OR WAIT 15 SECS
On August 8, 2016, Mitch Zeller, JD, blogged on the US Food and Drug Administration (FDA) website that beginning that day, federal law would protect the public-especially kids-from the dangers of all tobacco products, including electronic cigarettes (e-cigarettes), vapes, and more. The law, known as the Deeming Rule, would regulate the largely unregulated market that he referred to as having been the “wild, wild West.”
On August 8, 2016, Mitch Zeller, JD, blogged on the US Food and Drug Administration (FDA) website that beginning that day, federal law would protect the public-especially kids-from the dangers of all tobacco products, including electronic cigarettes (e-cigarettes), vapes, and more. The law, known as the Deeming Rule, would regulate the largely unregulated market that he referred to as having been the “wild, wild West.”1
Electronic nicotine delivery systems (ENDS), also called e-cigarettes, personal vaporizers, vape pens, e-cigars, e-hookahs, or vaping devices, are exploding in popularity, according to the American Academy of Pediatrics (AAP).2 Zeller cited a stunning statistic: E-cigarette use had increased more than 900% among high school students, from 1.5% in 2011 to 16% in 2015.1 The estimated $1.5 billion ENDS market is expected to grow 24.2% annually through 2018. In 2015, more teenagers used e-cigarettes than traditional cigarettes, according to the AAP.2
Under the law, the FDA would not only be able to restrict youth access to the products, but also have the authority to review new products to prevent misleading claims, require that manufacturers report on ingredients, and more.
However, consumer and health organizations are concerned that the law implemented last year might unravel-at least in part.
The Campaign for Tobacco-Free Kids (tobaccofreekids.org) announced on May 17 this year that 51 health groups, including the AAP, are concerned about judicial and regulatory delays associated with the Deeming Rule, and they are urging the Trump administration to defend and fully implement the law.3
The groups’ concerns stem from what the Campaign for Tobacco-Free Kids calls industry’s “multifront attack” on the rule and 2 recent instances in which the US Department of Justice delayed filing legal briefs defending the rule against industry challenges. To further erode the consortium’s confidence that the FDA Deeming Rule would be fully enforced, the FDA announced on May 1, 2017, that it was delaying enforcement of future rule deadlines to allow new FDA and US Department of Health and Human Services leadership to mull over issues in the final rule that are the subject of lawsuits in federal court.3
Industry is lobbying for looser regulations, and it has allies in high places, among them US Representative Duncan Hunter (R-CA). Fox News reported on April 27, 2017, that the long-time vaping proponent had introduced a bill in April focused on loosening regulations for e-cigarette products, which, if passed, would reverse the Obama administration’s rule categorizing e-cigarettes as tobacco products under the FDA. Hunter’s bill, for example, would exempt vaping devices from a 2-year review process requiring the FDA’s nod prior to new products entering the market.4
E-cigarette makers say the regulatory hurdles would make it difficult for smokers to use e-cigarettes, which they say are a safer alternative to traditional cigarettes, according to Fox News. How the FDA will ultimately enforce the Deeming Rule remains unclear, but industry may have someone sympathetic to the cause in the FDA’s newly appointed Commissioner of Food and Drugs, Scott Gottlieb, MD, who in 2015 to 2016 was a director at Kure Corporation, a Charlotte, North Carolina-based company that distributes vaping pens and e-juices in vaporiums-coffee house-type settings for vaping-according to Fox.4,5
Karen Wilson, MD, MPH, a pediatrician and chair of the AAP Section on Tobacco Control, says that even if the FDA’s Deeming Rule remains intact, it falls short in a few important areas for children’s health. The rule doesn’t restrict marketing in the way that tobacco marketing is restricted, and it doesn’t restrict flavors, she says.
“There’s a lot of variability in how these products are made-in particular, in the e-cigarette liquid and how that is packaged,” says Wilson, who also is the Debra and Leon Black professor of Pediatrics and division chief of General Pediatrics at the Icahn School of Medicine at Mount Sinai, New York City.
The AAP was instrumental in passing the Child Nicotine Poisoning Prevention Act of 2015, which requires child-safe packaging on nicotine-containing liquids.
“That was a major step forward in protecting children from potential nicotine poisoning,” Wilson says. “As for marketing, the current rules are obviously much broader, but the AAP would have preferred that these regulations extended to TV and other types of marketing, as well as to flavors.”
There are studies to suggest teenagers are lured in by the ads, including recent research by Pierce and colleagues,6 which found a large proportion of adolescents in the United States who never used tobacco are receptive to tobacco advertising. Television advertising for e-cigarettes had the highest recall. This receptivity to advertising for ENDS was associated with susceptibility to smoke cigarettes.
