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.

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.

On Friday, November 13, 2020, a federal district court entered a preliminary injunction against the City of Philadelphia’s Ordinance 180457, which purported to ban the sale of flavored tobacco products, with minor exceptions.  As in all cases where a preliminary injunction is entered, the court found that the Plaintiffs demonstrated a likelihood of success on the merits and would be irreparably harmed absent an injunction, and that the balance of the equities and the public interest weighed in favor of an injunction.

On October 27, FDA issued a new draft guidance, entitled “Tobacco Products:  Principles for Designing and Conducting Tobacco Product Perception and Intention Studies.”  The draft guidance describes the FDA Center for Tobacco Products’ proposed recommendations on designing and conducting tobacco product perception and intention studies (TPPI).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. 

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 …

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 …

Plaintiffs have appealed to the Eighth and Ninth Circuits, challenging flavored tobacco bans in Los Angeles County, California, and the City of Edina, Minnesota. The cases could have implications for similar laws in other States and localities.

Has Congress preempted local authority to ban the sale of flavored tobacco products? Two different U.S. Courts of Appeals will have the opportunity to answer the question in R.J. Reynolds Tobacco Co., et al. v. City of Edina, et al., No. 20-2852 (8th Cir.), and R.J. Reynolds Tobacco Co., et al. v. Los Angeles County, et al., No. 20-55930 (9th Cir.).

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.

On Thursday, July 30, 2020, Democratic Senator Tina Smith (D-MN) filed a new bill to federally legalize marijuana. The bill, titled the “Substance Regulation and Safety Act,” would “decriminalize and deschedule cannabis” and provide for its regulation by removing both marijuana  and tetrahydrocannabinols from the Controlled Substance Act and giving the Food and Drug Administration the authority to regulate cannabis products in the same manner, and to the same extent, as FDA regulates tobacco products.