– Daren Bakst, 6/5/19

Sometimes, it feels like we live in Bizarro World, where everything is the opposite of what we would expect.

Consider, for example, the regulation of e-cigarettes and other alternatives to traditional cigarettes. Those who advocate policies that would help maintain existing levels of cigarette smoking are somehow viewed as the “righteous.”

The Tobacco Control Act, which gave the Food and Drug Administration the power to regulate tobacco products, is creating major obstacles for the sale of e-cigarettes and other alternative products, thereby doing more to block cigarette smokers from quitting than allowing them to stop.

This all needs to change.

One of the leading tobacco researchers, the late Michael Russell, famously said, “People smoke for nicotine but they die from the tar.”

It’s the burning of tobacco that releases thousands of harmful chemicals. New products like e-cigarettes reflect this understanding, delivering nicotine without burning tobacco.

That doesn’t necessarily mean they are safe, but the research shows that they are less harmful than combustible cigarettes.

The liberal Left continue to push their radical agenda against American values. The good news is there is a solution. Find out more >>

In the most comprehensive government report of its kind, Public Health England described e-cigarettes in 2015 as “95% less harmful that tobacco cigarettes.”   The FDA also recognizes that these new products are less harmful than combustible cigarettes.

Yet, the FDA, through its implementation of the Tobacco Control Act, has issued regulations that will effectively put an end to many alternative products that are currently available to smokers.  Specifically, the FDA is requiring these products to go through the costly and burdensome pre-market tobacco-application process. That’s a barrier that, once enforced, will jeopardize the continued existence of many of these products.

Ironically, some e-cigarette opponents irrationally justify their dislike for the products based on a dislike of big tobacco companies.  Yet, the big tobacco companies and other big businesses are the ones that will be able to afford the costly approval process, while the many small businesses in the field will likely cease to exist.

The entire narrative and policy debate around e-cigarettes ignores the critical benefits of these products.  Instead of shouting from the mountaintops that private innovations are now available that can help reduce cigarette smoking, the FDA is using concern over youth usage of e-cigarettes as a way to demonize the products.

To be clear, the FDA should be concerned about youth usage of nicotine delivery products; nicotine is addictive and the safety of these new products still needs to be monitored.  The FDA, however, shouldn’t be using this concern as a reason to promote policies that would help maintain current levels of smoking or prevent Americans from having access to products that could save their lives. Nor should they be diverting attention from the critical importance of these alternative products.

Underlying this entire narrative is an unfortunate and arguably dangerous conflating of two very different issues: the harmful and cancer-causing effects of smoking cigarettes and the harmful effects of nicotine.  Smokers get cancer from the combustion of cigarettes, not the nicotine.

In fact, data show that about half of American adults incorrectly think nicotine is the main substance in cigarettes that causes cancer.  Further, American adults increasingly think that using e-cigarettes is as harmful or more harmful than smoking cigarettes (as high as two-thirds of adults).

This is a true crisis, arguably caused in large part by government messaging.  If cigarette smokers don’t even know that e-cigarettes are less harmful than cigarettes, then they don’t have much reason to switch.

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While both Public Health England and the National Academies of Sciences, Engineering and Medicine acknowledge that completely switching from combustible cigarettes to non-combustible products, such as e-cigarettes, exposes users to substantially less toxicants and dangerous chemicals, there remains lacking support for their use as a quitting tool. For example, NASEM’s report concludes that: “Overall, there is limited evidence that e-cigarettes may be effective aids to promote smoking cessation.” On the contrary, however, there is evidence to suggest that e-cigarettes are growing in popularity as a quit tool.

Accordingly, in an effort to further probe the role of e-cigarettes in initiating cessation and/or maintaining abstinence, Peter Hajek and colleagues developed a randomized trial to compare smoking cessation and abstinence among populations that use traditional nicotine replacement therapies (NRT) versus those who use e-cigarettes (EC).

In terms of participant selection, subjects were accepted into the study if they were currently not using any products and had no strong preference for use of either nicotine replacement therapies or electronic cigarettes as a quit method. After being accepted, participants were randomized to receive either an e-cigarette or an NRT of their choice (the nicotine patch was used by 84 percent of participants generally along with a fast-acting oral product) and asked simply to adhere to their treatment group (EC or NRT). Participants were then asked about smoking status at 4, 26 and between 26-52 weeks—52-week abstinence was biochemically verified at the final visit.

