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Published: Sun, 22 Apr 2018 00:00:00 -0400

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Are Health Advocates Finally Wising Up About the Nature of Risk?

Fri, 02 Mar 2018 00:15:00 -0500

Not to be outdone by a friend who is having his mid-life crisis, I've been going through my own way-past-mid-life crisis. So I've been looking into motorcycle riding as a way to spark a little everyday excitement, which has naturally led to some reading and research about risk—and the amount of it that people are willing to endure. It's a fascinating topic. Every year, the Isle of Man—a self-governing British dependency in the Irish Sea—hosts a motorcycle race that zooms through the island's gnarled, twisting roadways. Competitors in the Tourist Trophy are routinely killed, with the total death count on the Snaefell Mountain Course hitting 255. It's amazing reading accounts of this risky contest. I doubt that Americans would tolerate such a dangerous spectacle. But we do accept everyday activities that have a high body count. Nearly 89 Americans die each day in car crashes. And 13 motorcyclists are killed in the U.S. daily on top of that, but risks for bikers are far higher when one factors in vehicle-miles traveled. Motorcyclists account for only 0.6 percent of the miles traveled yet riders account for 21 percent of all vehicle fatalities, according to the National Motorcycle Institute. Bikers are 38 times more likely to die in an accident than people in cars. Those figures—and anecdotal stories of riders clobbered by birds or killed after some "cager" on a cellphone cuts in front of them—ultimately put the kibosh on my thoughts of taking weekend motorcycle rides through the Sierra foothills. But others are more willing to accept the risk. And there's still plenty of risk that non-riders face on any given day. I have two friends who have been hit by cars while walking just in the past year. That brings me to the topic at hand: tobacco use. The statistics are even more daunting than those involving motorcyclists. The Centers for Disease Control blames cigarette smoking for 480,000 deaths in the United States per year. Even if those figures are inflated, that's still a shockingly high number. All these fatality numbers, by the way, are dwarfed by the injury and sickness numbers. I'm far more willing to risk death than I am willing to risk spending the next year in the intensive-care unit, or spending my golden years eating through a feeding tube. Policy makers are understandably intent on reducing risks wherever possible. Road safety groups are understandably intent on improving vehicle safety in a variety of ways (Anti-lock braking systems on motorcycles, for instance, are viewed as a great safety improvement). Anti-tobacco groups are understandably intent on convincing more Americans to give up a deadly habit. Smoking rates are down thanks in part to some public policies, but a certain level of zealotry has hobbled efforts to make even greater strides in reducing the number of tobacco-related deaths. Several California localities have passed bans on flavored tobacco products (menthol cigarettes, cheap flavored cigars, etc.) as a way to limit their appeal, especially to teenagers who might be tempted to try them. Unfortunately, the bans always include flavored electronic cigarettes. Because virtually all vaping liquids are flavored, that means a ban on a product that isn't risk-free—but is far less risky than combustible cigarettes. State officials have foolishly insisted that vaping is just another form of smoking and should be treated in the same harsh manner. But perhaps we're finally seeing a more sensible, less ideological approach to tobacco risk take hold among health advocates who are committed to reducing the death rate associated with cigarettes. For instance, this month the American Cancer Society, which had previously avoided recommending vaping, issued a statement that is worth applauding. The society supports "FDA-approved cessation aids" and recommends that people give up all tobacco products. That's nothing new, but it also included this sensible advice: "Many smokers choose to quit smoking without the assistance of a clinician and some opt to use e-cigarettes to accomplish this goal. The ACS [...]

Nonsensical FDA Ban On Vaping Products Faces 3 New Legal Challenges

Tue, 30 Jan 2018 11:10:00 -0500

A 2016 ruling by the Food and Drug Administration effectively banned new vaping products from the market unless they undergo an extensive, and expensive, approval process that was designed for traditional cigarettes. The so-called "deeming rule" also prevents e-cigarettes from being marketed as safer alternatives to traditional cigarettes or as a way to help smokers quit. Lawsuits filed Tuesday in federal courts in Minnesota, Texas, and Washington, D.C., ask judges to overturn that ruling on that grounds that such regulations must come from Congress, or at least from presidential-appointed agency heads. The decision to force electronic cigarettes and other vaping products to comply with the 1997 Tobacco Control Act is a head-scratcher for a number of reasons—not least of which being that e-cigarettes contain no tobacco. Forcing e-cigarettes to comply with a regulatory scheme devised for cigarettes, one that predates the introduction of e-cigarettes into the marketplace, has hurt vaping businesses and made it harder for smokers to switch from combustible cigarettes to the relatively safer electronic variety, which use a heating element and nicotine-laced liquids. Under the terms of Tobacco Control Act, vaping manufactures and sellers cannot market their products as a more healthy alternative to cigarettes that help smokers quit, despite the fact that study after study has shown that they are. Steve Green, owner of California-based Mountain Vapors and one of the plaintiffs in the lawsuit filed Tuesday in federal court in Washington, D.C., says the FDA's rule-change has damaged his business and his customers. Worse, it's stopped him from being able to share his personal story of using e-cigarettes to kick his smoking habit. "For years I smoked two-and-a-half packs of cigarettes a day, and it nearly gave me emphysema," says Green. "Vaping freed me from my addiction and the doctor says I've recovered." Vaping businesses in Michigan and North Dakota are also part of the lawsuit launched in D.C. Separately, a lawsuit was filed in federal court in Minnesota by a group of four small vape shops in the state and the Minnesota-based nonprofit Tobacco Harm Reduction 4 Life. Joosie Vapes, a vape shop in Mesquite, Texas, filed a federal lawsuit in the state. All three challenges are being backed by the Pacific Legal Foundation, a libertarian law firm, and all three make the same basic argument about the legality of the Food and Drug Administration's decision to apply the Tobacco Control Act to e-cigarettes. "Rules that affect the American people must be issued by officials who are answerable to the political process, not by bureaucrats who have no political accountability," says Thomas Berry, an attorney with PLF. "The Constitution requires that regulations with the force of law must be approved by agency executives nominated by the President and confirmed by the Senate." By contrast, the FDA's deeming rule was issued by Leslie Kux, an associate commissioner for policy, a career civil service employee at the FDA. The consequences of that rule are significant. Bringing any new e-cigarette products to the market will now require an application to the FDA and the administration's approval. That process will cost from $182,000 to $2 million for e-liquids and from $286,000 to $2.6 million for e-cigarettes themselves, the FDA estimates. That's a prohibitively high expense for many potential products, and it leaves bigger companies in control of the e-cigarette market. Berry says the FDA's rule also flaunts the First Amendment by forcing vaping businesses to "run a regulatory gauntlet" before being allowed to speak openly about their products. Under the Tobacco Control Act, which prohibits unapproved "modified risk" claims, e-cigarette companies are not allowed to advertise the main advantage of their products—that they are healthier than traditional cigarettes. The deeming rule survived an earlier court challenge that sought to overturn the 2016 rulemaking on the grounds that it exceeded the FDA's authority. W[...]

