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), industry expert insights and customer-centric data.

Bryan will present the Tobacco and E-Vapor Regulatory Update – Assessing the Current Landscape and Predictions for 2022.  Local, state and federal regulations, combined with new taxes and health warnings, add pressure to c-store tobacco and nicotine sales in 2022. Where is the FDA in its process to assess/approve/deny applications for new products? Are tax increases driving your customers across state lines? Will the FDA or other governmental authorities ban flavored tobacco products?  How will other FDA regulations impact the category?  Uncertainty still reigns in this category that remains the top sales and profit generator in the c-store channel.  Bryan will address these issues and more. 

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 – agustin.rodriguez@troutman.com

Click here for more information on the TPE.

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

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.” Continue Reading New Regulations Potentially on the Horizon for Synthetic Nicotine in 2022

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. Continue Reading Troutman Pepper Tobacco Team to Present at FDLI Enforcement Conference

The U.S. Postal Service (USPS) has made available the Field Information Kit and Management Instructions referenced in its November 4, 2021 Postal Bulletin, correcting hyperlinks in the Postal Bulletin. The Field Information Kit and the Management Instruction are posted to the USPS website, available here and here, respectively. Continue Reading US Postal Service Posts PACT Act/POSECCA Field Information Kit and Management Instructions

Bryan Haynes of the Troutman Pepper Tobacco Team was quoted in a recent Vapor Voice article on a proposed new nicotine tax that has been proposed in Congress.

Currently proposed as part of the so-called “Build Back Better” legislation, the bill would impose a new federal excise tax on “taxable nicotine.”  The bill would primarily impact the vaping industry and its consumers by taxing nicotine used in e-liquids on par with cigarettes and at higher rates than other tobacco products, such as cigars and pipe tobacco.  A prior version of the bill would have also raised federal excise tax rates for all tobacco products, but that proposal seems to have been abandoned, at least for now. Continue Reading Troutman Pepper Tobacco Team Quoted in Vapor Voice Article on Proposed Nicotine Tax