E-cigarettes: Facts, stats and regulations
Electronic nicotine delivery systems go by many names. The most common name is “e-cigarettes,” but others such as e-cigs, vapes, vape pens, mods and tanks are also common terms. Most recently, new products, such as JUUL, have created brand-centric terms for product use (“JUULing”). For this resource, the entire category will be referred to as “e-cigarettes.”
In addition to e-cigarette products, tobacco companies have introduced “heat-not-burn” tobacco products. These devices work by heating tobacco instead of burning it. Sometimes the tobacco is treated with a humectant, like propylene glycol, to produce an aerosol inhaled by the user. Manufacturers claim this delivery method is substantially less harmful than traditional cigarettes, but current data on the health effects of these devices are sparse (and most of what has been published has been by tobacco industry scientists).
While these products have not been approved by the FDA for use in the U.S., a new product application for IQOS — a heat-not-burn product by Philip Morris International — is currently pending. Data in foreign markets submitted by Philip Morris indicate that dual use of heat-not-burn products along with cigarettes is, by far, the most dominant pattern of use, which raises substantial issues about what impact they might have on overall public health. Read comments from Truth Initiative® on the IQOS application.
Dual use of tobacco products
Among all age groups, e-cigarettes are most commonly used by those who also use other tobacco products, such as combustible cigarettes. This pattern is commonly referred to as “dual use” or “poly tobacco use.”
Among adult users, dual use is a troubling pattern because it suggests that some e-cigarette use may be supplementing smoking instead of replacing it. Because there is no safe level of smoking, there are concerns that this behavior represses efforts to completely quit smoking (i.e., people choose to “cut down” instead of quitting smoking entirely). This issue is somewhat complicated because some individuals who use e-cigarettes to quit may experience a period of dual use as they change products.
Among youth, the data are more difficult to interpret. Dual use may indicate that kids who use other nicotine products are also more likely to use e-cigarettes due to shared character traits — like sensation seeking and openness to risk (the “shared liability” theory) — and/or the fact that initial e-cigarette use is a cause of subsequent use of other nicotine products (the “gateway” theory). A 2018 report from the National Academies of Sciences, Engineering, and Medicine addressed this issue and concluded that there is “substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults,” suggesting that e-cigarette use itself is a risk factor, not just a correlation with smoking.
PATTERNS OF USE
E-cigarette use has increased in recent years, especially among youth and young adults, who use e-cigarettes more than any other age group. E-cigarettes are now the most commonly used tobacco product among youth.
- Between 2011 and 2017, e-cigarette use significantly increased among youth in high school and middle school. The 2017 National Youth Tobacco Survey found that 11.7 percent of high school students and 3.3 percent of middle school students used e-cigarettes in the last 30 days, compared with 1.5 percent of high school and 0.6 percent of middle school students who reported current use in 2011.
- Using e-cigarettes has been shown to increase the likelihood of smoking cigarettes among young people, raising concerns that e-cigarettes are acting as entry nicotine products that may lead to use of more dangerous nicotine products. The 2018 NASEM report concluded that, “there is substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults.”
- Many young e-cigarette users do not know what is in the products they are using. A recent study found that 98.7 percent of all e-cigarette products sold at convenience stores, supermarkets and similar outlets contain nicotine. Yet, many young people aren’t aware that the products they use contain nicotine. In fact, 60 percent of teens incorrectly reported e-cigarettes as being comprised of mostly flavoring.
- Youth e-cigarette users cite flavors as a reason they begin using e-cigarettes. A study that included middle and high school students found that 43 percent of young people who ever used e-cigarettes tried them because of appealing flavors.
- Like youth, young adults aged 18 to 24 are also using e-cigarettes at increasing rates. The amount of young adults who use e-cigarettes every day or some days increased from 2.4 percent in 2012 and 2013, to 5.2 percent in 2015.
- A 2015 report from the National Health Interview Survey states that 40 percent of young adults who use e-cigarettes every day or some days were never smokers before trying e-cigarettes.
- Compared with adults aged 25 and older, young adults are more likely to try e-cigarettes and report having used e-cigarettes in the past 30 days.
- The growth in the popularity of e-cigarettes among young adults has caused concerns that use will lead to the initiation of cigarette and other tobacco product use.
- E-cigarette use has also increased among adults in recent years, albeit much less dramatically than among youth. Between 2012 and 2013, 2.4 percent of adults aged 25 to 44 and 2 percent of adults aged 45 to 64 used e-cigarettes. By 2016, those rates increased to 4.2 percent and 2.8 percent, respectively.
