Published: Tue, 06 Dec 2016 00:00:00 -0500
Last Build Date: Tue, 06 Dec 2016 00:36:37 -0500
Mon, 21 Nov 2016 12:00:00 -0500In India today, tobacco use is so widespread, a million deaths every year are attributed to its use. Tobacco can be stuffed inside of a wide variety of cigarettes and beedis, minced into a masala of spices known as gutka, or piled on top of paan – a leafy, addictive stimulant that multiplies a user's risk of oral cancer almost tenfold. Those million deaths a year are one reason why the Seventh Session of the Conference of the Parties is being held in Delhi this year. Run by the World Health Organization (WHO), the conference is dedicated to curbing tobacco use through education, taxation, bans, and worldwide enforcement against smuggling operations. One-hundred-and-eighty signatory nations are bound to follow the bylaws passed behind these doors. But who gets a say in what the WHO does is a hotly contest matter. Only thirty members of the public and selected members of the media are treated to limited, stage managed press conferences. Nations like China, with state-owned tobacco monopolies, are warmly welcomed, but anyone with the slightest connection to a private tobacco industry is shown the exit. Large pharmaceutical companies generously fund conference attendees, while their anti-tobacco products like Nicorette gum compete with products that the WHO views unfavorably, like electronic cigarettes. The secretive nature of the conference didn't go over well with India's tobacco farmers. After a few minutes of protest outside the convention, 500 farmers were corralled by police and detained inside this local police station. After a brief negotiation and a bribe offered from an unnamed source outside of ReasonTV, leaders of the movement were temporarily released to speak with us outside the walls of the police station. As the farmers were being released from jail that evening, convention delegates voted to expel the media from the remainder of the conference. Drew Johnson, a reporter and columnist for The Daily Caller, decided to stand up for transparency by staying seated in the press gallery. He was forcibly ejected. If it's hard to understand why a $4 billion organization like the WHO feels threatened by the average Indian farmer who lives on $3 a day, it's worth recalling the source of all the hostility. By hook or by crook, the tobacco industry has pushed back against every public health measure in the last fifty years. The result is today's polarized debate, one that values the elimination of tobacco over jobs, transparency, and consumer choice. Expanding its authority beyond tobacco control, e-cigarettes and vape products now find themselves potentially subject to a worldwide ban. Delegates to the convention have expressed support for "a complete ban on the sale, manufacture, import and export of Electronic Nicotine Delivery Systems". Small but determined activist communities like Asian Vape Association, are already fighting back, organizing their own counter-conferences in Delhi this year. It can't be easy getting 180 signatory nations to agree on much of anything. This year, the Seventh Session of the Congress of the Parties resolved only two things of note: reaffirming their determination to regulate vaping products. And further limiting access to the convention by the public, due to potential tobacco industry interference. Two resolutions that seemed designed to elicit more public protest at the next conference, two years from now. Produced, photographed, narrated, and edited by Todd Krainin. Subscribe to our YouTube channel. Like us on Facebook. Follow us on Twitter. Subscribe to our podcast at iTunes.[...]
Wed, 09 Nov 2016 00:01:00 -0500Survey data indicate that millions of Americans have used electronic cigarettes to quit smoking, thereby dramatically reducing the health risks they face. Thomas Frieden, director of the U.S. Centers for Disease Control and Prevention, is unimpressed. "The plural of anecdote is not data," Frieden recently told The New York Times. But when it comes to the dangers that vaping poses, he abandons his scientific stance, claiming without evidence that "many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes." No doubt Frieden and other e-cigarette alarmists will latch onto a new study that supposedly shows "Flavored E-Cigarettes May Entice Teens to Smoke," as one of the predictable headlines put it. But that is not what the study, reported this week in the journal Pediatrics, actually shows. Looking at data from the 2014 National Youth Tobacco Survey, biostatistician Hongying Dai and economist Jianqiang Hao found that nonsmokers who had used an e-cigarette in the previous month were less likely than other nonsmokers to rule out trying tobacco cigarettes in the future. That is not terribly surprising, since just 3 percent of teenagers who had never smoked reported past-month e-cigarette use, a small minority that is apt to differ from the remaining 97 percent in traits, such as rebelliousness, risk aversion, and sensation seeking, that might affect the propensity to experiment with smoking. Correlation is not causation. The fact that teenagers who vape are less inclined to say they will never smoke does not mean the experience of vaping made them that way. As Dai and Hao note, "we were unable to establish causal inferences" because "the data are cross-sectional." The idea that vaping promotes smoking seems implausible in light of the fact that smoking has fallen to record lows among teenagers even as experimentation with vaping has risen dramatically. Furthermore, teenagers who vape typically use nicotine-free e-liquids, and nonsmokers rarely vape often enough to develop a nicotine habit. According to the Monitoring the Future Study, nearly two-thirds of teenagers who have tried vaping consumed "just flavoring" the last time they did it. In the same