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.
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.
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.
Bill Regulating Synthetic Nicotine Clears Congress
As part of a federal funding bill, language giving the Food and Drug Administration authority over synthetic nicotine, and any other nicotine that is not derived from tobacco, was passed by Congress on March 11. President Biden is expected to sign the bill into law soon.
Troutman Pepper Tobacco Team to Attend TMA 2022: Policy and Practice
Bryan Haynes, Agustin Rodriguez and Nick Ramos of the Troutman Pepper Tobacco Team will attend TMA 2022: Policy & Practice in Leesburg, Virginia on March 28-30, 2022. This is TMA’s first in-person conference since 2019 and comes as the tobacco and nicotine industry is at another crossroads as we confront
Troutman Pepper Tobacco Team to Present at Convenience Retailing University
Bryan Haynes of the Troutman Pepper Tobacco Team will present at CSP’s Convenience Retailing University (CRU) on February 24 in Orlando, Florida. CRU is a conference dedicated to category manager education. This event gathers leading convenience store buyers and sellers to connect and build meaningful relationships while offering designated category
In a First, FDA Authorizes Marketing of Low-Nicotine Cigarette as “Modified Risk Tobacco Product”
Some cigarette pack labels may soon feature the phrases “95% less nicotine,” “helps reduce your nicotine consumption,” and “… greatly reduces your nicotine consumption.” On December 23, 2021, the Food and Drug Administration (FDA) issued modified risk granted orders to 22nd Century Group, Inc.’s VLN King and VLN Menthol King cigarettes, allowing the company to market the low-nicotine cigarettes with these proposed reduced exposure claims if the company adds the phrase “Helps you smoke less.” Of course, the company’s products will continue to be required to bear one of four Surgeon General’s warnings for cigarettes.
State Licensing and Excise Tax Considerations for Tobacco Companies
While it is always a good idea to focus on maintaining a healthy regulatory compliance program, the start of a new year seems like a particularly good time to review your tobacco company’s corporate hygiene with respect to state regulatory compliance. In this blog post, we provide a general overview of the state tobacco licensing and excise tax framework throughout the U.S. in a Q&A format. We also provide some general guidance about how to approach such laws and regulations. Tobacco companies, especially those operating in multiple states, should incorporate an appropriate state licensing and excise tax strategy into their compliance programs. Noncompliance with the myriad of state licensing and excise tax laws could have a significant impact on a tobacco company’s ability to operate and sell its products.
New Regulations Potentially on the Horizon for Synthetic Nicotine in 2022
On December 15, New Jersey Congresswoman Mikie Sherrill introduced the Clarifying Authority Over Nicotine Act of 2021 — a bipartisan bill designed to give the U.S. Food and Drug Administration (FDA) the authority to regulate synthetic nicotine products just as it regulates nicotine products made or derived from tobacco. In a press release, Rep. Sherrill stated, “This bill will ensure all tobacco products, including products made with synthetic nicotine, are regulated by the FDA in order to protect kids in our communities and those who may seek to use these products.”
Troutman Pepper Tobacco Team to Present at FDLI Enforcement Conference
Bryan Haynes of the Troutman Pepper Tobacco Team will be presenting on FDA Tobacco Enforcement in a Post-Compliance Policy World: Current Status and Future Implications, as part of the Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference on December 9-10.