Keller and Heckman Co-Authored Upcoming FDLI Publication on Nicotine Delivery Products
Keller and Heckman Co-Authored Upcoming FDLI Publication on Nicotine Delivery Products
Keller and Heckman Tobacco and E-Vapor attorneys, led by Partner Azim Chowdhury, co-authored with Latham & Watkins the upcoming Food and Drug Law Institute (FDLI) publication, “Nicotine Delivery Products: Navigating FDA’s Policies and Regulations in a Dynamic Environment.” The following Keller and Heckman attorneys also contributed: Kathryn Skaggs, Neelam Gill, LieAnn Van-Tull, Daniel McGee, Thomas Smith, Kelsey Anliker, Josephine Hsu, Ryan D’Souza, and Kaitlyn Johnson. The publication is now available for pre-order through FDLI’s website here.
“Nicotine Delivery Products: Navigating FDA’s Policies and Regulations in a Dynamic Environment” provides a comprehensive guide to the legal and regulatory landscapes that continue to shape the industry for tobacco and novel nicotine products. Industry professionals, attorneys, regulators, and the public health community will find this desk reference indispensable for understanding compliance, informing business decisions, and managing ever-evolving regulatory requirements in the United States.
This publication covers the U.S. Food and Drug Administration’s (FDA) regulation of the manufacturing, marketing, labeling, distribution, and sale of tobacco and nicotine products in the United States, across new and modified risk tobacco products, including rules governing advertising and promotion, preemption and the role of state authorities, recent litigation, FDA enforcement efforts to combat a growing black market, and a deep-dive into the Premarket Tobacco Product (PMTA) process for new products, including electronic nicotine delivery systems (ENDS) and modern oral nicotine products. The book also describes FDA’s potential issuance of tobacco product standards for menthol in cigarettes and flavors in cigars and the agency’s efforts to establish a standard for the nicotine content in cigarettes. Finally, the book addresses other key rulemakings, including the impact of the Deeming Regulation and FDA’s development of tobacco product manufacturing practices (TPMPs).
About Keller and Heckman’s Tobacco and E-Vapor Practice
Keller and Heckman services the global regulatory, public policy, and litigation needs for the tobacco, nicotine, and e-vapor industries. Our decades of comprehensive and extensive experience dealing with the regulation of food, supplements, drugs, and medical devices before regulatory agencies such as FDA uniquely positions us to guide companies through the myriad of federal and state requirements for tobacco and related products. We advise businesses on all levels of the tobacco and nicotine product supply chain, including ingredient and component suppliers, finished product manufacturers, distributors, wholesalers, and retailers.