FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access

• Looking at, and potentially changing, the FDA&rsquo s current compliance policy to determine whether it can better account for manufacturers that are not successfully preventing widespread youth use of their products. This means re-examining all aspects of the enforcement discretion that the FDA exercised when it extended the compliance dates for premarket authorization for certain newly deemed tobacco products. This could also mean revising the overall policy that applies to all manufacturers, which would go beyond the requests that were sent with respect to certain individual products today, and address the entire category of cartridge based e-cigarettes.
• Indefinitely stepping up FDA enforcement actions with a sustained campaign to monitor, penalize and prevent e-cigarette sales in convenience stores and other retail sites.
• Closely evaluating manufacturers&rsquo own internet storefronts and distribution practices and taking appropriate enforcement actions if we find violations of the restrictions on sales to minors. The FDA has at its disposal both civil and criminal remedies to address demonstrated violations of the law.
• Investigating whether manufacturers of certain e-cigarette products may be marketing new products that were not on the market as of Aug. 8, 2016, thus falling outside of the FDA&rsquo s compliance policy, and have not gone through premarket review.