survey, less than 1 percent of never-smokers had vaped on 20 or more days in the previous month. Dai and Hao seem to view flavored e-liquids, whether or not they contain nicotine, as a menace to the youth of America. "Flavored e-cigarette use is associated with increased risks of smoking among youth," they conclude. "Comprehensive tobacco control and prevention strategies that address flavored e-cigarette products are critically needed to reduce tobacco use among youth." It is pretty clear what "address[ing] flavored e-cigarette products" means to Dai and Ho, who repeatedly note that the Food and Drug Administration does not plan to ban flavors as part of its otherwise onerous e-cigarette regulations. They worry that "widespread availability of flavored e-cigarettes will increase the use of e-cigarette products by youth" and that "the normalization of e-cigarette use among youth could also lead to e-cigarettes becoming a gateway for future smoking, marking a setback in the decades-long antismoking battle." While there is little reason to think anything like that is happening, banning flavored e-liquids would make vaping less attractive to smokers, thereby discouraging them from making a switch that could save their lives. Contrary to the claims of politicians and activists who insist that candy and fruit flavors could not possibly appeal to anyone older than 17, adults who switch to vaping overwhelmingly prefer supposedly kid-friendly e-liquids. In a 2014 survey by E-Cigarette Forum, three-quarters of adult vapers who had quit smoking or cut back said they favored flavors other than tobacco. A 2013 study likewise found that flavor variety is important for smokers who switch to vaping. Dai and Ho are dismayed that the vaping market features "a large number of different flavors that might appeal to youth." But elimina[...]
Wed, 02 Nov 2016 10:30:00 -0400New York Times science reporter Sabrina Tavernise highlights the tendency of American public health officials to view e-cigarettes as a threat rather than an opportunity, even though vaping offers a much less dangerous alternative to smoking. "A growing number of scientists and policy makers say the relentless portrayal of e-cigarettes as a public health menace, however well intentioned, is a profound disservice to the 40 million American smokers who could benefit from the devices," she writes. Tavernise cites survey data indicating that the percentage of Americans who wrongly view e-cigarettes as no less hazardous than the conventional kind tripled between 2011 and 2015, from about 13 percent to nearly 40 percent. That misperception, encouraged by misleading and sometimes downright false statements from government officials and anti-smoking activists, surely discourages smokers from making a switch that could save their lives. "The unintended consequence is more lives are going to be lost," one critic tells Tavernise, who contrasts the U.S. approach with the attitude of British public health officials, who see e-cigarettes as way to dramatically reduce smoking-related disease and death. David Sweanor, a tobacco control specialist at the University of Ottawa, compares the enormous difference between the health hazards of smoking and the health hazards of vaping to "the relative risks of jumping out a fourth-story window versus taking the stairs." Although the advantage of the the latter option is obvious, he tells Tavernise, American officials "are saying: 'Look, these stairs, people could slip, they could get mugged. We just don't know yet.'" Thomas Frieden, director of the U.S. Centers for Disease Control and Prevention, tells Tavernise he is aware of smokers who say they quit with the help of e-cigarettes, "but the plural of anecdote is not data." Mitch Zeller, who as director of the FDA Center for Tobacco Products is overseeing regulations that are expected to cripple the vaping industry, is similarly dismissive. In a recorded interview that was played at last month's meeting of the Smoke-Free Alternatives Trade Association, Brad Rodu reports, Zeller said he is "absolutely aware of the anecdotal reports about individuals using e-cigarettes to help them quit, but we can't make population-level policy on the basis of anecdotal reports," because "FDA is required to use a population health standard." Rodu, a professor of medicine at the University of Louisville and a longtime tobacco harm reduction advocate, notes that we do have "population-level" data from surveys of current and former smokers. In the 2015 National Health Interview Survey, for instance, "2.5 million former smokers were current users of vapor products," which suggests e-cigarettes are a pretty popular and effective way to quit smoking. "These 2.5 million former smokers are more than anecdotes," Rodu writes. "They constitute population-level evidence." Likewise the survey data indicating that more than 6 million Europeans have quit smoking with the help of e-cigarettes, while more than 9 million have cut back. Tavernise notes that "surveys by Action on Smoking and Health, a British antismoking group, have found that half of Britain's 2.8 million e-cigarette users no longer smoke real cigarettes." She adds that another British study, published by the journal Addiction in 2014, found that "among people who are trying to quit smoking, e-cigarette users are 60 percent more likely to succeed than those who use over-the-counter nicotine therapies like gum and patches." Such observational evidence does not conclusively prove that e-cigarettes help smokers quit. Maybe the vapers who used to smoke would have quit anyway, and maybe the advantage over nicotine gum and patches has to do with the sort of people who choose e-cigarettes, as opposed to the e-cigarettes themselves. But controlled, randomized experiments, which are usually seen as offering stronger proof, have a weakness too, since they do not allow s[...]
