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.

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.

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.

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.

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.