E-Cigarettes Can Be Lifesavers

Wed, 24 Jan 2018 00:01:00 -0500

This week the National Academies of Sciences, Engineering, and Medicine (NASEM) weighed in on the question of whether e-cigarettes are a public health menace or a public health boon. The answer is yes, according to a NASEM report published on Tuesday. The report, which was sponsored by the Food and Drug Administration (FDA), concludes that "e-cigarettes cannot be simply categorized as either beneficial or harmful to health." While that is true in principle, the report gives too much weight to scenarios in which these products could be harmful, even while confirming that they dramatically reduce exposure to toxins and carcinogens for smokers who switch to them. NASEM's advice is important because it will guide the FDA as the agency decides how to regulate the vaping industry, which last year got a four-year reprieve from rules that threatened to drive the vast majority of companies out of business. The demands that the FDA ultimately imposes on manufacturers of vaping equipment and liquids will affect the options available to consumers and their knowledge of them, which in turn will determine the extent to which they take advantage of products that could save their lives. The NASEM report, which is the work of a committee chaired by University of Washington toxicologist David Eaton, acknowledges the harm-reducing potential of e-cigarettes. "E-cigarette aerosol contains fewer numbers and lower levels of most toxicants than smoke from combustible tobacco cigarettes does," Eaton et al. say. "Laboratory tests of e-cigarette ingredients, in vitro toxicological tests, and short-term human studies suggest that e-cigarettes are likely to be far less harmful than combustible tobacco cigarettes." When people who otherwise would be smoking use e-cigarettes instead, that represents an unambiguous gain from a public health perspective, which seeks to minimize disease and preventable death. "If e-cigarette use by adult smokers leads to long-term abstinence from combustible tobacco cigarettes," the report says, "the benefit to public health could be considerable." But Eaton and his colleagues worry that e-cigarettes also could increase tobacco-related morbidity and mortality if they encourage teenagers to smoke. Depending on how big that effect is, they say, it might even outweigh the benefit from smoking cessation among adults. That concern seems wildly implausible in light of current trends. Cigarette smoking by teenagers has continued to fall despite a surge in experimentation with vaping, and last year it reached the lowest level ever recorded by the Monitoring the Future Study, which began surveying high school students in 1975. Two other factors make it unlikely that significant numbers of teenagers become smokers after getting hooked on nicotine in e-cigarettes. The vast majority of nonsmoking teenagers who vape do so only occasionally, and most of them use nicotine-free e-liquids. Against these facts, the NASEM report cites studies that find teenagers who try vaping are more likely than those who don't to subsequently try smoking. According to Eaton et al., these studies amount to "substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults." As the report acknowledges, however, these observational studies do not distinguish between correlation and causation. They may simply show that teenagers who are inclined to try vaping are also inclined to try smoking. Such research cannot tell us how many of these teenagers become regular smokers or whether they would have experimented with tobacco even if e-cigarettes did not exist. Under the collectivist calculus prescribed by the Family Smoking Prevention and Tobacco Control Act, Eaton et al. note, it is not enough to show that e-cigarettes are much less hazardous than the conventional kind and therefore offer a big benefit to smokers who might want to switch. The FDA also must be persuaded that the product, on balance, benefits "the population as a whole." I th[...]

