Action needed on e-cigarettes
Since their introduction in 2008, e-cigarettes have become both ubiquitous and an increasing source of public policy concern and debate. This concern stems primarily from drastic increases in youth e-cigarette use. The most recent data show that 27.5% of high schoolers are using these products — a rate of youth tobacco product use not seen in nearly two decades. The public health community, parents and educators are shocked and worried to find their children and students using these products at home and even in class. Young people are reporting severe signs of dependence, including using e-cigarettes when they first wake up, inability to concentrate in the classroom without using an e-cigarette, and even waking in the night to get a nicotine fix.
We have known for decades that youth in particular should not be exposed to nicotine because it changes brain chemistry to create a stronger addiction, can lead to memory and concentration problems, and can make youth who use it more susceptible to addiction to other substances. Research also suggests that young people who use e-cigarettes are four times more likely to go on to smoke combustible cigarettes.
E-cigarettes are now threatening to undo all the progress that the public health community and government have made over decades to reduce cigarette smoking. Indeed, the surgeon general raised the alarm by issuing an advisory declaring a youth e-cigarette epidemic in December 2018. Since then, data show that more and more youth continue to use e-cigarettes. And this isn’t just experimental or occasional use — it’s regular use likely driven by addiction. The most recent National Youth Tobacco Survey data show that 34.2% of current high school e-cigarette users use them on 20 days or more per month.
Conversely, as the youth e-cigarette epidemic has continued unabated, we have seen adults, and especially older smokers, simply reject the product. In 2014, the first year that the National Health Interview Survey measured adult use of e-cigarettes, 3.7% of adults used the product in the last 30 days. In 2018, the adult usage remained low, at 3.2%, and was largely driven by young adult users (7.6%), who have matured during the youth e-cigarette epidemic. While some adults have switched completely to e-cigarettes from combustible cigarettes, the predominant pattern among adult users continues to be e-cigarette use in conjunction with smoking. This “dual use,” however, provides no reduction in the harms associated with smoking.
As youth use continues to rise, the science around the potential harms of e-cigarettes has grown. Studies show that e-cigarettes produce lower amounts, but are not free from the toxins found in cigarettes. At the same time, flavoring compounds and other ingredients may be producing their own unique harms. Recent studies demonstrate the harms e-cigarettes pose to the respiratory system. Similarly, new studies show e-cigarettes may present unique threats to cardiovascular health. It continues to be nearly impossible to make generalized statements about the potential harms and benefits of the overall category of e-cigarettes due to the incredible variation in hardware design and ingredients. Moreover, as industry executives themselves have acknowledged, we simply do not know the long-term health impacts of e-cigarette use. It took us many decades to understand the toxicity of cigarettes, and, even today, we are discovering new ways in which they harm health.
Simply put, the data show that e-cigarettes as they are currently sold and regulated in the United States are overwhelmingly a vehicle for youth initiation, not adult cessation. E-cigarettes expose kids — who otherwise never would have been — to nicotine and put them at risk for both long- and short-term health consequences.
Vaping-related illness outbreak
As of this writing (November 2019), the country is experiencing an outbreak of vaping related illnesses. More than 2,000 cases have been reported across 49 states with 39 deaths. Most of these cases were from users who reported use of THC, about 86% reported use of THC and 64% reported use of nicotine vaporizer products and 11% report exclusively using nicotine products. The Centers for Disease Control and Prevention continues to update this information on its website. On November 8, 2019, the CDC identified vitamin E acetate as a significant concern in the outbreak, finding the chemical in all 29 samples it had analyzed from victims. The CDC states, “it is possible that more than one compound or ingredient could be a cause of lung injury, and evidence is not yet sufficient to rule out contribution of other toxicants.” It continues to advise non-smokers to avoid vaping of any variety and for everyone to avoid all vaping products purchased “off the street.”
THE POSITION OF TRUTH INITIATIVE®
Truth Initiative has maintained that there may be some possible public health benefit from properly regulated e-cigarettes, provided manufacturers can demonstrate that the products can help adults quit smoking combustible cigarettes safely and completely. However, no e-cigarette has been approved for smoking cessation and no e-cigarette has gone through the rigorous scientific review necessary to determine whether it actually does help smokers to quit. Furthermore, any public health benefit from e-cigarettes for smokers must be weighed against the incredibly high youth use of e-cigarettes and the fact that there are currently no significant marketing restrictions on these products. Without a significant change in regulatory approach, it is unlikely that e-cigarettes will contribute to the overall benefit of public health.
