Durovic v. Palmer

1. Statutes and the Constitution. Section 704 of the FDCA, 21 U.S.C. 374 authorizes inspections "at reasonable times and within reasonable limits and in a reasonable manner." By and large this means that inspections usually occur during normal business hours rather than in midnight raids. Durovic sought to argue that an inspection outside of normal business hours is not at a reasonable time and therefore not authorized by the statute. Although this turned out to be a losing argument, note the close relationship between the statutory and constitutional tests. In order to pass constitutional muster according to the Colonnade-Biswell doctrine, the inspection must be authorized by a statute limiting discretion and providing notice. If an inspection is not authorized by statute meeting these requirements, then any occurring inspection would likely be a prohibited warrantless unreasonable search. What does section 704 authorize? Inspections occurring a reasonable times. If the actual FDA inspection occurred at an unreasonable time, then it is an inspection not authorized by the statute. If it is not authorized by the statute, the inspection constitutes an unconstitutional search. The constitutional validity of a given inspection then can turn on the seemingly mundane issue of what constitutes a reasonable time for an inspection. 2. Rules of Reasonableness. Section 704 authorizes FDA employees to enter and inspect a food enterprise, factory, warehouse, establishment, or vehicle, after presenting appropriate credentials and a written notice. 21 U.S.C. 374(A). The statutory requirements for reasonable time, reasonable limits, and reasonable manners have been interpreted in a series of FDA Rules and Policies. See, e.g., U.S. Food and Drug Administration Investigations Operations manual 2014. As noted in Durovic, the "reasonable time" requirement typically means normal business hours. The "reasonable limits" requirement typically means that the area or goods inspected must be relevant to the goal of the inspection. The "reasonable manner" requirement has been interpreted to mean that inspectors must present their credentials to gain entry into the facility and must issue the firm a Notice of Inspection at the commencement of the inspection. 3. Inspect What? In addition to equipment, storage facilities, foods, containers, and labels, FDA inspection authority includes the power to obtain company records of the interstate shipment of foods. FDA, Draft Guidance, Records Access Authority under Sections 414 and 704 Federal Food, Drug, & Cosmetic Act: Questions and Answers (Feb. 2012). Excepted from the records authority are records of recipes, financial data, pricing data, personnel data, sales data, and research data. 21 U.S.C. 350(c). Moreover, any confidential or trade secret information is protected from public disclosure. The food industry is notoriously secretive and it is not hard to imagine the anxiety about opening recipe records to government inspectors. See generally Trade Secrets, U.S. Food & Drug Administration (June 1, 2010).