Tobacco Sales Regs Punish Poor People

Wed, 10 Jan 2018 00:15:00 -0500

Store owner Kamal Saleh was just hit with thousands of dollars in fines. His crime? He sold three cigars for $8.89. "Too cheap!" say New York City bureaucrats. "The cigars should have cost 11 cents more." Politicians want you to spend more for tobacco. They decided this after anti-smoking crusader Dr. Kurt Ribisl told the Centers for Disease Control, "Higher prices will deter children from smoking." A pit of socialist micromanagers called the New York City Council quickly embraced the idea. "It's also being considered very seriously in a number of jurisdictions in California," Ribisl told me. When health totalitarians make suggestions, leftist politicians jump. Ribisl also told the CDC, "Very cheap (tobacco) products should no longer be available." So for my YouTube video this week, I asked him, "Why do you get to decide?!" "No, I'm not deciding," he insisted. "I'm a person who studies these policies. I'll let the policymakers decide." OK, I sighed, "Why do the politicians get to decide?" "Cigarettes are the most lethal product ever introduced," he replied. That may be true, although few people realize that half the people who smoke do not die from tobacco-related illness. Fatty foods, swimming pools and cars also kill lots of people. Maybe the health police will raise their prices next. But so far, it's just tobacco. At Ribisl's urging, New York City adopted price floors and taxes to bring the price of a pack of cigarettes to $13 a pack. "People still have the ability to buy it, if they so choose," he said. "Just not poor people," I told him. "You're screwing poor people." "We see much higher smoking rates among poor people," answered Ribisl. "We need policies that are going to reduce tobacco use among poor people." I think all people should get to decide for themselves, but Ribisl wants to engineer "a transition toward thinking more about healthy food and beverage." At the CDC, Ribisl suggested that it should also be government policy to "reduce the number of tobacco stores." That seems cruel to store owners like Kamal Saleh, but Ribisl said, "We're not interested in putting stores out of business ... They're going to find new products to sell." Really? How does he know? New York already has a blizzard of regulations that put little stores out of business. Tobacco sales regulations alone go on for 47 pages—confusing pages filled with fine print like: "the price floor for any package of cigars that contains more than one cigar and that has been delivered to a retail dealer in a package described by subdivision a of section 17-704 shall be computed by multiplying the number of cigars in the package by $1.75 and adding $6.25 to the total." The 47 pages are just for tobacco sales. "For food, refrigeration, deliveries and everything else, the administrative code could be thousands of pages," says lawyer Andrew Tilem. Tilem defends store owners who get fined. Many can barely afford to pay him. Sometimes they pay in "fish and paper plates and tortillas." Those who can't afford to hire a lawyer may just go out of business. City Council meddlers, who often complain about "big business," don't notice that their own rules make the big businesses bigger. "The big guy can hire lawyers," says Tilem. "It's the little guy who's trying to pinch his pennies and make a dollar that has the biggest problem." Playing devil's advocate, I tell him, the government just wants to protect people's health. "I'm not a smoking advocate," Tilem replied, "but I think in this country ... people have the right to do the wrong thing." We should. Watch this week's video: src="" allowfullscreen="allowfullscreen" width="560" height="340" frameborder="0">[...]

Stossel: NY Strangles Small Business

Tue, 09 Jan 2018 12:05:00 -0500

Kamal Saleh runs a small store in New York City. He was recently given a summons to appear in court for violating one of New York's many rules. His crime was selling cigars... 11 cents too cheaply.

It's not often people complain about things being too cheap. But New York City says stores may not sell tobacco below a certain price.

"Very cheap products should no longer be available. It deters children from starting smoking," says Dr. Kurt Ribisl, who studies tobacco policy and testified at the New York hearings in favor of the tobacco price floor. "Cigarettes are the most lethal product ever introduced into interstate commerce."

John Stossel agrees cigarettes are dangerous. But he asks Dr. Ribisl, "Shouldn't individuals have the right to decide for themselves if they want to smoke? And what is the cost to New York City businesses in complying with all these regulations?" For tobacco alone, the regulations are 47 pages long.

Saleh faces a $2,000 fine, a huge amount of money for a small store owner. "You have to sell a lot of sodas and sandwiches in order to make the $2,000," says Andrew Tilem, Saleh's lawyer. Tilem represents a lot of small businesses in New York and says all the regulations hurt them. "It's the big guy who basically can hire lawyers. It's the little guy who's trying to pinch his pennies to make a dollar that has the biggest problem."

Tilem says small stores are constantly going in and out of business, but "the big business community is thriving. You see Starbucks. You see 7-Eleven. You see Target, opening new stores."

John Stossel asks if New York has become a city of so much regulation where only big businesses can thrive?

Produced by Naomi Brockwell. Edited by Joshua Swain.

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Adolescent Smoking Rates Reach Historic Lows, Despite Vaping's Popularity

Thu, 14 Dec 2017 14:30:00 -0500

Survey data released today show that cigarette consumption by teenagers has reached "historic lows," nothwithstanding warnings that the rising popularity of vaping would make smoking cool again. In an interview with The New York Times, Thomas Glynn, former cancer science director at the American Cancer Society, called the dramatic decline in adolescent smoking since the late 1990s "an astounding accomplishment in public health." But he added that "I think we have to have alarms out" about adolescent vaping, which may yet lead to a surge in smoking. Don't give up fear!

The share of high school seniors reporting past-month cigarette use in the Monitoring the Future Study has fallen from 36.5 percent in 1997 to 9.7 percent this year—a 73 percent drop. The declines among younger students have been even more dramatic: from 30.4 percent in 1996 to 5 percent this year among 10th-graders (an 84 percent drop) and from 21 percent in 1996 to 1.9 percent this year among eighth-graders (a 91 percent drop). These downward trends have continued even as adolescent experimentation with e-cigarettes has become increasingly common.

(image) The survey puts past-month vaping this year at 16.6 percent among 12th-graders, 13.1 percent among 10th-graders, and 6.6 percent among eighth-graders. Those rates are up significantly since last year but about the same as in 2015 and lower than they were in 2014, when the survey first asked about vaping. Earlier data from the CDC's National Youth Tobacco Survey indicate that past-month e-cigarette use by teenagers tripled between 2011 and 2013.

One reason that teenagers who vape have not gotten hooked on nicotine and graduated to combustible cigarettes is that most of them are not consuming nicotine. In the Monitoring the Future Study, 58 percent of 12th-graders who reported vaping in the previous month said their e-liquid contained "just flavoring." Even those who vape nicotine rarely do it often enough to develop a habit. The Monitoring the Future Study does not report numbers for daily vaping. But in the National Youth Tobacco Survey, less than 1 percent of middle school students and less than 3 percent of high school students report vaping on 20 or more days in the previous month.

