On June 7, 2017, a group of thirteen tobacco companies sent the U.S. Food and Drug Administration (FDA) a letter requesting a meeting and providing the agency with a detailed list of recommended manufacturing practice regulations for e-cigarettes. This correspondence supplemented a letter about tobacco product manufacturing practices that the companies had submitted to the FDA on January 10, 2012.
These efforts by the tobacco industry sought to compel the FDA to fulfill certain duties it has under the Family Smoking Prevention and Tobacco Control Act (TCA). The TCA, enacted in 2009, requires the government to implement regulations that assure that “the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation[, …] packing, and storage of a tobacco product conform to good manufacturing practice, or hazard analysis and critical control point methodology.” This request for clarifying regulations came from the tobacco industry after the FDA deemed e-cigarettes to fall within its authority to regulate tobacco products.
On November 22, 2017, the FDA responded by opening a docket to receive public comments on these proposed regulations, and on December 21, the Public Health Law Center submitted a comment in response. As it did in its 2013 comment, the Center (then the Tobacco Control Legal Consortium) pointed out the tobacco companies proposed using an individual risk standard, rather than the “public health standard” that the TCA requires the FDA to use. Under the TCA standard, the FDA’s actions regulating tobacco must only be taken if they are “appropriate for the protection of the public health.”
The Center also noted that the proposed regulations do not indicate how they are to be enforced, effectively making enforcement a matter of self-policing by the tobacco industry. The Center reiterated that the tobacco industry cannot be trusted and encouraged the FDA to provide more transparency about its discussions with the tobacco industry about manufacturing regulations.