Why is the FDA Shielding Smokers from the Good News About e Cigarettes?
By Gilbert Ross, M.D.
Any clear-thinking health professional would agree that cigarette smoking is without question the most devastating and preventable public health risk that we need to address in this country. And now, four-plus years after the Food and Drug Administration (FDA) was given legal authority over tobacco products, the regulatory agency faces arguably its most important public health decision in its history. The time has come to confront their responsibility to smokers trying to quit and their families.
The worldwide death-toll of cigarette smoking is reliably predicted to hit one billion this century. Despite this depressing fact, the measures implemented by the FDA thus far, ostensibly to reduce the toll of smoking, have been almost entirely lip service, without making any real impact. A relatively new method of helping addicted smokers quit has been adopted by millions of smokers – many of whom are now ex-smokers — over the past few years. I refer of course to electronic cigarettes (e-cigarettes). Concurrent with the dramatic spike in sales of this device comes word of historic declines in the sale of real cigarettes.
E-cigarettes work by delivering a potent “hit” of nicotine in water vapor, with flavorings and propellants of no significant health concerns — neither to the “vaper” (as they call themselves), nor to bystanders. Most of them resemble cigarettes — which is both their blessing, and their curse.
Astoundingly, this nascent public-health miracle has been met with something between derision and hysteria by anti-tobacco groups worldwide: globally, the WHO, health-oriented NGOs, the British regulator MHRA, and many nations are sparing no effort to discourage smokers from trying them, employing misleading (even false) alerts and dire website warnings, phony surveys, and exaggerated concerns about youth being led astray. Unfortunately, and embarrassingly for science-based public health policy, our FDA and CDC have been willingly complicit in this widespread disinformation campaign. Meanwhile they purposely ignore studies that indicate the benefit of e-cigarettes for helping smokers quit. I ask, “How could this be?”
The possible explanations are not pretty: willful ignorance, dogma based on experiences garnered in the 20th century, or greed.
I accuse those responsible for impeding truthful communication about the real risks of e-cigarettes of collaborating in a “cigarette-protection campaign,” whose effects will be to discourage smokers from quitting, leading to more dead smokers. Consider this: those who stand in the way of acceptance of e-cigarettes are acting from motivations that are far removed from public health. The nonprofit groups in the forefront of anti-e-cigarette activism are also heavily funded by pharmaceutical companies in the business of selling near-useless cessation drugs — a fact which they conveniently neglect to disclose. If tobacco companies carried on the same way, they would be hauled into court by the FDA in a heartbeat. Meanwhile, the net result of the official campaigns: cigarette markets protected, worthless cessation aids promoted. Who profits? Not addicted smokers.
Despite the pervasive anti-smoking campaigns, a handful of marginally successful cessation drugs and the “denormalization” measures, the addictive drumbeat goes on. In our country alone, cigarettes exact an annual sacrifice of about 450,000 prematurely dead. Another 8 1/2 million people and their families suffer lingering ills thanks to smoking. And still, near twenty percent of our population continues to smoke, with little change over the century’s first decade.
While smoking rates did come down after the Surgeon General’s report in 1964, the sick and the dead pile up anyway: nothing can be done about this, since the damage was done decades ago, thanks to the nefarious, deceptive manipulation by the cigarette companies — experts in selling their deadly product to credulous, impressionable youngsters. But something must be done now to save future generations from the loss of life and health that continues to ravage those who were addicted last century.
Quitting cigarettes is extraordinarily difficult — most smokers want to quit, but of the millions who try each year, less than one in ten succeed for long. This abysmal result is improved only minimally by the currently available FDA-approved therapies. Despite these undeniable facts, the officials at our CDC and the FDA continue to tell smokers to stick with the “approved” products, and warn them against e-cigarettes — based on hypothetical fears, while perversely ignoring the body count.
The recently-appointed head of the FDA’s tobacco center, Mitch Zeller, has indicated that this is the month that the FDA will issue its ruling as to whether or not it will “deem” e-cigarettes to be tobacco products, in the same regulatory framework as cigarettes. If that is the decision, dire consequences will inevitably follow. The time has come, indeed well past time now, to deal with the problem of smoking-related disease with an eye toward the future, not the past.
Time is running out for the FDA. The law requires them to decide how to regulate novel tobacco products (a 2011 Federal court ruled that e-cigarettes are tobacco products, thanks to the nicotine they deliver). If the regulators flout all the science and squeeze e-cigarettes into the same framework as cigarettes, millions of ex-smokers will revert to toxic deadly cigarettes, or they’ll find them on the Internet (the black market) — and many more will die with a cigarette in hand. One thing is certain: this genie will not go gently back into the bottle.
But if the FDA’s Zeller decides to interpret the law flexibly — there are provisions in the law to allow it — and exempt e-cigarettes from such stringent regulation, while enforcing sound manufacturing practices, valid product labeling and a ban on sales to minors, a revolution in public health may transpire. Listen, to everyone’s surprise, the European parliament did just that! Those of us devoted to public health now have reason to hope that our FDA will hear the lesson from the EU, and flout the hysterics and rent-seekers whose messages would lead to more needless smoking-related death.
Gilbert Ross, M.D., is the executive and medical director of The American Council on Science and Health (ACSH.org) in New York.