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From Health Law Daily, September 13, 2018

FDA takes hard stance on youth e-cigarette use, puts manufacturers, retailers on notice

By Rebecca Mayo, J.D.

The FDA believes that youth use of e-cigarettes is reaching epidemic proportions and in response has announced a series of historic enforcement actions related to the sale and marketing of e-cigarettes to kids. The FDA conducted a nationwide undercover blitz of brick-and-mortar and online stores over the summer which has resulted in more than 1,300 warning letters and fines to retailers who illegally sold e-cigarette products to minors. The operation is the largest coordinated enforcement effort in the FDA’s history, and they aren’t finished yet. Enforcement will be stepped-up indefinitely and the FDA is reviewing its policies to determine what changes can be made to prevent youth use of e-cigarettes.

Epidemic. More than 2 million middle and high school students were current users of e-cigarettes in 2017, making it the most commonly used tobacco product by youth. The developing adolescent brain is particularly vulnerable to nicotine addiction, making this trend especially concerning to the FDA. FDA Commissioner Scott Gottlieb, M.D. believes that certain flavors are one of the principal drivers of the youth appeal of these products.

Stepped-up enforcement. More than 1,300 warning letters and fines to retailers were part of a large-scale, undercover nationwide "blitz" conducted from June through the end of August. As of September 1, 2018, the FDA had conducted 978,290 retail inspections, issued 77,180 warning letters to retailers for violating the law and initiated approximately 18,560 civil money penalty cases. It also issued more than 135 No-Tobacco-Sale Order Complaints, which can result in retailers being prohibited from selling tobacco products for specified periods of time. Warning letters were also issued to 12 online retailers that are selling misleadingly labeled and/or advertised e-liquids resembling kid-friendly food products.

Manufacturer compliance. Letters were issued to the five top-selling national brands, JUUL, Vuse, MarkTen XL, Blu e-cigs, and Logic who also made up a vast majority of the products illegally sold to minors as part of the blitz this summer. The letters asked each company to submit plans to the FDA describing how they will address the widespread youth access and use of their products. If they fail to submit plans within 60 days or the plans do not appropriately address the issue, the FDA will consider whether it would be appropriate to revisit the current policy that results in these products remaining on the market without a marketing order from the agency. The FDA could potentially require these brands to remove some or all of their flavored products from the market until they receive premarket authorization and otherwise meet all of their obligations under the law.

Future plans. The FDA is looking at and potentially changing the current compliance policy, as well as the enforcement discretion that the FDA exercised when it extended the compliance dates for premarket authorization for certain newly deemed tobacco products. Enforcement actions will be stepped-up indefinitely to monitor, penalize, and prevent e-cigarette sales in convenience stores and other retail sites. Manufacturers’ internet storefronts and distribution practices will be closely evaluated. Certain e-cigarette products will be investigated to determine if they are marketing new products that were not on the market as of August 8, 2016 and fall outside of the FDA’s compliance policy, and have not gone through premarket review.

Policy roadmap. The FDA will be developing an overall policy roadmap to accomplish the goals of rendering cigarettes minimally or non-addictive, less toxic, and less appealing, with an intense focus on youth. Additional rectification on the sale and promotion of electronic nicotine delivery systems (ENDS) will be explored to further reduce youth exposure and access to these products. "The Real Cost" public education campaign has been expanded to include messages on preventing youth use of e-cigarettes and a new full-scale e-cigarette campaign target to youth will be launch in the coming weeks.

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