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Sottera v. Food & Drug Administration - Tobacco Control Laws
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.
Challenge to Government Policies Relating to Tobacco Control/Public HealthTobacco 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 Enforcement ActionGovernment, 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.
Tobacco Control Topics
Contents and Disclosures MeasuresMeasures for testing, measuring, regulating, or disclosing the contents and emissions of tobacco products.
(See FCTC Arts. 9 and 10)
Right to CommerceA 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.
Right to PropertyA 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.
Legal ProductTobacco is a legal product and the tobacco industry is a legal industry.
Type of Tobacco Product
E-cigarettes and other ENDS productsElectronic 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 materials and analysis available at this website are for informational and educational purposes only and not for the purpose of providing legal advice.