 because the agency regulates both animal feed and human food.
Although the FDA's regulatory authority does not extend to enterprises located in the United Kingdom, the agency requested interviews with CPC officials through diplomatic channels. The United Kingdom's Ministry of Agriculture conducted the interviews, advised the FDA of the results, and provided documents requested by the U.S. investigators.
Whitehall and WaCon violated the Federal Food, Drug, and Cosmetic Act because they introduced misbranded and adulterated food into interstate commerce. Food cannot be misbranded with false or misleading labels, and food cannot be adulterated by leaving out essential ingredients, substituting ingredients, or adding a substance to increase the food's weight.
WaCon Corporation and Whitehall Specialties each pleaded guilty in late 2001 to one count of introducing food products containing an animal feed supplement into interstate commerce as human grade food products. Whitehall was fined $500,000, while WaCon was fined $163,000.