Big Tobacco vs little e-cigs

Last month, the FDA closed its comment period for its proposed regulations on e-cigarettes, cigars, and other tobacco products. The three Big Tobacco companies are among the parties submitted comment. The submission from Reynolds was particularly self-serving:

Reynolds American Inc. has fired an expected shot across the bow of small vapor cigarette manufacturers.

A Reynolds division recommended to the Food and Drug Administration in a 119-page submission that the agency ban the use of vapor electronic cigarettes.

Traditional e-cigs are battery-powered devices that heat a liquid nicotine solution in a self-contained disposable cartridge and create a vapor that is inhaled. The manufacturers have provided few flavor choices, in part in expectations that the FDA would limit flavorings as they do with combustible cigarettes.

By comparison, vapor products can feature a liquid capsule that is inserted into a cartridge, known as an open-system format. Vapors offer consumers a wider variety of flavors, included fruits and candy.

The Big Tobacco companies have invested heavily in disposable cartridge e-cigs. These compete with the more customizable, DIY devices favored by many vapers and sold by small producers. But why try to win consumers over when you can persuade the government to ban the competition instead? The FDA’s new regulations give Big Tobacco the opportunity to try that, so of course they’re taking it.

This kind of regulatory capture has been baked into the FDA’s handling of tobacco from the beginning. The initial legislation was backed and negotiated by Philip Morris, owner of Marlboro; it benefited from new marketing restrictions and barriers to entry that protect its brands from competition. The market for cigarettes has been essentially frozen in its favor since the FDA’s extremely burdensome review process went into effect in 2009.

Reynolds is trying to repeat the same trick with e-cigarettes, stoking fears of an unregulated market to protect big brands from competition. They might succeed. Meanwhile the public benefits of FDA tobacco regulation remain extremely dubious.

Previously: My own comments to the FDA are here, and more detail on the FDA’s anti-competitive tobacco regulation is in my article for Reason.


Multnomah County misleads bar owners

As a follow-up to my article in yesterday’s Oregonian about the failed attempt to include e-cigarettes in the state’s smoking ban, today I’m posting a memo Multnomah County officials have sent to local bars and restaurants. In it, they mislead business owners about the dangers of e-cigarettes, telling them:

State law does not currently prevent the use of e-cigs; however business owners are encouraged to include e-cigs in no-smoking policies. E-cigs pose serious health risks and challenges to enforcement of the Smokefree Workplace Law as it appears people are smoking indoors.

The letter then recommends that businesses include e-cigarettes in their no-smoking policies, adopt completely smokefree outdoor dining areas, and adopt a completely tobacco-free policy for their entire properties. (Here’s a PDF of the memo.)

There are valid reasons why a bar or restaurants might ban the use of e-cigs, such as the fact that some guests find them annoying. But county officials’ claim that the devices pose “serious health risks” is completely unsubstantiated. There’s not even much evidence that e-cigarettes are dangerous for users, much less for bystanders exposed to vapor secondhand.

There have been two recent studies on exposure to e-cigarettes in realistic indoor conditions. They are summarized here and here. Conclusion of the first:

… the quality and quantity of chemicals released in the environment [by vaping] are by far less harmful for the human health compared to regular tobacco cigarettes. Evaporation instead of burning, absence of several harmful chemicals from the liquids and absence of sidestream smoking from the use of the e-CIG are probable reasons for the difference in results.

And the second:

The study showed that e-cigarettes are a source of secondhand exposure to nicotine but not to combustion toxicants… Using an e-cigarette in indoor environments may involuntarily expose nonusers to nicotine but not to toxic tobacco-specific combustion products.

Even in the case of nicotine, exposure from real cigarettes was ten times higher than that from e-cigarettes.

Those are studies of indoor use. Multnomah County’s advice is to ban them outdoors too. The idea that indoor e-cigarette use could be harmful to bystanders is at least worthy of investigation, although the evidence so far is that it’s nothing to worry about. The idea that outdoor use presents serious health risks is wildly implausible.

This is yet another example of how the crusade against e-cigarettes is driven by unscientific alarmism rather than any empirical evidence of danger. County officials have shown that they have no credibility on the issue by misleading local business owners about the alleged risks.


Oregon’s war on vaping

The Oregon legislature recently failed to pass completely sensible restrictions on selling e-cigarettes to minor, an effort undermined by more extreme anti-smokers who were more intent on banning vaping in workplaces, bars, and restaurants. In today’s Oregonian, I write about lawmakers’ misguided attempt to include e-cigarettes in the smoking ban and their next proposal to impose new taxes on them. An excerpt:

I never thought I’d say this, but I’m actually getting nostalgic for the original smoking ban debate. Advocates exaggerated the dangers of secondhand smoke, but at least they made an effort to ground their views in science and demonstrate that non-smokers were being harmed.

