We recently discussed the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products’ (CTP) strategic plan intended to guide CTP’s activity for the next five years. On the same day, CTP released its annual regulation and policy guidance agenda, which “outlines rules and guidance documents that are in development or planned for development.” Below, we discuss CTP’s current priorities for new regulations. CTP’s policy agenda is important because it identifies the areas CTP views as most in need of regulation or guidance, and the key actions it plans to take in those areas.
Multiple States Consider Establishing Vapor Product Directories
This year, several state legislatures will consider bills to establish vapor product directories. Amid heightened scrutiny of illicit vapor products by the U.S. Food and Drug Administration (FDA), these product directory bills would create a mechanism for states to bar the sale of products that are not FDA-authorized or subject to a pending premarket application. Like state cigarette directories implemented in connection with the tobacco Master Settlement Agreement, these directories would specify which vapor products are permitted to be sold in the state.
Troutman Pepper Tobacco + Nicotine Team to Present at TPE24
The Troutman Pepper Tobacco + Nicotine Team will attend the Total Product Expo in Las Vegas, January 31 to February 2. TPE is a business-to-business trade show that brings manufacturers, distributors and retailers together under one roof, providing an opportunity for companies to exhibit their products, connect with buyers, network
FDA’s Center for Tobacco Products Publishes Strategic Plan
The Food and Drug Administration’s Center for Tobacco Products (“CTP”) has released a strategic plan intended to guide the Center’s activity for the next five years. While the strategic plan highlights the laudable goals of regulatory clarity, stronger enforcement against non-compliant actors and more timely and transparent application review, the plan is problematic in that it promotes an agenda of burdensome new regulations and does not provide a clear emphasis on the promotion of less harmful alternatives in the tobacco and nicotine marketplace.
FDA Maintains Heightened Enforcement Against Sellers of Illegal E-Cigarettes
In December, the U.S. Food and Drug Administration (FDA) issued warning letters to online retailers for reportedly selling unauthorized e-cigarette products. Consistent with the Center for Tobacco Products’ (CTP) recent focus, the letters target unauthorized products, which FDA states are particularly appealing to youth — including Lost Mary, Funky Republic/Funky Lands, and Elf Bar/EB Design. These warning letters follow FDA’s recent issuance of civil money penalty complaints against 25 brick-and-mortar retailers for failing to comply with prior warning letters. Those civil money penalty complaints, which we previously discussed here, continued the agency’s approach of seeking the maximum penalty approved by law.
FDA Continues ENDS Enforcement with New Injunction and Civil Money Penalty Proceedings
The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and retailers. The agency has been criticized for not doing enough to fight the sale of unauthorized vapor products, but these actions should at least remind manufacturers and retailers that the agency’s warning letters are not empty threats.
Troutman Pepper Tobacco + Nicotine Team to Attend FDLI Enforcement Conference
Bryan Haynes and Agustin Rodriguez of the Troutman Pepper Tobacco + Nicotine team will attend the Food and Drug Law Institute 2023 Enforcement Conference on Wednesday, December 6 in Washington D.C.
The conference will have two panels discussing hot topics in tobacco and nicotine enforcement and litigation matters. Bryan Haynes
ENDS Companies Take Legal Action Against Allegedly Noncompliant Competitors
Recently, NJOY LLC filed a complaint in the U.S. District Court for the Central District of California against more than 30 foreign and domestic defendants that manufacture, market, distribute, and sell tobacco products in an (indirect) effort to force them to comply with federal and state laws. R.J. Reynolds Tobacco Company and R.J. Reynolds Vapor Company (collectively, RJR) also recently filed a complaint with the U.S. International Trade Commission (ITC) against more than 25 foreign and domestic manufacturers, distributors, and retailers (collectively, the respondents) that seeks to prevent the import and resale of certain tobacco products. These lawsuits serve as two examples of how industry is trying to take independent legal action to target allegedly noncompliant actors and force them to comply with applicable law.
Members of Congress Propose Massive Tobacco Tax Increase
- double the federal tobacco products excise tax on cigarettes, small cigars and roll-your-own tobacco,
- increase the pipe tobacco tax rate to the same
FDA Ramps Up Enforcement Against Flavored Disposable E-Cigarettes as External Pressures Mount
In September, the U.S. Food and Drug Administration (FDA) issued two new rounds of warning letters to online retailers, manufacturers, and distributors for reportedly selling or distributing unauthorized e-cigarette products. Notably, FDA’s most recent letters target several popular disposable flavored products, including Elf Bar, EB Design, Lava, Cali, Bang, and Kangertech, which FDA states are particularly appealing to youth. FDA also sought civil money penalties against 22 retailers for failing to comply with prior warning letters and, for the first time, sought the maximum penalty allowed by law.