Another possible reason why adolescent vaping and smoking rates have been moving in opposite directions, of course, is that teenagers who otherwise would be smoking are vaping instead. Since the hazards of vaping pale beside the hazards of smoking, such substitution also should count as an "accomplishment in public health."

Fixating on Adolescent Vaping Could Be Deadly for Adult Smokers

Thu, 07 Sep 2017 14:50:00 -0400

The first surgeon general's report on e-cigarettes, published last December, could have highlighted the enormous harm-reducing potential of products that simulate smoking but do not contain tobacco or burn anything. Instead Surgeon General Vivek Murthy sounded the alarm about adolescent vaping, which he called "a major public health concern." A critique of Murthy's report, published online yesterday by Harm Reduction Journal, shows how dangerously misguided his concerns were. "The majority of e-cigarette use among US youth is infrequent and experimental, and minimal among never-smoking youth," note Italian internist and tobacco researcher Riccardo Polosa and his co-authors. "Additionally, the majority of the very small proportion of US youth who do use an e-cigarette frequently are actually using e-cigarettes that do not contain nicotine." Polosa et al. also point out that "the increasing prevalence of e-cigarette use between 2010 and 2015 has coincided with the sharpest declines in the smoking rate among US youth and young adults on record." Murthy, who was removed from his post in April but has not been permanently replaced yet, focused on the share of teenagers who report using an e-cigarette in the previous month, which rose "an astounding 900 percent" (from 1.5 percent to 16 percent) between 2011 and 2015, as measured by the National Youth Tobacco Survey (NYTS). Digging more deeply into the survey data, Polosa et al. show that relatively few teenagers vape frequently and almost all of those who do are current or former smokers. In the 2015 NYTS, for example, just 0.6 percent of middle school students and 2.5 percent of high school students reported vaping on 20 or more days in the previous month. According to the 2014 Monitoring the Future Study (MTF), less than 1 percent of teenagers who vape that often are never-smokers. The MTF data also indicate that most adolescents who vape use nicotine-free e-liquids, which makes Murthy's fear that they will get hooked on the drug and later graduate to smoking seem even more fanciful. On the face of it, nothing like that seems to be happening. As Polosa and his colleagues point out, "the increasing rate of ever-use of e-cigarettes among US youth has coincided with the sharpest declines in youth smoking rates in many decades." That is true for young adults as well as teenagers. The coincidence of these opposing trends does not necessarily mean that e-cigarettes have hastened the decline in smoking. But it is a plausible possibility that should not be overlooked by public health officials who want to reduce smoking-related morbidity and mortality, since e-cigarettes are far less hazardous than the conventional kind. Even in the rare instances where teenagers who have never tried tobacco take up vaping, they are far better off in terms of health risks if they otherwise would be smoking. As Polosa et al. note, "e-cigarettes may have the potential to reduce the likelihood of smoking initiation among youth who may be especially at risk for initiating smoking in the absence of e-cigarettes." The studies that Murthy cited as evidence that vaping leads to smoking show only that teenagers who try the former are more likely to try the latter. "There was no evidence that adolescents were regular e-cigarette users at baseline," Polosa et al. note, "and no evidence that they were smoking cigarettes regularly at follow-up." Even if some teenagers go through a vaping phase before becoming regular smokers, that does not necessarily mean the experience of vaping makes them more inclined to smoke. An attraction to both forms of nicotine consumption could be a function of personality and circumstance. If e-cigarettes are a gateway to the real thing, that gateway is so tiny that its impact cannot be seen in smoking trends. "At the very least," Polosa et al. observe, "available data appear reassuring that e-cigarettes are not decelerati[...]

FDA Lies About Vaping While the CDC Inches Toward the Truth

Thu, 31 Aug 2017 14:15:00 -0400

Between 2011 and 2016, according to survey data from the U.S. Centers for Disease Control and Prevention, cigarette smoking by teenagers fell by half, cigar smoking fell by a third, pipe smoking fell by two-thirds, and smokeless tobacco use fell by a quarter. Yet according to the Food and Drug Administration, there were "no significant declines in overall high school tobacco use" during that period. How is that possible? Let me answer that riddle by posing another one. If you call an e-cigarette a tobacco product, and the incidence of past-month vaping among high school students more than sextupled from 2011 to 2016, how does that affect the trend in overall tobacco use? The answer is that it does not affect the trend in overall tobacco use at all, because calling an e-cigarette a tobacco product does not make it a tobacco product. Yet that is what FDA does, partly for regulatory reasons. E-cigarette fluid often contains nicotine derived from tobacco, which supposedly transforms a tobacco-free product into a tobacco product, giving the FDA authority to regulate it. The FDA maintains that pretense even when reporting what is happening in the real world. The result, as Boston University public health professor Michael Siegel notes on his tobacco policy blog, is an alternative reality where dramatic declines in adolescent tobacco consumption never happened. The CDC plays the same game, falsely claiming "current use of any tobacco product did not change significantly" among high school students from 2011 to 2016. This blatant misrepresentation magnifies a problem (underage tobacco use) that the FDA and the CDC are charged with addressing, making their work seem more urgent and more worthy of funding. It also conflates e-cigarettes, a noncombustible, tobacco-free alternative to conventional cigarettes, with products that are far more dangerous, obscuring the enormous harm-reducing potential of this innovation. By lumping e-cigarettes in with tobacco products, the FDA and CDC may hope to scare kids away from them. But the message to current smokers—that they might as well keep puffing away, since all these nicotine sources are essentially the same—is potentially deadly. A new CDC webpage about e-cigarettes gives some ground on that score, conceding that "e-cigarettes have the potential to benefit adult smokers who are not pregnant if used as a complete substitute for regular cigarettes and other smoked tobacco products." But by insisting that e-cigarettes be a "complete substitute," the CDC dismisses the health benefits of smoking less, even if the number of cigarettes per day does not fall to zero. "Dual use is not an effective way to safeguard your health," the CDC says. "Because smoking even a few cigarettes a day can be dangerous, quitting smoking completely is very important to protect your health." This slippery formulation deliberately obscures the fact that smoking a few cigarettes a day is less dangerous than smoking a pack or two a day. If e-cigarettes help smokers make that change, they are reducing tobacco-related harm. The CDC's discussion of how the health hazards of vaping compare to those of smoking is similarly misleading. "Are e-cigarettes less harmful than regular cigarettes?" it asks. "Yes—but that doesn't mean e-cigarettes are safe. E-cigarette aerosol generally contains fewer toxic chemicals than the deadly mix of 7,000 chemicals in smoke from regular cigarettes. However, e-cigarette aerosol is not harmless. It can contain harmful and potentially harmful substances, including nicotine, heavy metals like lead, volatile organic compounds, and cancer-causing agents." Sadly, it counts as an improvement that the CDC is willing to explicitly say e-cigarettes are less harmful than regular cigarettes instead of dodging the question entirely. But you would not guess from its gloss that vaping is something like 95 percen[...]

