Are electronic cigarettes a safer alternative to combustible cigarettes, or are they a new gateway to a lifetime of nicotine addiction? In the past month, the editors of The New York Times noted the opposite conclusions from the British agency Public Health England that reported e-cigarettes can reduce the health risks of smoking by 95 percent, compared to a study in the Journal of the American Medical Association, which showed that ninth graders who tried e-cigarettes were far more likely to then use regular combustible tobacco within a year.
In a step that may help resolve this controversy, the Food and Drug Administration (FDA) is soon expected to pass federal e-cigarette “deeming” regulations, which are so named because the Family Smoking Prevention and Tobacco Control Act of 2009 grants the agency oversight authority for additional tobacco products that it “deems to be subject” to the Act.
But while the debate they have ignited is new, electronic cigarettes themselves are not. The patent for their first prototype was issued in 1963, and the tobacco industry was approached decades ago with this technology as an alternative to cigarettes. Not until nearly a decade after the 1998 Tobacco Master Settlement Agreement did the tobacco industry become interested in e-cigarettes, best displayed by their recent acquisition of many of the smaller e-cigarette manufacturers.
This delay leaves some to wonder: why didn’t Big Tobacco champion e-cigarettes much earlier if they truly believed them to be “harm reduction” devices? In the following blog post, I suggest five key steps that policymakers, regulators, and public health advocates should take on e-cigarettes.
E-Cigarettes And The Ongoing Public Health Battle On Smoking
The public health effort regarding e-cigarettes has evolved in the reverse order of most other medical interventions. Framed as an innovation, e-cigarettes entered the American marketplace in 2007 touted as a possible smoking cessation tool, without being subject to the rigorous clinical safety and efficacy evaluation that are required before FDA approval of a new medication or device.
Breaking the addiction to nicotine is difficult, even with the assistance of the nicotine patch, gum, or prescription medication, which is why preventing Americans from becoming addicted to nicotine in the first place has been and should continue to be a top public health priority. Only about 6 percent of smokers stop smoking each year with existing smoking cessation aids, and several research studies have shown that e-cigarettes are not particularly more effective, with a low quit rate of only around 7 percent.
There may be a silver lining, however, in that patients treated with placebo e-cigarettes without nicotine were nearly 60 percent as successful at quitting as those given e-cigarettes containing nicotine, suggesting that the removal of the nicotine in e-cigarettes (as has been done in other nations) could be a future public health strategy in America.
In 13 countries worldwide, e-cigarettes have been banned, in part due to their potential for promoting drug abuse in addition to nicotine addiction, since marijuana and other illicit substances can be vaped as well. In New Zealand, it is illegal to sell any e-cigarette that contains nicotine, and e-cigarettes containing placebo only are sold primarily in pharmacies. Perhaps the FDA can also incorporate these insights gleaned from the worldwide experience with e-cigarettes into the final deeming regulations?
In 2015, many unanswered questions remain regarding the dangers of e-cigarettes, both to smokers and those around them, but some initial myths have also been dispelled. Two initial claims by e-cigarette proponents: that there are not any carcinogens in e-cigarettes, and that the secondhand vapor does not contain nicotine or other toxic chemicals, have both been proven incorrect.
Scientific studies have characterized the toxicity of e-cigarettes, particularly in the exposure to propylene oxide, metals, and formaldehyde. As a novel innovation, e-cigarettes also pose unique health hazards not associated with traditional cigarettes. Calls to poison control centers by concerned parents have dramatically increased across America after the accidental ingestion of liquid nicotine by children, and other users have inadvertently instilled the e-cigarette fluid into their eyes after mistaking the storage bottles for eye drops.
The consequences and toxicity of direct contact of liquid nicotine on skin need to be better understood. Malfunctioning e-cigarette batteries and accidental activation of the heating element have spontaneously ignited fires in homes, on airplanes, and in high school gymnasiums, which prompted the issuance of a 2015 Federal Aviation Administration (FAA) Safety Alert recommending a ban on e-cigarettes in checked baggage. New research will characterize the potential effects of e-cigarettes on surgical patients, and explore the combined effect of inhaled propylene glycol, acetaldehyde, and metal particles upon perioperative anesthetic and respiratory outcomes.
A Safer Product Is Not Necessarily Safe
The claim that e-cigarettes are safer than traditional combustible cigarettes should thus be approached with caution, as safer is not the same as safe. Combustible cigarettes remain one of the most lethal products for sale in America — more than 10 times as many U.S. citizens have died from cigarettes than in all the wars fought in American history. Since the first Surgeon General’s report on tobacco in 1964, over 20 million Americans have succumbed to tobacco’s deadly toll, and countless more lives and families have been harmed. In many industries, the identification of a safer alternative to a dangerous product would trigger a recall, and discontinuation of the manufacture and sale of the more dangerous item.
In the fall of 2014, the tobacco industry voluntarily decided to place dire warning labels on e-cigarettes regarding their health risks and potential for promoting nicotine addiction. This action was reminiscent of the sudden shift in the tobacco industry’s stance towards combustible cigarettes after the 1998 Tobacco Master Settlement, and perhaps reflects the recognition by tobacco industry scientists of the new hazards posed by e-cigarettes and related legal liability?
The tobacco industry has asserted that e-cigarettes are not a tobacco product and therefore not subject to either regulation or taxation under the Tobacco Master Settlement, though the World Health Organization (WHO) has reported that 22 nations worldwide regulate e-cigarettes as a tobacco product. Some perceive the tobacco industry’s current efforts in State Capitols as seeking to ensure that e-cigarettes are not defined as a tobacco product in American legislation and to bypass FDA regulation a second time.
