During the mid-1990s, the Food and Drug Administration (FDA) adopted various regulations that restricted advertising and other marketing practices regarding tobacco products. The FDA premised these regulations on the theory that nicotine was a "drug" and cigarettes were a drug-delivery "device" for purposes of the Food, Drug & Cosmetic Act, which gives the FDA the authority to regulate such items.
Various tobacco companies and other parties challenged the regulations in federal court, arguing that Congress had not given the FDA authority to regulate tobacco products and that in any event, the advertising restrictions contemplated by the regulations violated the First Amendment. The litigation, which made its way to the ultimate forum—the United States Supreme Court—suggested fundamental questions that arise in the field of administrative law:- In what subject matter area has the relevant administrative agency been granted authority to regulate by Congress or, at the state level, by the state legislature? What are the specific boundaries of that subject matter area?
- In what ways has the administrative agency been empowered by Congress or the state legislature to exercise its regulatory authority? What restrictions, if any, have been placed by Congress or the state legislature on the ways in which the agency may regulate?
- Do regulations (i.e., rules) adopted by an administrative agency have the same force of law that statutes have?
- How do constitutional provisions affect the regulatory actions that administrative agencies may take?