- Adults aged 45 and older are significantly less likely to have ever tried an e-cigarette compared with young adults.
- In 2015, among adult e-cigarette users, 29.8 percent were former regular smokers, 58.8 percent were current cigarette smokers and 11.4 percent had never been cigarette smokers.
Since 2016, the e-cigarette brand JUUL has surged in popularity among young people, and as of June 2018, has taken 68 percent of the e-cigarette market share measured by Nielsen. JUUL’s emergence into the e-cigarette market has been so rapid that national surveillance systems have yet to ask specifically about its use.
A 2017 study by the Truth Initiative Schroeder Institute® found that 6 percent of youth and 10 percent of young adults have used a JUUL e-cigarette in the last 30 days. The study also found that while many young people are aware of JUUL, many are unaware that the product always contains the addictive chemical nicotine.
According to the product website, a single JUUL cartridge is roughly equal to a pack of cigarettes, or 200 cigarette puffs. JUUL is promoted as a “satisfying alternative to cigarettes,” and may be putting a new generation of youth at risk of nicotine dependence and future cigarette use.
There are substantial research gaps in proving the effectiveness of e-cigarettes as quit smoking aids. The 2018 NASEM report found limited evidence on the effectiveness of e-cigarettes to promote quitting. Additionally, e-cigarettes are not approved as quit aids by the U.S. Preventative Service Task Force.
There is, however, some evidence that supports the use of e-cigarettes as quit devices.
- A study published in 2016 reported that within two randomized control trials, e-cigarettes with nicotine helped individuals quit better than e-cigarettes without nicotine.
- The NASEM also reported that more frequent e-cigarette use may increase an individual’s likelihood to quit.
While some e-cigarettes may be an effective resource for quitting smoking, the variation in product quality and the lack of regulation make determining the potential of any particular product as a quit aid difficult.
Although there is limited research currently supporting e-cigarette use for quitting, a smoker who switches completely to e-cigarettes from combustible cigarettes will substantially reduce exposure to toxic chemicals and health risks. Some smokers have switched to e-cigarettes or used them to quit tobacco completely. Truth Initiative supports regulation that encourages the development of consistently less harmful nicotine delivery alternatives that allow smokers to quit tobacco altogether, or switch completely to a much less harmful product.
Product appeal, including flavoring, is likely to encourage smokers to try to use e-cigarettes to quit or switch completely. But, because flavors also appeal to youth, manufacturers should be prohibited from marketing flavored e-cigarettes unless they can show that the product helps adults switch and it is not attracting significant youth uptake (as verified by careful postmarket surveillance). Truth Initiative supports strong regulations to keep all tobacco products, including e-cigarettes, away from youth.
Using e-cigarettes is substantially less harmful than inhaling smoke from combustible tobacco, such as cigarettes and cigars. Much remains unknown, however, and it is critical to continue to monitor the potential health effects, addictiveness and toxicity of e-cigarettes.
ADDICTION AND BRAIN DEVELOPMENT
Nicotine is an addictive substance, but its level of addictiveness can vary substantially depending on its mode of delivery. Nicotine delivered by tobacco combustion is the most addictive form. The rise in the popularity of e-cigarettes that can deliver levels of nicotine similar to combustible cigarettes is causing concern about the potential risk for addiction.
- Exposure to nicotine among youth is particularly dangerous since it has been shown to have an effect on key brain receptors, making young people more susceptible to nicotine addiction.
- There is some evidence that the effect of nicotine on developing brains may result in nicotine addiction and greater vulnerability to addiction to other drugs as well.
- Because many e-cigarettes contain nicotine, which can alter nerve cell functioning in developing organisms, especially during fetal development, they should not be used by youth or pregnant women.
- Pregnant women who use nicotine are at a greater risk of stillbirth and preterm delivery.
While e-cigarettes contain far fewer toxins than combustible cigarettes, they are not free of toxins and still deliver harmful chemicals.
- At least 60 chemical compounds have been found in e-liquids, and more are present in the aerosol produced by e-cigarettes.
- Researchers have identified several substances which are either harmful or potentially harmful to e-cigarette users, including delivery solvents and propylene glycol, which can cause dry mouth and upper respiratory infections.
