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FDA: Assuming regulatory power over electronic cigarettes

The E-Cigarette Ban: A Win for Liars and Big Tobacco


By Dr. Steven J. Allen ——--September 15, 2016

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This article is part of the Green Watch series. Summary: Bureaucrats and politicians often cite “science” as justification for their efforts to exercise control over Americans’ lives. It’s a fake, politicized “science,” of course. When science suggests that government policy is ineffective or counterproductive, Washington elites ignore the science they claim to venerate. Case in point: the regulation of e-cigarettes, benefitting the big tobacco companies that the Left claims to hate. This reminds us of the “Joe Camel” controversy, which was fabricated and promoted so that the Left could get its hands on a fortune in tobacco money. The Food and Drug Administration has joined with Big Tobacco in an effort to crush the small businesses that make up most of the e-cigarette industry. In doing so, the FDA is putting at risk the lives of millions of Americans.
Part 1: The E-Cigarette Ban: A Win for Liars and Big Tobacco Part 2: E-cigs and Joe Camel: To the Washington elite, we’re all children

$2 million or more an item

Once again, bureaucrats and politicians are distorting scientific studies in order to support a political agenda. The ostensible mission of the FDA is to make sure food and medicine are safe, but FDA bureaucrats and the politicians who enable them have long sought to make the agency into a national nanny, a haven for prohibitionism and for meddling in people’s lives. Now, bureaucrats have issued a set of rules that would effectively ban 99 percent of e-cigarettes, scuttle innovation in the e-cig industry, and enrich the companies that misled the public about the health consequences of real smoking. The FDA announced in May that it was assuming regulatory power over e-cigarettes on the theory that e-cigs, which contain no tobacco, are “tobacco products.” Most of the FDA measures took effect in August. The agency issued new rules banning sales to anyone under 18 (a ban that most states had already enacted) and requiring warning labels. Most importantly, the rules on product approval, phased in over two years, will make virtually all e-cig products, even those currently on the market, subject to government approval. (The “Pre-Market Tobacco Application” rules apply to products released on the market after February 2007, but that’s almost all products created by the fledgling industry.) The cost of approval is estimated by the FDA at $285,000 to $2.6 million, taking 1,713 hours per application. Others, more realistically, put the cost at between $2 million and $10 million. That’s per item—an impossible burden for an industry with a myriad of products, dominated by small manufacturers and small shops.

According to the Wall Street Journal, “The FDA could move to regulate advertising or flavors such as cotton candy and watermelon that might appeal to youth.” (That’s based on the myth, popular among e-cig prohibitionists, that when a product tastes good, that means it’s targeted to young people.) The Journal continued: “The approval process is expected to be less damaging for major tobacco companies such as Altria [formerly Philip Morris], Reynolds American Inc., and Imperial Brands PLC that have launched their own versions of the battery-powered devices that heat nicotine-laced liquid into a vapor. Those companies have financial resources to cover the costs that many vape shops and liquid nicotine manufacturers lack.” Effectively, the FDA’s actions constitute a ban on e-cigarettes except for products from large corporations that can afford to deal with the FDA bureaucracy. That dramatically favors Big Tobacco over small manufacturers. Even more favorable to Big Tobacco is the removal from the market of countless e-cigarette products that would have served as alternatives to real smoking. Thus, as Jacob Sullum wrote in Reason magazine, the FDA’s regulatory scheme “privileges the most dangerous nicotine delivery devices (conventional cigarettes) while threatening to eliminate much safer alternatives and blocking the introduction of even better products. All in the name of public health.” Tony Abboud of the Vapor Technology Association, an industry group, noted that
The FDA’s actions will not improve our nation’s public health objectives. To the contrary, they will yank responsibly manufactured vapor products from the hands of adult smokers and replace them with the cigarettes they had been trying to give up. The FDA will kill nearly a decade of innovation in the vapor technology industry and the many thousands of small and mid-size businesses in communities across this country who have invested in establishing retail stores and developing new technologies that sit outside of the influence of Big Tobacco. If enforced as drafted, the unreasonable and excessive regulations proposed by the FDA will only serve to put these innovators out of business, their employees out of work, and will hand deliver Big Tobacco a monopoly on vapor products.
At this writing, U.S. Reps. Tom Cole (R-Okla.) and Sanford Bishop (D-Ga.) seek congressional approval for a measure to limit the most damaging part of the new FDA rules. The former Democratic National Chairman, Rep. Debbie Wasserman Schultz of Florida, has worked to block their efforts.

