Saturday, March 31, 2018
FDA Looks At Regulating E-Cigarettes As over-the-Counter Drug
The following article appeared in the Daily Vaper on March 28th
By Steve Birr
Officials with the Food and Drug Administration (FDA) may consider regulating electronic nicotine delivery systems as over-the-counter drugs in an attempt to better monitor health impacts of the devices.
FDA Commissioner Scott Gottlieb said in an interview Wednesday that the agency is considering different regulatory options for developing technologies that help smokers quit combustible cigarettes. He said e-cigarettes could be brought “into the over-the-counter regulatory pathway, which would give us many more tools to look at both safety and benefit,” reports CNBC.
Gottlieb qualifies this statement by saying it will also allow them to “study whether or not an e-cigarette actually does promote smoking cessation.” A 2014 European Union-commissioned study showed roughly 6 million European smokers have already quit cigarettes using vaping devices.
“The FDA is evidently struggling, as do other regulators, at reconciling the views of the prohibitionists and the harm reductionists,” David Sweanor of the Center for Health Law, Policy and Ethics at the University of Ottawa told The Daily Caller News Foundation. “As has been seen on many other issues, it is an impossibility, and eventually they have to choose a side.”
While public health experts are encouraged by Gottlieb’s seeming commitment to alternative nicotine technologies, they remain wary of the overarching agenda behind the promising rhetoric.
“If the idea of regulating vaping products like pharmaceutical nicotine is to impose the sort of oversight that has so greatly constrained the nicotine replacement therapy market, the prohibitionists (and the cigarette trade) will have won. It will be impossible for vaping to ever compete with cigarettes,” Sweanor told TheDCNF. “If the goal is to facilitate a broad range of low risk alternatives to cigarettes to access the market with the backing of the FDA, while encouraging innovation and using market forces to achieve a public health revolution, we would have something as historically significant as what the agency did on food in 1906 and drugs in 1938.”
Gottlieb rescheduled the deadline for complying with a rule that lets the FDA treat vaping devices like combustible cigarettes last summer from Aug. 8, 2018 to Aug. 8, 2022, but other aspects of the regulation are already undermining the industry. Vape shops are barred from giving customers free samples and face speech restrictions regarding what they can say about the impact of the products compared to smoking.
The Pacific Legal Foundation, which is representing shops from five states, filed three lawsuits against the FDA in federal courts Jan. 30 targeting this regulation, also known as the “deeming rule.” Meanwhile, the FDA is discussing potential restrictions to flavored vapor products and caps on nicotine levels, which could significantly undermine manufacturers and consumers relying on the devices to stay off cigarettes.
Gregory Conley, president of the American Vaping Association, does not anticipate the FDA will require all vapor products to go through the over-the-counter regulatory process, but noted the agency should be focused on maximizing the potential of current alternative smoking technologies.
“It is unfortunate that Commissioner Gottlieb is not showing the same drive to lower regulatory barriers for existing consumer products that are helping adult smokers quit that he is for hypothetical products that would be produced by pharmaceutical or tobacco companies,” Conley told TheDCNF.
Research studies from around the world are proving that vaping drastically improves future health outcomes for smokers.
The American Cancer Society, which is historically critical of vaping, issued a position statement Feb. 15 on e-cigarettes that acknowledges their safety compared to combustible cigarettes and even argues medical providers should support smokers who are attempting to quit with a vaping device.
The Royal College of Physicians agrees that using e-cigarettes eliminates most of the harms attributed to smoking. The medical body also recommends vaping for patients trying to quit traditional tobacco products. Vaping eliminates up to 95 percent of the risk associated with cigarettes because the majority of cancer-causing chemicals are inhaled through smoke, according to Public Health England.
Public health experts focused on harm reduction say federal and local health regulators in the U.S., who remain adversarial towards alternative smoking technologies, could learn a lot from the approach of medical bodies in the U.K. They say vaping should be promoted as a way to reduce smoking prevalence and improve health outcomes for millions of Americans.