Panel Examines Youth Vaping ‘Epidemic,’ Overlooks Real Threats

Yesterday Inside Sources published my column on how Congress focused on the vaping “epidemic” while ignoring legitimate threats to American teens.  Read it here or at Inside Sources.

The House Committee on Oversight and Reform held two days of hearings last week on “JUUL’s Role in the Youth Nicotine Epidemic.” Make no mistake: the hearings were about congressional grandstanding, not a discussion of what really threatens American teens.

According to data from the Centers for Disease Control, the high school vaping rate is lower than that for marijuana and alcohol use. It’s about the same as binge drinking (four or five drinks within a couple hours).  And, as we know, these activities don’t typically occur in a vacuum. High school students frequently drive after marijuana use, ride with a driver who has been drinking, text or email while driving, have sexual intercourse, and consider suicide.

But despite these truly worrisome activities, tobacco prohibitionists like Campaign for Tobacco-Free Kids have convinced Congress, school boards and parents that e-cigarettes have created “a public health emergency.”  Former FDA Commissioner Scott Gottlieb and other government officials fueled this anxiety by referring to the rise in teen vaping as an “epidemic.”

The hysteria stems from the CDC’s National Youth Tobacco Survey, which federal officials refer to as the gold standard of information about teen vaping. But they tout these numbers without any context.  And that context is critical.

We frequently hear that 3 million high school students in 2018 were “current vapers.” But if you look closer at the data, 3 million teens had used an e-cigarette at least once in the past 30 days. And 600,000 of the high school vapers were 18 or older, so they could purchase tobacco products legally in most states. The rest were underage. Of the 2.5 million underage vapers, about 1.7 million had also smoked a cigarette, cigar and/or had used smokeless tobacco.

Of the 807,000 underage vapers with no history of other tobacco use, 70 percent had used e-cigarettes only one to five days during the month — the equivalent of trying one at a party. Only 95,000 students had used the products 20 to 30 days, suggesting that they might be addicted.  And this represents just 0.6 percent of the nation’s nearly 15 million high school students — a far cry from Gottlieb’s hysteria that we’re “hooking an entire generation of children on tobacco and nicotine.”

These estimates are based on the CDC’s youth tobacco survey, so they’re certainly not “underestimates.”  Yet the rabidly anti-tobacco Truth Initiative produced an estimate for 2018 that is nearly half that of the 3 million number touted by the CDC.

In addition to faulty data, the House hearing echoed the government’s false narrative blaming teen vaping on illegal retail sales and “kid-friendly marketing.”  But the FDA’s own research shows that more than 90 percent of teens who use e-cigarettes obtain them from social sources, such as friends or family. Only 10 percent of current teen vapers buy their own — and many of those are of age. Raising the purchasing age from 18 to 21 could potentially disrupt high school “black markets.”

Lawmakers also go after fears about nicotine. They reference the Surgeon General’s claim that nicotine is “very and uniquely harmful” to the developing brain, and that vaping can impair learning and memory in those up to age 25.  Scientific evidence to support this is non-existent. In contrast, there is unequivocal evidence linking youth football and other concussion-producing sports activities to chronic traumatic encephalopathy (CTE) (here, for example).  If Congress wanted to protect children’s brains, this would be a more productive area for their focus.

Nicotine is about as safe to use as caffeine, which is also addictive, but it doesn’t cause any of the many cancers, heart attacks, strokes and emphysema that come from the toxins released from burning tobacco.

Congress wants you to believe that the increase in teen vaping will lead to a surge in young adult smoking.  But the reality is just the opposite. Cigarette smoking dropped in half among young adults between 2014 and 2018. And while vaping increased, use of both products fell during the same period. Vaping is contributing to the evaporation of smoking among young Americans.

American teenagers are engaged in lots of risky behavior — but vaping, which the prestigious British Royal College of Physicians says is 95 percent less hazardous than smoking — is not one of them.

Congress should focus on how to really keep high school students safe.

The Truth About Federal Warnings on Smokeless Tobacco Products

Cigarette smokers who are considering a switch to vastly safer smokeless tobacco are confronted with confusing government-ordered warning labels. Most would be surprised to learn that three of the four mandated warnings were fabricated by tobacco prohibitionists and codified into federal legislation in 1986 by a misinformed U.S. Congress. Despite their obvious flaws, the original warnings were re-confirmed in the 2009 Tobacco Act and a fourth was added.

Here are the underlying facts and fallacies related to the four warnings:

1. “This product can cause mouth cancer.” This warning was mandated in 1986, five years after Dr. Deborah Winn egregiously misinformed Americans about the magnitude and scope of mouth cancer risk from smokeless tobacco (discussed previously in this blog here and here). This warning is highly misleading. Contemporary American and Swedish smokeless products confer vanishingly small risk for mouth cancer. Now that the FDA has been given authority over the warnings, I hope the agency will provide comprehensive information about all health risks, as I did in this blog (here and here).

