In 2016, the U.S. Food and Drug Administration (FDA) began regulating all manufacturers, retailers, and distributors of electronic nicotine delivery systems (ENDS) with following the agency’s promulgation of the Final Deeming Rule under the 2009 Tobacco Control Act (see our prior post here). Since then, the number of regulations on tobacco products enacted by Congress and/or implemented by FDA has increased, for example minimum age requirements for purchasers (2019) and mandatory health warnings on packaging and advertisements (2020) (although due to litigation that ended in March 2024, the agency recently issued guidance for industry stating that enforcement of the health warnings rule will not begin until December 2025).
This article begins an exploration of regulation, enforcement, and associated challenges of the ENDS industry that continues on a deeper level in Part II.
As of August 8, 2016, (“the deeming date”) all tobacco products were placed under FDA authority. In regulating how new tobacco products access the market after the deeming date, Congress and FDA created premarket review processes similar to those that previously existed for medical products. They include Premarket Tobacco Product Applications (PMTAs), which must provide the agency with scientific data about a new product that demonstrates it is appropriate for the protection of public health. As part of the evaluation process, FDA considers the following factors, among others: risks and benefits to the population, including users and nonusers of the proposed product; the impact on current tobacco users’ likelihood of quitting given the availability of the proposed product; the likelihood of nonusers starting tobacco use if the new product is available; and the manufacturing, processing, and packaging methods of the product.
As of July 2024, FDA has authorized 34 specific tobacco-flavored e-cigarette products and devices via the PMTA process. FDA acknowledges that PMTA review is ongoing and thus permits continued sale and marketing for all products and devices that were sold and/or marketed in the U.S. prior to the deeming date, for which a PMTA was filed prior to September 9, 2020, and that have not yet been barred from legal sale due to a Market Denial Order (MDO) that is not under appeal. Those products introduced to the market after the deeming date and for which the FDA has not yet considered and favorably acted on a PMTA by issuing a Marketing Grant Order (MGO) cannot be legally marketed or sold.
Although regulations affecting the multibillion-dollar tobacco industry have increased in recent years, sale and use of unauthorized and illegal e-cigarettes, including many brands of “disposable” e-cigarettes which account for a sizable amount of the U.S. ENDS market despite failing to comply with applicable legal requirements, appear to have experienced little impact. For example, in a 2023 study published by the National Institutes of Health, the habits of adults using e-cigarettes were tracked following a ban on the sale of flavored products in several states. Within those states, data showed that most study participants continued to use prohibited products after the ban was established. The researchers further noted that compliance of local retailers with the ban was not high, and many alternative avenues for acquiring the banned products remained available.
FDA has ramped up its tobacco-related enforcement activities in recent years, mounting extensive retailer inspections and initiating administrative actions, from warning letters to civil penalty assessments (see here), available to it pursuant to the tobacco authorizing statute. For example, the agency has issued over 680 warning letters to firms for manufacturing, selling, or distributing new tobacco products without marketing authorization; has filed civil monetary penalty (CMP) complaints against 138 brick and mortar and 21 online retailers for selling illegal tobacco products; and has filed CMP complaints against 75 manufacturers that have failed to comply with the Act and its implementing regulations. It also has, in conjunction with the Department of Justice (DOJ), sought permanent injunctions against manufacturers because of the manufacture, sale, or distribution of unauthorized new tobacco products. Nonetheless, the U.S. marketplace for unlawful products remains extensive in light of the ease with which retailers can set up virtual or in-person storefronts, obtain imported unauthorized, illegal ENDS products, and advertise their commercial offerings aggressively through a variety of mechanisms. In fact, a study carried out in California in October 2023 tested an individual’s ability to obtain illegal flavored nicotine products. More than two-thirds of the buyers in the study were able to successfully acquire such products through online retailers using common shipping services (i.e., U.S. Postal Service and FedEx). Further, FDA has reported that challenges remain in importation compliance when manufacturers change product names and/or falsify declarations to avoid identification at the border.
It remains evident through the continued supply of illegal ENDS devices into the U.S. that further regulations and enforcement means are necessary for truly limiting these products from entering the consumer space. In Part II of this article, a deeper look into the various methods employed by both federal and third-party actors for limiting illegal nicotine products will be explored.
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