E-cigarette flavors — even those approved for ingestion — have not been studied for toxicity if inhaled over long periods of time. Many e-cigarette flavorings contain chemicals that are known to be respiratory irritants, and research has found that some flavors are potentially more toxic than others. For example, researchers found that exposure to increased cinnamon flavoring caused significant cell death, compared with other flavors. Additionally, mixing multiple flavors can be more toxic to cells than exposure to just one flavor at a time. The repercussions of long-term exposure to the chemicals found in e-liquids and produced by e-cigarettes are not yet known, since products have not been on the market long enough to conclusively study their effects.
EXPOSURE TO E-LIQUID
Accidental exposure to or ingestion of e-liquids can be very dangerous and, in the case of accidental swallowing or injection, even fatal.
Defective, poorly manufactured and improperly modified e-cigarettes have been known to explode and cause injury. The rate of explosions is unknown, but both hospitals and burn centers have reported injuries from e-cigarettes.
SECONDHAND AEROSOL EXPOSURE
- Exposure to aerosol from e-cigarettes may expose nonusers to nicotine, but research indicates that secondhand aerosol results in substantially lower exposure to toxicants and carcinogens than secondhand cigarette smoke. However, exposure among vulnerable populations, including pregnant women and children, could still be dangerous.
INDUSTRY MARKETING AND YOUTH TARGETING
The introduction of e-cigarettes has allowed companies to advertise through traditional outlets that have been heavily regulated to reduce combustible cigarette marketing to children. For example, e-cigarette advertising has appeared on TV and the radio, despite the ban on cigarette advertising on both outlets since Congress passed the Public Health Cigarette Smoking Act in 1970. The FDA banned flavors, except menthol, in combustible cigarettes in 2009 to curb youth appeal, whereas e-cigarettes capitalize on offering many kid-friendly flavors, such as cotton candy and gummi bear.
- Recent reports have found that e-cigarette companies are using scholarship offers as a way to recruit youth users.
- Individuals aware of e-cigarettes report that the most common ways to hear about e-cigarettes are through in-person communications, by seeing them for sale and by seeing them in online and TV ads, in which some celebrities have endorsed the products.
- E-cigarettes are promoted heavily online43 through e-cigarette company-sponsored advertisements, and on YouTube and Twitter.
- More recently, mobile ads have become a popular place to advertise e-cigarettes. Mobile ads, or paid advertisements on smartphone applications and websites optimized for mobile, have the potential to reach millions of young people.
- Some e-liquids have been marketed to look like common food items, many of which appeal to kids. Examples include marketing e-liquids as “Thin Mints,” like the Girl Scout’s cookie, and “Tootsie Roll.” Those e-liquids were removed, or at least renamed, after the companies owning those copyrights took action to protect their intellectual property. Other food and candy flavors remain on the market. In May 2018, the FDA and the Federal Trade Commission took joint action against several e-liquid companies that marketed their products to look like candy or other kid-friendly food items, such as Reddi-wip, Nilla Wafers and Warheads candy.
The retail environment for e-cigarettes
E-cigarettes are sold in conventional tobacco retail outlets, such as convenience stores, gas stations, pharmacies and tobacco shops. They are also sold at nontraditional outlets, such as online retailers and vape shops.
YOUTH EXPOSURE TO ADVERTISING
Youth and young adults are widely exposed to e-cigarette marketing and have high awareness of e-cigarettes.
- By 2016, nearly 4 out of 5 middle and high school students, or more than 20 million youth, saw at least one e-cigarette advertisement.
- Young people are most likely to see ads at retail stores (68 percent), followed by the internet (41 percent), television (38 percent) and newspapers and magazines (24 percent). Between 2014 and 2016, exposure to retail e-cigarette advertising among young people jumped nearly 20 percent.
- One study found that, among adolescents who had never used e-cigarettes, those who were exposed to four e-cigarette television ads reported a greater intention to use e-cigarettes in the future, compared with those who did not view the e-cigarette ads. Additionally, current cigarette smoking was highly associated with likelihood of future e-cigarette use.
- A randomized controlled trial among young adults showed that brief exposure to four e-cigarette print ads increased curiosity about e-cigarettes, and ad exposure was associated with subsequent trial of e-cigarettes in a small proportion of the young adults who had never used an e-cigarette or cigarette.
- Mobile device ownership is most prevalent among young people, and research has shown that mobile ads may attempt to capitalize on young audiences by highlighting the product as “cool” or “high tech,” and by featuring flavors.
Emerging e-cigarette products make frequent appearances on social media. As these products gain users and popularity, their likelihood of appearing on newsfeeds and timelines may be increasing.
- Among adults in 2013, 8.6 percent had seen or heard content related to e-cigarettes on Facebook and 3.8 percent on YouTube. These numbers were higher for current users of e-cigarettes.