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Safer than the alternative

An electronic cigarette or e-cigarette is a handheld electronic device that vaporizes a liquid, which is usually composed of flavorings, the common food additives propylene glycol and glycerin, and a small amount of the stimulant nicotine. The user inhales the vapor. E-cigarette use is often called “vaping.” E-cigarettes are considered a relatively safe alternative to old-fashioned, combustible cigarettes. After an independent study and an extensive review of toxicological research, Public Health England, a government agency in the United Kingdom that conducts anti-smoking campaigns, concluded that e-cigs are 95 percent safer than cigarettes. The Royal Academy of Physicians, in a 200-page report, reached the same conclusion. A study published recently in Preventative Medicine found an 11.7 percent increase in teen cigarette use after states introduced new age restrictions for e-cigarettes between 2007 and 2013. Smoking rates among 12 to 17-year-olds actually rose in states that banned e-cigarette sales to minors, according to one of the report’s authors, Abigail Friedman of the Yale School of Public Health. The lead author, Dr. Michael F. Pesko of Cornell, said that, “While there’s some risk [to e-cigarettes], it would be a mistake to regulate them the same way we regulate cigarettes.” (Politicians in California did just that in May, regulating e-cigarettes in the same manner as real cigarettes, raising the vaping age from 18 to 21, and banning vaping in public places.) Users of e-cigs are exposed to none of the roughly 7,000 chemicals associated with real cigarettes, with the exception of nicotine. They contain none of the chemicals associated with emphysema, and none of the 60 chemicals classified as carcinogens (cancer-causing agents). Walter Olson of the website Overlawyered noted in April 2015:
Actual cigarette smoking among teens, the kind that requires inhaling carcinogenic products of combustion, is down a startling 25 percent in one year and nearly 42 percent since 2011. The reason is the rapid substitution of vaping or e-cigarettes, which hold singular promise as a harm-reduction measure for those drawn to the nicotine habit. Great news, right? Not if you listen to Thomas Frieden of the Centers for Disease Control, who’s doing his best to disguise good tidings as bad so as to stoke the officially encouraged panic about vaping.
Again, recall that the CDC’s mission is public health, which is the prevention of disease from communicable disease (bacteria, viruses, and other pathogens) and from common environmental sources. The agency is located in metropolitan Atlanta because, when the CDC’s precursor was founded in 1942, the South was where the malaria was. Other agencies handle environmental threats, so the proper role of the CDC (formerly the Communicable Disease Center) is to prevent communicable diseases. When the CDC involves itself in attempts to alter people’s behavior—matters of private health such as smoking, consumption of alcohol, and overeating, even such behaviors as how people drive and whether they keep guns at home—it is acting unethically and outside its proper scope, and ignoring its legitimate function. Frieden served infamously as Commissioner of the New York City Department of Health and Mental Hygiene under Mayor Michael Bloomberg. Under his leadership, city officials took over the writing of restaurant menus and expanded their role in dictating the foods that restaurants could serve. Now, as CDC director, Frieden is obsessed with e-cigs. Joe Nocera wrote in the New York Times:
In a conference call with reporters, Tom Frieden . . . couldn’t stop talking about how awful this was. “It’s important that everyone, parents and kids, understand that nicotine is dangerous for kids at any age, whether it’s an e-cigarette, hookah, cigarette or a cigar,” he said. In addition to being addictive, nicotine was thought to affect the still-maturing adolescent brain—although Frieden also acknowledged that this had mainly been shown in animal studies, rather than studies of adolescents. What’s more, he feared that there was a “significant likelihood that a proportion of those who are using e-cigarettes will go on to use combustible cigarettes.”
Actually, e-cigs appear to be a strong deterrent to cigarette use, given the substitution effect. Vaping appears to be quickly replacing smoking among young people. By 2015, real smoking—the kind, as Nocera noted, “that kills one out of every two long-term smokers” —dropped to 9.2 percent among teens by 2015. That, Nocera wrote, was “the first time that teen smoking in America has ever hit single digits,” and
it seems pretty obvious that the decline in cigarette smoking has largely been caused by the rising popularity of e-cigarettes. This, too, was denied by Frieden. But as David Sweanor, a tobacco policy expert at the University of Ottawa, put it to me: “What other huge interventions have there been? It’s not like there has been a big new cigarette tax, or tough new package warnings. The only thing that is new is the introduction of e-cigarettes.”
(Nocera is no right-winger, by the way. A former New York Times op-ed columnist, he once likened “Tea Party Republicans” to terrorists.) In National Review Online, Andrew Stuttaford noted that “the experience of snus, a form of moist tobacco popular in Sweden that is almost infinitely safer than cigarettes, would suggest that a safer substitute is more likely to be a gateway away from cigarettes than an introduction to them.” Some suggest that Frieden is in denial about e-cigs, that he is blinded to the benefits of e-cigs. “That’s not the case,” wrote Walter Olson.
