Recent years have seen a marked surge in the sale and use of electronic cigarettes and other vaping products, with the global e-cigarette market exceeding $12 billion in 2019 and the WHO reporting in 2018 that over 41 million people worldwide use vaping products. Recognizing the regulatory challenges this trend presents, we have positioned ourselves at the forefront of addressing the evolving issues facing clients in the vaping industry.

Setting the Proper Framework for Industry Regulation

A team of Thompson Hine lawyers handled the landmark litigation that established the legal framework for the industry as it exists today, representing an e-cigarette distributor when the U.S. Food and Drug Administration (FDA) directed Customs to detain inbound shipments of its products at U.S. ports of entry because the FDA claimed that e?cigarettes were an unapproved new drug-device combination under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Our team successfully argued that e-cigarettes are the functional equivalent of traditional cigarettes and should be regulated as such. The decision resulted in a clearer definition of the FDA’s scope of authority to regulate e-cigarette use in the United States under the FD&C Act and the 2009 Family Smoking Prevention and Tobacco Control Act.

Advising on Regulatory Compliance

Since 2016, vaping products have become subject to extensive FDA and state regulation. We advise various market participants in the e-cigarette industry, including ENDS device and e-liquid manufacturers, distributors and retailers, as well as the nation’s largest vaping industry trade association, on state and federal regulatory compliance matters.

We provide guidance on the full range of regulatory requirements relating to the use of premarket pathways for newly deemed tobacco products, FDA enforcement policies, responses to FDA Warning Letters, establishment registration, product listing, ingredient and additive reporting, labeling, supply chain management, customs issues, compliance policies and tobacco product manufacturing practices. In addition, we counsel clients on compliance with the growing number of state and local laws and regulations that impact e-cigarette use, including California’s Proposition 65, state flavor bans and marketing restrictions, and state licensing requirements.

Counseling on Preventive Strategies

We advise e-cigarette manufacturers, distributors and retailers on developing and implementing effective risk mitigation strategies, such as devising appropriate packaging and labeling protocols, product warnings and marketing claims.

We also assist clients with all aspects of preserving and protecting their intellectual property rights, including submitting patent and trademark applications, representing clients in patent and trademark disputes, and preparing manufacturing, supply, distribution and marketing agreements. 

Defending Clients’ Interests When Disputes Arise

Despite a company’s best efforts to implement solid business practices, ensure regulatory compliance and minimize liability risks, sometimes claims still surface and need to be resolved. Whether a dispute involves business issues, such as contractual disagreements or infringement of intellectual property rights; consumer safety concerns, such as defective product allegations, misleading advertising or labeling, or inadequate instructions or warnings; responses to state attorney general investigations; or constitutional or other challenges to overreaching governmental restrictions, we vigorously defend our clients’ interests and work to achieve a just resolution, whether through litigation or alternative dispute resolution proceedings.

Our litigation experience includes successfully challenging Indiana’s e-liquid manufacturing permit regime; successfully challenging New York’s 2019 emergency flavor ban; defending multiple clients against patent infringement claims brought against them by JUUL; representing clients in investigations initiated by the attorneys general of Florida, Illinois and Colorado; defending clients in a lawsuit brought by New York City; and defending a client against unfair trade practices claims in the District of Columbia.