While the industry was creating the e-cigarette problem, the federal government had the tools it needed to slow — if not prevent — this epidemic. Unfortunately, it failed to use them. The government must use those tools now to rein in and reverse this dangerous turn of events. It took the Food and Drug Administration until 2016 to assert authority over e-cigarettes, despite being given the ability to do so by Congress in 2009. Once they had the authority, the FDA could have ensured that products were reviewed to determine whether they provided any public health benefit, as required by the Tobacco Control Act, and that strong marketing restrictions were in place to protect youth. However, in 2017 the FDA chose to delay the due date for all e-cigarettes to submit their scientific public health review applications to 2022. This left products on the market about which the public (or the FDA for that matter) knew nothing — particularly in terms of their individual health effects, appeal to youth, and risks and benefits to smokers — unchecked for five additional years. It also opened the door for the newest generation of high-nicotine content e-cigarette products, such as JUUL and Suorin Drop, to hit the market.
These high tech “pod” or “pod mod” products are easily concealable, come in fruit and candy flavors highly attractive to youth, and some were introduced to the market with advertising campaigns aimed directly at young people. Although one of the manufacturers, market leader JUUL, has announced its plan to halt distribution of some flavors, it will continue to sell mint/menthol flavors, which nearly two-thirds of high school vapers use. In addition, other nicotine pod brands continue to sell a wide variety of fruit and candy flavors and market the products, featuring highly appealing advertising and social media campaigns directed at youth.
As we find ourselves in the midst of another tobacco epidemic, many e-cigarette companies try to claim that they are not part of the tobacco industry. That is simply not true. Tobacco companies either fully own or have significant vested interest in four of the top five e-cigarette companies. E-cigarette companies are emulating their Big Tobacco siblings in order to entice kids and increase their market share. Tactics such as increasing their nicotine content; marketing their products with slick, colorful ads and using popular social media influencers; and claiming that their products are safer, despite no federal review of the products or these safety claims, come straight out of the Big Tobacco playbook.
E-cigarette companies are emulating their Big Tobacco siblings in order to entice kids and increase their market share.
As a result, we have a situation where millions of youth are at risk of addiction to these products while no one, including the FDA or the e-cigarette companies themselves, knows the long-term or even all the potential short-term health effects. Truth Initiative, along with several other public health organizations, has sued the FDA to force the agency to take action much sooner than 2022 in order to get this epidemic under control. The court ruled that e-cigarette manufacturers must submit their scientific information on the public health impact of their products by May 2020. Additionally, in September 2019, the administration stated that it would pull all flavored e-cigarettes off the market until the manufacturers could show that a flavored e-cigarette has a public health benefit. As of this writing, the administration has not moved forward with this plan.
In the meantime, the public health community and all levels of government must help the millions of youth and young adults who are now being exposed to nicotine and prevent this generation from falling into the next trap set by the tobacco industry. The FDA has many tools at its disposal to address the situation but it has chosen not to use them. The time is long past for the FDA to take action and use its authority to correct this massive regulatory failure. In addition, states and some localities can take action to protect their youngest citizens.
We outline key actions all levels of government should take below.
FEDERAL ACTION NEEDED
- FDA review: First and foremost, the FDA must enforce its authority to require a full scientific review of all e-cigarette products to determine their impact on public health. The agency must adhere to the court-ordered date of May 2020 and take products that do not comply off the market immediately. If the FDA had done this in the first place, many of the problems we’re seeing now, including skyrocketing youth use, would have been significantly reduced.
- Extend marketing restrictions on cigarettes to e-cigarettes: The FDA must restrict e-cigarette marketing so that it does not target or appeal to youth. Specifically, the agency must immediately extend the marketing restrictions that apply to combustible cigarettes to e-cigarettes. These include prohibitions on:
- Sponsorships of sports and cultural events
- Self-service access to the products (i.e., keeping the products behind the counter)
- Free gifts with purchase, other than tobacco products (i.e., no branded t-shirts, hats, etc.)
- Other marketing restrictions: E-cigarette manufacturers have marketed their product as sleek and high tech using similarly high-tech marketing tactics in digital and social media as well as social media influencer campaigns. The FDA must institute restrictions on this type of marketing — particularly as it applies to third parties who endorse products on behalf of tobacco companies.
- Other federal agencies have a role to play as well. For example, the Federal Trade Commission (FTC) must also ensure that all industry-funded influencer endorsements clearly indicate that they are paid advertisements and clearly indicate the risks associated with nicotine use.
- The FTC must collect data from the e-cigarette industry on marketing spending just as they do for cigarettes and smokeless tobacco.
- Internet sales: The FDA should prohibit all non-face-to-face sales, along with internet sales, of all tobacco products, including e-cigarettes.