With respect to findings, overall, the e-cigarette group had significantly higher abstinence rates at all time points than those in the nicotine replacement therapy group. For example, at the conclusion of the study (52 weeks), the abstinence rate was 18 percent for those in the EC group and only 9.9 percent for those in the NRT group. At the 4-, 26- and between 26-52-week points, it was approximately 44, 35 and 21 percent for the EC group and 30, 25 and 12 percent for NRT.

Moreover, even participants in the EC group who were unable to achieve abstinence had higher rates of reduction in cigarettes smoked (biochemically verified as a 50 percent reduction or more) than those in the NRT group (12.8 vs. 7.4 percent respectively). At the conclusion of the study, participants in the EC group also had a much higher rate of treatment adherence than those in the NRT group at 39.5 and 4.3 percent respectively.

While these numbers overwhelmingly suggest that ECs have the potential to be more effective quitting tools than NRTs, some limitations in the study’s methodology suggest that their full potential as a cessation tool may not even yet be realized. For example, at four weeks, 56 percent of participants in the EC group were not abstinent and although statistically significant, the urge to smoke in the first four weeks was only marginally lower for those in the EC group versus those in the NRT group. However, this may have been an unintentional result of the study’s design. Those in the EC group, were given an initial supply that consisted of a 30 ml bottle at 18mg/ml and were then encouraged to experiment with nicotine concentrations in subsequent refills. While supplementary data indicated that most participants moved to lower and not higher concentrations as the study progressed, it stands to reason that if a higher concentration had been delivered initially, it may have prevented drop out early on.

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When Gov. Larry Hogan and the Maryland legislature took a firm stance against selling Electronic Nicotine Delivery Systems, or “ENDS,” to minors, I applauded their efforts to keep these products out of the hands of children. Minors should not vape, plain and simple.

However, vaping products are designed specifically as a healthier and safer alternative for adult smokers. Vapor provides a pathway away from cigarette addiction. These products were never intended to encourage teenagers to smoke and therefore should never be marketed towards children.

Unfortunately, regulators are also taking steps to limit access to these important smoking cessation tools for adults that need them. As an active member of the Asian-American business community in Maryland, I am deeply concerned that pending regulations will not only harm adult Marylanders attempting to quit smoking, but also cause potentially devastating effects on Maryland small businesses.

Recently, the Trump administration announced plans to restrict the sales of most flavored e-cigarettes in convenience stores, a measure that baselessly attacks law-abiding business. In addition, there is state level legislation under consideration that would cripple access to vapor products for adults throughout Maryland.

The Maryland General Assembly also passed measures further restricting access to vaping products and the city of Baltimore is considering a ban on flavored e-liquid – a tool that many former smokers credit with helping them quit smoking.

The industry is in full support of denouncing the issue of teen vaping. It’s now illegal to sell vaping products to anyone under the age of 21 in the state of Maryland and businesses that sell vaping products go to great lengths to adhere to the law. Just as identification is required to purchase tobacco products, purchasers of e-cigarette products must provide state-issued identification. Duplicating regulations that restrict adult access to these products do not bring us any closer to solving this problem.

Furthermore, sales of e-cigarette products play a vital role in the Maryland economy and enable retailers to employ more Marylanders. Reducing access to these products in stores would make them only available online, therefore hurting Maryland businesses, impacting the number of jobs available, and ultimately reducing the tax revenue brought in by our state. With regulations coming down on the industry at the federal, state and local level, we need to critically evaluate where the line is for safety and health and a knee-jerk regulatory reaction.

I urge the city of Baltimore, the state of Maryland and the Trump administration to consider these facts before advancing additional unnecessary regulatory burdens on the industry. It’s not too late for our elected officials to change course and take a stand against these misguided proposals.

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From 2017 to 2018, the use of electronic cigarettes among high school youth nearly doubled. In response to this uptick in teen vaping, Massachusetts lawmakers have introduced legislation (S1279) to ban the sale of e-cigarettes in the Commonwealth (with the exception of tobacco-flavored products) except in adult-only smoking bars. This bill would also ban the sale of menthol cigarettes. At first blush, it may appear this is strong public health legislation, guided by the principle that we want to limit youth access to an addictive product. But upon closer inspection, it’s clear this bill is about politics, not public health.

