Eric Gotting Quoted in Law360 Article on FDA Changing Rules on Flavored Vaping Products
Partner Eric Gotting was quoted in the Law360 article, “Vaping Cos. Say FDA Changed Rules On Flavored Products.” The article discusses e-cigarette companies’ arguments before the Eleventh Circuit Court on May 17, 2022, regarding the U.S. Food and Drug Administration’s (FDA) application denials for flavored vaping products. Eric, along with Partner Azim Chowdhury, argued that the Agency changed the rules and requirements in the midst of companies completing Pre-Market Tobacco Product Applications. According to FDA, the companies needed to show evidence, through a specific type of study like a randomized controlled trial, that their non-tobacco flavored products provided additional benefit to adult smokers compared to tobacco-flavored products, given the known risks that flavored products pose to youth. However, Eric argued, on behalf of Bidi Vapor LLC, that FDA never before required that specific type of study, and that the Tobacco Control Act’s appropriate for the protection of public health standard requires FDA consider much more, such as the lower health risks for adults who use these vaping products instead of traditional combustible cigarettes.
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