TIME Law

White House Softens Proposed E-Cigarette Regulations

A patron demonstrates an e-cigarette at Vape store in Chicago, April 23, 2014.
A patron demonstrates an e-cigarette at Vape store in Chicago, April 23, 2014. Nam Y. Huh—AP

The long-awaited regulations on electronic cigarettes go through a review phase before they become final.

Newly published documents show that the White House watered down restrictions on electronic cigarettes proposed by the Food and Drug Administration.

The White House’s Office of Management and Budget regularly analyzes proposed regulation for its potential economic impact. A Reuters review of the documents published in the Federal Register on Tuesday shows that the OMB weakened language detailing concerns over e-cigarettes and nixed a clause that could have been used to ban online sales.

The FDA proposed the long-awaited regulations in April, banning their sale to minors and requiring that makers of e–cigarettes register their ingredients within the next two years. The proposal also would ban “non-face-to-face sales,” which would have prohibited vending machine sales but also could have targeted online sales.

But the proposal was open to comment and review, and OMB edited that sentence to refer specifically to vending machines, Reuters reports.

The OMB’s review of the proposal aimed “to ensure that the regulations through which agencies implement policies are efficient, well-designed to achieve their objectives, and based upon the best available evidence,” spokeswoman Emily Cain told Reuters. “It is routine for agencies to make changes to their draft rules during the course of OMB review.”

[Reuters]

TIME E-Cigarettes

Snuff and E-Cigs Are Not Harmless, Say Scientists

New research casts doubt on nicotine's safety—even if you aren't smoking

New research from the American Heart Association journal Circulation shows that patients who stopped using smokeless tobacco after a heart attack had improved life expectancy—similar to that of people who quit smoking. The finding offers new information about the dangers of smokeless tobacco, the risks of which are not as well understood as cigarettes’.

“That was a big surprise for us,” said Dr. Gabriel Arefalk, lead researcher and a cardiologist at Uppsala University Hospital in Uppsala, Sweden. “For smoking, it has been known for decades now that people benefit from discontinuation, especially after having suffered a heart attack, but for snus we had no idea what to expect.”

The researchers reviewed data on 2,474 heart attack survivors under 75 in Sweden who used snus (oral snuff) from 2005 to 2009. About 675 quit. During the two years of follow-up, 69 of those who continued using snus died, compared with only 14 quitters. Based on this data, researchers determined that those who quit snus had almost half the mortality risk of those who didn’t quit, which is similar to the benefit of smoking cessation, according to a release from the American Heart Association

Dr. Arefalk, who is also a clinician, said the researchers wanted to study the problem because they didn’t know what to tell patients about the risks of using snus after a heart attack. He cautioned that the study was small and far from enough to determine a causal relationship, but added “It’s the best evidence we’ve got so far, so from our perspective at our clinic, [the advice to patients] is probably that you should discontinue all kinds of tobacco,” if you’ve had a heart attack, Dr. Arefalk told TIME.

The study is one more piece of evidence that ads to our understanding that smokeless tobacco carries its own risk. Though the study was about snus, it has implications for other kinds of nicotine delivery systems, including e-cigarettes.

The FDA is currently taking comment from experts over the next few weeks as the agency tries to determine the best rules to regulate the nascent e-cig industry, which is approaching nearly $2 billion in U.S. annual sales. And though there isn’t yet enough information or scientific research to back this up, common sense says that e-cigs, which do not burn and contain fewer chemicals than regular tobacco cigarettes, must be better for a smoker’s health. Yet, some cardiologists, as TIME learned, are reluctant to see electronic cigarettes as harm-reduction tools.

For starters, nicotine is not a benign substance, especially when it comes to cardiovascular health. As Dr. Steven Nissen, Department Chair of Cardiovascular Medicine at the Cleveland Clinic, put it, nicotine has “profound effects on the heart.” The highly addictive drug can lead to surges in heart rate, constriction in the blood vessels, and spikes in blood pressure—the very effects that heart medications are designed to counteract.

“To come up with new diabolically clever way to addict Americans to nicotine is a terrible idea,” says Dr. Nissen. “[E-cigarette companies] are pitching very hard that they can make smoking safer. [But] nicotine is an addictive drug, no matter if you smoke it or ‘aerosolize’ it. Why you would want to addict another generation to nicotine is beyond me. Public health suggests we should fight electronic cigarettes the same way we fought tobacco.”

Another concern, beyond the possible impact of nicotine, are concerns about small, potentially toxic, particles and what they can do to the sensitive cardiovascular system, says Dr. Aruni Bhatnagar, a professor of medicine at the University of Louisville and spokesperson on electronic cigarettes for the American Heart Association.

Dr. Bhatnagar is studying the toxic effects of e-cig vapor on mice. Like all doctors, he is careful to point out that we don’t know enough about these devices. But he says that wishful thinking about harm reduction could be especially problematic when it comes to cardiovascular health. The risk of cardiovascular disease for a person who smokes only 2-3 cigarettes a day is already 80 percent of the risk to a pack-a-day smoke. “Very low levels of smoke are very dangerous for cardiovascular tissues. Cancer is more linear—you have to smoke a large amount for a very long period of time to get lung cancer,” he says. “But reducing harmful levels is not going to mitigate the cardiovascular risk. That is why we are greatly concerned about e-cigarettes when it comes to the high sensitivity of cardiovascular tissues to a low level of these pollutants.”