Supporters of this proposed bill purport to deem any tobacco product that is addicting large numbers of youth to be off-limits when it comes to sale in convenience stores, gas stations, pharmacies, and other retail outlets. There is one gaping exemption in the legislation, however, that undermines its entire purpose.

Legislators have carved out a huge exception for Marlboro cigarettes – the #1 brand of cigarettes used by youth smokers in Massachusetts. While most Newports, Kools, and Salems could not be sold in the state because nearly all of their sub-brands are menthol-flavored, virtually every sub-brand of Marlboro would be able to remain on store shelves that are easily accessible by minors.

If this legislation goes into effect, it will actually be easier for both youth and adults to get access to a traditional Marlboro cigarette than to a strawberry vape. Youth will quickly figure out that it is much easier for them to smoke than to track down a healthier alternative in an e-cigarette.

The last thing in the world that we should be doing is to give tobacco cigarettes a competitive advantage over fake (electronic) cigarettes, which contain nicotine but do not involve combustion and the release of toxins that are the driver of smoking-related illnesses. There is no justification for targeting e-cigarettes, a less harmful product, while leaving combustible cigarettes on the shelves.

What’s more, by choosing to ban menthol cigarettes, while leaving all other cigarettes untouched, Massachusetts lawmakers are arbitrarily picking one tobacco company over another. There is no public health rationale for singling out certain cigarette brands for a sales ban but not others – these brands are equally deadly.

In fact, the majority of youth smokers prefer non-menthol cigarettes; and the most popular brand among youth smokers is Marlboro, with Newport being a distant third. And the data on cigarette brand preferences among youth do not provide a justification for banning menthol cigarettes and giving non-menthol cigarettes a huge competitive market advantage. If lawmakers are sincere about wanting to protect kids from nicotine addiction, banning Newport sales but allowing Marlboro sales makes no sense.

Why, then, are policy makers targeting e-cigarettes, but not real ones? Why are they ignoring the fact that in 2017, there were 19,000 Massachusetts high schoolers who were current cigarette smokers and an additional 38,000 who had experimented with tobacco cigarettes? Why are they doing nothing to address the 10.3% of high school seniors who are cigarette smokers, according to the most recent data from the Massachusetts Youth Risk Behavior Survey?

Politics. Our elected officials appear not to have the political courage to take on the cigarette industry, with its powerful lobbying, but find it easy to go after a product being sold overwhelmingly by small businesses with little, if any, political influence. They appear to care about our kids only enough to take the politically expedient step of banning e-cigarettes, but not enough to take the principled step of removing from the youth market a product that we know has the potential to kill half of those kids who become addicted to it.

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The Food and Drug Administration (FDA) is actually doing too much to regulate e-cigarettes. While concern over youth use is indeed warranted, the agency’s overall strategy threatens access to e-cigarettes for adult smokers.

E-cigarettes are a great public health advance, intended for smokers who cannot or will not give up nicotine. Vapers inhale nicotine via a propylene glycol-based and/or glycerin-based aerosol estimated to be at least 95 percent less hazardous than conventional cigarettes, which burn tobacco and release carcinogens and carbon monoxide. A recent, rigorous study reported that “vaping” was twice as effective as FDA-approved nicotine replacements (patches, gum, lozenges) in helping smokers quit cigarettes for one year.

Unfortunately however, the FDA’s premarket regulations are needlessly burdensome. They require every electronic cigarette product on the market (the devices and the liquids that give them taste and vapor) to be accompanied by a separate application to the FDA showing that the product is beneficial to the public’s health.

To do this successfully, a company must show that its e-cigarette product is safer than regular cigarettes; that it helps smokers to quit; and that the above benefits won’t be outweighed by the adoption of the product by nonsmokers, including young people. To satisfy this last requirement alone — the so-called population effects — long-term clinical and epidemiological studies are likely to be required.

According to the FDA itself, the cost of processing these applications — dozens to hundreds from each company — will take more than 5,000 hours to complete and cost a minimum of $330,000 per product. This extremely high cost will almost surely limit applicants and thereby protect actual cigarettes upon which the agency, per congressional mandate, can impose no approval requirements.

A far better approach would entail product quality standards, reminiscent of the United Kingdom’s approach. A compendium of agency-issued rules should establish prudent vapor battery and electrical standards that prevent overheating of the charger, explosion, etc., along with restrictions that ban potentially harmful ingredients.

