Keller and Heckman Partner Azim Chowdhury was quoted in the Law360 article, “Product Liability Regulation & Legislation To Watch At Midyear.” The article discusses e-cigarette company Juul’s decision to file an application with the U.S. Food and Drug Administration (FDA) for a new device that has been on the market in the U.K. for several years now. The new device, marketed as the JUUL2, has age-verification capabilities and prevents the use of unauthorized refill cartridges. Although multiple flavors of the product are available overseas, Juul is currently seeking FDA authorization for only the lower nicotine, tobacco-flavored version. “It sounds like it could check all the boxes,” said Azim.
“FDA has made clear tobacco-flavored devices do not produce the same risks for youth use,” commented Azim. “It’s the non-tobacco flavors that have the additional burden of demonstrating that they don’t have an increased risk for youth use.”
Additionally, the vaping industry is waiting to see whether FDA will approve a menthol e-cigarette product. To date, PMTAs for menthol and non-tobacco flavored e-cigarettes have all been denied for failing to include robust evidence demonstrating that the flavored product is likely to promote complete switching, or likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarette products. According to Azim, FDA has indicated that such data is needed to overcome the “known risk” that flavors, including menthol, pose to youth. “Until we see authorization for flavored or menthol flavors, we won’t know where FDA has drawn the line.”
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