The same cannot be said for those seeking to extend current bans to cover vaping. They’ll be the first to tell you that more study of e-cigarettes is needed. But why wait for results? They’re ready to ban first and ask questions later.

Read the whole thing here.


Two new cigarettes, now authorized for sale

This week the FDA sent out a press release boasting that its Center for Tobacco Products has finally issued a few decisions on new tobacco products:

For the first time since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the U.S. Food and Drug Administration the authority to regulate tobacco products, the agency has authorized the marketing of two new tobacco products and denied the marketing of four others through the substantial equivalence (SE) pathway. […]

“Today’s historic announcement marks an important step toward the FDA’s goal of reducing preventable disease and death caused by tobacco,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA has unprecedented responsibility to protect public health by not allowing new tobacco products under FDA’s authority to come to market without FDA review.”

To put this into context, when I wrote about the FDA in March the agency had received about 3,500 new product applications. The most reasonable interpretation of the law giving the agency authority over tobacco implies that these reviews should take only 90 days, and certainly no more than 180, yet some of these have languished in a bureaucratic quagmire for years. Issuing only six decisions since 2009, with more than 100 employees at work reviewing them, is hardly an accomplishment worthy of praise.

(If you’re wondering, Hestia Tobacco, the brand I profiled for The Atlantic, remains tied up in the review process with no end in sight.)

It’s also worth emphasizing what these approvals don’t mean. They don’t mean that these two new cigarettes are any safer than products already on the market, only that they don’t raise any new questions of health. In other words, they’re just as lethal — though no more so, we are told to believe — as other cigarettes. New cigarettes like Hestia, which by any sensible standard also raise no new questions of public health, continue to be blocked. It’s difficult to see what good is accomplished by requiring them to go through this lengthy approval process.

And in the midst of this, the future of e-cigarettes remains unclear. As I explained at The Umlaut this week, this product that is indisputably safer than real cigarettes may soon fall under the same heavy-handed regulation that has brought the tobacco industry to a standstill. If that happens, the FDA will have even less to brag about that it does today.


Who’s killing the electronic cigarette?

That’s the topic of my article for The Ümlaut, a new website published by Jerry Brito and Eli Dourado:

Since no one seriously disputes that using e-cigarettes is far safer than habitually inhaling cigarette smoke, allowing them to compete should be a no-brainer. Unfortunately, the law allows the FDA to ban new tobacco products even when they are irrefutably safer than what is already for sale. The agency evaluates applications based not only on the risk to individual users, but also on how they impact smoking cessation and initiation in the population as a whole. If the FDA decides that these effects outweigh the health benefits, it could ban e-cigarettes not because they are dangerous, but rather in spite of their safety.

I feel obliged to make one update to the story. In it I say that the nadir of fear-mongering about e-cigarettes is a doctor from the Mayo Clinic telling journalist Eli Lake that the propylene glycol used in some brands is “similar to antifreeze.” He was recently outdone by a North Carolina doctor who appeared on a local news segment to warn viewers that e-cigarette vapor could be “several thousand degrees” when it hits your lungs. The physics of this would be rather remarkable, as would e-cigarette users’ ability to endure the product if it were true. Michael Siegel has the details and you can watch the segment here.


CA bill bans sales of e-cigs to minors

A bill introduced in California would ban the sale of electronic cigarettes to minors. While it’s not clear that there are a significant number of minors buying the products anyway, nobody wants to get kids hooked on nicotine. This is a much more sensible approach than that pursued here in Oregon, where the AG is strong-arming stores to take them off shelves.

To put the issue in clearer perspective, be sure to read Jacob Sullum’s post (linked in the sidebar too) about a new study on the effects of smokeless tobacco (as in snuff and snus, not e-cigs). The conclusion:

This comparison highlights the absurdity of the main “public health” objection to promoting smokeless tobacco as a harm-reducing alternative to cigarettes. Opponents of this strategy claim to be worried that it could lead to more tobacco-related mortality in the long run if it attracts nonsmokers to smokeless tobacco. But Lee and Hamling’s numbers indicate that if a significant percentage of smokers switched to oral snuff, the tobacco-related death toll would be smaller than it is now even if every nonsmoker in America started using oral snuff too. By the professed standards of public health, which seeks to minimize morbidity and mortality, this is a no-brainer. As with the opposition to electronic cigarettes, something else is going on here: a moralistic crusade to conquer sin disguised as a scientific quest to conquer disease.

For a variety of reasons, cigarettes are by far the most dangerous form of tobacco/nicotine. Occasional pipe and cigar use, snuff, and e-cigarettes are all safer by varying degrees, but the moral crusade of public health has placed discussion of these alternatives off limits.

[Thanks to Jan for the link!]