Recently, the FDA has devoted enormous attention to the rise in youth use of Juul, a vaping device. Doubtless, teen use is an unwanted development, but the agency has fomented alarm, absent meaningful evidence of harm to date (including convincing data on a net “gateway-to-smoking” effect or compromised cognitive functioning), regarding the impact of vaping on teens.

There is wide agreement that e-cigarettes should not be available to minors who do not smoke and that the government should restrict marketing to them. But the intense focus on teen use has diverted almost all attention from the importance of adult access.

Availability and product innovation for adult smokers should be encouraged. The FDA has lost perspective when it comes to the adult side of this policy challenge.

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Some lawmakers at the statehouse want to increase taxes on cigarettes to nearly $3 a pack, but a group of convenience store owners said the plan might not work as intended.

Illinois adds a $1.98-tax to each pack of cigarettes. Senate President John Cullerton said he’ll file legislation to increase the tax by a dollar, making it $2.98 a pack.

“The governor’s proposal in cigarette taxes is pretty modest,” Cullerton said.

Gov. J.B. Pritzker proposed increasing cigarette taxes by 32 cents. His administration has said that would provide $55 million in new revenue.

“We have tripled his initial request because we know from this research that we can actually affect behavior,” Cullerton said.

Bill Fleischli with the Illinois Association of Convenience Stores said behavior will be changed if the tax is increased. He said it will encourage people to shop for cigarettes and other things outside of Illinois.

“They’ll buy everything they need, they’ll make a one-stop-shop,” Fleischli said of shoppers going to other states for goods. “They’ll buy their groceries, they’ll maybe take their dry cleaning. All of those things people do on a Saturday, they will do it, and you’ll find volumes drop in the state of Illinois.”

Cullerton said he wants Illinois to be a leader and to have other states follow suit by raising their taxes.

Supporters of increasing the tax have said it will bring in more revenue for the state while encouraging people to quit smoking. To those who question that logic, Cullerton said the state will save much more than it loses in the long run by not having to cover the cost of smoking-related health problems.

There’s also an effort to hike the tax on e-cigarettes.

Smoke-Free Alternative Coalition of Illinois President Victoria Vasconcellos said it’s not fair to lump e-cigarettes, which she called harm-reduction products, in with other legacy tobacco products.

“So cigarettes kill you, vaping products help you quit smoking,” Vasconcellos said. “It doesn’t make any sense to tax someone looking for a healthier alternative.”

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Keep vaping away from kids by restricting access, direct marketing

Just because a kid can potentially gain access to something intended for adults doesn’t mean you ban that item from being sold to everyone.

That goes for cigarettes. It goes for alcohol. And now, it seems, it goes for flavored vaping products.

The Albany County Legislature is among those government entities, including the New York State Legislature, considering trying to ban flavored vaping.

The argument supporters of the ban make is commendable — that too many kids are lured to vaping and its potential harmful effects by the fanciful flavor names like moo coffee milk, circus cookie, dinner lady mango tart and unicorn poop.

They say getting rid of the flavors will discourage kids from picking up the habit.

Vaping has been associated with its own direct health problems, as well as with enticing kids into other harmful habits like smoking.

But while vaping might be bad for kids, it’s proven to be a godsend for cigarette smokers trying to kick the habit.

Smoking is a notoriously difficult habit to break. Vaping products, which either contain no nicotine or very small amounts, has proven to be an effective tool in helping many smokers to quit — more for them than nicotine patches, nicotine gum and quitting cold-turkey.

Vaping gives many smokers the sensation of smoking and fulfills the habitual allure without pumping their lungs full of cancer-causing smoke and chemicals.

Flavors help draw them away from their cigarettes to a less harmful habit. So while a ban on flavored vaping products might discourage kids from picking up vaping, it also may very well deprive some long-time smokers of an effective quitting tool.

The answer isn’t to ban the flavors; it’s to put more restrictions on access to kids.

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As a former smoker, I used to be cynical about vaping. I have now experienced firsthand just how effective flavored vapor products can be to help transition smokers away from deadly cigarettes.

I believe it is important that these safer, healthier products remain available to adult smokers throughout Illinois. I also believe action should be taken to further regulate vapor products to make sure minors cannot purchase them.

It’s important that our representatives in Springfield recognize that vapor products can be life-changing tools to help people like me quit smoking. We should set reasonable standards and regulations to protect young people while making it clear to adult smokers that vaping is a much safer and healthier alternative. These products played a crucial role in my journey to kick my smoking habit, and it’s important that other adult smokers have the same opportunity.

