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Source & Scope of Public Health Legal Powers

Nicopure Labs v. U.S. Food & Drug Administration (FDA)

Overview

Nicopure Labs v. U.S. Food & Drug Administration (FDA) (U.S. Court of Appeals for the Federal Circuit, Dec. 10, 2019): The Federal Circuit Court of Appeals upheld FDA’s deeming rule, which brought under FDA regulation all tobacco products, including electronic cigarettes (vapes). Vape industry plaintiffs challenged the rule alleging: (1) the requirement that any new tobacco product, including vapes, be subject to a rigorous pre-market approval process before being marketed is arbitrary and capricious; and (2) the prohibition of vape manufacturers from marketing their products as presenting less risk of harm than cigarettes as well as bans on giving away vape products violates the First Amendment. The court found that FDA acted rationally by requiring manufacturers to demonstrate that allowing vapes on the market is consistent with public health given evidence of the product’s harms. Considering the addictiveness of nicotine, the complex health risks of tobacco use, and the tobacco industry’s history of misleading consumers about product safety, the court upheld the requirement that vape manufacturers must prove their products present less risks before making such claims to consumers. Read the decision here.

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