The FDA denied e-cigarette products from entry into the U.S. under the Food, Drug, and Cosmetic Act (FDCA). Two companies, importers of e-cigarette products, challenged the FDA and won a preliminary injunction to release their products. The companies argued that the FDA did not have authority to regulate their products under the FDCA. In this case the appellate court agreed with the lower court, holding the FDA must regulate these products under the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Act) and upheld the injunction. The concurring opinion of the appellate court highlighted the definition of “tobacco products” in the Tobacco Act to include e-cigarettes while the controlling authority, FDA v. Brown and Williamson, did not contain a similar definition.
Tobacco companies or front groups may challenge any legislative or regulatory measure that affects their business interests. Unlike public interest litigation, these cases seek to weaken health measures. These cases frequently involve the industry proceeding against the government. For example, a group of restaurant owners challenging a smoke free law as unconstitutional.
Government, through its agencies and officials including prosecutors, may seek to enforce its health laws. For example, the government may revoke the license of a retailer that sells tobacco products to minors. These cases may also directly involve the tobacco industry, for example, a government might impound and destroy improperly labeled cigarette packs.
A violation of the right to carry on trade, business, or profession of a person’s choice. This right may also be called the right to free enterprise or economic freedom. The industry may argue that a business should be able to conduct its business without government regulation, including whether or not to be smoke free.
A violation of property rights, sometimes in the form of an expropriation or a taking by the government. The tobacco industry may argue that regulations amount to a taking of property rights because they prevent the use of intellectual property such as trademarks.
Electronic and/or battery-operated devices designed to deliver an inhaled dose of nicotine or other substances. Examples include electronic cigarettes (e-cigarettes), electronic cigars, electronic cigarillos, electronic hookah, vaporizers, and vape pens. ENDS does not include any device or medication approved by the government as nicotine replacement therapy.
The FDA denied e-cigarette products from entry into the U.S. under the Food, Drug, and Cosmetic Act (FDCA). Two companies, importers of e-cigarette products, challenged the FDA and won a preliminary injunction to release their products. The companies argued that the FDA did not have authority to regulate their products under the FDCA. In this case the appellate court agreed with the lower court, holding the FDA must regulate these products under the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Act) and upheld the injunction. The concurring opinion of the appellate court highlighted the definition of “tobacco products” in the Tobacco Act to include e-cigarettes while the controlling authority, FDA v. Brown and Williamson, did not contain a similar definition.