Adolescents are “heavily” targeted by the e-cigarette industry, according to another study.7 “If you look at the marketing for electronic cigarettes, they clearly are [targeting teenagers]. They’re using cartoons; they’re using highly sexualized imagery; they’re using flavors, like bubble gum and cherry crush, that are very appealing to young people,” Wilson says.
In addition, there’s a lot that we don’t know about the long-term impact of flavors, according to Wilson. The liquid in e-cigarettes is heated and aerosolized, typically in propylene glycol or vegetable glycerin base, along with chemicals to provide the flavors, she says. “The flavors can be things like eucalyptol. Many of these are ‘generally recognized as safe’ for ingestion but no one has tested whether they’re safe for inhalation.”
There are other studies that question the safety of these products, regardless of whether they contain nicotine. An animal study suggested that exposure to the propylene glycol base without any nicotine, for instance, has a negative impact on a mouse model of newborn lung development.8
Another big concern at the AAP, according to Wilson, is that e-cigarettes and other ENDS are creating lifelong hooked customers, who are more likely than those who don’t use ENDS to smoke combustible tobacco.
Wilson cites a study out of California that looked at a cohort of kids who started smoking e-cigarettes but had never smoked tobacco cigarettes. The adolescents who said they would never smoke and started smoking e-cigarettes were more likely to be smoking cigarettes a year later than kids who weren’t using e-cigarettes or other tobacco products.9
An important first step for pediatricians is to recognize that e-cigarettes are not a safe alternative to tobacco, Wilson says. “They need to counsel their patients and parents that this is not something you should be encouraging your child to do. This is not something you should be allowing your child to do. And this is not something you should be experimenting with, even if you think that using the non-nicotine kind is safe,” she says.
Teenagers and their parents should know that products claiming to be nicotine free might not be. “It’s important to remind people that this is not a harmless water vapor,” Wilson says.
Pediatricians should stress to parents that it’s not safe to use these products in the presence of young children. For those who say they’re using ENDS to quit regular smoking, pediatricians can offer other, better ways to quit, according to Wilson.
Pediatricians also can advocate for laws that treat e-cigarettes like tobacco. “Electronic cigarettes should be considered to be tobacco products in clean indoor air laws, for example,” Wilson says. “Some states are trying to get it so that you can use e-cigarettes in a place like a restaurant. We’re strongly against that because not only are you being exposed to the secondhand aerosol, but children are also seeing this and it’s making tobacco once again a normative behavior.”
1. Zeller M. Protecting the public and especially kids from the dangers of tobacco products, including e-cigarettes, cigars, and hookah tobacco. FDA Voice. FDA.gov website. Available at: https://blogs.fda.gov/fdavoice/ index.php/2016/08/protecting-the-public-and-especially-kids-from-thedangers-of-tobacco-products-including-e-cigarettescigars-and-hookah-tobacco/. Published August 8, 2016. Accessed July 25, 2017.
2. American Academy of Pediatrics Julius B. Richmond Center of Excellence. Electronic nicotine delivery systems. Available at: https://www.aap.org/en-us/advocacy-and-policy/aap-health-initiatives/Richmond-Center/Pages/Electronic-Nicotine-Delivery-Systems.aspx. Accessed July 25, 2017.
3. Campaign for Tobacco-Free Kids. 51 health groups urge administration to defend and enforce FDA rule for e-cigarettes, cigars [press release]. Available at: http://www.tobaccofreekids.org/press_releases/post/2017_05_17_fda. Published May 17, 2017. Accessed July 25, 2017.
4. Lawmakers push to roll back Obama-era e-cigarette regulations. Fox News website. Available at: http://www.foxnews.com/politics/2017/04/27/lawmakerspush-to-roll-back-obama-era-e-cigarette-regulations.html. Published April 27, 2017. Accessed July 25, 2017.
5. US Food and Drug Administration. About FDA: Meet Scott Gottlieb, MD, Commissioner of Food and Drugs. FDA.gov website. Available at: https://www.fda.gov/AboutFDA/CentersOffices/ucm557569.htm. Updated May 18, 2017. Accessed July 25, 2017.
6. Pierce JP, Sargent JD, White MM, et al. Receptivity to tobacco advertising and susceptibility to tobacco products. Pediatrics. May 22, 2017. Epub ahead of print.
7. Chen Y, Fowler CH, Papa VB, et al. Adolescents’ behavioral and neural responses to e-cigarette advertising. Addict Biol. April 11, 2017. Epub ahead of print.
8. McGrath-Morrow SA, Hayashi M, Aherrera A, et al. The effects of electronic cigarette emissions on systemic cotinine levels, weight, and postnatal lung growth in neonatal mice. PLoS One. 2015;10(2):e0118344.
9. Barrington-Trimis JL, Urman R, Berhane K, et al. E-cigarettes and future cigarette use. Pediatrics. 2016;138(1):e20160379.