‘Vaping Congressman’ introduces bill to ease FDA’s e-cigarette restrictions

April 29--Rep. Duncan Hunter, a prominent advocate of using e-cigarettes for smoking cessation, has introduced legislation to ease impending federal restrictions on vaping products.

The Cigarette Smoking Reduction and Electronic Vapor Alternatives Act, numbered H.R.2194, rejects the policy of the Food and Drug Administration that deems e-cigarettes as tobacco products. Vaping liquids don't contain tobacco, and may not even contain nicotine.

The "deeming regulation" is now being phased in, taking full effect on Aug. 8, 2018.

The bill establishes a separate category for e-cigarettes, and amends the Tobacco Control Act to include tobacco reduction strategies as part of American policy.

Vaping's potential benefit or harm is fiercely debated. Advocates say it provides an exit for millions of smokers who couldn't stop any other way. Hunter is a former smoker who credits vaping to helping him quit. Detractors say vaping introduces a new health risk of unknown proportions.

Hunter's bill lifts requirements for FDA certification of each individual product.

Vaping industry advocates say certifications would cost hundreds of thousands of dollars per individual product, putting small and medium-sized vaping companies out of business. Only the big tobacco companies, whose main products are not e-cigarettes, could survive. It would also benefit sellers of nicotine patches, gum and other smoking cessation therapies.

By introducing standards, the bill will also make vaping safer, Hunter said.

"The liquids will have standards. The atomizers and the coils will have standards," the San Diego County Republican said. "You're going to have the same kind of standards that you have when you buy lithium-ion batteries."

Vaping liquids will have to be prepared in dedicated rooms with specified safety and hygienic standards, said Hunter, who represents the 50th Congressional District.

The FDA's "deeming" rule was imposed under the administration of former president Barack Obama. Vaping advocates have voiced hope that President Donald Trump will be more sympathetic to vaping.

Vapers were recently encouraged by Trump's firing of former Surgeon General Vivek Murthy, a vaping foe.

And Trump's pick to head the FDA, Scott Gottlieb, is friendly enough to vaping to have served on the board of an e-cigarette company. Vaping opponents say that's a conflict of interest, although Gottlieb no longer sits on the board.

Hunter is a Trump supporter. Early last year, he created a stir in a House committee by briefly vaping and discussing the benefits he sees in it.

Alternatives

Molly Sylvester, owner of Vapin' the 619 with locations in El Cajon and Clairement, said her businesses can work with the regulations. These include separate sinks, food-grades areas to prepare the juices, wearing hair coverings and laboratory clothes in the room, and other common safety standards.

"That's something that is doable," Sylvester said.

If the FDA rules aren't changed, Sylvester said she'd have to go out of business.

"If it goes through as-is, it's going to shut us down."

Vapers have organized to influence the debate. It's not difficult to find personal testimonials from vapers who say e-cigarettes helped them quit smoking. A recent movie, "A Billion Lives," describes vaping as a potential lifesaver for the billion people projected to die of smoking-related illnesses.

Gregory Conley, president of the American Vaping Association, said he liked the bill's intent, but another alternative may be more practical. That's the Cole-Bishop amendment, which exempts nearly all existing vaping products from the FDA's deeming rules.

Currently, the FDA's rules have a predicate date giving it authority over all vaping products introduced since Feb. 15, 2007, or virtually all vaping products on the market.

The Cole-Bishop Amendment, by Reps. Tom Cole (R-OK) and Sanford Bishop (D-GA), allows the FDA to exert authority over vaping products introduced since Aug. 8, 2016.

Vaping makers would still have to file with the FDA to list their products' ingredients and comply with general standards, without the great expense under the current regulation.

"It would be a way to avoid 99.9 percent of products being banned on Aug. 8, 2018," he said.

Regarding the Hunter bill, Conley said the existing state of politics at the federal level makes it difficult to get new legislation passed.

"The last year Harry Reid was Majority Leader of the Senate, they passed something like 70 bills, and most of them were renaming post offices," Conley said. "I don't believe the situation has gotten much better since Republicans took control of the Senate."

"I certainly would like to see this bill become law," Conley said. "But in all likelihood, this is a bill that is going to be a great conversation-starter to talk about where we should go in the future," Conley said.

E-cigarette proponent Michael Siegel called Hunter's bill "a major embarrassment to the FDA" in a post on his blog.

"This is critical and much-needed legislation that would put an end to the lunacy going on with the current regulation by the FDA of cigarettes and e-cigarettes," Siegel wrote.

Harm reduction -- another approach to cigarettes

The FDA and many other U.S. public health agencies condemn e-cigarettes as a dangerous lure to nonsmokers that add their own dangers. Hunter's legislation adopts the prevailing policy in the United Kingdom, which treats e-cigarettes as a useful tool in reducing harm from tobacco smoking.

Hunter's bill mentions a 2015 report from Public Health England that estimated e-cigarettes to carry only about 5 percent of the risk of cigarettes.

There's numerous studies that indicate potential harm from e-cigarettes. Preliminary research indicates e-cigarette vapor could possibly lower resistance to the superbug MRSA, cause heart damage, and introduce flavorings with potentially damaging effects, such as cinnamon -- a claim that is strongly disputed.

However, none of these dangers have actually been demonstrated in people; they are inferences from animal studies and short-term research. Since e-cigarettes have been popular for scarcely a decade, there hasn't been enough time to document any long-term effects, or the lack of.

Other studies point to health benefits of switching from cigarettes to vaping, such as greatly reduced exposure to carcinogens and other harmful substances.

Meanwhile, the great health hazard from cigarette smoking has been well established over decades of intensive research.

But in the absence of rigorous studies documenting the ability of vaping to stop smoking, academic researchers are wary. That frustrates vapers, who say tobacco companies benefit from this attitude.

Harm reduction has been used in other areas of public health, such as the needle exchange programs for intravenous drug users. It's not an explicit endorsement of the use, but a practical attempt to deal with the reality that those who engage in dangerous behaviors often don't quit.

Nicotine isn't the most harmful substance in tobacco; in fact it is being studied for therapeutic uses, including cognitive impairment such as that caused by Alzheimer's disease. And it's used in approved therapies such as nicotine gum, lozenges and patches.

This harm reduction strategy assumes that smokers who quit in favor of e-cigarettes are replacing that habit with one that is less harmful overall. Exactly how much harm is in e-cigarettes isn't clear. Lung specialists say it isn't a good idea to inhale anything into your lungs other than air, except for necessary medications.

Varying views

Tobacco researchers are all over the map on e-cigarettes. Stanton Glantz, a prominent foe of smoking and strong opponent of e-cigarettes, says vaping incurs substantial dangers.

Michael Siegel, the e-cigarette supporter, says the risks are very low, especially in comparison to the dangers of smoking. Public health campaigns that portray e-cigarettes as dangerous may discourage smokers from using them to quit, he says.

Health professionals generally say its's difficult to believe e-cigarettes could be as dangerous as cigarette smoking. However, there's also concern that e-cigarettes are being portrayed as a safe habit, attracting those who wouldn't dream of smoking because of its known dangers.

Glantz has said it's probable that e-cigarette use presents the same risk of heart problems as smoking, but a lower risk of cancer. However, those who vape and smoke are probably increasing their overall risk.

For more pro-vaping information, visit the American Vaping Association.

For more anti-vaping information, visit Still Blowing Smoke, a website from the California Department of Public Health.

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