A couple of years ago we posted an overview of state licensing and excise tax considerations for tobacco companies. In this post, we take a closer look at state excise tax considerations. When approaching state excise tax issues, it may be helpful to establish a checklist to help manufacturers, distributors, and retailers determine the impact of these laws on their products and distribution models.Continue Reading State Excise Tax Considerations for Tobacco and Nicotine Manufacturers, Distributors and Retailers
Over the past decade, at least five states and hundreds of localities have passed, or attempted to pass, laws banning flavored tobacco products. To date, litigants have brought many challenges to these laws, often arguing that such bans are preempted under the federal Family Smoking Prevention and Tobacco Control Act (TCA). This argument, however, has largely proven unsuccessful — a trend that continued in January when the U.S. Supreme Court declined to hear R.J. Reynolds Tobacco Company’s challenge to California’s ban on the sale of flavored tobacco products.Continue Reading US Supreme Court Declines to Hear Challenge to California’s Flavor Ban
We recently reported that several state legislatures are considering bills to establish vapor product directories this year—namely Florida, Indiana, Missouri, and Virginia. Throughout January and early February, similar bills have been introduced in Arizona, Hawaii, Iowa, Nebraska, New York, South Carolina, South Dakota, Vermont, Washington, West Virginia. Additionally, a bill in Oklahoma would update the state’s existing directory framework to be consistent with the proposals of these recent bills. The directories would allow states to prohibit the sale of vapor products that are not authorized by the U.S. Food & Drug Administration (FDA) or subject to a pending premarket application. Like the proposals discussed in our previous coverage, these bills are intended to reduce the proliferation of illicit vapor products.Continue Reading More States Consider Establishing Vapor Product Directories
In early January, the U.S. Court of Appeals for the Fifth Circuit, sitting en banc in Wages & White Lion Investments, L.L.C. v. U.S. Food & Drug Administration, held that the U.S. Food and Drug Administration’s (FDA) marketing denial order (MDO) of petitioner’s premarket tobacco applications (PMTAs) violated the Administrative Procedure Act (APA).Continue Reading En Banc Fifth Circuit Solidifies Circuit Split on Flavored ENDS Product MDOs
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.Continue Reading FDA’s Center for Tobacco Products Releases Annual Regulatory Agenda
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.Continue Reading Multiple States Consider Establishing Vapor Product Directories
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 with industry professionals, and obtain expert guidance and tools for navigating the regulatory landscape.
Bryan Haynes and Agustin Rodriguez of the Troutman Pepper Tobacco + Nicotine Team will participate in the TPE “Fortify Your Future” Education Sessions sponsored by Chemular. Bryan will participate in a panel discussion on “The Future of Flavors,” in which panelists will discuss the legal status of flavored cigars and menthol cigarettes today, tomorrow and for the future. Agustin will present on compliance with the federal Prevent All Cigarette Trafficking Act and state excise tax requirements, including key compliance processes and considerations for online retailers.
We look forward to seeing our clients and friends at TPE24.
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.Continue Reading FDA’s Center for Tobacco Products Publishes Strategic Plan
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.Continue Reading FDA Maintains Heightened Enforcement Against Sellers of Illegal E-Cigarettes
In 2021 we wrote about the California Office of Environmental Health Hazard Assessment’s (OEHHA) plans to amend regulations governing Proposition 65 (Prop 65) short-form warning labels. On May 20, 2022, however, OEHHA notified the public that it was unable to complete the regulatory process within the required time period (i.e., one year of the date it was first noticed to the public), and that it instead intended to restart the process with a new regulatory proposal. OEHHA issued its Notice of Proposed Rulemaking Clear and reasonable Warnings: Short-form Warnings on October 27, 2023, and on November 30, 2023 issued a notice that it will hold a public hearing on December 13, 2023. The public may submit comments until December 20, 2023.Continue Reading California Considers Modifying Prop 65 Warning Requirements (Again)