A recent study published in Tobacco Control suggested that current Food and Drug Administration (FDA) oversight of the American vaping industry is likely to have minimal impact. The study analyzed the Food and Drug Administration (FDA) warning letters sent to vaping companies to determine the nature of current e-cigarette regulation.
The researchers coded FDA warning letters to indicate a company type (retailer, manufacturer, or distributor), location (domestic or international), and types of infractions such as PMTA (premarket tobacco product application), selling to minors, advertising to youth or packaging violation/mislabeling). The study categorized product type (e-liquid, device, or both), flavor (including fruit, candy, tobacco, menthol/mint, and concept flavor). The study also noted a range of consequences for infractions such as civil money penalties, product seizure and injunction, product detention and refusal of entry to the USA, no-tobacco-sales order, and criminal prosecution.
A total of 303 letters were coded (126 from 2020 and 177 from 2021) and analyzed. 97.4% of the letters were sent to small online retailers. A majority of the companies were located in the U.S. (94.1%). Reviewing a company’s website resulted in identification of 75.2% of the infractions. 70.5% were Premarket Tobacco Application (PMTA) violations. At the time of the review, a majority of the websites (72%) cited for 2020 infractions 29% of websites cited for 2021 infractions were still operational.
PMTA for each year were also analyzed. 55.6% of 2020 infractions were PMTA violations whereas most 2021 infractions were PMTA violations. In this process, the letters cited 880 products. Over 92% were e-liquid products including 32.4% fruit and 31.1% concept flavors.
The FDA sent warning letters to more small online retailers than larger brands, and they focused on products like disposable vapes most often used by youth. The research suggests FDA is failing to target key players or products marketing to young people. Although the FDA’s Juul product ban appears to be a significant step towards reform, many believe the FDA should impose strict regulations on products responsible for increased youth vaping rates.
Sources: Eureka News Alert, Tobacco Control