Vapers, Birthers, what’s the difference?

Last week The Oregonian published a letter from me responding to Doug Bates’ post about a statewide ban on the sale of some e-cigarette products:

Doug Bates’ praise of Attorney General John Kroger’s negotiated ban on e-cigarette sales lacks perspective. Bates notes that trace amounts of carcinogenic nitrosamines have been found in e-cigarettes, but neglects to mention that comparable amounts are also found in FDA-approved nicotine patches and gums. More importantly, they exist in conventional tobacco at concentrations hundreds of times higher, along with dozens of other carcinogens not present in e-cigarettes. If Kroger’s ban causes consumers to revert back to smoking real cigarettes, that will be a perverse victory for public health.

Other readers wrote in with similar views and many testified that e-cigarettes have helped them quit smoking tobacco, prompting this thoughtless response from Doug:

As a footnote, I should add that last week’s posting produced quite a number of e-mails from around the country from those contending I’m a complete idiot because e-cigs are safe and actually help smokers give up tobacco. Yes, and Barack Obama was born in Kenya and his health plan is designed to kill old people.

I’m braced now for the next barrage. Bring it on . . .

I’m glad he’s braced for a barrage, but I’d rather just see him present some evidence that the trace amounts of nitrosamines in e-cigarette vapor cartridges are more dangerous than those in FDA-approved patches and gums and that smokers’ claims about using them to quit are false.

In the same post Doug admits that he’s “a bit rabid on the subject of legalized drug pushers.” That’s fine if he can back up his arguments with scientific evidence. Until then he’s not doing The Oregonian’s credibility any favors.

E-cig panic comes to Oregon


E-cig panic comes to Oregon

Via Doug Bates, resident anti-tobacco zealot at The Oregonian, comes word that Oregon Attorney General John Kroger has bullied two convenience store chains into agreements not to sell electronic cigarettes:

The Oregon Department of Justice today filed two settlements that prevent two national travel store chains from selling “electronic cigarettes” in Oregon. The action is the first of its kind in the country and prevents Oregonians from buying potentially dangerous products that the U.S. Food and Drug Administration (FDA) has yet to approve.

“When products threaten the health and safety of Oregonians, we will take action,” said Mary Williams, Deputy Attorney General. “If companies want to sell electronic cigarettes to consumers, they have to be able to prove they are safe.” […]

The settlement announced today prohibits the sale of electronic cigarettes in Oregon until they are approved by FDA, or until a court rules the FDA does not have the authority to regulate electronic cigarettes. Even if courts decide that the FDA does not have regulation authority, the settlement stipulates that electronic cigarettes may not be sold in Oregon unless there is competent and reliable scientific evidence to support the product’s safety claims. In addition, the companies must give the Attorney General advance notice that they intend to sell electronic cigarettes in Oregon, provide copies of all electronic cigarette advertising, and provide copies of the scientific studies they maintain substantiates their claims.

I’m going to go out on a limb and guess that Kroger’s office isn’t going to take an unbiased look at any evidence the chains might bring forward. And while it’s of course worthwhile to study e-cigarettes further, this ban and the panic spread by the FDA and anti-smoking groups is based upon virtually no evidence that they are dangerous. Michael Siegel has been doing his usual bang-up job putting the science in perspective:

As these data show, the level of tobacco-specific nitrosamines present in electronic cigarettes is at the trace level. It is measurable in parts per trillion (nanograms per gram). It is comparable to the nitrosamine levels in nicotine replacement products which are approved by the FDA.

In contrast, the level of tobacco-specific nitrosamines present in tobacco products are 300 to 1400 times higher. On a weight-for-weight basis, Marlboro has 1400 times higher the level of tobacco-specific nitrosamines than an electronic cigarette cartridge. And keep in mind that these represent the levels in the cartridges and cigarettes, not in the tobacco smoke or e-cigarette vapor which are directly inhaled. Because of the much higher temperatures generated in tobacco combustion compared to propylene glycol vaporization, the delivery of these carcinogens into the vapor is expected to be much lower than into the tobacco smoke.

Moreover, there are approximately 56 other carcinogens that have been identified to be present at high levels in tobacco smoke, while there are no other carcinogens that have been identified to be present in electronic cigarettes.

Siegel acknowledges that some minor steps should be taken, such as forbidding sale of e-cigarettes to children and ensuring that the diethylene glycol issue is fixed. Both of these goals are easily accomplished without banning the product entirely.

Slight alterations to e-cigarettes may make them safer. The important thing to keep in mind though is that they are already much, much safer than real cigarettes, and if e-cigs are removed from the market many of the people who buy them will go back to smoking actual tobacco. Banning what so far appears to be an effective smoking cessation device is no victory for public health.

