The U.S. Food and Drug Administration is preparing to walk a regulatory and marketing tightrope when it comes to youths and electronic cigarettes.
This fall, the agency will roll out an online extension of its “The Real Cost” public-health campaign.
The goal: emphasizing the risks it believes youths face when using e-cigs, vaporizers and other electronic nicotine delivery products, or, more simply, ENDS.
In the meantime, anti-smoking advocates question whether the FDA campaign could cause more harm than good, especially if it attempts to tell youths — as some anti-tobacco public-health advocates claim — that e-cigs are no safer to use than a traditional cigarette.
Some studies, most notably one by the Royal College of Physicians in London, have determined that e-cigs may be 95 percent less harmful than traditional cigarettes.
There does not appear to be much disagreement with the FDA rule that prohibits the sale of e-cigs and vaporizers to people under age 18. That rule, and several other sales and marketing restrictions on innovative tobacco products, went into effect in August 2016.
A national campaign will begin in 2018 that will deal with the FDA’s concerns about “evidence that youth exposure to nicotine affects the developing brain and may rewire it to be more susceptible to nicotine addiction in the future.”
Dr. John Spangler, a professor of family and community medicine at Wake Forest Baptist Medical Center, expressed similar concern about young people’s use of ENDS leading to addiction.
“Nicotine rewires brain areas associated with mood, causing predisposition to mood disorders in the future,” Spangler said. “Nicotine also affects the heart among adolescents, predisposing them to cardiac disorders, and nicotine can affect a youth’s immune system.
“Ideally, it would be best if no young person were exposed to nicotine because of its adverse brain development,” he said.
It is the FDA’s first specific youth campaign on ENDS. The FDA estimates that about 2 million middle and high school students used an e-cig at least once over a 30-day period in 2016.
“These efforts are part of the agency’s new comprehensive plan for tobacco and nicotine regulation, as well as ongoing efforts to educate youth about, and protect them from, the dangers associated with using all tobacco products,” the FDA said.
The FDA plans to explore additional restrictions on the sale and promotion of ENDS, “including restrictions on how products may be sold and advertised, to further reduce youth exposure and access to these products.”
Mitch Zeller, the director of the FDA’s Center for Tobacco Products, said the agency will evolve its e-cig policies on youths “through science-based educational efforts and regulatory policies that will ultimately pay the greatest dividends in reducing tobacco-related disease and death.”
The campaign follows the FDA’s submission on July 28 of regulatory proposals that recognize a continuum of risk for nicotine and tobacco products for adults that could include a reduced-risk role for e-cigs and vaporizers. The proposal also included limiting, if not eliminating, menthol as a tobacco flavoring.
“While we pursue a policy that focuses on addressing the role that nicotine plays in keeping smokers addicted to combustible cigarettes, and to help move those who cannot quit nicotine altogether onto less harmful products, we will also continue to work vigorously to keep all tobacco products out of the hands of kids,” said Dr. Scott Gottlieb, the FDA commissioner.
Gregory Conley, the president of the American Vaping Association, questions whether the FDA will truly embrace a continuum of risk policy with ENDS as it urges youths not to try them as an alternative to traditional cigarettes.
“Credibility is hard to get and extremely difficult to regain back once it has been lost,” Conley said.
“Even though these videos may have been budgeted and approved before Gottlieb came into office, it is his responsibility to ensure that they are scientifically accurate and not misleading,” Conley said. “If these videos send the inaccurate message to viewers that all nicotine products are equally capable of producing dependence, Gottlieb will have failed in bringing scientific integrity to the FDA.”
E-cigs and vaporizers surpassed traditional cigarettes as the tobacco product of choice for youths in 2014, according to several national youth-smoking studies.
Some analysts say the jump from 4.5 percent in 2013 to 13.4 percent in 2014 came primarily from changes in how questions about other tobacco products were presented.
“Including e-cigarettes and other ENDS products in our prevention work not only makes sense,” Gottlieb said, “it reflects the troubling reality that they are the most commonly used tobacco product among youth.”
The National Youth Tobacco survey and the Monitoring the Future study showed smoking among high school students reaching an historic low for traditional cigarettes in 2016, as well as a decline in e-cig and vaporizer use — from 16 percent in 2015 to 11.3 percent in 2016 — for the first time since those products came on the market in 2011.
Anti-smoking advocates say the increased use of e-cigs and vaporizers is a sign of youths recognizing that those products are a potential reduced-risk way to consumer tobacco and nicotine.
On March 18, a study commissioned by the National Institutes of Health and the FDA determined that the driving factor for why youths smoke e-cigs is avoiding or reducing harm from smoking traditional cigarettes, rather than the attraction of candy and fruit flavorings.
In August 2016, the Monitoring the Future researchers determined the majority of students consume ENDS products for flavor, and not nicotine. They said the results “challenge the common assumption that all vaporizer users inhale nicotine.”
On April 17, the U.S. Centers for Disease Control and Prevention released a 26-month study of 15,943 adult cigarette smokers that determined when it came to a potential smoking-cessation device, substituting some cigarettes with e-cigs (35.3 percent) was used by a greater percentage of smokers than the nicotine patch or gum (25.4 percent) or other cessation aids approved by the FDA.
And 24.7 percent switched completely from cigarettes to e-cigs to try to stop smoking.
“Given that our data show that e-cigarettes are more commonly used for quit attempts than FDA-approved medications, further research is warranted on the safety and effectiveness of using e-cigarettes to quit smoking,” the CDC said. “There is no conclusive scientific evidence that e-cigarettes are effective for long-term cessation of cigarette smoking. E-cigarettes are not approved by the FDA as a smoking cessation aid.”
‘Not be using’
In December, former U.S. Surgeon General Dr. Vivek Murthy said in a presentation that there’s no safe use of the products for people younger than 25.
“There is confusion around e-cigs and youths, are they safe to use?” Murthy said. “We know enough right now to say that youth and young adults should not be using e-cigarettes or any other tobacco product, for that matter. Electronic cigarettes place a whole new generation at risk for nicotine addiction.”
David Sweanor, an adjunct law professor at the University of Ottawa and the author of several electronic-cigarette studies, said that as the FDA has “endorsed the concept of the continuum of risk, and recognize that there are vast differences in risk between products, their campaigns should start to reflect that.”
Sweanor said that by trying to discourage behavior “at the very low end of a continuum of risk, they can lead to people simply changing to more dangerous activities.”
“Just as telling people about the risks of sex with a condom can result in significantly riskier unprotected sex,” he said.
Sweanor said the FDA must incorporate into its campaign the recent reports that show that youths who are experimenting with tobacco products are doing so with products other than cigarettes.
“This coincides with teen cigarette use having fallen dramatically, and to record lows,” he said.
Abigail Friedman, a Yale University researcher with a focus on tobacco and nicotine products, said she is concerned about the FDA campaign “potentially backfiring” by equating the harm in e-cigs with those in traditional cigarettes.
A study Friedman released in October 2015 found that states that have banned the use of e-cigs and vaporizers by people younger than 18 — including North Carolina — have experienced an increase in the number of youths smoking traditional cigarettes.
“There is strong evidence that e-cigs are less harmful that traditional cigarettes, so by not emphasizing that difference, it could lead to more youths smoking traditional cigarettes in experimenting with tobacco products,” Friedman said.
Sweanor said he believes “the really big health risk over the next few years is from the tens of millions of (adult) smokers who could dramatically reduce their risks by switching to non-combustion products but whom surveys show to be unaware of the difference in risk between products.”
“Even a campaign aimed at teens runs the risk of resulting in unnecessary disease and premature death among their parents and grandparents,” he said.