On April 28, 2022, the FDA proposed a rule to ban flavors in cigars. This Notice of Proposed Rulemaking (NPRM) follows a collection of information in 2018 that did not include a proposal to act. Members of the public health community had until August 2, 2022, to submit comments to the FDA.
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.
On April 28, 2022, the FDA proposed a rule to ban menthol in cigarettes. The presence of menthol in cigarettes has been an issue that has been at the forefront of FDA commercial tobacco product regulation since the FDA began regulating.
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.
Request for Information (RFI): 2022 HHS Environmental Justice Strategy and Implementation Plan Draft Outline
On April 8, 2022, The U.S. Department of Health and Human Services (HHS)—the parent agency of the Food and Drug Administration (FDA), which regulates tobacco products—issued a Request for Information (RFI) on its Draft Outline to further develop the agency’s 2022 Environmental Justice Strategy and Implementation Plan (EJ Plan). The EJ Plan will serve as a guide to confront environmental and health disparities and implement a strategy to serve vulnerable populations and communities disproportionately impacted by environmental burdens.
Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products
In 2015, the FDA issued an advanced notice of proposed rulemaking (ANPRM) and solicited comments on whether/how FDA should regulate nicotine warnings and child-resistant packaging for e-liquids containing nicotine as well as potentially other novel types of nicotine-based tobacco products e.g. gels and dissolvables.
National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions
In 2015, the FDA issued its final rule implementing regulations for the National Environmental Policy Act. This rule created categorical exclusions for substantial equivalence reports, exemption reports, tobacco product applications, and rescission/suspension of orders. These actions do not require an Environmental Assessment.
Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco
The FDA issued this rule in conjunction with the Deeming Rule to require domestic manufacturers and importers of cigars and pipe tobacco to provide information to FDA in order to assess and collect applicable fees.
In 2012, the FDA issued an established list of harmful and potentially harmful constituents to tobacco products. A proposed amendment to the original notice adding additional constituents to the proposed list, primarily reflecting upon those constituents to e-liquids, electronic cigarettes, and other novel tobacco products, was issued in 2019.
Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act
In 2014, the FDA issued a proposed rule - known broadly as the "Deeming Rule" - to bring a broad range of tobacco products under its regulatory oversight, including electronic cigarettes and cigars. The rule became effective on August 8, 2016. A citizen petition requesting that the FDA assert jurisdiction over other products was filed in 2014.
In 2016, the FDA issued a proposed rule regarding its process for refusing to accept Premarket Tobacco Product Applications that do not meet the "minimum threshold for acceptability." The rule took effect on March 21, 2017.
In 2017, the FDA issued a proposed rule that would set forth requirements and limits on the amount of N-nitrosonornicotine (NNN) in smokeless tobacco products. NNN is a known to have carcinogenic properties and is associated with elevated cancer risk for smokeless tobacco product use.
In 2018 the FDA issued an advance notice of proposed rulemaking (ANPRM) regarding setting a maximum limit on permissible nicotine levels in some or all tobacco products. Preliminary research suggested a lower nicotine ceiling could make initiation to tobacco products less likely and cessation easier, especially for youth and young adults.
In 2018, the FDA issued an advance notice of proposed rulemaking (ANPRM) regarding the regulation and restriction of flavored tobacco products. The ANPRM sought information and comments on 1) whether and how flavors attracted youth to initiate tobacco product use, and 2) whether and how flavors may help adult consumers reduce cigarette use and "switch to potentially less harmful" products.
The FDA issued an advance notice of proposed rulemaking (ANPRM) in 2018, regarding the proposed regulation on premium cigars. FDA had deemed premium cigars within the scope of its regulatory authority for tobacco products in 2016, and thereby sought additional comments and research input pertinent to 1) the definition for premium cigars, 2) use patterns for premium cigars, and 3) public health considerations specific to, or otherwise pertinent to, premium cigars.
Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports
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.