On April 14, 2022, the U.S. Food and Drug Administration (FDA) formally took on a new role: the regulation of synthetic nicotine, which now falls under the definition of a tobacco product. Although the agency believes that it needs to have this authority, the sudden change threatens adult access to hundreds of thousands of safer tobacco products.
The new authority was included in the 2,700-plus pages of the omnibus appropriations bill at the behest of a squad of liberal, nanny-state lawmakers that continuously refuse to acknowledge tobacco harm reduction, and in fact, have urged the FDA to ban all sales of flavored vapor products.
While the FDA has not banned all flavored vapes, in September 2021, the agency did issue denial orders to nearly 1 million flavored e-liquid products, commonly found in adult-only, specialty vape shops. Per FDA requirements, these products had to have been on the market before August 2016 to have legally marketed their products for the past half-decade.
Despite youth rarely using open-source vapor products, the FDA still issued denials citing the companies’ failure to prove a benefit to adult consumers in the face of the so-called “youth vaping epidemic.”
But the FDA isn’t even paying attention to what youth are vaping. Nor the fact that youth vaping decreased from 2019 to 2020, and further between 2020 and 2021.
According to the National Youth Tobacco Survey (NYTS), in 2019, among high school students, 6.4% used a “tank” vape device. By 2020, this had decreased by 54.7% to 2.9% of high school students using open-sourced vapor products.
Moreover, overall e-cigarette use among youth has declined. According to the NYST, in 2021, among high school students, only 11.3% reported using an e-cigarette on at least one occasion in the 30 days prior to the survey. This is a 76.1% decrease from 2020, when 19.9% of high school students reported past 30-day e-cigarette use.
Not that the FDA took note of the decline in youths using e-cigarettes. In fact, according to a July, 2021-dated memorandum issued by Matthew Holman, Director of the FDA’s Office of Science (OS), the FDA planned to issue a “Fatal Flaw review” to all remaining applications which companies must have submitted to the agency by September 2020. It should be noted that according to the memo, FDA’s review process was “limited to determining presence or absence of such studies.” It did “not evaluate the merits of the studies.”
Many of those companies did move to synthetic nicotine, but they shouldn’t have been forced to. FDA was made aware of the issues of the then-non-regulation of synthetic derived nicotine when the deeming regulations were first issued on e-cigarette products in 2016. In fact, in comments to the agency, one e-cigarette manufacturer remarked that while, at the time, most nicotine was derived from tobacco sources, it was still “possible to (but not yet cost effective) to produce synthetic nicotine.”
Ultimately, the broad federal regulations over vapor products are a disservice to consumers of tobacco harm reduction products, as well as useless in reducing youth vapor product use. Hopefully, the FDA can learn to recognize the differing types of vapor products, understand which are more likely to be used by youth, and practice enforcement discretion when applying this new regulation upon thousands of tools used by adults to remain smoke-free.