Keller and Heckman - Tobacco Reporter

‘Implementation of Tobacco Act Flawed’

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.”

November 15, 2022

K&H Announces E-Vapor Symposium

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.

October 17, 2022

China: E-Cig Licensing Rules Explained

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.

June 7, 2022

Van-Tull to Lead D.C. Bar Association

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.

June 6, 2022

Daniel McGee Joins Keller and Heckman

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.

April 12, 2022

Promotions at Keller and Heckman

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.

January 29, 2022

Tag: Keller and Heckman