- Those who were looking to share information with their peers about e-cigarettes were most likely to use word of mouth (53.9 percent) and Facebook (33.2 percent). Nearly half (48.5 percent) of adult e-cigarette users sharing information related to these devices used Facebook to do so.
- In 2013, researchers analyzed e-cigarette content on YouTube and found that there were nearly 30,000 videos posted to the site related to e-cigarettes. These videos came from 10,000 unique accounts and had more than 100 million views.
POTENTIAL PUBLIC HEALTH IMPACT
There are varying estimates of the potential public health impact of e-cigarettes.
The recent review of the health impact of e-cigarettes from the 2018 NASEM report is instructive. It found that, if three conditions are assumed about e-cigarettes — that they are 90 percent less harmful than cigarettes, that they increase cigarette quitting rates by 15 percent and that they result in no increase in cigarette initiation by youth — they would contribute to a 1.5 percent decrease in expected smoking-related deaths in 50 years. If the assumptions are changed to show only a 5 percent increase in quitting and a 10 percent increase in initiation, the result is a 0.2 percent decrease. In contrast, the first 50 years of traditional tobacco control measures in the U.S. after the 1964 surgeon general’s report on smoking resulted in a more than 35 percent decrease in expected deaths due to tobacco.
While e-cigarettes may have a role to play in curbing the tobacco epidemic, potential positive effects will be limited if they are not considered as part of comprehensive product regulation, like reducing nicotine to non-addictive levels in the most dangerous products, such as cigarettes, and eliminating flavors and marketing practices that attract youth. Continuous and rigorous implementation of traditional tobacco control measures, such as taxation, clean indoor air policies and public education, is also essential. Additionally, an overarching nicotine regulatory policy is needed to help improve quitting drugs and to ensure that the FDA reviews tobacco products, including e-cigarettes, so that consumers better understand what can help them quit or completely switch from combustible cigarettes.
In May 2016, the FDA finalized its “deeming” regulation, asserting the agency’s authority to regulate e-cigarettes and any product meeting the definition of “tobacco product” under the Family Smoking Prevention and Tobacco Control Act.
The FDA can now establish product standards and regulate the manufacturing, importing, packaging, labeling, advertising, promotion, sale and distribution of e-cigarettes, including components and parts of e-cigarettes.
The deeming regulation includes requirements for premarket review of e-cigarettes as new tobacco products. In order to receive marketing approval for a new product, a manufacturer would need to demonstrate that the marketing of the new product would be “appropriate for the protection of the public health,” taking into account both the likelihood of new tobacco product initiation and the increased or decreased likelihood that existing users of current tobacco products would stop using such products.55 In July 2017, the FDA announced that it would extend the timeline to submit tobacco product review applications to market newly-regulated noncombustible products, including e-cigarettes, to Aug. 8, 2022. This means that more than 13 years will have passed from the passage of the Tobacco Control Act to the full regulation of e-cigarettes. Said another way, an entire generation of young people will have passed through their teen years during this time frame. This is noteworthy given that 90 percent of all tobacco users start using tobacco before age 19.
MODIFIED RISK TOBACCO PRODUCTS
Under FDA rules, before an e-cigarette manufacturer can market a product as having lower risk of exposure to toxins or lower risk of adverse health effects, it must submit the proposed marketing to the FDA for approval to assess veracity of the claim and whether the marketing of the product would benefit the health of individuals and the population as a whole, considering factors such as new initiation of tobacco use or suppression of quitting of more harmful products like cigarettes. To date, no e-cigarette manufacturer has requested such permission from the FDA.
CLEAN INDOOR AIR POLICIES
- There are no federal policies restricting indoor use of e-cigarettes other than policies in individual federal buildings or properties.
- Thirteen states and 752 municipalities have expanded their smoke-free air laws to also prohibit e-cigarette use in places where cigarette smoking is prohibited. However, there are no clean air restrictions covering e-cigarettes in the majority of the U.S.
There are currently no federal restrictions on flavored e-cigarettes.
- In March 2018, the FDA issued an advance notice of proposed rulemaking to request public comment to better understand the role that flavors in tobacco products play in attracting youth, as well as the role they may play in helping some smokers switch to potentially less harmful forms of nicotine delivery. However, this request for comment is not a guarantee of agency action and no date has been set for action by the FDA on this issue.