From what I can tell, the main reason people oppose e-cigarettes is because the devices look like real cigarettes and mimic the act of smoking. Yet it’s those very qualities that may make them an effective way to quit. Nicotine habits are hard to break not only due to chemical dependence, but also because of the rituals involved. E-cigs mimic those rituals in a way that gums and patches, which also contain trace amounts of nitrosamines, cannot.

Perhaps in a perfect world there would be nothing resembling a cigarette. In the real world there are about 45 million smokers in the US, many of whom would like to quit. It’s perverse to take away one of the tools they could use to do so just because it looks like the far more dangerous product it’s meant to replace.


Saletan’s fatal conceit

Ben points me to William Saletan’s article on the FDA bill and asks what I think of it. Obviously Saletan’s far more of a paternalist than I am and thinks he knows best what people should and should not consume. The only reason he wouldn’t ban tobacco is because a black market would develop. The fact that some people want to enjoy it doesn’t even enter into his calculations.

But that aside, his take on the bill is better than most, but still too optimistic. If all we wanted was safer tobacco products we would allow the FDA to approve them based on a straightforward comparison to existing products. Instead the law requires the agency to take the much more paternalist approach of trying to predict whether the gains from safer products would be offset by more people taking up tobacco or fewer people quitting. It’s too early to tell just how this will play out, but it’s a potentially huge hurdle to the creation and marketing of safer cigarettes and alternatives.

I’m also skeptical that the FDA can optimally regulate nicotine yields. Mandating lower yields, as the FDA is now empowered to do, would cause current smokers to light up more frequently or inhale more intensely. They’d be taking in more tar and carcinogens to get the same hit of nicotine, a substance that in itself is basically harmless. The hope would be that lower yields cause fewer new smokers to become dependent and ween some smokers off the drug; I’m not comfortable with the idea of sacrificing smokers’ lives to potentially prevent others from taking up the habit.

Saletan thinks that FDA tobacco regulation will be “rational.” I disagree, and the recent uproar over e-cigarettes is an example of how regulations are more likely to play out. Michael Siegel highlighted the absurdity a couple weeks ago:

The Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, and American Lung Association have supported the legislation, about to be enacted, which asks the FDA to make cigarettes safer by removing certain of the more than 4,000 known constituents in the tobacco smoke.

At the same time, these groups have asked the FDA to ban a product (electronic cigarettes) which has already been developed and which already has eliminated all of the 4,000 known constituents in tobacco smoke, other than the nicotine.

I can’t help it, but this is the ultimate in insanity.

Why would you put your heart and soul into a a piece of legislation that, at very best, will allow the FDA to remove a few of the constituents from cigarette smoke but at the same time, demand that a product which has succeeded in removing all (but nicotine) of these constituents be immediately taken off the market?

E-cigarettes resemble smoking in appearance, threaten the market for patches and gums produced by major drug companies, and give health activist groups a new evil to rail against, but there’s no evidence whatsoever that they are harmful — certainly not more harmful than real cigarettes. In a rational regulatory environment they would not be threatened. What we have instead is a highly politicized regulatory environment, one in which the lobbying arms of drug companies, Big Tobacco, and public health groups will wield the greatest influence. Expecting good regulations to emerge from this process is, well, irrational.


Thank you, senator, for proving my point

I swear I hadn’t read this story when I wrote the previous post. Frank Lautenberg, a senator from New Jersey and a supporter of the bill giving the FDA authority over tobacco, is urging the agency to ban the sale of electronic cigarettes. For those of you who are unfamiliar with the product, e-cigarettes deliver nicotine without tobacco smoke, making them much safer than real cigarettes and a potentially useful tool for quitting smoking. Predictably, the response from government officials is to ban anything that could make the enjoyment of nicotine less dangerous. As Michael Siegel sums up the situation:

One company has a product on the market which delivers only nicotine. There are potentially serious health effects of this nicotine, especially with regards to heart disease. However, there are no other toxic chemicals and no carcinogens, so there is no risk of cancer or chronic obstructive lung disease.

Another company has a product on the market which delivers nicotine plus more than 4000 other chemicals and toxins, including over 60 proven carcinogens, and which we know kills over 400,000 people a year.

Our health groups’ response: prohibit the first company from marketing its product, but officially provide government approval of the products manufactured by the second company.

What Senator Lautenberg and the health groups are trying to do is ban a much less harmful type of cigarette but to give an official government seal of approval to the much more toxic one that we know is killing hundreds of thousands of Americans each year.

Siegel goes on to hypothesize that opposition to e-cigarettes is driven by money from pharmaceutical companies who stand to lose from competition to their nicotine gums and patches. I have thus far been skeptical of this idea, but I am beginning to find it more plausible.

In any case, this example demonstrates the dangers of allowing the FDA to control which tobacco-related products Americans may or may not legally consume.