In late June, the U.S. District Court for the District of Montana held that federal law preempts the Montana Attorney General (AG) from removing the cigarette brands of Grand River Enterprises Six Nations, Ltd. (Grand River) from the state tobacco directory based on Grand River’s alleged violations of the Federal Food, Drug, and Cosmetics Act (FDCA). The FDCA preempts state law actions based solely on FDCA violations if the U.S. Food and Drug Administration (FDA) has not already found that such violations exist, the court explained.

Continue Reading Federal Court Rules Montana AG Preempted from De-Listing Cigarette Manufacturer

In this post, we take a closer look at state tobacco and nicotine product licensing considerations. When approaching state licensing issues, it may be helpful to establish a checklist to help manufacturers, importers, distributors, and retailers determine the impact of these laws on their products and distribution models. State licensing requirements can be complicated but, with a basic understanding of the key issues described below and good practices, manufacturers, importers, distributors, and retailers can ensure they remain compliant.  

Continue Reading State Licensing Considerations for Tobacco and Nicotine Product Manufacturers, Importers, Distributors, and Retailers

In the first half of 2024, the U.S. Food and Drug Administration (FDA) continued ramping up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened enforcement against sellers of unauthorized ENDS in 2023 and predicted that this pattern of enforcement would continue. A year-to-date review of 2024 shows that FDA is placing a high priority on action against unauthorized ENDS. 

Continue Reading FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

We have previously reported on the proliferation of tobacco product flavor bans imposed by localities and subsequent legal challenges throughout the U.S. See Oregon Court Upholds Local Tobacco Product Flavor Ban; Troutman Pepper Tobacco Team Featured in Vapor Voice Post on Ninth Circuit’s Holding that L.A. County’s Flavor Ban Is Not Preempted; Philadelphia Flavor Ban Case Results in Permanent Injunction Against the City. In another example of locality action on this issue, the San Francisco City Attorney’s Office initiated a lawsuit against three California-based e-cigarette distributors (defendants), alleging violations of the city’s ban on flavored tobacco products and California law. The lawsuit was filed in the Superior Court of California, County of San Francisco. The case has been dismissed as to one of the defendants, but the litigation remains active against the other defendants.Below is a summary of the city’s allegations against the defendants.

  • The city alleges that the defendants engaged in unlawful business acts and practices in violation of the California Business and Professions Code for the following reasons:

    • The unlawful sale of flavored tobacco products to people in San Francisco, in violation of Section 19S.2 of the San Francisco Health Code;

    • The unlawful sale of e-cigarettes to people in San Francisco, also in violation of Section 19S.2 of the San Francisco Health Code; and

    • Failure to comply with mandatory procedures in Section 22963(b) of the Business and Professions Code, a provision of the Stop Tobacco Access to Kids Enforcement Act, which includes requirements to call the purchaser after 5 p.m. prior to shipping tobacco products, and to deliver the tobacco product in a container conspicuously labeled with the words: “CONTAINS TOBACCO PRODUCTS: SIGNATURE OF PERSON 21 YEARS OF AGE OR OLDER REQUIRED FOR DELIVERY.”
    The city alleges that the defendants violated the San Francisco Health Code for the following reasons:

    • The defendants sold flavored tobacco products and e-cigarettes to consumers in San Francisco, which is prohibited under Section 19S.2 of the San Francisco Health Code;

    • The products sold included flavored e-liquids and disposable e-cigarettes, which are classified as “flavored tobacco products” and “electronic cigarettes” under the San Francisco Health Code; and

    • The defendants’ products are new tobacco products requiring premarket review under federal law, but they do not have premarket review orders.
    • The city seeks injunctive relief to stop these practices and civil penalties for each violation of the Business and Professions Code Section 17200 and San Francisco Health Code Section 19S.2.

    If the court rules in favor of the city, the defendants could face significant financial penalties and be compelled to cease their operations within San Francisco. This case is yet another example of enforcement of local public health regulations and the broader war that some states and localities are waging against flavored e-cigarettes and tobacco products. As the legal proceedings unfold, they should be closely monitored by public health advocates, the e-cigarette industry, and regulatory bodies alike.

    Agustin Rodriguez and Cole White of the Troutman Pepper Cannabis Team will be attending the 2024 CANNRA External Stakeholders Meeting. This in-person event will be held in Minneapolis, MN from June 3-6, 2024, and presents a great opportunity for government and industry members to share perspectives on issues related to regulatory compliance and policy.

    The Cannabis Regulators Association is a nonpartisan, nonprofit 501(c)(4) association of government agencies engaged in cannabis and cannabinoid regulation across 45 states, two U.S. territories, Canada, and the Netherlands. The purpose of the 3rd Annual External Stakeholder Meeting is to bring together a diverse array of national and international stakeholders from across the cannabis, cannabinoid, and hemp space to engage in discussions with CANNRA member regulators and other attendees on regulatory and policy topics. This year’s meeting will be focused across three content tracks:

    1. Emerging Topics in Regulatory Science
    2. Consumer and Product Safety, Research & Public Health
    3. Social and Economic Equity

    We look forward to interacting with regulators and members of industry regarding these themes at the conference. 

    The landscape of tobacco product and cannabis flavor bans or restrictions varies significantly across the country. In both industries, some states restrict all or some flavors in all types of products, while other states restrict all or some flavors in some, but not all, products. Below, we provide a high-level overview of the flavor ban and restriction landscape in both industries. As we will discuss, there is a wide disparity between cannabis and tobacco product flavor bans or restrictions and, where they exist, there appears to be more flexibility among cannabis flavor restrictions than for tobacco product flavor bans or restrictions.

    Continue Reading The Varied Landscape of Tobacco and Cannabis Flavor Bans or Restrictions

    The Food and Drug Law Institute’s 2024 Annual Conference is happening May 15-16, 2024! Agustin Rodriguez of the Troutman Pepper Tobacco + Nicotine team will be participating in a panel discussion on “State Regulation of Nicotine Products: Evaluating Flavor Bans and Registration Lists.” Agustin’s panel will discuss actions being taken at the state and local level to regulate unlawful tobacco products. We look forward to seeing our clients and friends at the conference!

    In August 2023, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia partially vacated a Food and Drug Administration (FDA) rule that had “deemed” premium cigars subject to the Federal Food, Drug, and Cosmetic Act (FDCA), known as the “Deeming Rule.” This decision exempted premium cigars from FDA’s tobacco product authorities. In September 2023, however, FDA appealed, and the U.S. Circuit Court of Appeals for the D.C. Circuit is currently weighing the matter. So, what would it take for FDA to succeed on appeal, and what is at stake for the premium cigar industry?

    Continue Reading What’s at Stake for the Premium Cigar Industry as DC Circuit Considers FDA Appeal?

    FDA recently announced the launch of a new searchable database containing almost 17,000 tobacco products that may be legally marketed in the U.S. The database provides information on each tobacco product including product names, company names, categories (e.g., cigarette, roll-your-own, e-cigarette, cigar, heated tobacco product), sub-categories (e.g., e- components, filler, leaf wrap), source of U.S. marketing authority (e.g., marketing granted order, substantially equivalent order, found exempt order), and the date of FDA’s action on the tobacco products. FDA indicates that it plans to update the database on a monthly basis. This database is helpful to industry members seeking more transparency from FDA about which products are authorized for sale in the U.S. The database is not, however, without limitations.

    Continue Reading FDA Launches Legally Marketed Tobacco Products Database