Electronic cigarette manufacturers and their customers often point to the low levels of particles in electronic cigarette smoke as compared to the appropriate levels of air pollution determined by agencies like OSHA. But, Dr. Bhatnagar says, these claims can be misleading because the thresholds take into account the necessity of polluting the air to some degree—they aren’t an endorsement of a safe level of pollution. From a cardiovascular perspective, he says: “There is no threshold, there is no level of these particles that you can say is safe.”

For now: Smokers—and snuffers, and e-cig smokers—beware.

TIME Companies

Dutch Company Rolls Out ‘E-Joints’ Modeled After E-Cigarettes

This company is high off innovation

First e-cigarettes, now “e-joints”: the Dutch company E-Njoint B.V. is introducing a new, “100% legal” product that allows “people to enjoy a variety of flavors, relaxing, while expressing themselves in a unique way.”

Designed to look like a marijuana cigarette, the E-Njoint, as it’s called, has an image of a marijuana leaf on its tip that lights up when in use, the International Business Times reports. The fake joints don’t have nicotine or THC in them, but rather vegetable glycerin, propylene glycol and flavoring. After the E-Njoints vaporize the original contents, however, consumers can load the reusable products with liquid forms of marijuana and “vape” those — a way of getting high that’s already inspired some entrepreneurs.

“Holland is well known in the world for its tolerant and liberal attitude toward soft drugs, and the introduction of this new product clearly makes a statement,” said Menno Contant, the CEO of E-Njoint B.V., which is manufacturing 10,000 E-Njoints a day. “As long as you don’t bother or disturb other people and stay within the legal boundaries, all is well.”

[IBT]

TIME E-Cigarettes

10 New E-Cig Brands Hit the Market Every Month

A series of studies shows just how prevalent e-cigarettes are, and what that means for smokers, non-smokers and would-be smokers alike

+ READ ARTICLE

In the most comprehensive look at e-cigarettes to date, from how they are used to how they are marketed and where they are sold, researchers are surprised by how quickly the devices have taken hold worldwide.

In nine studies published in the journal Tobacco Control by the State and Community Tobacco Control Research Initiative (SCTC), scientists looked at where e-cigarettes are sold, the status of state laws regulating e-cig sales and use, and how taxes and pricing may affect the popularity of the devices, among other topics.

MORE: 5 Sketchy Things We Still Don’t Know About E-Cigarettes

When it comes to e-cig marketing, researchers found that about 10.5 new brands appear online every month, touting 242 novel flavors. “The most surprising thing was how quickly they became available across the country,” says Frank Chaloupka, a professor economics at University of Illinois and a co-author of the study. “A few years ago, they were hardly available anywhere, and by 2012, they were available in about a third of the stores we were going into.”

He and his colleagues found that at least initially, e-cigs were targeted in areas with weaker tobacco regulations, including areas with lower taxes and more lenient smoking policies in public places. E-cig makers, says Chaloupka, likely focused their early marketing strategies in areas with the greatest density of smokers.

MORE: Industry Is Winning the E-Cig Regulation Battle

That may be shifting, however, as the latest data suggests that e-cigarettes are now marketed more heavily in higher income communities, and less so in lower income neighborhoods, which traditionally have higher proportions of smokers. That may be because e-cig manufacturers are promoting claims that their products are safer than traditional cigarettes and are also hoping to capture those who may turn to their devices to help them quit smoking. “Groups that are more likely to switch to e-cigarettes in the long run are more interested in the health benefits, and tend to be more highly educated and have higher incomes” says Chaloupka.

That’s supported by evidence from some of the other studies in the series; scientists led by researchers at Harvard University’s School of Public Health conducted the largest study of e-cig use in Europe and found that the bulk of users were young smokers who had tried to kick the habit in the past year. These smokers were twice as likely to try e-cigs as smokers who hadn’t tried to quit.

MORE: Here’s Why Bacteria Like E-Cigs

On the one hand, the quick penetration of e-cigs into nearly every retail outlet, from pharmacies to convenience stores, grocery stores and gas stations may help more smokers to try the devices and try to quit. On the other hand, the ubiquity of the devices, and the unsubstantiated claims about their safety over regular cigarettes, may lead younger smokers to try them and potentially serve as a gateway to tobacco-based cigarettes. “Just the fact that their availability increased so rapidly means that people, especially kids, may see them a lot more in the stores they go into, and perceive them as normative, and that could by contributing to the big increases in use that we are now seeing,” says Chaloupka. The percentage of teens who have ever tried e-cigarettes doubled from 3.3% in 2011 to nearly 7% in just one year, according to the latest data from the Centers for Disease Control and Prevention.

The Food and Drug Administration recently announced its intention to regulate e-cigarettes as tobacco products; although they don’t contain tobacco, the agency says the devices meet the “statutory definition of a tobacco product.” As such, the FDA wants to ban sales to minors, require health warnings and keep e-cigs out of vending machines. The proposal is up for public comment until July, and may take another year before they become enforceable. In the meantime, 34 states have laws addressing e-cigs, but primarily to prevent minors from buying them and to ensure they don’t violate existing smoke-free air laws.

MORE: The Future of Smoking

The safety of e-cigarettes isn’t clear yet, despite claims by some manufacturers that they are less dangerous than traditional cigarettes. While they don’t envelop smokers in the carcinogenic smoke emitted by burning tobacco, they do contain other compounds such as propylene glycol, which the FDA is still studying for its health effects.

Your browser, Internet Explorer 8 or below, is out of date. It has known security flaws and may not display all features of this and other websites.

Learn how to update your browser
Follow

Get every new post delivered to your Inbox.

Join 46,421 other followers