A Cap on Nicotine in Cigarettes Would Be Hazardous to Health

Wed, 02 Aug 2017 15:20:00 -0400

Robert Proctor, the historian of science who wrote the fascinating 1999 book The Nazi War on Cancer, loves the Food and Drug Administration's idea of "reducing the nicotine in cigarettes to a nonaddictive level." Writing in The New York Times, Proctor, now a professor at Stanford, calls the FDA's proposal "exceptionally good news for tobacco control, and for human health." In fact, he says, "a legal cap on the nicotine in cigarettes could be one of the most important interventions in human health history." I don't think this intervention would work out the way Proctor imagines. His op-ed piece is an excellent example of expecting good intentions to ensure good outcomes, even when experience tells us the policy is bound to backfire. "Cigarettes with nonaddictive nicotine levels would be radically different from what used to be known as 'low tar' or 'light' cigarettes, marketing gimmicks now barred by law," Proctor assures us. "Those cigarettes were advertised as delivering less nicotine and tar into the lungs, even though there was no actual reduction." Although it is by no means clear that "there was no actual reduction," it's true that "light" cigarettes were at best only slightly less harmful than regular cigarettes. But the reason for that casts doubt on the logic of the proposal Proctor is championing. It turned out that smokers who switched to "light" cigarettes tended to engage in "compensatory behavior" that boosted nicotine delivery and moved them closer to their usual dose. They smoked more cigarettes, took more puffs from each one, took bigger puffs, or held the smoke deeper and longer. They even subconsciously covered the tiny filter holes that helped reduce a cigarette's machine-measured tar and nicotine yields. The upshot is that "light" cigarettes did not offer anything like the health advantage implied by those official, government-certified numbers. The problem was that tobacco companies reduced nicotine along with tar, when what they should have done was reduce tar while keeping nicotine the same. E-cigarettes embody the latter approach taken to its logical conclusion: They deliver nicotine with no tar at all, since they do not contain tobacco and do not rely on combustion. To its credit, the FDA has finally begun to recognize the huge potential health benefit of reducing the toxins and carcinogens that smokers absorb along with nicotine. In the case of conventional cigarettes, however, the agency is considering the opposite approach: forcing smokers to absorb more toxins and carcinogens for any given dose of nicotine. The aim, as Proctor says, is to "make addiction virtually impossible," so that "kids might start smoking, but they wouldn't have trouble quitting." But what about the 30 million or so Americans who already smoke cigarettes? Deliberately increasing their exposure to the dangerous compounds generated by burning tobacco is neither ethical nor sensible, even (or especially) from a "public health" perspective. There are other problems with the FDA's proposal, aside from its health-damaging paternalism. Proctor notes that "sales were disappointing" when Philip Morris introduced three brands of nicotine-free cigarettes in the 1980s, "in part because high-nicotine cigarettes remained on the market." But forcing cigarette manufacturers to dramatically reduce nicotine levels would stimulate a black market supplied by smuggled imports and illicitly manufactured smokes. Smokers could dodge the cap on nicotine by turning to the black market, spiking their cigarettes with liquid nicotine, or rolling their own using full-strength tobacco. As longtime British anti-smoking activist Clive Bates notes, it is not even clear that the FDA has the authority to mandate the nearly complete removal of nicotine from cigarettes. The Family Smoking Prevention and Tobacco Control Act bars the agency from[...]