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San Francisco is on a bit of a banning spree. Last year, it was electric scooters. Now, the city is considering a bill to get rid of cashless stores and legislation that could effectively ban vaping. That last bit of proposed legislation hinges on the idea that we don’t yet know enough about e-cigarettes to allow them. It’s not an outright ban; it’s a proposed ban of vapes that have not undergone review by the Food and Drug Administration. But at the moment, that’s all of them.

The vaping ban is meant to “protect youth from e-cigarettes,” according to a press release put out by City Attorney Dennis Herrera, who is proposing it along with Supervisor Shamann Walton. It’s of a piece with the recent outcry over the “epidemic” of teen vaping, as outgoing FDA Commissioner Scott Gottlieb has described it (he led his agency in restricting the sale of vaping cartridges in flavors like mango and sour gummy). Worry over e-cigs has been building since research last year showed a rise in teen vaping. Juul, the only brand named in the San Francisco press release, is a bit of a phenomenon with teens: The product’s early ads featured young people, and its Urban Dictionary definition notes that the device is “commonly mistaken for a USB stick,” making it easy to conceal at school.

San Francisco is on a bit of a banning spree. Last year, it was electric scooters. Now, the city is considering a bill to get rid of cashless stores and legislation that could effectively ban vaping. That last bit of proposed legislation hinges on the idea that we don’t yet know enough about e-cigarettes to allow them. It’s not an outright ban; it’s a proposed ban of vapes that have not undergone review by the Food and Drug Administration. But at the moment, that’s all of them.

The vaping ban is meant to “protect youth from e-cigarettes,” according to a press release put out by City Attorney Dennis Herrera, who is proposing it along with Supervisor Shamann Walton. It’s of a piece with the recent outcry over the “epidemic” of teen vaping, as outgoing FDA Commissioner Scott Gottlieb has described it (he led his agency in restricting the sale of vaping cartridges in flavors like mango and sour gummy). Worry over e-cigs has been building since research last year showed a rise in teen vaping. Juul, the only brand named in the San Francisco press release, is a bit of a phenomenon with teens: The product’s early ads featured young people, and its Urban Dictionary definition notes that the device is “commonly mistaken for a USB stick,” making it easy to conceal at school.

Cutting down on teen vaping is a fine goal. Like all tobacco products, e-cigarettes cannot be sold to those under 18 years of age (though some states have upped that to 21). But calls like this one show how moral panic over teen e-cigarette use tends to obscure e-cigarettes’ potential as an essential harm reduction tool and a safer alternative to cigarettes, a known cancer causing agent.

The lawmakers behind the San Francisco proposal say they just want the FDA to move faster on evaluating e-cigarettes’ role in public health. It’s true that the FDA has not vetted e-cigarette products—but it has a plan to do so by 2022 (a deadline it pushed back for good reason, as Jacob Grier has argued in Slate). Requiring vaping to be regulated right now or else also stands in contrast to the comparatively lax requirements for cigarettes: As Herrera pointed out to me in an email, “there is no legal requirement for the FDA to conduct that type of review for traditional cigarettes, which were on the market before that law went into effect.”

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San Francisco has a decidedly selective way of policing healthy living. It curbs smoking by banning it nearly everywhere. Yet it still allows tobacco and marijuana sales, gives away syringes to addicts and wants to open drug-injection facilities. City politicians go after Big Soda with glee, but mostly stay out of the way of the more powerful alcohol lobby.

Some of those seeming contradictions make practical sense. Others do not.

This latest one is flat-out ludicrous: Embarrassed that the No. 1 vaping company is prospering on port property, city leaders are in a legal fury. The city attorney and a member of the Board of Supervisors have proposed to bar e-cigarette firms from renting city property and, more sweepingly, block the sale of e-cigarettes in the city.

The stated rationale, of course, is a concern for public health. After all, vaping companies prey on a young audience with candy-flavored offerings and a hip, streamlined device. For other users, e-cigarettes are sold as a pathway from the chemical harms of tobacco, though the danger of nicotine addiction remains.

E-cigs are no fad, with the big tobacco company Altria in December buying a 35 percent share of Juul, based on Pier 70, giving the company a value of $38 billion. This city, an ostensible temple of clean living, is home to the leading edge firm in the vaping game — and yet the proposed measures can’t chase it out of town as long as its lease runs.

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