2. “This product can cause gum disease and tooth loss.” In 1986, prohibitionists were desperate to blame smokeless tobacco for causing something besides mouth cancer, but twenty-five years ago there was virtually no scientific evidence that smokeless tobacco was an independent risk factor for any dental problem. The same is true today. A comprehensive review of the subject was published by Kallischnigg and colleagues in BMC Oral Health in 2008 (available here). The risk for all dental problems is either very low or nonexistent among smokeless tobacco users.

3. “This product is not a safe alternative to cigarettes.” The purpose of this 1986 warning was to deceive smokers into believing that smokeless tobacco was just as dangerous as smoking. As I wrote in my 1995 book, For Smokers Only: How Smokeless Tobacco Can Save Your Life (link), this warning “is simply ludicrous…Not even potato chips or nature hikes are ‘safe.’ If we look at ‘safe’ to mean relatively safe or ‘safer,’ something the government warnings inanely avoid here, then use of smokeless tobacco products is far safer than cigarette smoking.”

To apply an absolute standard of safety to any product or activity is preposterous. It’s worse to use this standard to deny smokers access to life-saving smokeless products and information.

4. “Smokeless tobacco is addictive.” This was added in the 2009 legislation, and it’s the only warning with a legitimate scientific rationale. It is entirely appropriate for consumers to be warned that any product containing nicotine is addictive. But the warning also reinforces what switchers already know -- that smokeless tobacco can be a satisfying cigarette substitute precisely because it provides satisfying doses of nicotine.

Congress was misinformed in 1986, when it dictated the mouth-cancer, gum-disease and not-safe warnings for smokeless tobacco. In view of the extensive relative risk data published since then, Congress should have revised the warnings to reflect the facts, rather than just rubber-stamp them in 2009.

The FDA prides itself on being science-driven; that provides some hope that smokeless tobacco warnings will some day be appropriately and accurately revised. In the meantime, the mouth-cancer, gum-disease and not-safe warnings exaggerate and distort the vanishingly small health impact of smokeless tobacco. Medical ethics and principles of public health dictate that smokers and smokeless tobacco users should not be subject to such health-endangering deception.

Congressional Craziness: Requiring Population-Level Proof for Harm Reduction

In 2009, anti-tobacco extremists won adoption of the Tobacco Act, which is likely to effectively prohibit tobacco manufacturers from participating in tobacco harm reduction.

The Tobacco Act forbids manufacturers’ communication with consumers about the relative risks of different tobacco products. This prohibition is not limited to commercial speech (i.e., advertising); it could be applied to essentially any public statement by tobacco company scientists or executives. If a manufacturer wants to market a tobacco product as a lower-risk alternative to cigarettes, Section 911 of the law contains evidentiary requirements that are nearly impossible to fulfill, even though the product already has been proven to be safer than cigarettes.

Section 911 is aptly numbered; it will significantly extend a tragic health crisis for legions of inveterate cigarette smokers.

In order to market a smokeless product as a less harmful alternative to cigarettes, a manufacturer has to satisfy the FDA that (a) the product will “significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and (b) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.”

Is it possible to implement a clinical trial that could evidence the population benefit of safer tobacco alternatives? A recent analysis, published in Regulatory Toxicology and Pharmacology, attempts to provide an answer. The first author of the study (abstract here) was Lenn Murrelle from Altria; collaborators included statisticians and epidemiologists from consulting firms. It does not provide much hope that a clinical trial will ever be conducted.

Murrelle and colleagues start with some reasonable assumptions. First, they propose to study a very low-risk cigarette alternative such as snus. They designed the clinical trial to include four groups: continuing smokers, smokers who quit altogether, smokers who switch to snus, and nonsmokers. The latter group is important because of the Tobacco Act’s mandate to monitor possible future snus use among those who never used tobacco.

Murrelle used lung cancer as the outcome measure, which was the only practical choice. Smoking is the dominant risk factor for lung cancer, and snus use plays no role in this disease, so this maximizes the differences between continuing smokers and those who quit or switch. In fact, Murrelle assumed that the lung cancer rate among smokers who switch to snus would be the same as that among quitters.

Murrelle et al. found that a clinical trial would need to enroll 8,000 subjects (2,000 in each of the four groups) and follow them for 5 years in order to see differences in lung cancer between smokers who quit or switched to snus, and those who continued to smoke. Most clinical trials enroll a few hundred subjects at most, so 8,000 is an enormous number.