Mon, 19 Sep 2016 00:01:00 -0400Three years ago, Thomas Frieden, director of the U.S. Centers for Disease Control and Prevention (CDC),warned that "many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes." That fear is one of the main justifications for the CDC's hostility toward vaping and the Food and Drug Administration's onerous new e-cigarette regulations, which are expected to cripple the industry. Yet there is no evidence that Frieden's claim is true and considerable evidence that it's not, especially since smoking rates among teenagers have fallen to record lows even as more and more of them experiment with vaping. Two new studies cast further doubt on the idea that e-cigarettes are a "gateway" to the real thing. Frieden and other e-cigarette alarmists make much of the fact that the percentage of teenagers who report vaping has risen dramatically in recent years. They like to focus on the percentage of teenagers who have ever tried e-cigarettes and the percentage who have used them in the last month, without asking how many are experimenters or occasional users and how many are daily vapers—the sort who might get hooked on nicotine and eventually progress to conventional cigarettes. It turns out there's a good reason for the CDC's lack of curiosity on this point: Survey data show that few teenagers who have never smoked use e-cigarettes and that even fewer do so on a regular basis. "Many fear that e-cigarette use by non-smoking students will lead many to nicotine addiction and subsequent cigarette smoking," notes University of Michigan health economist Kenneth Warner in an American Journal of Preventive Medicine article published last month. But based on data from the Monitoring the Future Study (MTF), which surveys students in the eighth, 10th, and 12th grades, Warner finds that "non-smoking high school students are highly unlikely to use e-cigarettes" and even less likely to use them regularly. Among the 12th-graders who had never tried conventional cigarettes, 94 percent had not used an e-cigarette in the previous month. Among the never-smokers who reported using e-cigarettes in the previous month, 60 percent used them on only one or two days. Less than 1 percent of never-smokers had vaped on 20 or more days in the previous month. The MTF numbers, which are similar to the findings of British surveys, suggest it is quite unlikely that "many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes," because nonsmokers rarely use e-cigarettes often enough to develop a nicotine habit. Another point Warner emphasizes makes Frieden's claim even less plausible: "A large proportion of students use e-cigarettes containing no nicotine." Warner cites a 2014 study that found most never-smoking Connecticut teenagers who vaped used nicotine-free e-liquid. The significance of that point is underlined by another recently published analysis of MTF data. Richard Miech and three of his colleagues at the University of Michigan's Institute for Social Research (which conducts the survey) report in the journal Tobacco Control that nearly two-thirds of teenagers who have tried vaping consumed "just flavoring" the last time they did it. "Nicotine use came in a distant second," Miech et al. write, "at about 20 percent in 12th and 10th grade and 13 percent in 8th grade." The other options were marijuana and "don't know." The MTF data indicate that the more frequently teenagers vape, the more likely they are to vape nicotine. Among high school seniors, 47% of those who had vaped six or more times in the previous month reported consuming nicotine, compared to 23 percent of those who had vaped one to five times in the previous month. But "in no case did the prevalence of nicotine vaping reach 50% or greater." In other words, "the majority of US youth who use vaporisers and e-cigarettes do not vape nicotine," a fact that "challenges many common assumptions and practices." Consider the CDC's practice of counting vapin[...]
Fri, 16 Sep 2016 06:30:00 -0400
(image) For several years now, the CDC has been freaking out about adolescent e-cigarette use, which it warns will boost smoking by getting teenagers hooked on nicotine in a more palatable form. But as I explain in my latest Forbes column, that does not seem to be happening, and new research suggests it probably never will:
Three years ago, Thomas Frieden, director of the U.S. Centers for Disease Control and Prevention (CDC),warned that "many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes." That fear is one of the main justifications for the CDC's hostility toward vaping and the Food and Drug Administration's onerous new e-cigarette regulations, which are expected to cripple the industry. Yet there is no evidence that Frieden's claim is true and considerable evidence that it's not, especially since smoking rates among teenagers have fallen to record lows even as more and more of them experiment with vaping. Two new studies cast further doubt on the idea that e-cigarettes are a "gateway" to the real thing.
