FDA oversight of vaping industry and impact on use ‘likely minimal’

FDA enforcement actions have a “likely minimal” impact on the vaping industry since they target smaller retailers rather than larger e-cigarette brands or products, according to researchers.

From 2017 — the first year of the enforcement practice — to December 2020, the FDA sent more than 700 warning letters to e-cigarette manufacturers, distributors and retailers for marketing, packaging and product violations, Barbara Schillo, PhD, senior vice president of the nonprofit tobacco control organization Truth Initiative, and colleagues noted in The BMJ.

However, “little is known about the type of companies that received letters, the products identified for violations, the types of infractions identified and the consequences for violators,” the researchers wrote. “This research sheds light on the focus of FDA enforcement and the actions of e-cigarette companies during the period in which their products were largely not subject to regulatory and enforcement actions.”

Schillo and colleagues retrieved and coded all FDA letters that were sent to e-cigarette retail shops, distributors and manufacturers from Jan. 1, 2020, to Sept. 9, 2021. They also identified company, product and violation characteristics, as well as consequences like civil money penalties or loss of tobacco sales license.

Of 303 total warning letters — which cited 349 infractions and 880 products — 97.7% (n = 296) were sent to small retailers, while distributors and manufacturers saw a letter frequency of 84.2% (n = 255) and 70.4% (n = 214), respectively.

“None of the retailers, manufacturers or distributors identified in the warning letters were large companies with any measurable market share, according to sales data,” the researchers reported.

The majority of infractions were for the sale of products without a premarket approval process (n = 246; 76.5%), while civil money penalties and seizure of products were tied for the most frequent consequences (n = 262; 86.2%).

According to the researchers, agency warning letters focused heavily on flavored e-liquid products used with refillable devices, “rather than large tobacco-affiliated brands or the e-cigarette products most used by youth and young adults.”

E-cigarettes have seen significant popularity and usage amongst U.S. adolescents in the last several years. According to data from MMWR, 14.1% of high school students (n = 2.14 million) and 3.3% of middle school students (n = 380,000) smoke e-cigarettes in 2022, while 46% of high school students (n = 980,000) smoked at least once within the last 20 to 30 days as of Oct. 7.

As such, the researchers wrote that while warning letters “were an important and necessary step in the process of enforcing FDA regulations, the FDA must target the brands and products most used by youth as it moves forward in regulating the larger market.”

Adding that the study was unable to determine how companies responded to letters or whether warned consequences were followed through, the researchers deemed more transparency is needed from the agency.

Schillo and colleagues concluded that the analysis shows the FDA has only begun its process of gaining more regulatory control in a “relatively small segment” of the e-cigarette market, while advocating for future research of FDA enforcement and actions.

“Strong, impactful and transparent consequences need to be in place to prevent the sale of products that violate regulations necessary in protecting the health of adult users of e-cigarettes and preventing youth use alike,” they wrote.

References:

• Cooper M, et al. MMWR Morb Mortal Wkly Rep. 2022;doi:10.15585/mmwr.mm7140a3.
• Current FDA oversight of vaping industry likely to have minimal impact. https://www.eurekalert.org/news-releases/967509. Published Oct. 13, 2022. Accessed Oct. 13, 2022.
• Schillo B, et al. BMJ. 2022;doi:10.1136/tobaccocontrol-2022-057359