On February 16, 2021, the Food and Drug Administration published the long-awaited “public list” of “deemed” tobacco products that:  (1) were on the US market on August 8, 2016, (2) are currently on the U.S. market, and (3) were the subject of a request for marketing authorization submitted to FDA by September 9, 2020. The stated intent of the “public list” is to advise stakeholders of “deemed” tobacco products that can be legally sold in the United States.  However, FDA’s approach to the list leaves critical gaps that, in many cases, fails to apprise stakeholders of unlawfully marketed products and, in other cases, fails to identify products that are lawfully marketed.
Continue Reading FDA Publishes “Public List” of Deemed Tobacco Products, But Leaves Critical Flaws in Apprising Stakeholders of Lawfully-Marketed Products

On February 19, 2021, a proposed rule from the U.S. Postal Service (the “USPS”), regarding the treatment of electronic nicotine delivery systems (“ENDS”) in the mail, was published in the Federal Register. The USPS will receive comments on or before March 22, 2021.
Continue Reading U.S. Postal Service Issues Proposed Rule Regarding ENDS Nonmailability and Exceptions

The Biden administration and Democratic majorities in both the Senate and House could implement significant changes to federal tobacco and cannabis policy over the next two years. For tobacco, the change in party control of the White House and Senate will likely revive the debate around electronic nicotine delivery systems (ENDS) products. For cannabis, the policy may shift toward outright reform (such as federal decriminalization or legalization), federal taxation, or the enactment of legislation beneficial to the cannabis industry.
Continue Reading Tobacco & Cannabis Policy in 2021

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.
Continue Reading THC, CBD and other Non-tobacco Vaping Product Sellers Should Take Note of New PACT Act Provisions

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.
Continue Reading DC Circuit Decides Deeming Rule Doesn’t Violate Appointments Clause or First Amendment

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.
Continue Reading California Attorney General Continues Fight to Ban Flavored Tobacco Products

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. 
Continue Reading FDA Releases Draft Guidance on the Design and Conduct of Tobacco Product and Intention Studies

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 the review of FDA requests

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 this space. There are many

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.
Continue Reading FDA Premarket Review Process for Premium Cigars Halted