Tobacco and E-Vapor
Keller and Heckman LLP is the premier law firm servicing the global regulatory, public policy, and litigation needs for the Tobacco and E-Vapor industry. Our decades of comprehensive and extensive experience dealing with the regulation of food, supplements, drugs, and medical devices before regulatory agencies such as the U.S. Food and Drug Administration (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, e-vapor, and vaping supply chain, including ingredient and component suppliers, finished product manufacturers, distributors, wholesalers, and retailers.
Keller and Heckman attorneys carefully track tobacco legislative and regulatory developments around the world, including in the United States (U.S.), European Union (EU), Middle East, China, and other parts of Asia. In the U.S., the Family Smoking Prevention and Tobacco Control Act (TCA) became law in 2009, amending the existing Food, Drug and Cosmetic Act (FD&C Act) to give the FDA authority to regulate “tobacco products” for the first time. On August 8, 2016, that federal authority was extended beyond traditional cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco, to include electronic nicotine delivery systems (ENDS) such as e-vapor and e-liquid products, and other products that contain tobacco-derived materials (e.g., cigars, pipe tobacco, hookah/shisha, dissolvable tobacco, and heat-not-burn products).
Our attorneys and scientists help manufacturers and importers of tobacco products navigate the complicated FDA requirements established by the TCA/FD&C Act and the Deeming Rule, including premarket applications, manufacturing facility registration and product listing, ingredient reporting, labeling, advertising and warning requirements, and retailer and distributor compliance. We also advise on product testing and perform toxicity analyses and risk assessments. We help companies resolve enforcement actions brought by federal, state, and local agencies, such as responding to Warning Letters and developing corrective action plans to ensure youth access prevention and targeted marketing to adult consumers. In addition, we assist companies and trade associations in drafting and submitting comments to FDA proposed rules and draft guidance, as well as filing Citizens Petitions.
Beyond FDA, we also advise companies on Federal Trade Commission (FTC); Consumer Product Safety Commission (CPSC); and Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) requirements, including compliance with the Prevent All Cigarette Trafficking (PACT) Act. Keller and Heckman attorneys guide manufacturers on environmental compliance, including with state and federal hazardous waste disposal requirements (e.g., Resource Conservation and Recovery Act (RCRA)). We regularly prepare Environmental Assessments required by the National Environmental Policy Act (NEPA) to be included in tobacco product premarket review submissions, including Substantial Equivalence (SE) Reports and Premarket Tobacco Product Applications (PMTAs).
Keller and Heckman attorneys advise on state and local laws, including sales restrictions, age-limits, flavor bans, and licensing and tax requirements that are greatly impacting businesses in these industries, as well as consumers. We regularly advise clients on compliance with California’s Stop Tobacco Access to Kids Enforcement (STAKE) Act, California Department of Tax and Fee Administration (CDTFA) licensing requirements, and warning requirements under Proposition 65, for example.
On the global front, we work with companies marketing products around the world, including Canada, the United Kingdom (UK) and the European Union (EU), the Middle East, and Asia. Specifically, in the EU, we provide guidance on numerous regulations and directives including, among others, the Tobacco Products Directive; General Product Safety Regulations; chemicals laws such as the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH); and Classification and Labelling (CLP/GHS) Regulations. We also advise clients on the sales of e-vapor and e-liquid products in compliance with standards and regulations in China and other Asian countries.
- Advised clients on FDA compliance, including:
- Ingredient, additive, and harmful and potentially harmful constituent (HPHC) testing and disclosure requirements
- Health document submissions
- Manufacturing facility registration and product listing (TRLM/FURLS)
- Good Manufacturing Practice guidance
- Substantial equivalency determinations and exemptions
- Premarket Tobacco Product Applications
- Environmental Assessments for premarket applications
- Tobacco Product Master Files
- Modified Risk Tobacco Product Applications
- Labeling and warning requirements
- Retailer compliance issues
- Tobacco product testing requirements
- E-liquid and aerosol toxicity analyses and risk assessments
- Advised coalition of e-vapor and e-liquid manufacturers through the PMTA process, filing over 350 applications with FDA ahead of the September 9, 2020 deadline
- Advised clients on import and export of tobacco products under U.S. law
- Represented collation of e-vapor and e-liquid manufacturers in relation to U.S. Consumer Product Safety Commission (CPSC) new interpretation of the Child Nicotine Poisoning Prevention Act (CNPPA) and associated enforcement efforts
- Represented over a dozen manufacturers of liquid nicotine products to resolve CPSC allegations that their products did not meet restricted flow requirements under the CNPPA
- Advised e-liquid and e-vapor companies on EU Tobacco Products Directive and Member State laws and labeling requirements
- Advised e-liquid and e-vapor companies on various EU directives and regulations, including the Liability for Defective Products Directives; General Product Safety Regulations; RoHS2 Directive; Electrical Equipment Safety Regulations; Batteries Directive; and chemicals laws such as the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Classification and Labelling (CLP/GHS) Regulations
- Counseled clients on permitted ingredients in tobacco products under National legislation in Europe and around the world
- Advised clients regarding novel technologies for harm reduction in tobacco products
- Counseled clients on the regulation of tobacco additives under the EU REACH Regulation
- Counseled Chinese tobacco manufacturers on U.S. and Canada regulation of e-vapor and heat-not-burn products
- Provided strategic advice on the sales of e-vapor and e-liquid products in most Asian jurisdictions
- Advised clients on FDA compliance, including:
- Represented a coalition of e-vapor companies in a successful challenge to the constitutionality of Indiana's 2015 e-liquid law (HEA 1432/SEA 463) before the U.S. Court of Appeals for the Seventh Circuit
- Represented 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 and U.S. Court of Appeals for the District of Columbia
- Represented E-Vapor Industry trade associations in an appeal before the U.S. Court of Appeals for the Fourth Circuit of the PMTA compliance deadline set by the U.S. District Court for the District of Maryland
- Defended and settled numerous actions brought by state and local governments, including the City of Chicago, New York City, Massachusetts, and Florida, against e-liquid companies alleged to have violated local consumer protection and advertising laws
- Defended a major e-liquid company and manufacturer in a false advertising class action lawsuit in California’s Orange County Superior Court, Complex Division
- Defended online and brick-and-mortar retailers in personal injury and class action lawsuits, including actions alleging damages from exploding batteries and e-liquid contents
- Advised coalition of Michigan businesses challenging the state’s attempted emergency flavor ban in state court and filed a lawsuit in the U.S. District Court for the Western District of Michigan challenging the constitutionality of the ban which resulted in Michigan immediately limiting the applicability and scope of the emergency rule
Areas of Focus
Counseling on U.S. federal regulatory compliance, including Food and Drug Administration (FDA), Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), and Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) requirements, and internationally in the European Union, China, and ASEAN countries
Providing guidance on the Administrative Procedure Act (APA) and the notice and comment rulemaking process; drafting comments and preparing Citizens Petitions
Preparing National Environmental Policy Act (NEPA)-required Environmental Assessments for premarket submissions, and advising on the federal Resource Conservation and Recovery Act (RCRA) and state hazardous waste compliance
Challenging federal, state, and local laws under the federal APA and state equivalents, as well as on constitutional grounds (e.g., Preemption, Commerce Clause, and First Amendment); defending vapor companies in product liability and tort suits
Advising clients on sales restrictions, licensing requirements, and flavor bans