The FDA issued a warning to one e-cig maker that reportedly violated the Food, Drug, and Cosmetic Act.
The FDA is casting a closer eye on HelloCig Electronic Technology, an e-cigarette manufacturer, after FDA researchers discovered that not only were the fruit-flavored products found to impair lung function in trials on mice, but the liquids contained prescription erectile dysfunction drugs as well.
While e-cigarettes, vapes, and their ilk have been touted as a healthier alternatives to smoking for years, the truth is that the products were simply too new to allow any deep understanding about the possible adverse risks they carry as well as what product regulations should be put in place to protect consumers.
This lack of regulation may have contributed to HelloCig’s inclusion of tadafil and sildenafil, usually used as the active ingredient to treat erectile dysfunction, in their e-cigarette liquids.
“There are no e-liquids that contain prescription drugs that have been proven safe or effective through this route of administration,” said Scott Gottleib, FDA Commissioner.
The FDA also undertook a surprise inspection of popular San Francisco e-cig manufacturer Juul, snatching up their marketing documents to ensure the company is not marketing to minors. Juul has been a runaway success, seeing a massive increase in sales from 2.2 million devices in 2016 to 16.2 million devices in 2017.
Considering that 2 million high schoolers reported using e-cigarettes in a National Youth Tobacco Survey study, a significant portion of these sales made their way to the hands of minors.
That’s why last September, the FDA warned and fined any e-cig manufacturers found to have sold products to minors and gave them 60 days to prove they had mechanisms in place to prevent minors from purchasing their products.
The fruity flavors that are most attractive to teens have been linked to impaired lung function in mice. While this does not necessarily mean that the same effects will be seen in humans, it’s an important first step to determining the risks the products present.
“Our findings suggest that exposure to e-cig vapor can trigger inflammatory responses and adversely affect respiratory system mechanics,” wrote the study’s authors. “We conclude that both e-cig vaping and conventional cigarette smoking negatively impact lung biology.”
Groups of mice were exposed to cigarette smoke as well as different formulations of e-cigarette vapor. After three days, all the mice were found to have problems with inflammation, mucous production, and lung function.
Bryan Le/The Fix