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Tag: Keller and Heckman

  • Keller and Heckman Responds to FDA’s ENDS Guidance  

    Keller and Heckman Responds to FDA’s ENDS Guidance  

    Following the FDA’s March 9 draft guidance on flavored electronic nicotine delivery systems, Keller and Heckman LLP highlighted the agency’s continued focus on youth-risk concerns while providing more clarity on the evidentiary expectations for adult-benefit claims. Keller and Heckman encouraged industry stakeholders to submit comments during the 60-day public comment period to ensure FDA considers the latest evidence on youth use and adult-benefit outcomes.

    The firm emphasized that FDA’s risk-proportionate framework formalizes how the evidentiary burden rises with youth appeal, but that the guidance does not yet incorporate the 2025 National Youth Tobacco Survey (NYTS) data showing a substantial decline in youth vaping. Keller and Heckman noted that evolving data could inform public comments, particularly on whether the agency should recalibrate its comparative-efficacy requirement, given that factors beyond flavors—such as peer influence, boredom, and experimentation—also drive youth use. Keller and Heckman said the draft also opens the door to using non-clinical sensory studies to assess relative appeal and clarifies the limited role of device access restrictions in mitigating youth risk.

    The firm will further address the guidance and other regulatory updates at its 2026 E-Vapor, Nicotine, and Tobacco Law Symposium on May 4–5 in Las Vegas, offering attendees practical insights into navigating the PMTA process under FDA’s clarified expectations.

  • K&H Announces Agenda for Industry Law Symposium

    K&H Announces Agenda for Industry Law Symposium

    Keller and Heckman LLP announced the agenda for its 10th Annual E-Vapor, Nicotine, and Tobacco Law Symposium, scheduled for May 4–5, 2026, in Las Vegas, Nevada, ahead of the CHAMPS Trade Show. The two-day seminar will feature the firm’s attorneys alongside industry and scientific guest speakers, offering in-depth insights into legal, regulatory and scientific developments affecting tobacco, nicotine and CBD/hemp product manufacturers, suppliers, distributors and retailers. Organizers also reminded prospective attendees that the super early-bird registration rate expires February 20.

  • K&H Tobacco/Nicotine Symposium Registration Open

    K&H Tobacco/Nicotine Symposium Registration Open

    Keller and Heckman announced it will host its 10th annual E-Vapor, Nicotine, and Tobacco Law Symposium May 4–5 at the Paris Las Vegas Hotel, returning to Las Vegas ahead of the CHAMPS Trade Show. The two-day program is positioned as a comprehensive briefing on the legal, regulatory, and scientific issues shaping the tobacco, nicotine, and CBD/hemp sectors. The symposium is designed for manufacturers, suppliers, distributors, and retailers navigating FDA oversight and evolving compliance requirements.

    Registration is now open, with a Super Early-Bird rate of $999 available through February 6, representing a $200 discount. Early-bird pricing runs through March 27, after which standard registration applies. Organizers say upcoming announcements will detail the agenda and confirm participating scientific experts, FDA officials, and attorneys.

  • Vape, Nicotine, Tobacco Law Symposium Dates Announced

    Vape, Nicotine, Tobacco Law Symposium Dates Announced

    Keller and Heckman announced that it will be hosting its 10th Annual E-Vapor, Nicotine, and Tobacco Law Symposium, taking place on May 4 – 5, 2026, in Las Vegas, NV, at the Paris Las Vegas hotel. This two-day seminar is designed to provide in-depth knowledge on legal, regulatory, and scientific issues essential for tobacco, nicotine, and CBD/hemp product manufacturers, suppliers, distributors, and retailers. 

    Registration for the symposium will begin in December. For questions related to the program, contact Emma Kyle at kyle@khlaw.com.

  • EPR for Packaging is Here:What Tobacco & Nicotine Companies Need to Know

    Date: Tuesday, June 24, 2025
    Time: 11:00 AM – 11:30 AM ET
    Cost: Complimentary
    Registration: Click Here
     

    Keller and Heckman LLP is pleased to announce a complimentary webinar, EPR for Packaging is Here: What Tobacco & Nicotine Companies Need to Know, hosted by Keller and Heckman LLP Partners Azim Chowdhury and Katie Skaggs.

    This webinar is intended for tobacco and nicotine companies. It will provide an overview of existing and emerging Extended Producer Responsibility (EPR) legislation impacting tobacco and nicotine packaging and the obligations coming due.

    As early as July 2025, “producers” of covered products will need to join and pay dues to a “Producer Responsibility Organization” (PRO) as part of the state’s EPR program covering a wide array of packaging. Oregon will collect dues from producers of packaging starting in July, but it is only one of several states that have adopted EPR programs for packaging, and EPR policies continue to gain momentum around the U.S.

