The U.S. Food and Drug Administration (FDA) recently conducted a surprise inspection of the San Francisco headquarters of the e-cigarette maker Juul Labs.1 The inspection reflects the FDA’s increased efforts to combat e-cigarette use among youth as part of its Youth Tobacco Prevention Plan. This client alert discusses the FDA’s recent regulatory and enforcement efforts in the e-cigarette industry. With the industry growing so rapidly, there is growing concern regarding sales of e-cigarettes to minors. While the vast majority of e-cigarette retailers and manufacturers comply with FDA regulations, staying apprised of the agency’s efforts may help retailers and manufacturers ensure continued compliance as the FDA takes additional steps to curb e-cigarette sales to minors.
1. FDA Declares “Epidemic of E-Cigarette Use Among Teenagers”
The FDA recently declared that e-cigarette use among youth has reached “nothing short of an epidemic proportion of growth.”2 To combat that trend, the FDA has implemented a plan that consists of three primary strategies: (i) preventing youth access to tobacco products; (ii) curbing the marketing of tobacco products aimed at youth; and (iii) educating teens about the dangers of using any tobacco products.3
2. Recent Efforts Toward Manufacturers
As part of its plan, the FDA is examining how e-cigarette manufacturers market their products. For example, the agency sent letters to five manufacturers (Juul, Vuse, MarkTen, blu e-cigs, and Logic) whose products were discovered to have been sold to kids during an undercover FDA enforcement operation, giving them 60 days to respond with “robust plans on how they’ll convincingly address the widespread use of their products by minors.”4 The FDA also declared that it would be conducting “boots on the ground inspections” of manufacturers in connection with investigating their marketing and sales practices.5 A recent surprise inspection of manufacturer Juul Labs’ San Francisco headquarters appears to be one such operation. As a result of the inspection, the FDA obtained over one thousand documents said to be related to the company’s sales and marketing practices. The agency said it was particularly interested in whether Juul targeted minors as consumers.6
3. Enforcement Efforts Toward Retailers
In addition to its increased efforts aimed at manufacturers, the FDA is focusing on retailers that sell e-cigarettes to minors. In its September announcement, the FDA declared that this initiative is “the single largest enforcement action in agency history.”7 In connection with these increased efforts, the agency conducted an undercover nationwide blitz from June through the end of August. As a result, the agency sent over 1,100 warning letters to retailers for the illegal sale of e-cigarettes to minors.8 The agency also issued 131 civil monetary penalties to retailers that continued to violate restrictions on sales to minors.9 The amount of such penalties varies based upon a number of factors, including the number of previous violations and the time period in which the violations occurred.10
The FDA has made clear that it intends to “permanently step up [its] enforcement actions with a sustained campaign to monitor, penalize and prevent e-cig sales to minors in convenience stores and other retail sites.”11 The agency has also vowed to take “a hard look at the manufacturers’ own internet storefronts and distribution practices,” with an emphasis on “whether internet sites are being used to make straw purchases with the intent for redistribution to minors.”12
As the FDA increases enforcement against e-cigarette retailers, it is important that retailers ensure compliance with relevant regulations, including those that prohibit the sale of covered tobacco products, such as electronic nicotine delivery system products, to individuals under the age of 18,13 and those that require retailers to check the photographic identification for any person under the age of 27 who attempts to purchase covered tobacco products.14
Retailers that receive a warning letter regarding regulatory violations are given “15 working days” from the date of receipt to respond.15 The response must outline the retailer’s “plan for correcting the listed violations and preventing future violations.”16 Retailers who receive such warning letters should consider contacting counsel in connection with preparing a response.
While the FDA’s most recent enforcement efforts have been primarily aimed at retailers, manufacturers should continue to ensure compliance with relevant warning and labeling requirements, as we noted in our prior alert.