Such a trial, including 5 years of follow-up, would cost tens of millions of dollars. But that’s not the only problem. First, an ethical review board would never permit an investigator to assign a smoker to keep puffing. Challenges with the switch-to-snus group include finding an acceptable product, monitoring compliance and consumption, and determining who pays for the products. The quit-altogether group would be almost impossible to maintain, because sustained quit rates among smokers are so miserable. Finally, it would be terribly awkward to enroll people who don’t currently use tobacco, because they would have to be truthfully informed about the entire study.

The “claim” that might result would be very narrow: “Switching to this (specific) snus product could reduce your risk of lung cancer to the level of quitting tobacco altogether.” Murrelle and colleagues point out that if manufacturers want data for claims involving other diseases and/or products having smaller risk differentials than snus and lung cancer, they might have to enroll up to 10 times the number of subjects. That’s as many as 80,000!

Congress invoked this virtually unattainable population standard under the influence of tobacco prohibitionists. It is important to point out that setting such an extraordinarily high evidentiary bar is unprecedented. For example, consider the lack of such an evidentiary requirement to support the federal requirement for automobile seatbelts, another type of harm reduction. First pioneered by Swedish carmakers Saab and Volvo, (history here), seat belts were mandated by the federal government for all new automobiles starting January 1, 1968 (regulation here). While there was adequate laboratory evidence that wearing seat belts provide protection (but in rare instances slightly increase risks, similar to smokeless), there was virtually no population-level proof until this decade that seat belts actually save lives (an example).

It would have been disastrous if Congress had passed a bill in 1968 requiring population-level evidence before seat belts could be marketed for harm reduction. The same applies to smokeless tobacco.

Dissolvable Tobacco

During the past month the U.S. Congress passed landmark legislation authorizing the federal Food and Drug Administration to regulate tobacco. In classic Washington terms the bill was portrayed as saving our children from tobacco's evil grasp, although a detailed review by the American Association of Public Health Physicians concluded that it would have little effect on teen smoking rates. Senators Sherrod Brown (D-OH) and Jeff Merkley (D-OR), accused RJ Reynolds of marketing "tobacco candy" to children. The target of this attack was a new dissolvable tobacco product called Camel Orbs, which is being test marketed by Reynolds in Columbus, Indianapolis and Portland, Oregon.

Senator Brown said there is no doubt that these products "…are aimed squarely at children." His evidence: Orbs come in "mellow" and "fresh" flavors, and "are sold in containers that resemble cell phones. From a distance, the packaging and design of the individual Orbs are virtually indistinguishable from breath mints."


It is almost beyond belief that two U.S. senators would engage in an unsubstantiated and specious attack on a manufacturer who is trying to convert its consumers (and those of other cigarette manufacturers) from a product that is very hazardous (cigarettes) to one that has almost no demonstrable health risks (smokeless tobacco). Instead of challenging the senators to validate their allegations, American media reported this story with little regard for the truth.

It is clear that the senators had no substantive evidence that Reynolds is actually marketing these products to children. If they had proof, they could simply turn it over to a State Attorney General. Since the 1998 Master Settlement Agreement (MSA), tobacco manufacturers have been prohibited from directly or indirectly targeting children, and many states have an expedited process for policing and enforcing MSA provisions.

Brown was wrong on another critically important point: He called the Orbs "dangerous." In fact, there is broad scientific consensus that smokeless tobacco products are 98% safer than smoking. Unlike cigarettes, smokeless tobacco does not cause lung cancer, heart disease or emphysema. The risk for mouth cancer with smokeless is far lower than it is with cigarettes. Statistically, smokeless users have about the same risk of dying from a tobacco-related illness as automobile users have of dying in a car wreck. Apparently, the senator doesn’t understand that tobacco smoke is the real killer. Eliminate the smoke, and you eliminate nearly all the risk. I refer interested readers to my website, www.smokersonly.org, for more information.

Senators Brown and Merkley sponsored an amendment to the FDA bill that would require the new Tobacco Products Scientific Advisory Committee to immediately study the public health effects of dissolvable tobacco and report its findings to the FDA. The committee will find that the products are not marketed to children, that they satisfy adult smokers who are unwilling or unable to quit nicotine and tobacco altogether, and that they are far safer than continuing to smoke.


According to the Public Health Physicians, "the most substantial problem with this severely flawed [FDA] bill is the fact that it ignores the plight of the 45 million Americans who are current adult cigarette smokers. All of the 8 million deaths due to cigarette smoking that will occur over the next 20 years in the United States... in this group." They are not children today; they are adults, 35 years and older. Preventing youth access to tobacco is important, but that effort should never be used as a smokescreen to condemn smoking parents and grandparents to premature death.

If any other consumer product was as dangerous as cigarettes, society would demand safer alternatives, and it would be scandalous if consumers were denied them. But Senators Brown and Merkley want these products banned, which is counterproductive. Smokers in Ohio and Oregon and Indiana and every other state are literally dying for ways to step away from the fire. They deserve accurate information about safer smokeless substitutes.