In 2009, Congress knew it needed to stop companies that manufactured tobacco and nicotine products from deceptively marketing new products such as “light cigarettes” and e-cigarettes as “healthier alternatives,” particularly to the nation’s youth.
In an effort to stop those tactics, lawmakers passed the Family Smoking Prevention and Tobacco Control Act (TCA) and charged the Food and Drug Administration (FDA) with putting new tobacco products through premarket reviews, including labeling and marketing plans. The TCA prohibited manufacturers from selling new tobacco products unless company executives could prove that each product was “substantially equivalent” to those commercially available in 2007, or that allowing its sale would be “appropriate for the protection of public health.”
But, as the U.S. District Court for the District of Maryland found, FDA officials didn’t follow through with what Congress mandated it to do under the TCA and youth tobacco and nicotine use has soared. The court told manufactures they must file premarket applications by May 2020, saying it was not lawful or reasonable for the FDA to abdicate its statutory obligations by delaying review until 2021 for combustible products and 2022 for noncombustible products.
With the health of the nation’s youth at stake, the Litigation Center of the American Medical Association and State Medical Societies urged a federal appeals court to uphold the lower-court decision in the case, American Academy of Pediatrics (AAP), et al. v. United States Food and Drug Administration, et al. The AMA Litigation Center joined with the Public Health Law Center and