A new federal definition of “tobacco products” to include e-cigarettes might be an appropriate action to standardize the variable definitions by states across America. Funding the research and development endeavors to answer the unresolved questions about e-cigarette safety and efficacy is both costly and time consuming, and the burden of proof should have been required of manufacturers before their introduction into the marketplace.
The number of grant applications about e-cigarettes to California agencies, such as the University of California’s Tobacco-Related Disease Research Program that allocate grant dollars raised by taxes on combustible cigarettes, have increased significantly. A direct tax on e-cigarette companies could help fund the ongoing research into these unanswered questions about e-cigarettes.
Finding Common Ground
As ongoing research further characterizes the public health hazards of e-cigarettes, tobacco control advocates and Big Tobacco should identify areas they can agree on. One such area is not imperiling youth to the harm of cigarettes and nicotine addiction. Marketing of e-cigarettes to children, through product placement in film, television, and magazine advertisements that portray e-cigarettes as hip and cool, and using cartoon characters once used by Big Tobacco to attract young smokers, should end.
Use of e-cigarettes tripled among middle and high school students from 2013 to 2014, along with a significant increase in the use of hookah. While the share of high school students who smoke traditional cigarettes fell to 9 percent, the concern is that about a quarter of all high school students, and 8 percent of middle school students reported using a tobacco product in 2014, representing the first increase in years.
Another area that should be agreed upon is the need to exercise caution to safeguard the health and safety of the public. Over the past years, anti-smoking advocates have become concerned that the expansion of e-cigarettes risks renormalization of cigarettes, potentially reversing decades of success in tobacco control.
To protect the health of the public, clean indoor-air laws should not be weakened by allowing the increased use of e-cigarettes in public areas where conventional smoking is prohibited. The FAA is also currently considering a complete ban on the use of e-cigarettes on airplanes, both to improve air quality and avoid accidental fires during flights.
E-Cigarettes And The Path Forward
Moving forward, policymakers, regulators, and public health advocates should take five key steps on e-cigarettes with the health and safety of the public in mind:
1. Public health organizations, such as the American Cancer Society, American Lung Association and American Heart Association must work together to organize the scientific evidence to assist the FDA Commissioner to finalize the FDA deeming regulations.
2. In advance of the release of the FDA regulations, Congress should prepare a legislative plan to supplement any gaps in the agency’s authority and resources. In March 2015, Congresswoman Jackie Speier (D-CA) submitted H.R. 1517 “Stop Selling and Marketing to Our Kids E-Cigarettes Act (the SMOKE Act)” to give the FDA the added authority to regulate e-cigarettes as tobacco products, require warning labels and child proof packaging, and prohibit advertising to minors. Congresswomen Rosa DeLauro (D, CT) and Elizabeth Esty (D, CT) later proposed H.R. 3042 to close loopholes in the sales of e-cigarettes to minors, particularly online. These bills can provide the foundation for companion legislation to be submitted this fall.
3. The smaller e-cigarette companies should follow the lead of Big Tobacco and place a warning label on their products both in America and worldwide.
4. The FDA should change who sits on its Tobacco Products Scientific Advisory Committee, and reducing the number of tobacco industry representatives should be considered.
5. Finally, the White House Office of Management and Budget should be prepared to score new legislation seeking to tax e-cigarettes, with the revenue directed towards scientific research, and to offset the costs associated with ongoing oversight and law enforcement. Minnesota and North Carolina have led the way by imposing taxes upon single use e-cigarettes and liquid cartridges (e-juice). Just this month, a 30-percent excise tax on the wholesale price of e-cigarettes went into effect in Montgomery County, Maryland. The opportunity exists to separately tax each of the key components of a reusable electronic cigarette, such as the refillable delivery device and the liquid nicotine. The greatest tool to discourage smoking over the decades has been taxes on traditional cigarettes. This success should now be extended through taxes on e-cigarettes to help defray the health care costs of those e-cigarette users who become addicted to nicotine through their use, and to fund ongoing investigations into e-cigarette safety.
The debate over the dual nature of electronic cigarettes will be answered with time. In the final analysis, e-cigarettes will likely be proven to be a smoking cessation aid for some. But this benefit must be balanced with the fact that other adults and children who never previously smoked will be first introduced to nicotine via an e-cigarette rather than a traditional combustible cigarette, and others will use both e-cigarettes and regular cigarettes in a “dual-use” fashion. Therefore, any efforts to disseminate electronic cigarettes as a potential smoking cessation tool by Big Tobacco should also be combined with a coordinated strategy to reduce, and perhaps even phase out the sales of traditional combustible cigarettes in America over the years.
Tobacco control advocates should take comfort that a wave of e-cigarette regulation to prohibit e-cigarette use indoors has swept through City Halls in New York, Chicago, Los Angeles, San Francisco, and nearly 100 cities across America. More than 40 states have banned e-cigarette sales to minors. These efforts have been joined by the Attorney Generals of 40 states, the Senate and the Senate HELP committee, the World Health Organization, and the American Heart Association in the call for oversight into these nicotine delivery devices.
Building on these efforts, model legislation should be developed by policymakers in collaboration with tobacco control advocates to catalyze the rapid adoption of new laws in City Halls and State Capitols to regulate and tax e-cigarettes across the nation to promote the health and safety of the public.
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