Frieden is many things, but he is not a fool. What he is, however, is an absolutist, a moral crusader, pur et dur [pure and hard], who enjoys wielding the power that the nanny state has given him, and, of course, the opportunity to show his own (as he sees it) superior virtue. There can be no compromise with tobacco or even (in isolation, far safer) with nicotine, at least if the latter is associated with pleasure rather than the weaning process represented by patches or gum.
CDC bureaucrats and CDC-connected politicians are especially bothered that e-cigarette advertising supposedly targets young people by focusing on themes of “independence, rebellion, and sex.” Sex is, of course, the most common theme in advertising, but it’s the “independence” and “rebellion” part that is most bothersome. Nothing offends Progressives like an appeal to the human need for freedom. Frieden has asserted repeatedly that e-cigarettes are addictive. In 2014, he claimed that “Many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes.” He said earlier this year that e-cigs “may well result in changes in the adolescent brain and increase the chances that a kid will smoke regular cigarettes and have to deal with the suffering and disability and cost that that causes for a lifetime.” The Daily Caller News Foundation reporter Guy Bentley asked the CDC for the evidence behind Frieden’s assertions, and the CDC cited two studies.
The first is a study on school students in LA showing those who use e-cigarettes are 2.7 times more likely to report using conventional tobacco over the next year. On the face of it, this seems pretty damning evidence. The only problem, or rather one of the several problems, is the study’s own authors say “we cannot conclude that e-cigarette use directly leads to smoking.” This is because the study had several major drawbacks that make it null and void when trying to draw a cause and effect relationship between vaping and smoking. “The study did not measure ‘e-cigarette use.’ It merely asked kids whether they had ‘ever’ tried an e-cigarette. Kids who had ever tried an e-cigarette, even a puff, were compared with all kids who had never even puffed on an e-cigarette,” Dr. Michael Siegel, a professor in the Department of Community Health Sciences, Boston University School of Public Health, points out. “Kids who would not even try an e-cigarette, despite their popularity, represent a different population than kids who would try a puff on an e-cig,” according to Siegel. The research team doesn’t even record whether any of the subjects were regular vapers or had a nicotine addiction before they experimented with cigarettes. . . . Smoking is defined in the study as any use of a cigarette—even a single solitary puff. Critically, the research also fails to tell us how many people used a tobacco cigarette and then became regular smokers. The editorial that accompanied the study . . . [declared that] the current study cannot determine whether e-cigarette exposure was associated with [progressing to becoming regular smokers].” Clive Bates, a leading anti-smoking campaigner and former director of the United Kingdom’s Action on Smoking and Health, writing in August last year, agrees: “It is not possible to conclude that smoking is caused by prior e-cigarette use from this data (and the authors are clear about that) so no-one should be stating that this establishes a gateway or even hints at it.”
Likewise, the second study failed to show what the CDC claimed it did. Bentley:
Using two questionnaires a year apart sent to 728 young people, . . . [the study found that] just 16 subjects tried an e-cigarette at the beginning of the process. One year on, six of the sixteen reported trying a cigarette. The study claims they progressed to “traditional cigarette smoking.” Nowhere in the study is it known whether these six are regular smokers or whether they have even had more than one puff of a cigarette. Nor did the study say whether the 16 who tried e-cigarettes were regular vapers or addicted to nicotine. But the researchers did deem it appropriate to classify people who had ever tried an e-cigarette as regular users.
Another CDC fake-out involved the agency’s claim that overall tobacco use by middle and high school students has not changed since 2011. The CDC got to that result by classifying e-cigarettes, which contain no tobacco, as part of overall tobacco use. Seriously. Bentley again:
Vaping has surged among middle and high school students in recent years despite age restrictions and cigarette use has fallen markedly. “From 2011 through 2015, significant decreases in current cigarette smoking occurred among youth,” says the CDC. Between 2011-2015, cigarette use among high school students plummeted by more than a third from 15.8 percent to 9.3 percent. Instead of welcoming the fall in teen smoking, CDC’s director Tom Frieden focused on climbing e-cigarette use and falsely equated it with tobacco. “E-cigarettes are now the most commonly used tobacco product among youth, and use continues to climb,” said Frieden.
Gregory Conley, president of the American Vaping Association, characterized the CDC claim as “staggeringly dishonest.” Part 2: E-cigs and Joe Camel: To the Washington elite, we’re all children

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Dr. Steven J. Allen——

Steven J. Allen, Senior Editor, Labor Watch and Green Watch
Dr. Allen covers labor union organizing and the environmental movement for Capital Research Center, CRC. He previously served as press secretary to U.S. Senator Jeremiah Denton, as editor of Tea Party Review magazine, and as senior researcher for Newt Gingrich 2012. He has a master’s degree in political science from Jacksonville State University, a law degree from Cumberland Law School, and a PhD in Biodefense from the College of Science at George Mason University.


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