Juul e-cigarettes will be temporarily reinstated in the United States while the Food and Drug Administration (FDA) reviews the company’s appeal of a late-last-month decision to pull the products from the market.
In late June, as part of a broader crackdown on teen smoking and the tobacco industry, the FDA decided to deny the company’s application to remain on store shelves.
Juul was rejected while many other major e-cigarette manufacturers were allowed to remain on shelves. The company from San Francisco, California, appealed the decision.
Tuesday, America’s top regulatory agency cited “scientific issues” as the reason for temporarily lifting the ban and allowing the return of the products.
The Biden administration has also cracked down on cigarettes, reducing their nicotine content to levels deemed “non-addictive.”
The FDA administratively stayed the marketing denial order on July 5, 2022. The FDA has determined that there are scientific issues unique to the JUUL application that require further review,’ the FDA tweeted.
This administrative stay suspends the marketing denial order temporarily during the additional review but does not overturn it.
‘All electronic nicotine delivery systems, or ENDS, including those manufactured by JUUL, are required by law to have FDA approval to be legally marketed. The stay and the agency’s review do not authorize the marketing, sale, or shipment of JUUL products.
In the 2010s, Juul skyrocketed in popularity in the United States as its fruit-flavored nicotine products became fashionable among younger smokers, resulting in the company being held responsible for increases in teen smoking.
To prevent increases in teen smoking, the FDA banned fruit-flavored e-cigarettes and required companies to submit individual applications to keep their products on store shelves. Juul’s application was anticipated to be approved.
Juul has marketed its products as aids for gradually and safely weaning nicotine addicts off the substance, as vape devices lack many of the negative effects of smoking tobacco cigarettes.
However, the fruity and mint flavors in a number of its products have led many children and adolescents to begin smoking, when they likely would not have done so otherwise.
In recent years, this has placed Juul and the e-cigarette market in general in the FDA’s crosshairs.
In April 2021, the agency banned menthol-flavored cigarettes and all flavored cigar varieties.
E-cigarettes with refillable cartridges that contain fruit or mint flavors have also been banned, although disposable cartridges can still be sold.
Flavored products are frequently the target of regulations because they are easier to use as a gateway for people who do not currently smoke since taste is one of the primary deterrents to starting to smoke.
It is particularly important for younger smokers who use vaping devices like Juul.
While they may not enjoy the taste of nicotine, it is much simpler for them to become addicted to fruity, tasty flavors.
Last year, the FDA wrote in a statement, “[The bans in April] will help save lives, particularly among those disproportionately affected by these deadly products.”
With these actions, the FDA will significantly reduce youth smoking initiation and increase the likelihood of quitting.
Under the new regulations, a company wishing to market a refillable device with a fruit or mint flavor must first receive approval from the FDA, which rejected hundreds of similar products.
To circumvent these orders, many companies began to use synthetic forms of the drug in their medical devices. In April, this loophole was closed.
In March, the Centers for Disease Control and Prevention (CDC) published a study revealing that more than 2.5 million U.S. students had used a tobacco product of some kind in 2021. This definition includes nicotine delivery systems that do not contain tobacco.
Officials reported that 80% of tobacco use was due to disposable e-cigarettes and cartridge products, such as the Juul.
Approximately 2.06 million high schoolers, or 13% of the study population, and 4% of middle schoolers, or 470,000 participants, reported ‘current’ tobacco use in the study.
In comparison, the CDC reported in 2020 that 8% of high school students and 3% of middle school students were current tobacco users.
Additionally, students were asked if they had ever used tobacco products; 34% of high schoolers and 11% of middle schoolers reported at least one use.
According to the CDC study, electronic cigarette devices were primarily responsible for the increase in nicotine and tobacco use over the past year.
54% of the students who reported being current smokers use disposable e-cigarettes, while 29% use a refillable device comparable to a Juul.
Over 80 percent of all student tobacco use is attributable to the devices that permit teens to use nicotine easily and in plain sight.
Nicotine does not carry any of the same negative effects and cancer risks as tobacco, but it does increase the risk of hypertension, atherosclerosis, and heart rate.
E-cigarettes’ popularity among school-aged children can be attributed to their flavors and the devices’ resemblance to USB sticks, which make them easy to conceal at school.
Some states and municipalities have outlawed the sale of flavored nicotine products, with varying degrees of success in preventing adolescents from picking up the habit.
Opponents of these bans argue that they will encourage adolescents to use more dangerous tobacco products, such as cigarettes, rather than nicotine, which carries a lower risk.
Mark Oates, director of the consumer advocacy group We Vape, told DailyMail.com in March, “By bashing safer nicotine products such as vaping, we will inadvertently encourage high school students to smoke instead, which is a terrible outcome.”