Opinion ID: 2967173
Heading Depth: 2
Heading Rank: 1

Heading: FDA's Asserted Basis for Jurisdiction

Text: The FDA3 has authority to regulate products only if they fall within one of the categories defined by Congress in the Act.4 In the jurisdictional determination attached to its August 28, 1996 regulations, the FDA asserted jurisdiction over tobacco products under the drug5 and device6 definitions in the Act. 61 Fed. Reg. at 44,628. According to the FDA, tobacco products fit within these definitions because they are intended to affect the structure or any function of the body. More specifically, the FDA concluded that tobacco products are combination products consisting of nicotine, a drug that causes addiction and other significant pharmacological effects on the human body, and device components that deliver nicotine to the body.7 61 _________________________________________________________________ 3 On most occasions, the Act refers to the authority of the Secretary of the Department Health and Human Services (HHS) to take certain actions. However, the Secretary acts through the Commissioner of Food and Drugs. 21 U.S.C. § 393(d)(2). For simplicity, we will refer to any legislative delegation as if made directly to the FDA. 4 The categories of products subject to regulation by the FDA are food, drugs, devices, and cosmetics. 21 U.S.C. § 321. 5 The Act defines drug in pertinent part as articles (other than food) intended to affect the structure or any function of the body of man or other animals. 21 U.S.C. § 321(g)(1)(C). 6 In relevant part, device is defined as an article which is: intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes 21 U.S.C. § 321(h)(3). 7 A combination product is described as a product that contains a combination of a drug, device, or biological product. 21 U.S.C. § 353(g). Neither party contends that tobacco products contain any biological product, as that term is used in the Act. See 42 U.S.C. § 262(I) (defining a biological product as a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product . . . applicable to the prevention, treatment, or cure of a disease or condition of human beings). 15 Fed. Reg. at 44,628, 44,649-650. Based on its classification of tobacco products as combination products, the FDA claimed that it could exercise its discretion in deciding whether the drug provisions or device provisions of the Act should apply. 61 Fed. Reg. at 44,400. Although finding that tobacco products function primarily as drugs, 61 Fed. Reg. at 45,209-218, the FDA concluded that tobacco products are most properly regulated under the device provisions of the Act, in particular the restricted devices section, 21 U.S.C. § 360j(e).8 61 Fed. Reg. at 44,400. The FDA's jurisdictional determination encompasses over 600 pages in the Federal Register; however, its basic premise can be fairly summarized in one sentence. That is, the FDA asserted jurisdiction over tobacco products based on its conclusion that tobacco products fit within the literal definitions of drug and device as set forth in the Act. In short, the FDA's inquiry began and ended with the definitions section of the Act. We are of opinion that the FDA's limited, mechanistic inquiry is insufficient to determine Congress' intent. Therefore, as directed by Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), we employ the traditional tools of statutory construction to ascertain congressional intent regarding whether the FDA has authority to regulate tobacco products.