The number of unique e-cigarette products, many of which come in youth-appealing flavors, more than quadrupled from 453 in June 2021 to 2,023 in June 2022, according to a Truth Initiative review of U.S. retail sales data. The increase, based on retail sales estimates from NielsenIQ,* shows how companies continue to flagrantly flout the regulatory process and launch new products without authorization from the U.S. Food and Drug Administration (FDA), a requirement to legally enter the market.youth e-cigarette use remains a serious public health threat, with over 2.5 million middle and high school students reporting current e-cigarette use in 2022, the proliferation of unauthorized e-cigarettes underscores the urgent need for comprehensive regulation and enforcement.
After years of delays, the FDA isundergoing its review of pre-market tobacco applications (PMTA) frome-cigarette makers to determine whether their products can stay on the market.Any products that had not received authorization by September 2021 were supposedto have been removed and no new products are allowed to enter the marketwithout pre-authorization. Yet the tobacco industry continues to flood themarket with new products and apparently little fear of federal reprisal.
To date, less than 30e-cigarette products have been granted marketing authorization by the FDA,covering a small slice of the e-cigarette market that does not include theproducts most popular with youth. Decisions remain pending on applications fromleading e-cigarette brands such as JUUL, Vuse (Alto), blu, and others that makeup between 65% and 70% of the market and are among the most popular with youth.In the meantime, the FDA issued marketing denial orders to two Reynoldsmenthol e-cigarette products in January 2023, and in 2022 to Logic,which makes up just over 1% of the e-cigarette market according to retailer scannerdata. The recent acquisition of popular e-cigarette brand NJOY by Altria alsoraises concerns that the tobacco company will use its vast marketing anddistribution systems to increase NJOY’s reach and availability.
The FDA says it hasacted on 99% of the 6.7 million applications received, and morethan 260 e-cigarette companies that submitted a PMTA have receivedmarketing denial orders. This should translate to fewer e-cigarettebarcodes with recorded sales dollars. Instead, NielsenIQ data clearly show asharp increase in the number of unique e-cigarette product barcodes with salespeaking at 2,023 products in June 2022. Although data indicate that the numberof unique products has leveled off recently, there were still nearly 2,000e-cigarette products with sales in September 2022, the most recent datareviewed.
The rapid rise of e-cigarette products has the effect of overwhelming theFDA. The flood of new e-cigarette products creates an even greater back log ofPMTAs for the FDA.
The FDA has acted in the past to addressthe situation. For example, in October 2022, the FDA filed complaints forpermanent injunctions against several e-cigarette manufacturers through theU.S. Department of Justice. In February of 2023, the FDA also announced itfiled civil money penalty (CMP) complaints against four tobacco productmanufactures for making and selling e-cigarette liquids without FDAauthorization.
The Center for Tobacco Products (CTP)recently shared concrete steps thatmay ultimately help prevent tobacco manufacturers from playingcatch-me-if-you-can with the FDA. CTP announced its intention to develop andimplement a five-year strategic plan by December 2023, which will help theagency pivot from a reactive mindset to a proactive one. Truth Initiativeunderscores the need for this plan to include a clear, scientifically sound,and executable strategy to regulate and enforce the continued proliferation ofyouth-appealing tobacco products. The agency pledged commitment to greatertransparency about its compliance and enforcement, promising to publicly sharea list of legally marketed products. The agency also announced that it willwork with other federal agencies to enhance their enforcement work.
It is critical for the FDA to pursue theseefforts expediently to protect our nation's young people from companies thatcontinue to thwart the law and put a new generation of young people at risk fornicotine addiction.