Food and Drug Administration (FDA) commissioner Scott Gottlieb has warned that e-cigarette manufacturers face threats if more young people continue to use such products. The government agency has tried to stop distributors and stores selling vaping products from promoting flavored nicotine products and marketing them to teens and minors.
Growing numbers of young people have used e-cigarettes in many flavors, prompting Gottlieb and the FDA's concern. The FDA has long considered banning flavored e-cigarettes and has banned many flavors (https://www.nytimes.com/2013/07/24/health/fda-takes-steps-toward-ruling-on-menthol-cigarettes.html?_r=0&module=inline) of traditional cigarettes.
Even though the rate of smoking among adults is at its lowest in more than fifty years(https://www.cdc.gov/media/releases/2018/p1108-cigarette-smoking-adults.html), there has been growing concern over smoking and vaping among teens and children. Teen vaping increased 78 percent(https://www.cdc.gov/mmwr/volumes/67/wr/mm6745a5.htm?s_cid=mm6745a5_w), according to a 2018 report, while 3.6 million young people (https://www.yahoo.com/lifestyle/fda-threatening-take-e-cigarettes-off-market-180221452.html) in middle school and high school had used e-cigarettes in the past year. Meanwhile, a 2016 report stated that 9.5 percent (https://www.drugabuse.gov/related-topics/trends-statistics/infographics/teens-e-cigarettes) of U.S. eighth graders vaped.
Vaping products could be removed from the market if they do not adhere to regulations and if there is no significant decline in use among young people, said Gottblieb. “If the youth use continues to rise, and we see significant increases in use in 2019, on top of the dramatic rise in 2018, the entire category will face an existential threat."(https://www.nbcnews.com/health/health-news/fda-chief-threatens-take-e-cigarettes-market-n960411)
Groups such as the American Heart Association and the Campaign for Tobacco-Free Kids have been urging the FDA to contain the rise in teen vaping. The FDA banned the sale of many flavored e-cigarettes in stores and is considering taking other actions against e-cigarette manufacturers.
Gottlieb said that his agency may be forced to take this step to contain the problem. “It will be game over (https://www.nbcnews.com/health/health-news/fda-chief-threatens-take-e-cigarettes-market-n960411) for these products unless they can successfully transverse the regulatory process."
Legal challenges could emerge as the FDA and other parties seek to ban flavored cartridge-based e-cigarettes. Leaked reports suggested that the FDA would adopt stringent measures against e-cigarette manufacturers. The agency shelved those plans because of potential long and protracted legal battles.
E-Cigs Nicotine Addiction and Treatment
Manufacturers and others have promoted the use of e-cigarettes as a safer alternative to smoking combustible tobacco. E-cigarettes work by using electronic circuits to burn nicotine and other substances. Users inhale (or vape) the vapor produced by such burning.
Critics believe that manufacturers should not promote e-cigarette devices as a solution for smoking cessation. They say that e-cigarettes contain harmful ingredients (https://e-cigarettes.surgeongeneral.gov/) in addition to flavoring. This is contrary to claims that they are a safer way for smokers to get their fix of nicotine. Flavorants such as diacetyl found in some vapes have been linked to serious lung disease.
Another problem with e-cigs is that they contain nicotine – often a lot of it. Nicotine can cause dependency and addiction, which can lead to the need for addiction treatment.
Flavored E-cigarettes
The FDA has been trying to persuade manufacturers to implement changes voluntarily. It faces legal hurdles and procedures that may take years to process. The current focus is to strike a balance between preventing access for minors while allowing adult smokers to access tobacco alternatives, alternatives that could potentially help reduce the health risks for former tobacco smokers.
In July 2017 the FDA extended the period for e-cigarette manufacturers to comply with regulations to the year 2022. Health-related organizations sued the agency and asked the commissioner to enact the compliance process for e-cigarettes.
Supporters of the delayed compliance process says the delay gives manufacturers time to make adjustments and provide safe alternatives for smokers. Opponents of the delay see this strategy as favoritism for big brands and a way to allow them to buy time before compliance occurs.
Proponents of immediate compliance state that many teens use e-cigarettes. So many, in fact, that FDA commissioner calls e-cigarette use among teens an epidemic (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620185.htm). Flavored vaping devices such as JUUL devices are widely used by teenagers and high school students. JUUL sells e-cigarettes and nicotine cartridge refills called pods in different flavors, such as mango, mint, and fruit.
Other manufacturers are hoping to capitalize on the popularity e-cigarettes, a market that is expected to earn more than $44 million (https://globenewswire.com/news-release/2018/10/11/1619692/0/en/E-Cigarette-Market-is-Estimated-to-Reach-44-610-6-Million-by-2023-P-S-Intelligence.html) by 2023. Despite this, JUUL has been the key driver in this market, reporting a market share of 68 percent (https://www.cnbc.com/2018/07/02/juul-e-cigarette-sales-have-surged-over-the-past-year.html) in July 2018.
This means that JUUL controlled more than two-thirds of the market for electronic cigarettes at that time. Traditional tobacco companies have noticed this success. Altria, the parent company of tobacco companies such as Philip Morris, even invested billions of dollars in JUUL in December, 2018.
E-cigarettes are clearly popular. But, that doesn't mean that they are a safe option:
E-cigarette use among teens has surpassed the rates of teens who use traditional tobacco products. The 2014 Monitoring the Future study indicated that eighth graders and tenth graders used vaping devices at twice the rate (https://news.umich.edu/e-cigarettes-surpass-tobacco-cigarettes-among-teens/) of conventional tobacco products.
There is no evidence that vaping products can assist with smoking cessation. E-cigarette use is not effective in short-term smoking cessation (https://tobaccocontrol.bmj.com/content/25/Suppl_1/i90). Furthermore, using vaping products may result in the use of both. Teens may be exposed to large amounts of nicotine, a substance that can have detrimental effects on the brain.
Critics believe that flavors of e-cigarettes such as milk chocolate, bubble gum, and mango may make e-cigarettes more appealing to younger users. The American Cancer Society believes that the use of vaping products among young teenagers has reached epidemic proportions (https://www.cancer.org/latest-news/fda-proposes-regulations-as-teen-e-cigarette-use-skyrockets-78-percent-in-1-year.html). There was a 78 percent increase in e-cigarette use in teenagers between 2017 and 2018.
Discussing different views about how to handle the growing problem, Commissioner Gottlieb says his agency did not intend to completely ban e-cigarettes:
“I still believe e-cigarettes present an opportunity for adult smokers to transition off cigarettes and onto nicotine delivery products that may not have the same level of risks. However, if the youth use continues to rise (
), the entire category will face an existential threat.”https://twitter.com/SGottliebFDA/status/1086271157232418817
- SGottliebFDA
Meanwhile, market leader JUUL has made significant changes to comply with regulations. In a November, 2018 statement, JUUL chief executive officer Kevin Burns stated that the company would remove flavored e-cigarettes (https://newsroom.juul.com/2018/11/13/juul-labs-action-plan/) from more than 90,000 retail outlets. The company would also make certain flavors available only on its websites, limit the amount of products consumers can purchase, and enforce online verification system to ensure minors that cannot access the products online.
Will e-cigarettes still be available to minors? Given proposed constraints, will they be available to anyone? It will be interesting to see if e-cigarette purchases and consumption continue to rise.
Charles Watson
https://www.sunshinebehavioralhealth.com/
Pic Credit - https://pixabay.com/en/e-cigarette-steam-evaporator-health-1881957/