The FDA Warms to Vaping

Wed, 02 Aug 2017 00:01:00 -0400

On the face of it, the decision that the Food and Drug Administration (FDA) announced on Friday, extending by four years a crucial deadline for e-cigarette manufacturers to seek approval of their products, was no more than a stay of execution. But the FDA also signaled a new receptiveness to vaping as a harm-reducing alternative to smoking, which suggests this reprieve could turn into a commutation. That would be good news for smokers who want to quit and for anyone sincerely interested in helping them. For too long American public health officials have been unreasonably hostile to e-cigarettes, which are far less hazardous than the conventional kind and offer a closer simulation of the real thing than nicotine gum or patches do. Scott Gottlieb, the new FDA commissioner, seems to appreciate the public health potential of this innovation. "The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes," he says. "Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts—and we believe it's vital that we pursue this common ground." Gottlieb's vision of nonaddictive cigarettes involves mandating a gradual reduction in nicotine content, which would increase the risks that smokers face by forcing them to absorb more toxins and carcinogens for the same dose of nicotine. But his interest in less dangerous alternatives to cigarettes is encouraging. The FDA says "a key piece" of its new approach is "demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes." The agency wants to strike "an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes." Toward that end, the FDA is giving e-cigarette companies until August 8, 2022, to apply for permission to keep their products on the market under regulations published last year, rather than the original deadline of November 8, 2018. The agency says it will use the extra time to seek additional public comment and develop clearer guidance for the industry. The 2016 regulations require manufacturers of vaping equipment and e-liquids to demonstrate that approval of their products "would be appropriate for the protection of the public health." It is not clear what that means in practice, but the FDA projected that applications would cost hundreds of thousands of dollars per product, and many observers thought that was an underestimate. To give you a sense of how expensive and burdensome the process was expected to be, the FDA anticipated that it would receive applications for just a tiny percentage of existing products. The implication was that the regulations would drive the vast majority of companies out of business. If the FDA is serious about making "less harmful sources" of nicotine "the cornerstone of our efforts," it will develop transparent, straightforward, and practical criteria for approval of current and new vaping products. Standing between smokers and products that can save their lives is surely not "appropriate for the protection of the public health." Nor is making those products less appealing by arbitrarily restricting flavors. Since supposedly "kid-friendly" e-liquids are very popular among adults who switch from smoking to vaping, it's a bit worrisome that the FDA plans to solicit public comment on regulation of flavors, which it acknowledges may be "helping some smokers switch to potentially less harmful forms of nicotine delivery." A recent BMJ study suggests that e-cig[...]

Embracing Harm Reduction, FDA Gives E-Cigarette Industry a Regulatory Reprieve

Fri, 28 Jul 2017 13:15:00 -0400

Today the Food and Drug Administration (FDA) said it is giving manufacturers of electronic cigarettes until August 8, 2022, to apply for approval of their products under regulations announced last year, which were widely expected to drive most companies out of business. The original deadline was November 8, 2018, and the four-year extension is supposed to provide more time for public comment and industry guidance as part of a "comprehensive regulatory plan" that aims to strike "an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes." The agency says "a key piece of the FDA's approach is demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes." That is music to the ears of harm-reduction advocates who see vaping as a life-saving alternative to smoking and viewed the original FDA rules as misguided, heavy-handed, and potentially deadly meddling that effectively gave conventional cigarettes an advantage over competing sources of nicotine that are much less dangerous. In addition to providing regulatory relief for the e-cigarette industry, the FDA will be investigating the possibility of mandating a gradual reduction in the nicotine levels of combustible cigarettes. The idea is to make cigarettes less addictive for new smokers, but the policy is apt to hurt current smokers by forcing them to absorb more toxins and carcinogens along with their usual dose of nicotine. The FDA "intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes." The FDA's new commissioner, Scott Gottlieb, sees a nicotine-reduction mandate as complementing the agency's new receptivity to harm-reducing cigarette alternatives. "The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes," Gottlieb says. "Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts—and we believe it's vital that we pursue this common ground." The FDA also seems to be contemplating flavor regulations that might favor e-cigarettes over the real thing. It says it will "seek public comment on the role that flavors (including menthol) in tobacco products play in attracting youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery." The Family Smoking Prevention and Tobacco Control Act, the law that gave the FDA authority to regulate tobacco products, banned most "characterizing flavors" from cigarettes but made an exception for menthol, by far the most popular one (and, not coincidentally, a big moneymaker for Philip Morris, which supported the law). It sounds like the FDA might be reconsidering that exception, while at the same time recognizing that so-called kid-friendly e-cigarette flavors are in fact very popular with adults who switch from smoking to vaping. The FDA says it will use the reprieve it is giving e-cigarette companies to clarify what will be required to keep their products on the market. The agency also plans to develop product standards that address battery hazards and help keep e-cigarette liquids away from children. Over all, it looks like the FDA under Gottlieb will be taking a much more practical approach to e-cigarette regulation that recognizes the realities of the existing market and the relative hazards of different nicotine sources. Instead of [...]

