Current FDA oversight of the vaping industry is likely to have minimal impact

Current Food and Drug Administration (FDA) oversight of the U.S. vaping industry is likely to have minimal impact, suggests an analysis of the regulator’s warning letters about marketing violations published online in the journal Tobacco control.

The regulator does not target key players or the most popular products youthAnalysis shows that more than 90% of warnings are sent by small online stores, not by the leading ones tobacco companiesand an emphasis on reusable devices.

While the prevalence of vaping among US adults remains low at just under 4% in 2020, it is four times higher among young adults.

In 2016, the FDA announced plans to regulate the vaping industry, including requiring e-cigarette manufacturers to obtain prior approval (PMTA) to ensure their products protect public health.

In 2017, the regulator began sending warning letters to manufacturers, retailers and distributors about possible violations such as advertising to youth, sales to minors, packaging or labeling that contravenes the rules, and refusal to apply for a PMTA.

But little is known about who received these letters, the types of goods they covered, or the details of the violations and their consequences.

To try to find out, authors from the non-profit tobacco control organization Truth Initiative evaluated the content and recipients of the FDA’s public warning letters issued in 2020 and 2021. In total, the FDA issued 303 warnings: 126 in 2020 and 177 through September. 9, 2021.

The analysis showed that in 2021, more than 98% of all target companies fulfilled all three roles (manufacturer, distributor and retailer). But almost all of the letters (97%) were sent to small online stores, none of which were large companies with a measurable market share as evidenced by sales data.

The companies were cited for one to three violations. Most commonly included is a refusal to receive a PMTA. In 2020 and 2021, respectively, 56% and 99%+ of violations involved PMTA violations. In addition, more than 90% of the products mentioned — 880 different ones in total — were flavored refillable e-liquids, rather than disposable vaping devices (“sub-mods”), which the data shows are most popular among young people.

Penalties ranged in severity from product detention to product confiscation and fines. But loss of a tobacco distributor’s license and criminal charges were less common in both years than other consequences.

At the time of review, the majority (72%) of websites listed in the 2020 breach were still live, as were 29% of the websites listed in the 2021 breach. As the authors note, it was not possible to determine how the target companies responded and whether the FDA followed through on the consequences outlined in the warning letters because this information is not publicly available.

“Although current research assesses this online sales make up about one-third of the market, the data tells us that most young people get items from friends (32.3%), buy them from another person (21.5%), or buy from a vape shop (22.2%).” – the authors note.

“Prioritizing products that are most accessible to youth and that come from a variety of sources will be important to deter youth use,” they add. “Strong, effective and transparent consequences must be adopted to prevent the sale of products that violate the regulations necessary to protect the health of adult e-cigarette users and prevent their use among young people.”

“The FDA must use its enforcement authority to combat the manufacture, distribution, and sellers of tobacco products that have the greatest impact on youth and products that do not provide public health benefit,” they conclude.