Fri, 02 Sep 2016 10:20:00 -0400The Food and Drug Administration (FDA), having decided to regulate tobacco-free e-cigarettes as tobacco products because they deliver tobacco-derived nicotine, now has the challenge of explaining how even nicotine-free e-liquids can qualify for the same label. E-cigarette alarmists at the U.S. Centers for Disease Control and Prevention (CDC) have a similar problem. They insist on counting vaping as "tobacco use," which leads them to claim there has been "no decline in overall youth tobacco use since 2011," even though that is clearly not true. Now a new study in the journal Tobacco Control reveals the CDC's position to be even more ridiculous than it already seemed, showing that a large majority of teenagers who vape are not only not consuming tobacco; they are not consuming nicotine either. Based on data from the 2015 Monitoring the Future Study, which surveys students in the eighth, 10th, and 12th grades, Richard Miech and three of his colleagues at the University of Michigan's Institute for Social Research (which conducts the survey) report that nearly two-thirds of teenagers who have tried vaping consumed "just flavoring" the last time they did it. "Nicotine use came in a distant second," Miech et al. write, "at about 20% in 12th and 10th grade and 13% in 8th grade." The other options were marijuana and "don't know." The survey data indicate that the more frequently teenagers vape, the more likely they are to vape nicotine. Among high school seniors, 47 percent of those who had vaped six or more times in the previous month reported consuming nicotine, compared to 23 percent of those who had vaped one to five times in the previous month. But "in no case did the prevalence of nicotine vaping reach 50% or greater." The fact that most adolescent vapers do not vape nicotine was mentioned in a summary of the 2015 survey results published last year, as Pennsylvania anti-smoking activist (and harm reduction advocate) Bill Godshall pointed out at the time. I noted that finding in a blog post last April and a column last June. But the Tobacco Control article presents more-detailed data on this question and highlights the CDC's mendacity. It was already absurd to claim teenagers were using tobacco when they weren't, especially since the CDC used that inaccurate terminology to imply that the rising popularity of vaping somehow cancels out the health gains from the continuing decline in smoking, a far more dangerous habit. Now that it's clear the typical adolescent vaper is not even using nicotine, the CDC cannot assume any chemical connection between e-cigarettes and tobacco. Furthermore, its warnings that teenagers might start smoking after they get hooked on nicotine by vaping look even more overblown than they did before. As Meich et al. note, even the practice of referring to vaporizers as "electronic nicotine delivery systems" (as both the CDC and the FDA do) is quite misleading, at least in the context of adolescent use. "The majority of US youth who use vaporisers and e-cigarettes do not vape nicotine," the authors write. "This finding challenges many common assumptions and practices." The numbers "suggest that the recent rise in adolescent vaporiser use does not necessarily indicate a nicotine epidemic," and they show how misleading the CDC's equation of vaping with tobacco use is. Meich et al. note that counting every vaper as a tobacco user doubles the supposed prevalence of tobacco use among 12th-graders and nearly triples it among 10th- and eighth-graders. If vapers are counted as tobacco users only when they vape nicotine (still a dubious maneuver), the effect is much less dramatic. "If vaporiser users are considered nicotine users only if they last vaped nicotine in the last 30 days," the researchers say, "then national estimates of nicotine prevalence increase by a much smaller percentage of 23–38% across the three grades," compared to the increases of 100 percent to 200 percen[...]
