Several tobacco companies sued the U.S. Food & Drug Administration (FDA) after the FDA denied their ability to market and sell their e-cigarette/vape products. The Eleventh Circuit ruled that the FDA, in reaching its decision, refused to consider marketing and sales-access-restriction plans that the companies submitted to minimize youth exposure and access to the products. Accordingly, the Eleventh Circuit vacated the FDA’s decision and ordered the FDA to consider the youth restriction plans when it assesses whether to grant or deny the companies’ ability to market their products.1
This decision impacts more than just tobacco companies. Retailers and distributors that help manufacturers comply with the FDA’s youth restriction requirements will likely stand a better chance of being able to sell new e-cig/vape products. For example, if a retailer can verify to a distributor or manufacturer that they only sell products to adults, the retailer may become a repeat customer for that manufacturer or distributor.
The dispute stemmed from the Tobacco Control Act of 2009 (the Act), which prohibits manufacturers from selling any “new tobacco product” without FDA approval.2 The Act provides that the FDA shall deny applications for new tobacco products if, based on the information it reviews, the FDA finds a company failed to show the new product would be appropriate for the protection of public health.3 Although the relevant information the FDA considers may vary, the FDA had repeatedly told companies seeking to market and sell e-cig/vape products that youth restriction plans are relevant to its determination.4 In particular, the FDA emphasized that it is important to consider how e-cig/vape products are marketed towards youth, including critical factors such as making cartoonish advertisements and providing flavored products.5
The tobacco companies at issue explained to the FDA that they had taken steps to prevent sales to youth, such as discontinuing direct sales through their websites, only advertising on age-gated websites and adult-only brick-and-mortar stores, monitoring distribution channels for compliance with its adult-only marketing and sales policies, and producing ads in only black-and-white. For those companies that continued online sales, they relied on technology that reviewed public records to verify a purchaser’s age.
The Eleventh Circuit determined that the FDA ignored these and other steps taken by the tobacco companies, and instead relied on a since rescinded memorandum stating the FDA would not review the youth restriction plans “for the sake of efficiency” because the FDA was not aware of restrictions that, to date, had been successful in sufficiently decreasing the ability of youth to obtain and use e-cig/vape products.
The Eleventh Circuit also observed that after the FDA denied the tobacco companies’ applications, the FDA issued a rule explicitly requiring the tobacco companies to describe their products’ intended audience and how youth access would be restricted.6 The FDA further stated that information contained in the youth restriction plans was “necessary” to properly evaluate the extent of youth exposure and the likelihood that they would use the products.7 This about-face from the FDA led the Eleventh Circuit to conclude that the FDA’s rejection of the tobacco companies’ applications should be reversed because the FDA had failed to consider all of the information it stated was relevant to evaluating whether products are appropriate for the protection of public health.
Based on the Eleventh Circuit’s decision, while the FDA is not required to grant the companies’ applications (and a dissenting opinion noted that the FDA most certainly will not grant them), it is required to consider the youth restriction plans. Accordingly, e-cig/vape companies submitting applications for new products to the FDA should continue to include detailed plans for preventing youth access and exposure to the products.
For more information about how to best protect your business and/or current or pending litigation, please contact one of the attorneys on the E-Cigarette/Vape Team.