Analysis of FDA Warning Letters to E-cigarette Industry
An analysis of warning letters sent by regulatory agencies regarding marketing violations indicates that the current oversight of the US electronic cigarette industry by the Food and Drug Administration (FDA) may have minimal impact, according to an article published in Tobacco Control.
In 2016, the FDA announced a plan to regulate the electronic cigarette industry, which included requiring manufacturers to obtain pre-market approval (PMTA) to ensure their products protect public health before being sold.
In 2017, regulatory agencies began sending warning letters to manufacturers, retailers, and distributors regarding potential violation of rules, such as advertising to young people, selling to minors, non-compliant packaging or labeling, and lack of PMTA application.
However, little is known about who received these letters, which product types they were concerned with, the details of the violations, and their consequences. To uncover the answers, researchers from Truth Initiative evaluated the contents and recipients of publicly available FDA warning letters released in 2020 and 2021. A total of 303 warnings were issued by the FDA: 126 in 2020 and 177 as of September 9th, 2021.
An analysis shows that by the year 2021, over 98% of target companies fulfilled all three roles (manufacturer, distributor, and retailer).
Almost all of the emails (97%) were sent to small online retailers, which sales data shows are not large companies with measurable market share. The company was cited for one to three violations, with most involving failure to obtain PMTA (Post-Market Tobacco Product Applications). Between 2020 and 2021, over 56% and 99% of the violations were related to PMTA noncompliance.
More than 90% of the products are flavored e-cigarette liquids, rather than the disposable e-cigarette devices that have been shown to be most popular among young people.
The severity of the penalties ranged from product detention to product seizure and fines. During the review, it was found that the majority (72%) of the websites cited as violating regulations in 2020 were still operating, while 29% of those cited in 2021 were also still active. As the author noted, it is impossible to determine how the target companies responded or whether the FDA followed up on the consequences mentioned in the warning letters, as this information is not publicly available.
Although current research estimates that online sales account for about one-third of the market, data tells us that most young people purchase products from friends (32.3%), from another person (21.5%), or from an e-cigarette shop (22.2%),” said the authors in a statement. They added, "Prioritizing products that young people most commonly use and can obtain from various sources is crucial for curbing youth use.
The author further suggests that there is a need to establish a strong, influential, and transparent consequence for the sale of products that violate regulations necessary to protect the health of adult electronic cigarette users and prevent youth from using such products. The FDA should utilize its enforcement authority to target manufacturers, distributors, and sellers of tobacco products that have the greatest impact on youth and do not provide public health benefits.
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