Mon, 22 Aug 2016 08:53:00 -0400A new experimental study—the first of its kind, according to the authors—confirms that smokers can dramatically reduce their exposure to toxins and carcinogens by switching to e-cigarettes. "They are safer," the lead author, Maciej Goniewicz, a toxicologist at the Roswell Park Cancer Institute, told Buffalo Business First. "It's the first time we have very strong evidence that we will be able now to give [smokers] that the answer is, yes, this you should consider a transition, a substitute for your tobacco cigarette that will save your life." The study, reported last week in the journal Nicotine & Tobacco Research, involved 20 Polish smokers who were encouraged to replace their cigarettes with the M201, a pen-style vaping system popular in Poland. Each week during the two-week experiment, the researchers supplied the subjects with 20 tobacco-flavored cartridges, each containing 11 milligrams of nicotine in a solution of propylene glycol and vegetable glycerin. Goniewicz and his colleagues used questionnaires and urine tests to assess the subjects at the beginning of the study, after a week, and after two weeks. Nine of the subjects stopped smoking completely, while the rest cut back, from an average of 16 cigarettes a day at the beginning of the study to an average of just one a day at the end. Based on tests for seven nicotine metabolites, the researchers found that nicotine intake stayed the same, while exposure to tobacco-related toxins and carcinogens fell. Goniewicz et al. measured biomarkers for 13 toxins and carcinogens; all but a few declined substantially after the smokers started using e-cigarettes. For example, exposure to NNK, a tobacco-specific nitrosamine "directly associated with lung cancer risk," had fallen by 64 percent after the second week. Exposure to the volatile organic compounds acrolein, ethylene oxide, benzene, and 1,3-butadiene fell by 56 percent, 61 percent, 76 percent, and 84 percent, respectively. "The observed decline in various urine toxicant biomarker levels in our study was similar to decline among smokers who have quit smoking completely and did not substitute with any other product," Goniewicz et al. write. "This observation suggests that e-cigarettes are not a significant source of exposure to those toxicants." Based on chemical analyses of e-cigarette vapor, other researchers have estimated that switching from smoking to vaping reduces health risks by at least 95 percent. Goniewicz et al. also found declines in reports of chest tightness, visual disturbances, daytime coughing, difficulty concentrating, irritability, and phlegm, although only the first two changes were statistically significant. A larger sample with a longer follow-up period probably would supply further evidence of health improvement. The authors note that a 2014 survey of 19,000 e-cigarette users "suggest[s] use of these products pose minimal side effects to users and can in fact improve reported health issues experienced when using tobacco cigarettes," including respiratory symptoms caused by asthma and chronic obstructive lung disease. "This study showed for the first time that after switching from tobacco to e-cigarettes, nicotine exposure remains unchanged, while exposure to selected carcinogens and toxicants is substantially reduced," Goniewicz et al. conclude. "These findings suggest that e-cigarettes may effectively reduce exposure to toxic and carcinogenic substances among smokers who switched to these products."[...]
Fri, 19 Aug 2016 09:16:00 -0400This week, responding to one of the lawsuits challenging its e-cigarette regulations, the Food and Drug Administration (FDA) further muddied the question of whether those regulations apply to products that do not contain tobacco-derived nicotine. The lawsuit, which was brought by Nicopure, a manufacturer of e-liquids and vaping systems, argues that such a result would be unfair, illogical, and illegal. In response, the FDA says Nicopure has failed to show that any of its nicotine-free liquids are actually covered by the regulations and therefore has no standing to challenge that aspect of the rules. At the same time, the FDA concedes that "e-liquids marketed as 'nicotine-free' may properly be considered tobacco products—or components or parts thereof—under certain circumstances." What circumstances are those? "Some e-liquids 'claiming to be nicotine-free actually contain high levels of nicotine," the FDA says, quoting its regulations. "Others are tobacco flavored, and are thus 'made or derived from tobacco' regardless of their nicotine content." Does that mean e-liquids are not subject to the FDA's burdensome, prohibitively expensive regulations as long as they do not contain nicotine or any other tobacco derivative? No, because the FDA's definition of "tobacco product" does not require nicotine or any other tobacco derivative. The Family Smoking Prevention and Tobacco Control Act, the statute that gave the FDA authority over tobacco products, defines them as products "made or derived from tobacco that [are] intended for human consumption, including any component, part, or accessory of a tobacco product." In deeming e-cigarettes to be tobacco products, the FDA defined "component or part" as "any software or assembly of materials intended or reasonably expected...to alter or affect the tobacco product's performance, composition, constituents, or characteristics" or "to be used with or for the human consumption of a tobacco product." Hence vaping equipment, whether a closed, disposable e-cigarette or an open system with a refillable tank and parts that can be switched out, is a "component or part" of a tobacco product, which means it is also a tobacco product. Does that mean a nicotine-free e-liquid is a "component or part" of a tobacco product—i.e., the vaporizer? The FDA can't or won't give a straight answer to that question. "The only nicotine-free e-liquids that the rule brings under the FDA's regulatory authority are those that are made or derived from tobacco (such as tobacco-flavored varieties) or that otherwise meet the definition of a 'component' or 'part,'" it says. "Thus, nicotine-free e-liquids not made or derived from tobacco are subject to the deeming rule only where they meet the definition of a 'component or part.'...Whether nicotine-free e-liquids meet this definition 'will be evaluated on a case-by-case basis.'" That means a company like Nicopure cannot know ahead of time which of its products are covered by the regulations. It can only find out by asking the FDA about each one, a process that will carry its own costs, even if they do not rise to the hundreds of thousands or millions of dollars that each "premarket tobacco product application" is expected to cost. The FDA's position is that Nicopure can't challenge the potential regulation of its nicotine-free e-liquids because it does not know whether they will actually be regulated. Never mind that it doesn't know because the FDA won't say.[...]
