Recent years have seen a marked surge in the sale and use of electronic cigarettes, also called e-cigarettes. According to a 2015 Reuters/Ipsos poll, about 10 percent of Americans now “vape,” or use e-cigarettes and other vaping devices as alternatives to traditional tobacco products, a significant increase from just two years prior, when a U.S. government study showed that 2.6 percent of U.S. adults used e-cigarettes. Estimates indicate that the U.S. market for vaping devices is on track to reach $3.5 billion by the end of 2015, up from $2.5 billion in 2014.
Recognizing the regulatory challenges this trend presents, we have positioned ourselves at the forefront of addressing the evolving issues facing clients in the e-cigarette industry.
Setting the Proper Framework for Industry Regulation
A team of our lawyers handled the landmark litigation that established the legal framework for the industry as it exists today. We represented an e-cigarette distributor in its case against the U.S. Food and Drug Administration (FDA) when inbound shipments of its products from overseas manufacturers were detained by Customs officials at U.S. ports of entry at the direction of the FDA, which 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 the use of e-cigarettes in the United States under the FD&C Act and the 2009 Family Smoking Prevention and Tobacco Control Act.
Advising on Regulatory Compliance
With the recent finalization of the Deeming Rule, e-cigarettes and other tobacco products are now subject to extensive FDA regulation. We advise various market participants in the e-cigarette industry, including e-cigarette and e-liquid manufacturers, suppliers, trade associations, and retailers, on regulatory compliance matters impacting their businesses. Under the Final Rule, e-cigarettes are now subject to various market entry requirements, including the submission of a Premarket Tobacco Product Application (PMTA). Specifically, we advise clients on the full range of current regulatory requirements relating to use of premarket pathways for newly deemed tobacco products, establishment registration, product testing, ingredients and additives reporting, labeling, supply chain management, customs issues, compliance policies, and tobacco product manufacturing practices (TPMPs). 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.
Counseling on Preventive Strategies
We provide guidance to e-cigarette manufacturers and distributors on developing and implementing effective risk mitigation strategies, such as devising appropriate packaging and labeling protocols, product warnings and marketing claims.
We also counsel clients in the e-cigarette industry on all aspects of preserving and protecting their intellectual property rights, including the submission of patent and trademark applications, and the preparation of distribution 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, or consumer safety concerns, such as allegations of a defective product, misleading advertising or labeling, or inadequate instructions or warnings, we vigorously defend our clients’ interests and work to achieve a just resolution, whether through litigation or alternative dispute resolution proceedings.