    Tobacco and nicotine companies should know that the new responsibilities created by these schemes – including reporting obligations and fee payments for packaging – may fall directly on them. This webinar will catalog the EPR schemes now in place and discuss practical steps that tobacco and nicotine companies can take to comply. The following is a short summary of the topics to be covered:

    • Introduction to EPR for tobacco and nicotine companies
    • Key elements of EPR programs for packaging (definitions, etc.)
    • Current and proposed state EPR legislation
    • Upcoming deadlines and obligations

    Click here to register.

    This webinar will offer the option for live captioning, provided by Zoom.

  • New EPR Requirements for Companies Selling Tobacco and Nicotine Products

    New EPR Requirements for Companies Selling Tobacco and Nicotine Products

    A wave of new “Extended Producer Responsibility” (EPR) programs is beginning to impact companies placing packaged products, including tobacco products, on the market in U.S. states, including California, Colorado, Maine, Minnesota, and Oregon. 

    Kathryn C. Skaggs, a partner with Keller and Heckman, writes “The five EPR programs for packaging enacted thus far have different facets. However, at their core, each of the EPR programs requires companies that sell packaged products (with some limited exceptions) to join a newly formed, state-recognized organization (typically called a “Producer Responsibility Organization” or “PRO”) and pay annual dues based on the amount and type of packaging placed on the market in that state. California’s PRO, for one, must collect $500,000,000 annually from producers of covered products, like single-use packaging. Producers also will need to eventually meet certain sustainability goals for single-use packaging, such as ensuring compostability or recyclability of packaging or meeting minimum post-consumer recycled content targets. What is more, the EPR programs encompass not just primary packaging that directly contacts a good, but often shipping and display packaging as well.”

    EPR program obligations typically fall on the “producer” of the covered product, generally defined to be the brand owner that places a packaged good on the market. Accordingly, it is the companies marketing the finished products, not packaging companies, that will need to register as producers of tobacco product packaging in the states with packaging EPR programs.

    Certain state EPR programs – including Colorado’s and Minnesota’s – also include “paper products” as a covered product. While tobacco companies making roll-your-own (RYO) papers and other such paper-based products may be able to avail themselves of certain exemptions, they must assess this on a case-by-case basis.

    Skaggs says the existing EPR laws do not include any explicit exemptions for tobacco product packaging or paper used in tobacco products. Accordingly, absent another applicable exemption, tobacco product manufacturers are likely to meet the producer definition under the state EPR laws, and thus will need to register with applicable state PROs, pay dues based on the product packaging sold in the state, and eventually meet certain goals for the packaging.

    In complying with the state EPR schemes, the tobacco and nicotine product industries can expect to face not only supply chain challenges (e.g., the availability of post-consumer recycled content), but also possibly significant regulatory hurdles under the Family Smoking Prevention and Tobacco Control Act. Under the EPR programs, producers may need to make changes to product packaging to meet sustainability targets. Changes to the container-closure system for a legally marketed tobacco product may well require a new premarket authorization from the U.S. Food and Drug Administration (FDA), which can be a costly and timely endeavor. 

  • Law Firm Announces Vapor Symposium

    Law Firm Announces Vapor Symposium

    Keller and Heckman will hold its nineth Annual E-Vapor and Tobacco Law Symposium Jan. 27-28, 2025, in Las Vegas, right before the Total Product Expo. This two-day seminar is designed to provide in-depth knowledge on legal, regulatory and scientific issues that are essential for tobacco, nicotine and CBD/hemp product manufacturers, suppliers, distributors and retailers.

    Registration for this seminar, which will be held at the Hilton-Conrad Resorts World Las Vegas, will launch in September 2024.

  • Brief Supports Limiting ‘Chevron Deference’

    Brief Supports Limiting ‘Chevron Deference’

    Image: Tobacco Reporter archive

    Keller and Heckman has filed an amicus brief with the U.S. Supreme Court on behalf of members of the electronic nicotine-delivery system (ENDS) industry in support of petitioners in a case to overturn or limit the so-called Chevron deference.

    Named after a landmark Supreme Court decision dating from 1984, the Chevron deference is a legal doctrine that generally requires courts to defer to an administrative agency’s interpretation of ambiguous statute so long as that interpretation is reasonable. 

    In practice, Chevron deference often gives agencies broad leeway to reach beyond the limits of a statute’s plain language, often bypassing the rulemaking process otherwise required under the Administrative Procedure Act and making it more difficult to challenge an agency action in court.