New Study Provides Strong Evidence That E-Cigarettes Boost Smoking Cessation

Thu, 27 Jul 2017 17:15:00 -0400

A new study, based on data from a large survey of current and former smokers in the United States, provides some of the strongest evidence yet that electronic cigarettes are helping Americans move from the first group to the second. The study, reported this month in the BMJ, finds that quit attempt and smoking cessation rates both increased significantly during the period when e-cigarette sales took off. Furthermore, these changes were entirely attributable to increased quitting among e-cigarette users, who were more likely to try and more likely to succeed than smokers who did not vape. The researchers, led by University of California at San Diego public health professor Shu-Hong Zhu, found that 45.9 percent of smokers reported quit attempts in the 2014-15 Current Population Survey, up from 41.4 percent in 2010-11. The percentage who stopped smoking for at least three months also rose, from 4.5 percent to 5.6 percent. "This is the first time in almost a quarter of a century that the smoking cessation rate in the US has increased at the population level," Zhu and his colleagues write. "The 1.1 percentage point increase in cessation rate...might appear small, but it represents approximately 350 000 additional US smokers who quit in 2014-15." What happened during this period that might account for the change? Zhu et al. note that e-cigarette use in the U.S. "became noticeable around 2010 and increased dramatically by 2014." That correlation is reinforced by the researchers' subgroup analysis of the 2014-15 data, which found that 65 percent of smokers who had used e-cigarettes in the previous year had tried quitting, compared to 40 percent of the other smokers. "Numerically speaking," the authors say, "it was this e-cigarette user subgroup that raised the overall quit attempt rate for 2014-15, and thus the rate was statistically significantly higher than in all previous survey years." Vapers also had a higher cessation rate than nonvapers in 2014-15: 8.2 percent vs. 4.8 percent. "Again," Zhu et al. write, "the 2014-15 survey had a noticeably higher overall cessation rate because the e-cigarette user subgroup had a higher cessation rate than those who did not report e-cigarette use in the past year." Since this is an observational study rather than a randomized, controlled experiment, alternative explanations are possible. But the researchers persuasively argue that neither the 2009 increase in the federal tobacco tax nor the TIPS From Former Smokers ad campaign that began in 2012 can adequately explain the increase in smoking cessation, especially in light of the stark subgroup differences. The impact of the tax hike was relatively small and short-lived, Zhu et al. say, while it is hard to see why the anti-smoking ads would have had an impact only on smokers "who happened to use e-cigarettes in 2014-15." Still, smokers who try vaping may differ from those who do not in ways that make them more likely to quit. "Given that the e-cigarette user subgroup was the only group that had statistically significantly higher rates in 2014-15," Zhu et al. say, "it is tempting to attribute the increase in the overall smoking cessation rate in 2014-15 solely to e-cigarette use. However, e-cigarette use itself could be an indicator of motivation to quit smoking, which would predict a higher quit rate. Thus, attributing the full 73% relative difference to e-cigarettes is likely an overestimate of their effect." These results nevertheless should allay fears that e-cigarettes might somehow make smoking more common than it would otherwise be. To the contrary, the vaping alternative seems to be accelerating the downward trend in the smoking rate, which in this survey fell from 21 percent in 2001-02 to less than 14 percent in 2014-15. Any regulatory[...]

Don't Buy the Hype About an Increased Smoking Age

Tue, 25 Jul 2017 11:15:00 -0400

When New Jersey Gov. Chris Christie signed a bill increasing the smoking age from 19 to 21 last week, he said that the higher age would give young people a "better understanding of how dangerous smoking can be" and that the fewer smokers there are, "the less strain there will be on our health care system." These claims are ubiquitous among anti-smoking activists, who have gotten some 250 localities and now four states to increase their smoking ages to 21 on the promise that it will slash smoking rates among high schoolers and others under 18. But closer scrutiny suggests that these promises are speculative at best—and that the immediate fiscal consequences of the change will put more strain, not less, on budgets. "Increasing tobacco age to 21 decreases high school use by about half," says Rob Crane, president of Tobacco 21. As evidence, he cites the example of Needham, Massachusetts, the first city in America to raise its smoking age to 21. The percentage of high schoolers there who reported using tobacco subsequently fell from 35 percent in 2006 to 17 percent in 2014. Crane's conclusion is undercut by a 2015 Institute of Medicine study (found on Tobacco 21's own website). "Although Needham...has been cited as having seen significant declines in tobacco use and tobacco-related disease, there are no published data on these outcomes," the paper notes. The paper explains that no baseline data exists for Needham prior to its raising the smoking age, and that other factors could have been responsible for the decline. Indeed, teen smoking has fallen across the United States independently of whether jurisdictions raise their smoking age. In 2005—just as Needham was getting its ban up and running—some 50 percent of American high school seniors had reportedly tried tobacco. By 2015 that figure had fallen to 31 percent according to the University of Michigan's Monitoring the Future study. The number who have smoked in the last 30 days is down even more, from 23 percent to 11.4 percent, the lowest the rate has ever been in the University of Michigan's data. Proponents of a higher smoking age—from the American Cancer Society to Vox—fall back on that Institute of Medicine study's conclusion that raising the legal age to 21 will reduce smoking for those aged 15 to 17 by 25 percent. Yet that number is not based on empirical data of smoking age increases. Little of that exists, given how recent most of these laws are. Instead it relies on complex logic models that try to predict the ability of teenagers to get cigarettes from retailers and older friends and family in a world with a nationwide smoking age of 21, and then tries to extrapolate the rates of smoking and smoking related diseases from those models out to the year 2100. You don't have to be a hardcore Austrian economist to doubt the efficacy of this approach. Nor do you have to be a doctrinaire libertarian to question the idea of criminalizing the habits of 20-year-old smokers in the hopes of stopping 16-year-olds from doing something that is already illegal. We do have some pretty good forecasts on one effect the bill is likely to have. Legislative analysis of New Jersey's "raise the age" bill estimates that it will cost the state between $4.5 to $12.5 million this fiscal year in foregone tax revenue. That matches the experience of Oregon and Maine, both of which also passed smoking age increases this year. Maine will lose $4 million a year. Oregon will lose nearly $2 million a year by 2019, with most of that money coming out of public health budgets. Smoking is risky, but it is victimless and consensual. Individuals are in the best position to determine if that risky behavior is worth it to them. Governments, activists, and speculative public h[...]

