On December 22, 2020, we blogged about the omnibus 2021 Consolidated Appropriations Act passed by Congress, which included legislation extending the applicability of the Prevent All Cigarette Trafficking (“PACT”) Act to electronic nicotine delivery systems or “ENDS.” The legislation, called the ‘‘Preventing Online Sales of E-Cigarettes to Children Act,’’ sweeps ENDS into the PACT Act by amending the PACT Act’s definition of a cigarette to include electronic nicotine delivery systems, thereby subjecting remote sales of these products to various requirements and restrictions. Another important feature of this new law is that the defined term “ENDS” in this new legislation actually covers more than electronic nicotine delivery systems.
DC Circuit Decides Deeming Rule Doesn’t Violate Appointments Clause or First Amendment
By Robert Claiborne, Dascher Pasco & Bryan Haynes, Troutman Pepper Hamilton Sanders LLP
Did the FDA violate the Constitution when it issued its rule Deeming Tobacco Products to Be Subject to the Federal Food, Drug, & Cosmetic Act, 81 Fed. Reg. 28,973 (May 10, 2016) (the “Deeming Rule”)? No, according to a recent decision from the U.S. Court of Appeals for the D.C. Circuit.
California Attorney General Continues Fight to Ban Flavored Tobacco Products
As many in the tobacco industry know, there is a growing trend among state and local governments to prohibit or restrict the sale of flavored tobacco or nicotine products. Some governments are focusing on narrow subsets of flavored tobacco or nicotine products, like vapor products or electronic cigarettes, while others are intent on a broader prohibition or restriction that might include more traditional products like cigarettes, cigars, or smokeless tobacco. At the state level, Attorneys General have been at the forefront of the ensuing legal battles over this type of legislation.
FDA Releases Draft Guidance on the Design and Conduct of Tobacco Product and Intention Studies
On October 27, FDA issued a new draft guidance, entitled “Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies.” The draft guidance describes the FDA Center for Tobacco Products’ proposed recommendations on designing and conducting tobacco product perception and intention studies (TPPI). Such studies may be submitted as part of FDA tobacco product applications, including modified risk tobacco product (MRTP) applications, premarket tobacco applications (PMTA) and substantial equivalence (SE) reports.
Troutman Pepper Tobacco Team Presents at FDLI Tobacco and Nicotine Products Regulation and Policy Conference
Bryan Haynes of the Troutman Pepper Tobacco Team presented at the Food and Drug Law Institute Tobacco and Nicotine Products Regulation and Policy Conference on October 23, 2020.
Bryan participated in a panel discussion entitled “The Post-PMTA Deadline Landscape: What Happens After September 9th?” The panelists discussed enforcement, compliance and
Troutman Pepper Tobacco Team Featured in Vapor Voice Article discussing Legal Issues Related to the Online Sale of ENDS to Consumers
By Troutman Pepper Tobacco Practice, Bryan Haynes, Agustin Rodriguez, & Nicholas Ramos on October 22, 2020
Online businesses selling electronic nicotine delivery systems (ENDS) to consumers must contend with a “patchwork quilt” of state laws. This patchwork of laws creates significant regulatory uncertainty and risk for businesses selling online in
FDA Premarket Review Process for Premium Cigars Halted
On Wednesday, August 19, 2020, the U.S. District Court for the District of Columbia issued an order enjoining FDA from enforcing the premarket review requirement contained in the agency’s “Deeming Rule” against “premium cigars” (as defined in the order) until the agency completes a review of the question of “whether a streamlined substantial equivalence process is appropriate for premium cigars.” The opinion does not throw out the Deeming Rule in its entirety but only remands it to the agency for further consideration of this question.
Troutman Sanders Tobacco Team Featured in Vapor Voice Article on FDA Enforcement Against Allegedly Youth-Appealing Products
In a May 21, 2020 Vapor Voice article, the Troutman Sanders Tobacco Team discuss the FDA’s enforcement actions against manufacturers and retailers whose electronic nicotine delivery system (ENDS) products and “other components” allegedly target youth. Having targeted flavored e-liquid products, ENDS items that resemble food and ENDS products that
Troutman Sanders Tobacco Team to Participate in TMA Virtual Conference
TMA is presenting an unprecedented digital conference addressing the business and policymaking of the tobacco and nicotine industries. Titled “Unsteady Ground: Shifting Landscapes,” this eight-part series is a must for industry members seeking to stay abreast of recent initiatives and to gain insights on future developments.
Bryan Haynes of the
Troutman Sanders Tobacco Team Featured in the August 2019 SMOKESHOP Magazine Article Regarding Trump’s Limits on Federal Regulations that Could Impact FDA Tobacco Regulations
In the August 2019 edition of SMOKESHOP Magazine, Troutman Sanders attorneys Robert Claiborne and Bryan Haynes discuss the tobacco regulatory implications of President Trump’s 2017 Executive Order 13771 reducing regulation and adding cost controls. The Office of Management and Budget (OMB) issued guidance surrounding the Order which prompted a