Mon, 15 Aug 2016 00:01:00 -0400The Food and Drug Administration's e-cigarette regulations, which took effect last week, immediately struck two blows against public health. As of Monday, companies that sell vaping equipment and the fluids that fill them are forbidden to share potentially lifesaving information about those products with their customers. They are also forbidden to make their products safer, more convenient, or more pleasant to use. The FDA's censorship and its ban on innovation will discourage smokers from switching to vaping, even though that switch would dramatically reduce the health risks they face. That effect will be compounded by the FDA's requirement that manufacturers obtain its approval for any vaping products they want to keep on the market for longer than two years. The cost of meeting that requirement will force many companies out of business and force those that remain to shrink their offerings, dramatically reducing competition and variety. All of this is unambiguously bad for consumers and bad for public health. Yet the FDA took none of it into account when it estimated the costs imposed by its regulations, simply assuming that good intentions would ensure good results. Although preventing fraud is the official intent of the FDA's speech restrictions, the agency's rules prohibit statements that are accurate and highly relevant to consumers choosing between smoking and vaping. Nicopure, one of the companies that is challenging the FDA's regulations in federal court, used to tell consumers that in vaping "nothing is burned," "no smoke is released," and "no ash" is generated. It also noted that the aerosol produced by e-cigarettes contains "no tar" and only "a fraction of the 4000 chemicals currently found in standard tobacco cigarettes." Although all of these statements are indisputably true, they are illegal under the FDA's reading of the Family Smoking Prevention and Tobacco Control Act. That law gave the FDA authority over tobacco products, a category to which it has arbitrarily assigned tobacco-free e-cigarettes, even when they contain nicotine that is not derived from tobacco or no nicotine at all. The Tobacco Control Act prohibits unapproved "modified risk" claims, including any "explicit or implicit representation that [a] tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke." According to the FDA, that means e-cigarette companies are not allowed to advertise the main advantage of their products. Even describing an e-cigarette as "smokeless" or "smoke-free" is asking for trouble, since "the Agency will evaluate an [e-cigarette] manufacturer's use of 'smokeless' or 'smoke-free' (and similar descriptive terms) on a case-by-case basis." Instead of immediately banning all e-cigarettes and e-fluids, the FDA gave manufacturers a couple of years to seek approval for each of their products. But that grace period does not apply to any variations introduced after August 8, 2016, so the FDA has in effect banned product improvements. In a declaration supporting Nicopure's lawsuit, CEO Jeff Stamler notes that his company "introduced approximately 288 new e-liquid products, 6 new vaporizer products, and 23 new vaporizer components" in 2015 alone. Now any new product requires premarket approval, so "as a practical matter Nicopure will be unable to introduce new products for several years." The ban applies even to minor changes. The American Vaping Association notes that "any variation of the nicotine level, bottle size, flavor amount, ingredient type, etc. in a current product (i.e., one being marketed on August 8, 2016) will result in a 'new' product that will be illegal to sell without preapproval from the FDA." But the FDA is also blocking substantial improvements in the designs of vaping s[...]
Fri, 12 Aug 2016 06:30:00 -0400
(image) The FDA's e-cigarette regulations, which were published last May, took effect this week. As I explain in my latest Forbes column, the rules will dramatically reduce competition, variety, and innovation, retarding the replacement of smoking with a much safer alternative:
The Food and Drug Administration's e-cigarette regulations, which took effect this week, immediately struck two blows against public health. As of Monday, companies that sell vaping equipment and the fluids that fill them are forbidden to share potentially lifesaving information about those products with their customers. They are also forbidden to make their products safer, more convenient, or more pleasant to use.
The FDA's censorship and its ban on innovation will discourage smokers from switching to vaping, even though that switch would dramatically reduce the health risks they face. That effect will be compounded by the FDA's requirement that manufacturers obtain its approval for any vaping products they want to keep on the market for longer than two years. The cost of meeting that requirement will force many companies out of business and force those that remain to shrink their offerings, dramatically reducing competition and variety.
All of this is unambiguously bad for consumers and bad for public health. Yet the FDA took none of it into account when it estimated the costs imposed by its regulations, simply assuming that good intentions would ensure good results.
Mon, 08 Aug 2016 04:00:00 -0400
(image) Michigan State University has banned the use of all tobacco products, vaporizers and e-cigarettes anywhere on campus, even in private vehicles.