FDA's Vaping Regulations Will Hurt Smokers Trying to Quit

Mon, 03 Jul 2017 14:46:00 -0400

Electronic cigarettes are now the most popular technique used by Americans who want to quit smoking. But that pathway could close later this year, thanks to shortsighted federal regulations that effectively prevent innovation. When Congress passed the Tobacco Control Act in 2009, few electronic cigarettes were on the market. Under the terms of that law, the Food and Drug Administration (FDA) would have the authority to approve or deny any new tobacco products introduced after February 15, 2007, while products that had been on the market before that so-called "predicate date" would be free from the new level of scrutiny. That works out fine for cigarettes, cigars, chewing tobacco, and other items that have been around a long time, but it effectively froze the market. Any new products—including almost all vaping devices and the nicotine-laced liquids used in those devices—would have to go through an expensive and vague regulatory process before being offered to consumers. The deadline for filing those applications is November 8 of this year, unless Congress and the FDA act to change the rules and let e-cigarettes remain on the market. Greg Conley, president of the American Vaping Association, explains it like this. If you have not filed a retroactive application for any vapor product that has come to market since 2007—which is every single product on the market today—your product is banned. If you file an application before November 8, and the FDA doesn't like what you have included, you're banned. If you file an application on November 8, and the FDA hasn't ruled on that application by November 8, 2019, you are banned. "So you could spend millions and millions of dollars to try to comply with very vague requirements that have been put out by the FDA, and the FDA could still simply never review your application or just turn it down for an arbitrary reason," Conley said at a recent forum sponsored by the American Enterprise Institute. The FDA's own economic analysis of the regulation suggests that 98 percent of all e-cigarette products will not apply to stay on the market. That's bad news for vaping businesses, but it's also bad news for Americans hoping to stop smoking cigarettes. According to research from the Center for Disease Control, 35 percent of Americans who sought to quit smoking from 2014-2016 used electronic cigarettes as a substitute. Vaping allows would-be smokers to get a hit of nicotine and to maintain the same physical routine, while avoiding the dangerous chemicals and soot that come from burning tobacco and inhaling it into their lungs. Compared to other methods used to quit smoking, the CDC reports, e-cigarettes are the most popular, beating out nicotine gum, anti-smoking patches, and FDA-approved medications such as Zyban and Chantix: Killing the majority of vaping products currently available on the market while leaving cigarettes available is almost certain to drive some e-cigarette users back to combustible tobacco options. That means the FDA—the very government agency that claims it is "responsible for protecting the public health" and "for advancing the public health by helping to speed innovations"—will be banning innovative products that are helping Americans improve their health. They'll be doing that because Congress, a decade ago, made an arbitrary decision that tobacco products made after 2007 should have to face a different level of scrutiny than those that came earlier. Imagine how a similar rule would effect any other industry. What would computers look like today if Congress decided in 1999 to force any new microchip-using devices to jump through additional regulatory hurdles while leaving older models on the market? What car w[...]

As Vaping Exploded Among Teenagers, Smoking Fell by Half

Mon, 19 Jun 2017 09:15:00 -0400

Survey data published last week cast further doubt on warnings that e-cigarettes are a gateway to the real thing for teenagers. Between 2011 and 2016, according to the National Youth Tobacco Survey (NYTS), the share of high school students who reported smoking cigarettes in the previous month fell from almost 16 percent to 8 percent, even as past-month use of e-cigarettes rose dramatically. The incidence of past-month cigarette smoking among high school students in the NYTS, which is conducted by the U.S. Centers for Disease Control and Prevention (CDC), fell from 9.3 percent to 8 percent last year, continuing a downward trend that began in the late 1990s. The incidence of past-month vaping, which rose steadily from 1.5 percent in 2011 to 16 percent in 2015, also fell last year, to 11 percent. From 2011 to 2016, in other words, e-cigarette use more than septupled, while cigarette smoking was cut in half. "The rate of decline in youth smoking is unprecedented," writes Boston University public health professor Michael Siegel on his tobacco policy blog. "This despite the rapid rise in e-cigarette experimentation. These data are simply not consistent with the hypothesis that vaping is going to re-normalize smoking and that e-cigarettes are a gateway to youth smoking." In theory, it is possible that adolescent smoking would have declined even faster if e-cigarettes had never been introduced. But on the face of it, these trends do not look like evidence that vaping entices teenagers who otherwise never would have tried tobacco into a nicotine habit that ultimately leads to smoking. Making that scenario even more unlikely, most nonsmoking teenagers who vape use nicotine-free e-liquids, and very few of them vape often enough to get hooked on nicotine in any case. If anything, it looks like e-cigarettes have taken the place of the conventional kind for at least some teenagers who otherwise would be smoking. That is unambiguously an improvement from a public health perspective, since smoking is far more dangerous than vaping. Yet the CDC continues to talk as if there is little or no difference between smoking and vaping as far as health hazards go. "Current use of any tobacco product did not change significantly during 2011–2016 among high or middle school students," says the article on the latest NYTS data in the CDC's Morbidity and Mortality Weekly Report. That is true only if you classify e-cigarettes, which contain no tobacco, as tobacco products, which they aren't. The report's authors concede that "combustible tobacco product use declined" during this period but obscure the significance of that development. "Use of tobacco products in any form is unsafe," they say, ignoring the enormous difference between combustible cigarettes and alternatives such as e-cigarettes, which are something like 95 percent safer. By exaggerating the threat posed by adolescent experimentation with vaping (and experimentation is all it typically amounts to), the CDC hopes to justify policies that will make e-cigarettes less accessible and less appealing to adult smokers. "Sustained efforts to implement proven tobacco control policies and strategies are critical to preventing youth use of all tobacco products," say the authors of the NYTS report, citing the Food and Drug Administration's regulation of e-cigarettes as an example. But the FDA's rules threaten to cripple an industry that could help millions of smokers prolong their lives by switching to a far less hazardous source of nicotine. The CDC therefore is endangering public health when it rationalizes those regulations as sensible safeguards against adolescent vaping.[...]