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.
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.
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.
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.
The U.S. Food and Drug Administration’s implementation of the 2009 Tobacco Control Act, which gave the agency authority to regulate tobacco products, has been fundamentally flawed from the beginning, according to Azim Chowdhury, a partner in the Keller and Heckman law firm.
Writing in Filter, Chowdhury explains that the premarket authorization requirements for “new” products subjects potentially reduced-harm products to nearly insurmountable hurdles while allowing preexisting products, including combustible cigarettes, to mostly escape FDA scrutiny.
In his article, Chowdhury suggests several ways in which the FDA can more effectively implement the Tobacco Control Act.
For example, rather than conducting reviews in silo, the FDA should consider the totality of evidence in a premarket tobacco product application, according to Chowdhury.
“It is also critical that the FDA hamper the spread of counterfeit products, which may be riskier for consumers and are drowning out the small businesses and vape shops that continue to bear the brunt of FDA enforcement,” he writes.
“Finally, the FDA should shift more resources to developing reasonable safety, quality and marketing product standards.”
The law firm Keller and Heckman will holds its Annual E-Vapor and Tobacco Law Symposium Feb. 15–16, 2023, at the Courtyard Irvine Spectrum in Irvine, California, USA.
This year’s program will feature topics designed to help vapor and deemed tobacco product manufacturers stay in compliance with rapidly evolving laws and policies.
The conference will cover marketing denial orders, FDA proposed rulemakings and youth access prevention plans, among other topics.
For more information, please visit the symposium information webpage.
The law firm Kelller & Heckman has published an article summarizing the requirements for obtaining an e-cigarette manufacturing license in China.
The State Tobacco Monopoly Administration (STMA) has now published a rule outlining the process for Chinese e-cigarette manufacturers to obtain the required manufacturer license. This rule applies not only to manufacturers producing e-cigarettes for the domestic Chinese market, but also to the manufacturing of e-cigarettes solely for export.
According to Keller & Heckman, manufacturers will have to prepare many materials for their license application. Among other information, they will have to provide proof of suitable funds, production and sales information, including the balance sheet, income statement, cash flow statement and production and sales statistics.
E-liquid manufacturers will have to supply a license for operating dangerous chemicals and identify the sources of nicotine used in the past three years. Applicants for export must submit materials explaining the export business and the scale of export, including the customs declaration forms for the past three years
Remarkably, the rules require companies manufacturing exclusively for export to obtain trademark registration in China. Although Keller and Heckman considers it unlikely that the STMA intended to impose the Chinese trademark registration requirement on exporters, the law firm advises clients to seek clarification from the authorities.
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-elect of the Washington Bar Association (WBA) on June 1, 2022.
“I feel honored to have the opportunity to serve an organization that provides an avenue for attorneys to excel,” said Van-Tull. “I have enjoyed contributing to the WBA as secretary, former membership chair, and as an active committee member, and look forward to expanding my impact as president. In particular, I am eager to broaden the organization’s membership base, create new mentorship and leadership opportunities, and further its advocacy efforts for underrepresented members of the legal community.”
The WBA is the oldest and largest predominantly Black bar association in Washington, DC. Founded in 1925, the WBA consistent with the philosophy of Houstonian jurisprudence, 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 while preventing discrimination within the legal field.
“LieAnn exemplifies a commitment to legal excellence, community engagement and enhancing diversity in the legal profession,” said Cynthia Lieberman, the chair of Keller and Heckman’s diversity and inclusion committee. “We could not be more thrilled to see her elected to the Washington Bar Association’s executive leadership team.”
“LieAnn’s new position at the Washington Bar Association showcases her dedication to protecting equal justice under the law and inspires the firm in our own pursuit for increasing diversity in the workplace,” said Richard Mann, chair of Keller and Heckman’s management committee.
Van-Tull will assume the role of WBA president in June 2023 for the 2023-2024 bar year.
Daniel P. McGee has joined Keller and Heckman’s expanding tobacco and vapor practice as counsel.
Prior to joining Keller and Heckman, McGee worked as in-house counsel for several multinational tobacco, vapor and CBD companies, where he honed his skills advising on compliance and regulatory issues related to tobacco, vapor, nicotine, hemp, CBD and related products.
McGee has experience counseling companies on a broad range of complex tobacco and U.S. Food and Drug Administration regulatory matters and developing strategies to help companies bring new products to market.
“Daniel’s expertise and industry perspective will be invaluable to Keller and Heckman clients who are carefully navigating the challenges and pitfalls of a highly regulated and rapidly evolving legal landscape,” said Azim Chowdhury, a Partner in the firm’s tobacco and vapor and food and drug practices.
“In addition to expanding our tobacco and e-vapor capabilities, we are especially looking forward to utilizing Daniel’s expertise in state law compliance, particularly for clients expanding into the hemp and CBD categories.”
“The addition of Daniel to our practice demonstrates Keller and Heckman’s commitment to helping our clients understand and comply with continuously evolving regulations in this growing field,” said Richard Mann, chair of Keller and Heckman’s management committee.
“I am honored to work with Keller and Heckman’s experienced team of tobacco and e-vapor attorneys and to share the corporate perspective with my new colleagues,” said McGee. “After spending the bulk of my legal career as in-house counsel to the tobacco industry, I made a strategic decision to focus on the industry as a whole and join a law firm that is a leader in tobacco regulatory compliance and public policy initiatives.”
McGee received his J.D. degree from the University of Oregon School of Law and his B.A. degree from Boston College, where he graduated with honors.
Keller and Heckman, a law firm specializing in the tobacco and vaping industries, has promoted Neelam Gill to counsel and Eric Gu to senior regulatory counselor.
A resident in the firm’s Washington, D.C., office, Gill practices in the area of food and drug law and tobacco and e-vapor law. In her tobacco and e-vapor practice, she advises tobacco, e-cigarette and e-liquid manufacturers, distributors, retailers, suppliers and trade associations on FDA, state and global regulatory compliance issues.
In the food and drug arena, she assists clients with a variety of FDA regulatory matters and labeling issues. Gill advises clients on preparation of FDA submissions, including premarket tobacco product applications, substantial equivalence reports, tobacco product master files and quality issues pertaining to the entire tobacco and nicotine product lifecycle.
A resident in Keller & Heckman’s Shanghai office, Gu practices in the area of food and food packaging law. He counsels clients on food labeling, food ingredients and food packaging compliance matters. In addition, he counsels clients on regulatory issues with respect to other products, including cosmetics, drug/drug excipients, tobacco and e-cigarettes and other consumer products.
Gu frequently assists clients in obtaining important premarket approvals and permits, including approvals of new food packaging substances, the food production license and the drug excipient registration. Gu’s regulatory experience extends to China, Hong Kong, Taiwan, Japan, Southeast Asia, the European Union and the United States.