Earlier this year, the Food and Drug Administration (FDA) unveiled an unprecedented plan to cut smoking and nicotine addiction rates. Now, FDA commissioner Scott Gottlieb, M.D. says the agency is taking new steps to keep the popular JUUL and other vapes out of kids' hands.
The FDA announced today that they're cracking down on companies and retailers that may be marketing, selling, or redistributing JUUL and other vape products to minors.
Today—in what Dr. Gottlieb calls "the largest coordinated tobacco compliance effort in FDA’s history"—the agency sent letters to five major companies, including JUUL, Vuse, MarkTen, blu, and Logic. The letters allege that the companies' products were sold to underage users and give the companies 60 days to create new plans to prevent minors from using their products. In particular, the FDA is focusing on flavored e-cigarette liquid that may be especially attractive to younger users.
"This may require these brands to revise their sales and marketing practices, including online sales; to stop distributing their products to retailers who sell to kids; and to remove some or all of their flavored e-cig products from the market until they receive premarket authorization and otherwise meet applicable requirements," Dr. Gottlieb said in the statement.
The FDA also took actions (including warning letters and fines) against more than 1,300 retailers that may have illegally sold vape products to minors. And, on top of all that, the agency announced it will be examining its own compliance policies, including beefing up its efforts to monitor and enforce regulations and revisiting its premarket approval policy of new products.
"JUUL Labs will work proactively with FDA in response to its request. We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people," Kevin Burns, CEO of JUUL Labs, said in a statement regarding the FDA's actions.
"Our mission is to improve the lives of adult smokers by providing them with a true alternative to combustible cigarettes. Appropriate flavors play an important role in helping adult smokers switch. By working together, we believe we can help adult smokers while preventing access to minors, and we will continue to engage with the FDA to fulfill our mission," the statement continues.
But, wait, aren't e-cigarettes a way better alternative to regular cigarettes?
Yes, but…it's complicated. In today's statement, Dr. Gottlieb acknowledges that, previously, the FDA's guiding principle in its efforts to combat the harmful effects of smoking was the understanding that "what primarily causes death and disease from tobacco use isn’t the nicotine in these products. It’s the act of lighting tobacco on fire to free that drug for inhalation."
And, although nicotine is obviously what keeps people smoking, "it’s primarily the combustion, which releases thousands of harmful constituents into the body at dangerous levels, that kills people," Dr. Gottlieb says.
So, because e-cigarettes do not involve that key step, they present an opportunity to make the act of smoking less harmful and, possibly, help people transition away from cigarette smoking and nicotine consumption entirely.
And, until now, the FDA has tried to balance that potential with the efforts to keep a new generation of younger people from becoming addicted to nicotine via e-cigarettes.
But, according to Dr. Gottlieb, the FDA didn’t predict what he now refers to as "an epidemic of e-cigarette use among teenagers."
Nicotine isn't "a benign substance," he says, and children's brains may be particularly susceptible to its effects. The most obvious one is, of course, nicotine dependence, which makes it difficult (often nearly impossible) to quit using nicotine and causes withdrawal symptoms when you try to stop, such as irritability, anxiety, difficulty concentrating, insomnia, and diarrhea or constipation.
Additionally, because our brains are still developing until around age 25, nicotine exposure before that may interfere with the development process. Studies looking at cigarette smoking suggest that adolescents and young adults who smoke may show deficits in attention and memory tasks. And animal studies confirm that nicotine exposure at a young age can directly affect the development of neural structures in the brain and behavior associated with those changes (if you happen to be a rat, anyway).
E-cigarette vapor also contains other compounds that researchers are still working to understand. For instance, they may contain diacetyl, a chemical once commonly found in microwave popcorn flavoring that in large amounts is known to cause damage to the lungs (a condition called "popcorn lung"), according to the American Lung Association. (But it isn't clear that the level of diacetyl found in e-cigarettes poses a similar risk.)
There is also research to suggest that vaping as a teen is associated with a higher likelihood that you'll try other risky behaviors. For instance, a study published in Pediatrics last year looked at data from the CDC's 2015 Youth Risk Behavior Survey, which included information for 15,624 students in grades 9 through 12. Looking at the survey results, researchers found that students who reported using e-cigarettes were also more likely to report getting into physical fights, engaging in risky sexual behavior (such as having more than four sexual partners), and using other substances, including alcohol, cannabis, and non-medical use of prescription drugs.
Of course, this is an observational study and, therefore, can't tell us whether or not using e-cigarettes actually causes those other behaviors, only that they are correlated. Additionally, the data used in this study was all self-reported, which we know is not the most reliable because people may not accurately remember engaging in these behaviors or may not want to admit to engaging in them.
That said, it's particularly worrying that the use of e-cigarettes has been associated with an increased risk for transitioning to the use of traditional cigarettes, a pattern that is contradictory to that found in adults. So, even if the risks of adolescent e-cigarette use aren't totally understood, it makes sense that the FDA would want to err on the side of caution here.
So what does this mean for you if you're a JUUL user?
If you're an adult Juul user, this won't have any immediate impact on your life, but you may see changes in the near future. If you're below the legal age limit for purchasing e-cigarettes (age 21 in California, Hawaii, Maine, New Jersey, and Oregon, and age 18 in other states), know that retailers are increasingly discouraged from selling the devices to you.
As we mentioned, nicotine isn't harmless—even if it's coming from an e-cigarette. So if this is a habit you'd rather do without, now is a perfect time to look into resources for quitting. Your doctor or the CDC can point you in the right direction, which may include setting up a definite quitting plan, joining a support group, downloading an app, or managing cravings with specific activities or nicotine replacement therapy.