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HEALTHLINE NEWS

Legal Loophole a Matter of Survival for E-Cigarette Companies

Congress begins debate next week on whether to approve an amendment that would help ‘grandfather’ e-cigarettes and save vaping companies millions of dollars.

e-cig loophole

Are e-cigarettes an effective way to ease lifelong smokers off conventional cigarettes?

Or do they present a dangerous temptation to youth who might not otherwise have started smoking?

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It’s a question science has not yet answered, but the Food and Drug Administration (FDA) isn’t waiting until all the research is in before tightening regulations on the increasingly popular product.

Read More: Does Switching to E-Cigarettes Make Your Body Any Healthier? »

Not Your Grandfather’s Cigarettes

The FDA proposed regulations on e-cigarettes, vaping products, cigars, water pipes, and nicotine gel, in April 2014. That was about five years after it first won authority over tobacco products in the Tobacco Control Act.

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In the ensuing two-year grace period, a provision that would change the enactment date of an important “grandfather clause” was added to last year’s FDA budget, which would allow e-cigarette manufacturers to take advantage of a legal loophole. But Democrats scrapped that amendment before the final budget passed in December.

On April 29, the House Appropriations Committee approved an amendment to the 2017 federal agricultural bill approving that clause. The bill still needs approval from the full House.

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The amendment is essential to ensuring the survival of the vaping industry, which is primarily composed of small businesses, according to Gregory Conley, president of the American Vaping Association.

Without this policy rider, thousands of small businesses will close and a new era of prohibition will begin for vapor products.
Gregory Conley, American Vaping Association

“Without this policy rider, thousands of small businesses will close and a new era of prohibition will begin for vapor products,” Conley told Healthline.

Currently, the Tobacco Control Act says that any new tobacco product introduced after February 15, 2007 “must provide scientific data to demonstrate that the new tobacco product is beneficial to the population as a whole including users and nonusers.”

Such an investigation can cost several million dollars per product, Conley says, a price tag that small vaping companies cannot afford.

Since the law waives this requirement for any new product that is “substantially equivalent” to a pre-2007 product, it doesn’t apply to most new conventional tobacco products. However, few e-cigarettes were on the market before 2007, so most would have to go through the approval process.

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E-cigarette and vaping proponents want to change the date from 2007 to whatever day the regulation actually goes into effect, probably sometime later this year. That would make many e-cigarette and vaping products eligible to be “grandfathered” in.

Read More: Teen E-Cigarette Use Linked to Breathing Problems »

To Regulate or Not Regulate?

Last January, the American Society of Clinical Oncology and the American Association for Cancer Research published a joint press release supporting FDA regulation of e-cigarettes.

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“As a physician scientist who treats patients with cancer, I am concerned about the delayed time course that’s needed to assess the adverse impacts of Electronic Nicotine Delivery Systems (ENDS) use,” wrote Carlos L. Arteaga, a professor of medicine at Vanderbilt University.

“Therefore, although we call for additional research to determine with certainty the potential negative public health consequences of these products, particularly in youth, we cannot afford to wait to take prudent steps to stop those under 18 from using e-cigarettes. This is especially important since e-cigarette use is growing fast among this age group, as reported in the most recent National Youth Tobacco Survey.”

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electronic cigarettes loophole

However, Conley points to data from the Centers for Disease Control (CDC) that show conventional smoking is on the decline in teenagers and preteens, and that teenagers who vape tend to do so less frequently than teenagers who smoke.

Clive Bates, a policy consultant who keeps a blog about tobacco and other topics, is also skeptical that vaping is necessarily a bad thing for kids.

“It is no surprise that young people both vape and smoke — the same ‘risk factors’ (parental smoking, educational attainment, rebellious nature, etc.) predict for both behaviors given the similarities (other than the radical difference in harm),” Bates wrote in his blog. “If first-time vapers are vaping instead of smoking first, then that’s a good thing.”

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Read More: Teens Using E-Cigarette Devices to Smoke Marijuana »

Are E-Cigarettes Helpful?

In an email to Healthline, FDA spokesperson Michael Felberbaum conceded that e-cigarettes and vaping products might have potential to benefit public health.

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“If e-cigarettes have reduced toxicity, help smokers quit, or do not introduce adolescents to tobacco use, they may have the potential to reduce disease and death,” he wrote. “However, if e-cigarettes prompt young people to start using them separately or with other conventional tobacco products, or discourage or delay quitting tobacco use, then the public health impact could be negative.”

Proponents say that because e-cigarettes contain little or no tobacco, don’t burn, and are composed of relatively few ingredients, common sense dictates that they are less harmful than conventional cigarettes.

But the scientific research to back that up doesn’t quite exist yet.

A 2013 review found that “very little rigorous research has been done regarding the effects these devices have on human health.”

The studies that do exist are mixed. According to some, e-cigarettes do seem to contain fewer carcinogens than conventional cigarettes. However, a study conducted last year found the products give off high levels of the carcinogens formaldehyde and acetaldehyde.

There is also evidence that some contain a higher concentration of nicotine than they advertise.

Nicotine can be toxic in high doses, the review authors wrote, noting the potential tragedy of a child ingesting a vial of the e-cigarette liquid. 

And while some studies suggest that e-cigarettes can be an effective anti-smoking tool, others have found the opposite.

“We need studies that, for example, test e-cigarettes against current stop smoking aids (e.g. nicotine replacement therapy) or studies that examine the effect of e-cigarettes added to standard treatments versus standard treatments alone,” Hayden McRobbie, a tobacco researcher at the Queen Mary University of London, told Healthline in an email.

Conley says that changing the date and therefore the requirement that e-cigarettes undergo extensive review before sale does not mean the products won’t be regulated. 

“The FDA will be free to set rigorous product standards and require disclosure of all ingredients in products already on the market,” Conley noted. “The FDA just won't be free to set technology back a decade by banning these smoke-free and tobacco-free technology products.” 

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