On June 10, a bipartisan coalition of 31 state attorneys general, led by Idaho, Illinois, Nebraska, and Pennsylvania, sent a letter to Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf, asking the agency to reject premarket tobacco product applications (PMTAs) for all products that contain nicotine not derived from tobacco, also known as non-tobacco nicotine (NTN) or synthetic nicotine. Continue Reading Bipartisan Coalition of 31 State AGs Urge FDA to Deny Marketing Authorization for Non-Tobacco Nicotine Products
Deeming Regulations Litigation Update – FDA Files Status Report on Pending PMTAs for Popular Vapor Products
Status report concerns FDA’s review of 240 PMTAs submitted on or before September 9, 2020, for vapor products with larger market shares. FDA estimates that it will resolve most of these in the periods before July 2022 and from April through June 2023.
Pursuant to an order entered by Judge Paul W. Grimm in American Academy of Pediatrics, et al. v. FDA, et al., No. 8:18-cv-00883 (D. Md.), on May 13, 2022, FDA filed its first status report regarding its review of pending premarket tobacco applications (“PMTAs”) for certain popular vapor products. Continue Reading Deeming Regulations Litigation Update – FDA Files Status Report on Pending PMTAs for Popular Vapor Products
Troutman Pepper Tobacco Team to Participate in Food and Drug Law Institute (FDLI) Annual Conference
Bryan Haynes and Agustin Rodriguez of the Troutman Pepper Tobacco Team will be at FDLI Annual Conference on June 14-15 in Washington, DC. This is FDLI’s first in-person conference since 2019. The conference brings together leading regulators, attorneys, industry representatives, academics, consumer advocates, and consultants to discuss current issues and latest trends in tobacco, nicotine and other FDA-regulated products. Learn more and register here. Sign up with the discount code annual15 for 15% off registration.
Bryan Haynes will be presenting in a panel discussion titled Menthol and Other Tobacco Product Standards. In April 2022, FDA proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and to prohibit all characterizing flavors—other than tobacco—in cigars. This panel will provide an overview of these proposed rules, discuss the definition of “characterizing flavor,” and address the potential intended and unintended impacts these product standards may have on public health. Speakers will also discuss how these standards fit into broader harm reduction efforts, considering the impact this may have on health equity, as well as vis-à-vis menthol- and mint-flavored electronic nicotine delivery systems.
We look forward to seeing clients and friends at the conference.
Ninth Circuit Denies Petition for Rehearing en Banc in Appeal over Preemption of Los Angeles County’s Flavored Tobacco Ban
The U.S. Court of Appeals for the Ninth Circuit has denied the Plaintiffs’/Appellants’ petition for a rehearing en banc following a divided panel’s holding that the Family Smoking Prevention and Tobacco Control Act neither expressly nor impliedly preempts Los Angeles County’s ban on the sale of flavored tobacco products.
On May 11, 2022, a divided panel of the U.S. Court of Appeals for the Ninth Circuit denied a petition for rehearing en banc filed by Plaintiffs/Appellants R.J. Reynolds Tobacco, Inc., American Snuff Co., and Santa Fe Natural Tobacco Co. (together, the “Plaintiffs/Appellants”) in R.J. Reynolds Tobacco Co., et al. v. Los Angeles County, et al., No. 20-55930. As discussed more fully by Troutman Pepper in Vapor Voice, the same panel earlier held in a split 2-1 decision that Los Angeles County’s flavored tobacco ban is not preempted by the Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (June 22, 2009) (the “TCA”). Continue Reading Ninth Circuit Denies Petition for Rehearing en Banc in Appeal over Preemption of Los Angeles County’s Flavored Tobacco Ban
Cigarette Companies and Federal Government Reach Agreement on Warnings to be Displayed in Retail Stores
Retailers should take note that Philip Morris USA Inc., Altria Group, Inc, R.J. Reynolds Tobacco Company have reached an agreement with the United States Department of Justice on warnings to be placed in retail stores carrying the manufacturers’ cigarettes to warn consumers about the health effects of tobacco. These are referred to as “corrective-statement signs” because they are meant as “corrections” to the manufacturers’ alleged deliberate misleading of consumers as to the dangers of smoking from the 1950s until the early 2000s. Continue Reading Cigarette Companies and Federal Government Reach Agreement on Warnings to be Displayed in Retail Stores
Virginia Enacts Tobacco Products Tax Law Applicable to Remote Retail Sales of Cigars and Pipe Tobacco
New Virginia law addresses excise taxation and other requirements regarding remote retail sales of cigars and pipe tobacco to consumers in the Commonwealth.
On April 27, 2022, the Virginia General Assembly passed House Bill 1199 and Senate Bill 748 regarding the application of the Commonwealth’s tobacco products tax on “remote retail sales” of cigars and pipe tobacco and related requirements. Continue Reading Virginia Enacts Tobacco Products Tax Law Applicable to Remote Retail Sales of Cigars and Pipe Tobacco
Vermont Continues Its Crackdown on Online ENDS Sellers
Last year we reported that Vermont Attorney General T.J. Donovan’s office settled with several online sellers over alleged violations of the state’s delivery sales ban of electronic nicotine delivery systems (ENDS) (the Delivery Sale Ban) and that we expected Vermont’s scrutiny to continue. As predicted, Attorney General Donovan’s office recently announced two more settlements with online sellers, resulting in a total of 23 settlements with online ENDS sellers for a total of $833,750 in civil penalties dating back to December 2020. Continue Reading Vermont Continues Its Crackdown on Online ENDS Sellers
Deeming Regulations Litigation Update—Federal Court Exercises Even More Oversight over FDA’s PMTA Review
Under Judge Grimm’s Revised Remedial Order, FDA must submit quarterly status reports regarding its review of pending PMTAs for certain popular vapor products.
On April 15, 2022, Judge Paul W. Grimm of the U.S. District Court for the District of Maryland ordered FDA to submit status reports to the Court and to the Plaintiffs in the case every ninety days, beginning on April 29th. Continue Reading Deeming Regulations Litigation Update—Federal Court Exercises Even More Oversight over FDA’s PMTA Review
Troutman Pepper Tobacco Team Featured in Vapor Voice Post on Ninth Circuit’s Holding that L.A. County’s Flavor Ban Is Not Preempted
In a 2-1 decision, a panel of the U.S. Court of Appeals for the Ninth Circuit held that the Family Smoking Prevention and Tobacco Control Act neither expressly nor impliedly preempts Los Angeles County’s ban on the sale of flavored tobacco products.
In a Vapor Voice posting on April 2, 2022, the Troutman Pepper Tobacco Team provided a breakdown of the Ninth Circuit’s 2-1 decision that Los Angeles County’s flavored tobacco ban is not preempted by the Family Smoking Prevention and Tobacco Control Act. Kudos to Troutman Pepper Tobacco Team associate Robert Claiborne for his work on the piece, which follows up on this blog’s previous coverage of the case here and here.
Dr. Califf Takes the Reins at FDA: Five Takeaways for the Tobacco Industry
On February 15, the Senate confirmed cardiologist Robert M. Califf, M.D., to lead the U.S. Food and Drug Administration (FDA). He’s no stranger to the agency. Dr. Califf served a brief stint as FDA’s commissioner of food and drugs from February 2016 to January 2017, and before that, he was deputy commissioner for medical products and tobacco from February 2015 until February 2016. So what might his appointment mean for the tobacco industry? We have five takeaways.
Continue Reading Dr. Califf Takes the Reins at FDA: Five Takeaways for the Tobacco Industry