Appeal from orders and a judgment of the United States District Court for the Southern District of New York, McLaughlin, Judge, denying requests for discovery and for an evidentiary hearing on good faith, and convicting appellants of violating the Federal Food, Drug and Cosmetic Act. Affirmed.
Before: PIERCE and PRATT, Circuit Judges, and STEWART, District Judge.*fn*
Gel Spice Company, Inc., (Gel Spice) and Barry Engel, President of Gel Spice, appeal from a judgment of the United States District Court for the Eastern District of New York (McLaughlin, Judge), dated December 21, 1984, which found appellants guilty, after a bench trial, on all ten counts of an information charging them with violating the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 342(a) (4).
The district court found that the government did not act in bad faith in conducting inspections of Gel Spice's facilities and that Gel Spice had not made a sufficient preliminary showing to warrant an evidentiary hearing on this issue or to warrant access to certain government documents sought by appellants. The district court also held that appellant Engel did not establish the defense of impossibility. We affirm the decision of the district court.
At all relevant times, Gel Spice, a New York corporation, imported, processed, and packaged spices. The processing involved grinding, blowing, sifting, and repackaging the spices into consumer and industrial size containers. Barry Engel has been the President of Gel Spice since 1963 and has been responsible for the purchasing of spices and their storing, processing, and packaging at the company's office and warehouse at 593 McDonald Avenue, Brooklyn, New York. He, his brother Andre S. Engel, Gel Spice's Vice-President, and their mother owned equal share of Gel Spice and signed checks and documents on behalf of the company.
The Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 301 et seq., is enforced by the Food and Drug Administration (FDA). The purpose of the Act is the protection of the public from foods that are exposed to unsanitary conditions. The statute requires that foods be produced and held in sanitary facilities. 21 U.S.C. § 342 (a) (4). It prohibits distribution of "adulterated" food, which is defined, in part, as food which may have become contaminated with filth, regardless of whether filth is actually found in the food itself. Id.
FDA's primary statutory tool to ensure compliance with the Act is the statutory inspection authority granted in 21 U.S.C. § 374. FDA official sand employees are authorized by this provision "to enter, at reasonable times, [after presenting appropriate credentials and a written notice to the owner] any ... establishment in which food [and other regulated products] are manufactured, processed, packed, or held... and ... to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such ... establishment, [including the facility's] equipment, finished and unfinished materials[,] containers, and labeling." 21 U.S.C. § 374(a) (1). Nothing in 21 U.S.C. § 374 requires FDA to obtain a warrant from a judicial officer.
The Act provides FDA with three principal enforcement mechanisms when it determines that the Act has been violated. The agency can request the United States Department of Justice (DOJ)to initiate a civil seizure action against any food that is adulterated, 21 U.S.C. § 334, seek an injunction to restrain violations of any prohibited act, 21 U.S.C. §§ 331 and 332, or seek to initiate criminal proceedings against any person who commits a prohibited act, 21 U.S.C. §§ 331 and 333.
According to the government, the customary manner in which a legal action is initiated by the FDA is as follows:
1. An inspection is conducted by an FDA investigator and a report is prepared.
2. Where inspection reveals violative conditions, the inspection report is referred to the Compliance Branch of the field office for review.
3. The field office may then recommend appropriate regulatory action (including legal action), if any, to the pertinent FDA Bureau, in this case the Bureau of Foods.
4. Where the possible legal action is criminal prosecution, the field office provides the potential defendants with an Opportunity to Present Views, pursuant to 21 U.S.C. § 335, and 21 CFR 7.84 et seq. (a Section 305 hearing). The record from the hearing is then ...