A few months ago we reported on FDA’s recent enforcement efforts targeting electronic nicotine delivery systems (ENDS), such as e-cigarettes, and warned that the Agency is watching retailers and manufacturers closely (see here and here).
In a September 12, 2018 announcement, FDA summarized its enforcement efforts to reduce underage access to e-cigarettes over the last few months. Calling it “the largest coordinated enforcement effort in the FDA’s history,” the Agency reported that between June and September 2018, more than 1,300 Warning Letters and civil money penalty complaints were issued to e-cigarette retailers and manufacturers for illegally selling e-cigarette products to minors. The violations were discovered during an “undercover blitz of brick-and-mortar and online stores” conducted by FDA.
In a direct challenge to industry, FDA Commissioner Gottlieb said that there were “clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger.” Dr. Gottlieb stated that, although FDA had exercised discretion for e-cigarette products as part of the attempt to develop a pathway to transition adult smokers off combustible cigarettes, in light of the increased use by minors, the Agency is now seriously reconsidering the extension of compliance dates for the submission of product applications, particularly for flavored e-cigarettes. “I believe certain flavors are one of the principal drivers of the youth appeal of these products,” said Dr. Gottlieb (in March 2018, FDA issued an advance notice of proposed rulemaking to seek public comment on the role that flavors in tobacco products play in attracting youth).
FDA issued letters to the five manufacturers comprising 97% of the e-cigarette market, asking them “to put forward plans to immediately and substantially reverse these trends, or face a potential decision by the FDA to reconsider extending the compliance dates for submission of premarket applications.” The letters stated that the sale of e-cigarette products to minors “is unacceptable, both legally and as a matter of public health.” FDA requested that each manufacturer respond within 15 days including “a proposed timeline for meeting with FDA.” Within 60 days FDA requested “a detailed plan, including specific timeframes, to address and mitigate widespread use by minors.” FDA provided several plan elements for the manufacturers to consider, which included discontinuing sales to retailers that are subject to an FDA civil monetary penalty, reporting to FDA the name and address of retailers that have sold products to minors, eliminating online sales, and removing flavored products from the market until those products can be reviewed by FDA as part of a PMTA. The letters stated that the actions proposed by the manufacturers would need to “demonstrate that FDA should continue to defer enforcement of the premarket review provisions” of the Tobacco Control Act (TCA). FDA continued:
The youth tobacco use prevention imperative could affect the marketing of products that may have potential public health benefit for a different population, namely, cigarette smokers who may be seeking alternative forms of nicotine delivery. We recognize the challenge here. But steps must be taken to protect the nation’s young people.
Failure to respond to this letter may result in FDA taking action to enforce the premarket authorities in the TCA . . . .
FDA will review the information provided by your firm. If the agency determines that it should enforce the premarket authorization requirements in the TCA with respect to [your] products, we intend to communicate our expectations to you.
In other words, if FDA decides the actions are insufficient, it could require manufacturers to remove some or all of their products until they receive premarket authorization.
In addition, FDA committed to ramping up enforcement with a campaign to “monitor, penalize, and prevent e-cigarette sales in convenience stores and other retail sites” and “evaluating manufacturers’ own internet storefronts and distribution practices.” FDA intends to pursue appropriate enforcement actions if violations are found, including both civil and criminal remedies. Furthermore, FDA will be “[i]nvestigating whether manufacturers of certain e-cigarette products may be marketing new products that were not on the market as of August 8, 2016 . . . .” If these products are found to not have been on the market as of this date, they would fall outside of FDA’s compliance policy.
While the Commissioner did reinforce the Agency’s position that e-cigarette products may present an alternative for adult smokers to combustible cigarettes, the message to retailers and manufacturers is clear: reduce youth access and use or we will do it for you.