Gilbert Ross | 8 December 2013
Anyone with a modicum of knowledge regarding public health will agree that the most important, devastating, and preventable issue facing America is the human toll of cigarettes.
Yet our nation’s main health regulator, the Food and Drug Administration (FDA), will issue regulations within the next few weeks that could harm our nation’s 45 million smokers.
Smokers trying to quit have an extremely difficult time, yet a new technology which might ease their path — electronic cigarettes, or e-cigarettes — is facing relentless opposition from public health agencies such as the Centers for Disease Control, the FDA, and the American Cancer Society (which sponsors this week’s Great American Smokeout to encourage quitting) — and their antipathy is certainly not based on science.
We do not yet know what the long-term health effects of e-cigarettes are, nor the benefits for smokers who switch or cut down on their daily quota of smokes via “vaping” (using e-cigarettes) since there is no smoke involved. But simple common sense would dictate that inhaling the fewer, less harmful ingredients of e-cigarettes as compared to inhaling the thousands of chemicals in the smoke from burnt tobacco, many of which have been shown to be carcinogenic, is highly likely to be healthier.
The FDA should take the courageous, science-based, and compassionate course.
A tragic 450,000 Americans die from smoking each year. While the fraction of adult smokers has been in gradual decline since the groundbreaking 1964 surgeon general’s report confirmed the evidence of manifold smoking-related illnesses, the total number has not changed much and the decline in teen smoking initiation has stalled over the past few years. Although “cigarette smoke” is not listed as a cause of death per se, smokers whose lives are cut short die from a wide spectrum of illnesses, some chronic (cancers of many organs, COPD/chronic obstructive pulmonary disease), and some cruelly brief (heart attacks and strokes). If those who die prematurely from smoking were lumped together, they would constitute the third leading cause of death in America, after heart disease and cancer.
Most smokers understandably desire to quit. About half try each year, but a pitiful few — maybe 5 percent — succeed unaided or “cold turkey.” The addiction to smoking is extremely powerful, largely (but not solely) due to nicotine’s power. However, it is often believed by smokers, and even by some doctors, that it is the nicotine that is toxic and lethal. This is a dangerous myth. It has been proven that smokers smoke for the nicotine — but they die from the smoke. The FDA has approved various treatments to help smokers quit — NRT (nicotine replacement therapy) patches, gum, inhalers, and non-nicotine drugs such as bupropion and varenicline (Zyban and Chantix, respectively). The unfortunate fact is that adding one or more of these treatments to a smoker’s stated desire to quit increases his or her success rate — abstinence from cigarettes for one year — by about two- to three-fold, i.e. to 15 percent or less. These methods, which fail almost 9 times out of 10, provide an unacceptably low level of assistance in aiding escape from smoking’s deadly grip.
Over the course of the past few years, e-cigarettes (or “electronic nicotine delivery systems,” ENDS) have provided a ray of hope for an increasing number of desperate smokers. These devices use a battery to vaporize water and nicotine, which the user (“vaper”) inhales, along with vegetable glycerin and/or propylene glycol and flavoring. They often have a cigarette-like LED tip which glows red, or some other color if preferred, but without tobacco, without combustion, and without smoke. The ingredients noted are generally recognized as safe by regulatory agencies, and have been in common use for decades — although no long-term health studies have been done on their safety in combination with inhalational use.
Almost half of smokers try to quit each year, but a pitiful few — maybe 5 percent — succeed unaided.
Since 2007, when e-cigarettes were first imported from China, smokers have at first gradually, and more recently enthusiastically, become vapers. Solid data on long-term trends are only beginning to be accumulated, but the sales of e-cigarettes have doubled in each of the past few years, to the extent that a recent survey found that an astounding one-fifth of smokers had tried them — millions of people, in other words. How many have switched completely from deadly cigarettes? How many smokers also vape — “dual users”? None of this has been determined yet by randomized clinical trials. Although there are scant data even from observational studies, several small studies support the contention that vaping is likely to be more effective than NRT for smoking cessation, as well as for reducing the number of cigarettes smoked among those who have not yet quit.
The Upcoming FDA Decision
The Family Smoking Prevention and Tobacco Control Act, which granted the FDA oversight of tobacco in 2009, outlines a complex process for “modified risk tobacco products” (MRTPs) to be approved by the FDA. Such a product must undergo a lengthy and expensive trial process requiring demonstration that the product submitted reduces the harm of tobacco exposure not merely for the person using it, but for the population as a whole. Given the nefarious behavior of the tobacco industry over the 20th century, any proposal submitted to the FDA related to tobacco is going to have to strongly support any assertions with data.
Unfortunately, the Tobacco Control Act may become a detriment to public health if it is implemented to effectively ban e-cigarettes from the market. The Office of Management and Budget is currently deciding whether to designate e-cigarettes as a tobacco product to be regulated under the TCA, as a drug or medical device, requiring regulation from a different department of the FDA, or as neither such product. If e-cigarettes are designated as tobacco products requiring proof of modified risk, it is likely that the ramifications for millions of American vapers, and many more potential future ex-smokers, will be disastrous. E-cigarettes (at least those containing the nicotine smokers crave) would be exiled from the market while expensive, lengthy testing took place. Ironically, the industry’s small businesses would suffer while Big Tobacco would profit, since it has also gotten into the e-cigarette market, and since larger companies would be the only ones who could afford to cut through the regulatory thicket. Meanwhile, some ex-smokers who have become vapers will find a way to secure their e-cigarette nicotine, via online or black market sources. Many, however, will revert to the deadly, toxic cigarettes from which they thought they had, at last, escaped.
If those who die prematurely from smoking were lumped together, they would constitute the third leading cause of death in America, after heart disease and cancer.
There is, however, a better approach: the government could decline to classify e-cigarettes as tobacco products and allow their continued marketing, with the states establishing reasonable oversight — as many have already — for age limits, manufacturing standards, accurate ingredient listing, and warning labels. As a result, many lives will be saved from cigarette-related disease and death.
The World Health Organization predicts that the death toll from cigarettes could reach 1 billion this century, if current trends continue. The European Union only last month flouted the anti-e-cigarette campaigners and gave millions of European vapers a pass to keep on vaping. Given the current abysmal rate of successful quitting with the approved methods, the FDA should take the courageous, science-based, and compassionate course.
Effectively excluding e-cigarettes from the market via stringent regulation would have the effect of killing smokers and protecting cigarette and pharmaceutical markets. E-cigarettes, a far safer form of nicotine delivery, should not be submitted to tougher regulation than cigarettes.
Americans should not have to die from misguided regulation.
Gilbert Ross, MD, is medical and executive director of the American Council on Science and Health.