The Tobacco Control Act “imposed stringent restrictions on the conduct of cigarette manufacturers” and “limited marketing by prohibiting distribution of branded merchandise, false or misleading labeling, and claims of reduced risk of harm (such as the use of descriptors like ‘light’ or ‘mild’) without prior approval of the FDA.” United States v. Philip Morris USA Inc., 686 F.3d at 835.
They argued: (1) that the Tobacco Control Act’s restrictions “eliminated any ‘reasonable likelihood’ they would commit future RICO violations;” and (2) that “the court should vacate the injunctions out of deference to the FDA’s newfound primary jurisdiction over cigarette sales and marketing.” United States v. Philip Morris USA Inc., 686 F.3d at 835.
The modified-risk authorization must be periodically renewed and is conditioned on Philip Morris submitting HeatSticks’ promotional materials for FDA review and completing extensive data collection “concerning consumers’ behavior in relation to the IQOS system, including as to younger populations.” Id. at 11.
Judge Kessler discussed these products in the context of the government’s claim that the tobacco manufacturers deliberately chose not to “develop and market less hazardous cigarettes” to avoid “undermin[ing] the commercial viability of their existing brands.” United States v. Philip Morris USA, Inc., 449 F. Supp.
After the Tobacco Control Act was enacted, Judge Kessler declined to vacate Order #1015 despite the manufacturers’ argument that “court-ordered relief would interfere with the implementation of the agency’s expert regulatory judgment.” United States v. Philip Morris USA, Inc., 787 F. Supp.