This tracker provides information about the actions of federal agencies, such as the FDA and the USDA, on public health issues within the focus areas of the Center.
In 2019 the FDA proposed a rule to establish the general procedures that FDA intends to follow when evaluating substantial equivalence reports. The final rule was implemented on November 4, 2021.
In 2019, the FDA proposed a rule that would set forth requirements for premarket tobacco product applications (PMTAs) and would require manufacturers to maintain records establishing that their tobacco products are legally marketed. The objective of this rule is to provide FDA with sufficient information to make a determination on a preliminary PMTA for further, more substantive review or not.
The FDA issued an ANPRM seeking feedback on potential regulation of menthol cigarettes. Under its statutory authority, FDA is empowered to regulate, and restrict, the sale of tobacco products if the agency determines that such a regulation is appropriate for the protection of public health.
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.
On January 10, 2012, a group of thirteen tobacco companies sent the U.S. Food and Drug Administration (FDA) a letter requesting a meeting and a detailed list of recommendations for good manufacturing practice regulations. On May 2, representatives from these tobacco companies met with the FDA to present their recommendations.
In 2013, The Public Health Law Center filed a Citizen Petition to the FDA, requesting that the agency add menthol to the list of prohibited flavors in cigarettes. Menthol had been exempted from the product standard established in the Tobacco Control Act but the FDA was given the power to prohibit menthol. In the absence of prompt FDA action, the Public Health Law Center and its partners filed the Citizen Petition advocating for the exemption to be removed.