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

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 issues ranging from menthol and

The U.S. District Court for the Eastern District of Pennsylvania entered a permanent injunction against Philadelphia’s enforcement of an ordinance banning the sale of certain flavored tobacco products, after the U.S. Court of Appeals for the Third Circuit upheld a preliminary injunction against the same.

Litigation over a local flavor ban came to a close on March 8, 2022, with Judge Gene E.K. Pratter of the U.S. District Court for the Eastern District of Pennsylvania entering a permanent injunction:

  • prohibiting the City of Philadelphia from enforcing City Ordinance No. 180457 (the “Ordinance”); and
  • requiring the City to void and withdraw any and all regulations regarding the Ordinance.

The case is Cigar Association of America, et al. v. City of Philadelphia, et al., No. 2:20-cv-03220 (E.D. Pa.).

Continue Reading Philadelphia Flavor Ban Case Results in Permanent Injunction Against the City

In August 2021, Swisher International Inc. filed a lawsuit against the Food and Drug Administration (FDA) seeking to have the FDA’s Deeming Rule declared invalid. Swisher followed its lawsuit with a petition for injunction to prevent FDA from taking enforcement action against Swisher while Swisher’s lawsuit against the FDA’s implementation of the Deeming Rule is under consideration and while the FDA processes Swisher’s pending 173 premarket applications. On February 3, 2022, the Eleventh Circuit Court of Appeals upheld a lower court’s denial of a motion for a preliminary injunction finding that Swisher was not likely to suffer “irreparable harm.”
Continue Reading Eleventh Circuit Denies Swisher International’s Request For An Injunction of Further Enforcement by FDA

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 education (including tobacco and e-vapor),

Bryan Haynes and Agustin Rodriguez of the Troutman Pepper tobacco team will be attending the Tobacco Plus Expo in Las Vegas on January 26-28, 2022.  We look forward to seeing our clients and friends at the show.

For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 – bryan.haynes@troutman.com or Agustin Rodriguez, at 804.697.1381 –

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.
Continue Reading In a First, FDA Authorizes Marketing of Low-Nicotine Cigarette as “Modified Risk Tobacco Product”

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.
Continue Reading State Licensing and Excise Tax Considerations for Tobacco Companies

The scope and scale of state attorneys general investigations has expanded for several reasons, including a perceived lack of enforcement at the federal level. Many state attorneys general are not reticent to fill a perceived regulatory void, and they routinely conduct investigations and bring enforcement actions when they observe a federal agency is not moving fast enough or otherwise has neglected its responsibility.
Continue Reading Five Tips for When State Attorneys General Come Knocking