Fri, 01 Jul 2016 00:01:00 -0400The last time I wrote about tobacco-related measures, I concluded that California legislators and health advocates have let a bit of Puritanism get the better of them. Why else would the governor sign a law that makes no distinctions between smoking dangerous, combustible tobacco products (cigarettes) and puffing on vaping devices that are a safer, alternative product? I still think some Puritanism is at work—it bothers activists that smokers find vaping enjoyable, as opposed to arm patches, nasal sprays and ten-step programs. But some readers reminded me of an even bigger and more cynical reason for the state's approach: officials are addicted to their cut of tobacco-related revenues. Smoking rates are declining. As smokers give up their bad habit, anti-smoking programs lose tax dollars. Taking dollars from government agencies and government-addicted nonprofits makes them as grumpy as taking the last pack of cigarettes from a habitual smoker. Even though the state passed several new laws—raising the smoking age to 21 and regulating e-cigarettes like tobacco, for instance—anti-tobacco activists have qualified an initiative for the November ballot that would go even further. The "California Healthcare, Research and Prevention Tobacco Tax Act of 2016" is, as its name suggests, all about hiking tax rates. California has one of the nation's lower tobacco taxes. The initiative provides a $2 per pack tax boost on cigarettes (from 87 cents to $2.87). It raises taxes on other tobacco products by an equivalent amount. I'm no fan of tax increases. And sin taxes are regressive—they impose a particularly high burden on the poor. But at least advocates are trying to do something that might improve public health by discouraging the use of a dangerous product. But this line in the initiative suggests the anti-vaping craze is mainly about the money: "Tobacco products also shall include electronic cigarettes." To be clear, the liquid that is heated and "vaped" is not tobacco, even though most—but not all—liquids contain nicotine. The nicotine is the point. Smokers are addicted to it. These products provide a safer way to get that fix—95 percent safer, according to Public Health England. If the initiative passes, the state will have another way to get its fix of taxes. In fact, the measure would boost taxes on vaping products by 320 percent, according to industry estimates. The Legislative Analyst's Office explains the $1 billion a year in expected new revenues will go to replace lost tobacco-related revenues. A small portion will go to the Board of Equalization to administer the tax. Law enforcement will grab $48 million. The University of California will grab $40 million for "physician training." The Department of Public Health will get a $30-million cut and the state auditor will get some money to conduct audits. "Many believe this misguided measure is driven more [by] money than protecting California's public health due to the fact that tobacco tax revenues are declining as adult consumption rates continue to fall," Joshua Kane, president of the California chapters of the Smoke Free Alternatives Trade Association, argued in his recent testimony to the Legislature. Only 4.3 percent of the current $1.52 billion in smoking-related excise taxes and settlements actually are spent on smoking prevention and cessation programs, he added. That reinforces the cynics' view: The government wants its dollars. And so does the tobacco industry, of course. The Los Angeles Times obtained an email from a tobacco lobbyist suggesting the industry would pay up to $10 per signature to place a possible referendum on the ballot overturning the age-21 measure. It would have driven up signature costs and endangered this tax initiative and other prop[...]
Mon, 27 Jun 2016 10:20:00 -0400
(image) A large survey of Europeans indicates that more than 6 million have quit smoking with the help of e-cigarettes, while more than 9 million have cut back, according to a study recently published by the journal Addiction. "These are probably the highest rates of smoking cessation and reduction ever observed in such a large population study," says the lead researcher, Konstantinos Farsalinos, a cardiologist at the Onassis Cardiac Surgery Center in Athens. "The European Union data show that the use of electronic cigarettes seems to have a positive impact on public health for two main reasons: 1) High smoking cessation and reduction rates are observed, and 2) electronic cigarette use is largely confined to smokers (current and former), with minimal use by nonsmokers."
The study, based on responses from 27,460 participants in the Eurobarometer survey, found that 48.5 million citizens of E.U. countries have tried e-cigarettes, while 7.5 million are current vapers. Within the latter group, 35 percent reported that e-cigarettes helped them quit smoking, while 32 percent said they were smoking less thanks to e-cigarettes. Such self-reports are not conclusive, since the study did not independently verify smoking status, smokers who try to quit by vaping are probably different from those who don't, and it's possible these outcomes could have been achieved without e-cigarettes. But policy makers and regulators should not lightly dismiss the experiences of millions who say e-cigarettes helped them make changes that dramatically reduced the health hazards they face.
