Keller and Heckman LLP is the premier law firm for the Tobacco and E-Vapor industry. We counsel clients at every level of the tobacco, e-cigarette and vaping supply chain from manufacturers of components and additives, to manufacturers of finished products, both consumables and hardware, and their distribution and delivery to consumers.
Since the Family Smoking Prevention Tobacco Control Act (the Tobacco Control Act) amended the Food, Drug and Cosmetic Act to give the U.S. Food and Drug Administration (FDA) authority to regulate tobacco products Keller and Heckman has followed FDA’s implementation of the Tobacco Control Act. We have commented directly and assisted clients in commenting on FDA Guidance Documents and implementing regulations, including the proposed “Deeming Regulation,” which proposes to give FDA authority over currently unregulated tobacco products such as electronic cigarettes and advanced personal vaporizers, dissolvable tobacco, cigars, pipe tobacco and hookah (water pipes).
Keller and Heckman's comprehensive and extensive experience dealing with the regulation of food, drugs, medical devices and dietary supplements before the FDA uniquely positions us to guide tobacco product companies through the myriad of new FDA requirements for tobacco products. We provide legal and scientific support to tobacco product companies and their suppliers with respect to the statutory and regulatory requirements specifically imposed by the Tobacco Control Act, including:
Ingredient, additive, and harmful and potentially harmful constituent disclosure requirements;
Our attorneys and scientists also participate in tobacco industry meetings; FDA-sponsored workshops; and actively contribute to the Food, Drug Law Institute (FDLI) Tobacco Law, Regulation & Policy Resource Center. In particular, several of our attorneys contributed to FDLI's publication, Tobacco Regulation and Compliance: An Essential Resource¸ and FDA Regulation of Tobacco: A Comprehensive Guide – An FDLI Primer.
Representing E-Vapor Industry trade associations in a lawsuit challenging FDA’s Deeming Regulation and aspects of the Tobacco Control Act in the U.S. District Court for the District of Columbia.
Defending major e-liquid company and manufacturer in false advertising class action lawsuit in California’s Orange County Superior Court, Complex Division
Advised e-vapor companies on the development of product standards in the U.S., EU and China
Established a Working Group of Chinese e-cigarette stakeholders dedicated to working with the government authorities to develop appropriate, product-specific regulations and standards for e-cigarettes and e-liquids in China