- More than 100 localities have prohibited the sale of flavored tobacco products, including flavored e-cigarettes. These include San Francisco, Berkeley, Contra Costa County, El Cerrito, Los Gatos, Manhattan Beach, Oakland, Palo Alto, San Leandro, Santa Clara, Sonoma and Yolo County, California; Chicago, Illinois; Boston and 105 other municipalities in Massachusetts; Duluth, Minneapolis, Robbinsdale, Shoreview, St. Louis Park and St. Paul, Minnesota; and Barrington, Central Falls, Johnston, Middletown and Providence, Rhode Island. However, a large majority of the U.S. population is not covered by such restrictions.
- There are few federal restrictions on the marketing of e-cigarettes, and unlike traditional cigarettes, e-cigarettes can be advertised on television and radio.
- Marketing materials for e-cigarettes cannot make claims that the product exposes users to fewer toxins or reduces harm unless the FDA grants an order allowing such claims.
- E-cigarette products with misleading labeling or advertising can be considered misbranded under the Tobacco Control Act. This includes e-cigarette marketing that imitates food or beverages.
- States have the ability to regulate the time, place and manner of tobacco marketing, including e-cigarettes. For example, California and Delaware prohibit websites and online and mobile applications directed at minors from marketing or advertising e-cigarettes. California also prohibits ads for tobacco products, including e-cigarettes, on any outdoor billboard located within 1,000 feet of a school or public playground.
- The FDA deeming regulation, effective Aug. 10, 2018, established a nicotine warning label that must appear on all tobacco products, including e-cigarettes: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” The warning label must comprise 30 percent of the two principal display panels and be in a large, legible font.
- The Child Nicotine Poisoning Prevention Act of 2015 requires the Consumer Safety Product Commission to establish requirements for child-resistant packaging for e-cigarettes and e-liquids. The law, passed before the deeming regulation gave the FDA authority over e-cigarettes, maintains the agency’s ability to regulate such packaging. The FDA has indicated that it will also issue regulations requiring child-resistant packaging for e-cigarettes and e-liquids, but has not yet done so.
- There is no federal excise tax on e-cigarettes.
- States have the authority to tax e-cigarettes. Eight states and Washington, D.C., have imposed a tax on e-cigarettes.
YOUTH ACCESS AND MINIMUM AGE OF SALE
- The FDA deeming regulation established a federal minimum age of 18 for the sale of all tobacco products, including e-cigarettes. Retailers must check photo IDs of everyone under age 27 who attempts to purchase tobacco products, including e-cigarettes.
- Vending machine sales of e-cigarettes are prohibited, except in facilities where only those over age 18 are allowed.
- Free samples of e-cigarettes and their components are prohibited, as of Aug. 8, 2016.55
- The Tobacco Control Act required the FDA to issue regulations to establish age verification requirements for the internet and other non-face-to-face purchases of any tobacco products. However, the FDA has yet to implement this set of regulations.
- A 2014 study of internet tobacco vendors selling e-cigarettes found that 52.3 percent of them had an age warning on the homepage of their website. However, 51.9 percent exclusively used age-verification methods that could not effectively verify the age of a consumer. Additionally, 11.3 percent made no attempts to verify age at all.
- The Tobacco Control Act prohibits the FDA from further raising the federal minimum legal age of sale. However, states and some localities have the ability to establish a higher age of sale for tobacco products beyond the federal requirement. Five states (California, Hawaii, Maine, New Jersey and Oregon) and at least 290 localities have established a minimum age of 21 for the sale of tobacco products.
International regulation of e-cigarettes varies widely, and due to the relatively recent introduction of the product category, is rapidly changing.
- A 2016 study found that, of 90 countries surveyed, 25 banned e-cigarettes completely and 17 required premarket authorization before an e-cigarette could be sold. Thirty-five countries that allowed e-cigarettes to be sold prohibited them from being advertised.
- The European Union has enacted standards for e-cigarettes, including restricting the strength of nicotine fluids (2 percent maximum), limiting tank size on vaping devices (2 mL maximum), requiring child-resistant packaging and prohibiting cross-border advertising of e-cigarettes. Some member states have further restrictions on the age of sale and taxes.
- The landscape of international e-cigarette regulation is quickly developing. The Institute for Global Tobacco Control at the Johns Hopkins Bloomberg School of Public Health keeps a database of international e-cigarette laws. Notably, the United Kingdom has been most active in promoting e-cigarettes as a reduced harm alternative to cigarettes. Public Health England has encouraged the National Health Service to make e-cigarettes available to smokers looking to quit or switch. The U.K. allows for the licensing of e-cigarettes as medicinal quitting aids, but no manufacturer has yet taken this route to product approval.