Critics of vaping say the risk that it will lead to smoking in people who otherwise never would have used tobacco products must be weighed against the success stories of people who believe they'd still be smoking if it weren't for e-cigarettes. But this study found very little evidence of such a risk. Just 0.8 percent of respondents who had ever tried tobacco products said they had tried e-cigarettes first (which does not necessarily mean that the latter led to the former). Only 1.3 percent of never-smokers reported using e-cigarettes with nicotine-containing liquids, and only 0.09 percent did so every day. "In nonsmokers we observed some experimentation with electronic cigarettes, but regular use is minimal," says one of Farsalinos' collaborators, Jacques Le Houezec, a neuroscientist at the French National Research Institute for Health and Medical Research. "The concern that electronic cigarettes can be a gateway to smoking is largely rejected by our findings."
Mon, 20 Jun 2016 04:38:00 -0400Public statements from the U.S. Centers for Disease Control and Prevention (CDC) take an alarmist view of e-cigarettes, portraying them as a menace to the youth of America, who supposedly will start smoking again in droves once they try vaping and get hooked on nicotine. But the CDC's data tell a different story. This month the CDC released the latest results from its National Youth Risk Behavior Survey (NYRBS), which is conducted every two years. The 2015 numbers show that cigarette smoking continues to fall among teenagers even as more and more of them experiment with vaping. But as usual, the CDC chose to accentuate the negative. "Current cigarette smoking is at an all-time low, which is great news," CDC Director Tom Frieden conceded. "However, it's troubling to see that students are engaging in new risk behaviors, such as using e-cigarettes. We must continue to invest in programs that help reduce all forms of tobacco use, including e-cigarettes, among youth." You see what he did there? Frieden, as is his wont, called vaping "tobacco use," even though e-cigarettes do not contain tobacco. In fact, data from the Monitoring the Future Study indicate that the e-cigarette liquids used by teenagers typically do not even contain nicotine. Even when teenagers use e-cigarettes to inhale nicotine, they face far smaller health risks than smokers do—a crucial point that the CDC recklessly and routinely obfuscates by implying that the rising popularity of vaping wipes out any public health benefit from the ongoing decline in smoking. That decline has been dramatic. According to the NYRBS, the share of high school students who reported smoking cigarettes during the previous month fell from more than 36 percent in 1997 to less than 11 percent in 2015—a 70 percent drop. Other surveys, including Monitoring the Future and the CDC's National Youth Tobacco Survey, show a similar downward trend, even as interest in e-cigarettes has increased dramatically. The CDC has been raising the alarm about rising adolescent e-cigarette experimentation since 2012, based on answers to survey questions added in 2011. Yet the NYRBS shows that past-month cigarette smoking fell from 18.1 percent in 2011 to 10.8 percent in 2015. The CDC's own numbers belie the notion that vaping is renewing interest in smoking. A study published last week in the journal Pediatrics purports to show that vaping is nevertheless renewing interest in smoking. But that is not what the study actually shows. Jessica Barrington-Trimis, a postdoctoral research associate at the University of Southern California, and her eight collaborators started with the Children's Health Study, which has been following more than 5,000 kids in Southern California since 2002. The researchers focused on 213 subjects who in 2014, when they were juniors or seniors in high school, reported that they had never smoked. Barrington-Trimis et al. got 146 of those teenagers to complete new questionnaires an average of 16 months later. They found that teenagers who had reported trying e-cigarettes in 2014 were six times as likely as those who hadn't to report in the follow-up survey that they had tried conventional cigarettes. The researchers conclude that "e-cigarette use in never-smoking youth may increase risk of subsequent initiation of cigarettes and other combustible products during the transition to adulthood when the purchase of tobacco products becomes legal." Then again, it may not. While Barrington-Trimis et al. found a strong association between vaping and smoking, it does not necessarily follow that the former causes the latter. It may simply be that the sort of teenagers who are inclined to try vaping are also inclined to try smoking, and that [...]
Fri, 17 Jun 2016 07:30:00 -0400
(image) Data released last week by the CDC show that smoking continues to decline among teenagers, reaching a record low last year. But as I explain in my latest Forbes column, the CDC is still worried that the rising popularity of e-cigarettes will renew adolescent interest in the real thing:
Public statements from the U.S. Centers for Disease Control and Prevention (CDC) take an alarmist view of e-cigarettes, portraying them as a menace to the youth of America, who supposedly will start smoking again in droves once they try vaping and get hooked on nicotine. But the CDC's data tell a different story.
Last week the CDC released the latest results from its National Youth Risk Behavior Survey (NYRBS), which is conducted every two years. The 2015 numbers show that cigarette smoking continues to fall among teenagers even as more and more of them experiment with vaping. But as usual, the CDC chose to accentuate the negative.