Flavors have overwhelmingly been used to attract those who have not previously used nicotine or tobacco products.
- Product standards: The FDA also has the ability to institute product standards on e-cigarettes, preventing the sale and marketing of any product that does not adhere to those standards. This is a powerful tool the agency needs to exercise in several areas:
- Flavor restrictions: Truth Initiative has long supported the removal of flavors in cigarettes, cigars and smokeless tobacco products. We know that flavors have overwhelmingly been used to attract those who have not previously used nicotine or tobacco products. Given the state of the youth e-cigarette epidemic, we strongly support removing all flavored e-cigarettes from the market, including mint and menthol, pending an FDA review. The burden should always have been on manufacturers to show that their products would not appeal to youth before going to market. Given what we now know about how dramatically flavors influence youth e-cigarette use, the burden should be high. We support a permanent ban on flavors unless a manufacturer can demonstrate three things to the FDA: 1) that a particular flavor helps current tobacco users to stop smoking, 2) it will not lead non-tobacco users, such as youth, to start, and 3) it does not increase the risk of harm from using the product.
- Product packaging: E-cigarettes and e-liquid in particular should come only in child-resistant packaging to prevent young people from ingesting these products, which causes sickness and, in some cases, can be fatal.
- Restrictions on nicotine concentrations and delivery: There are currently no restrictions on the concentrations of nicotine in e-cigarette products in the U.S. JUUL, the most popular e-cigarette in the U.S., contains 59mg/ml (or 5%) nicotine. Some of its competitors contain as much as 7% nicotine. This is in stark contrast to the European Union, where the highest nicotine concentration allowed is 20 mg/ml (2%). Truth Initiative supports restricting not only the nicotine levels but also the mechanism by which nicotine is delivered to reduce the level of nicotine actually delivered to the body in e-cigarettes. This will help reduce its addictiveness.
- Good manufacturing standards: The FDA must ensure that all e-cigarettes deliver nicotine at the level indicated on the package, minimize hazardous constituents and are manufactured at the highest quality standards.
- Battery safety: The FDA should ensure that battery and device quality are sufficient to prevent explosions and overheating.
- Enforcement: The FDA must use its considerable enforcement authority to ensure that all aspects of the Tobacco Control Act, as well as all subsequent regulations, are enforced to the full extent of the law. Without enforcement, these measures will not protect youth. Additionally, other federal agencies, such as the FTC, should work with the FDA to protect against misleading marketing.
- Taxation: Federal, state and local tax-writing authorities should set the highest possible taxes on all tobacco products, including e-cigarettes, to discourage youth use. Above that, combustible tobacco products should be taxed at the highest level, and the least harmful, well-regulated and FDA-reviewed noncombustible tobacco products should be taxed at lower levels.
- Cessation: Federal agencies such as the FDA and the National Institutes of Health must redouble all efforts to develop nicotine cessation interventions for the millions of youth and young adults who now find themselves addicted to nicotine from e-cigarette use. Additionally, the Centers for Medicaid and Medicare Services and insurance companies should make quitting services available for all those addicted to nicotine — whether from e-cigarettes or combustible tobacco products — with no barriers to treatment, such as co-pays.
- Federal research: The FDA and NIH should fund research to better understand e-cigarette harms, behavioral use patterns and impact on tobacco use cessation (separate from the research mentioned above).
STATE AND LOCAL ACTION NEEDED
States and local communities are often the incubators of strong tobacco control policies. They have an important role to play when it comes to protecting youth from e-cigarettes as well. Some examples include:
- Licensing: Requiring all e-cigarette vendors to be licensed and registered with the state or local (where allowed) government. Licensing, besides being an important way to keep track of who is selling tobacco products, can also be a tool to limit the density and location (i.e., not near schools) of tobacco retailers.
- Flavor restrictions: Many local jurisdictions have taken action to restrict or prohibit the sale of flavored tobacco products. Truth Initiative supports such actions because they limit the availability of such highly appealing tobacco products to youth.
- Clean indoor air: State and local governments should require e-cigarette use to be subject to clean indoor air laws and requirements.
- Tobacco 21: State and local jurisdictions should limit sales of all tobacco products, including e-cigarettes and their components, to those age 21 and older, with the onus lying with the retailer. We note that the tobacco industry has recently supported Tobacco 21 policies, selling the idea that this policy will take care of the youth tobacco problem. While Tobacco 21 is an important tool in the tobacco control toolbox, by itself it is not sufficient to keep tobacco out of the hands of young people. Tobacco 21 policies must be accompanied by complementary and strong policies, including but not limited to those listed above, to protect youth from tobacco.