    In the years since ENDS became subject to Food and Drug Administration regulation, the vast majority of courts reviewing ENDS industry challenges to premarket application denials, as well as FDA rulemakings and guidance documents, have rubber-stamped the agency’s interpretation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the “appropriate for the protection of the public health” standard, Keller and Heckman wrote on its blog.

    Critics contend that the Chevron deference has enabled the FDA to impermissibly interpret the TCA to implement a de facto ban on all nontobacco-flavored ENDS products without any requisite notice and comment rulemaking or congressional amendments to the TCA.

    The filers on the amicus brief urge the Supreme Court to at least restrict the application of Chevron deference so that it is the exception, not the rule. The Supreme Court will hear oral arguments in the case in its fall 2023 term.

    The petition to overturn or limit the Chevron deference was brought by a group of fishing companies challenging the National Marine Fisheries Service’s construction of the Magnuson-Stevens Act to require the industry to pay the salaries of federal monitors.

    The ENDS industry amici include the American Vaping Manufacturers Association, the American Vapor Group and Bidi Vapor.

  • Keller and Heckman Files Amicus Brief

    Keller and Heckman Files Amicus Brief

    Image: Tobacco Reporter archive

    Eric Gotting and Azim Chowdhury, partners at Keller and Heckman, filed an amicus brief with the Supreme Court of the United States (SCOTUS) in support of Avail Vapor’s writ of certiorari petitioning the SCOTUS to review the 4th Circuit’s decision to uphold the Food and Drug Administration’s marketing denial order of Avail’s premarket tobacco product application for its nontobacco-flavored e-liquids, according to a post on The Continuum of Risk.

    The brief, filed on behalf of a group of public health experts, is intended to provide relevant scientific background on comparative health impacts of electronic nicotine-delivery system (ENDS) products with combustible cigarettes. The brief argues that ENDS are, beyond reasonable doubt, much safer than cigarettes; ENDS help adult smokers quit and can reach many adults who would not otherwise quit smoking; ENDS flavors are important to adults trying to quit smoking; youth vaping has declined markedly since 2019, with most youth vaping being infrequent, nonaddictive and temporary, and more frequent and intense vaping generally limited to adolescents who are otherwise likely to smoke; young people do not generally use the refillable tank devices sold in vape shops but instead use more mass-market products; claims that vaping is a gateway to smoking are based on a misunderstanding of the evidence; and because smoking and vaping are linked, measures like e-liquid flavor bans can cause more smoking or other damaging unintended consequences.

  • Van-Tull Sworn in as President of WBA

    Van-Tull Sworn in as President of WBA

    LieAnn Van-Tull | Image: Tobacco Reporter archive

    LieAnn Van-Tull, an associate with Keller and Heckman’s Food and Drug Packaging and Tobacco and E-Vapor practice groups, was sworn in as president of the Washington Bar Association (WBA) on June 14, 2023. In addition, Van-Tull was honored as a National Conference of Bar Presidents (NCBP) Diversity Scholar for the 2023–2024 class.

    Founded in 1925, the Washington Bar Association is the oldest and largest predominantly Black bar association in Washington, D.C. The WBA’s leadership team is dedicated to improving and protecting the well-being of the legal profession and its members, advancing the science of jurisprudence and the administration of justice and promoting diversity within the legal field.

    “Having served as president-elect, secretary and membership chair, LieAnn has been an active member of the WBA since 2016,” said Cynthia Lieberman, chair of Keller and Heckman’s diversity and inclusion committee. “She is also a talented and hardworking attorney here at Keller and Heckman. Both of LieAnn’s accomplishments—being elected WBA president and receiving the NCBP Diversity Scholar award—highlight her commitment to legal excellence and LieAnn’s dedication to the greater legal community.”

    The National Conference of Bar Presidents was founded in 1950 to empower, connect and inspire bar leaders and organizations. As a Diversity Scholar, Van-Tull will attend NCBP leadership trainings and conferences throughout the year.

    “It is such an honor to be of service as the president of the WBA and to have been selected as an NCBP Diversity Scholar,” said Van-Tull, “and I am excited about the promising year ahead. I am especially looking forward to fulfilling this year’s bar theme, ‘Legacy is the Foundation Upon Which We Build: Moving Forward Boldly,’ by building upon the WBA’s current membership and creating more opportunities for law students, lawyers and judges to collaborate with WBA’s stakeholders.”

    “LieAnn’s clear dedication to protecting equal justice under the law, community engagement and improving diversity in the legal profession will make her a natural fit for the president role,” said Richard Mann, chair of Keller and Heckman’s management committee. “As a firm, we look forward to watching her succeed in her new position.”

    Van-Tull will serve as president of the WBA for the 2023–2024 bar year.