FDA Moves to Regulate E-Cigarettes

Published May 15, 2015

The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would extend the agency’s tobacco authority to cover additional products that meet the legal definition of a tobacco product, such as e-cigarettes.

At present, only e-cigarettes that are marketed for therapeutic purposes are regulated by the FDA Center for Drug Evaluation and Research. The FDA Center for Tobacco Products currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.

Dr. Stephen Ostroff, the acting head of FDA who was appointed in April, says strengthening e-cigarette regulations is one of his top priorities because new federal data show the use of e-cigarettes among middle and high school students has tripled over the past year.

Before FDA can regulate e-cigarettes the same as it does other tobacco products, it must first send a “deeming regulation” to the Office of Management and Budget (OMB) for review. It usually takes two months for OMB to hold meetings and assess the consequences of proposed final regulations.

E-cigarettes are devices that heat liquid nicotine in a disposable cartridge, creating a vapor the user inhales. There is no burning of tobacco and no secondhand smoke. The devices have been widely touted as successful smoking cessation products by many scientists and doctors.

‘Safer Alternative to Smoking’

Devon Herrick, a senior fellow with the National Center for Policy Analysis, says the concept of a nicotine substitute for smoking dates back to the 1960s, when a Swedish scientist heard about flight crews and submariners switching to smokeless tobacco when they could not smoke. 

“Since that time, nicotine replacement therapy has been shown to benefit smokers wanting to quit,” said Herrick. “It seems odd then the FDA is rushing to put the kibosh on a safer alternative to smoking.”

FDA’s push to regulate e-cigarettes may invite unintended health consequences, says Gennady Stolyarov, editor-in-chief of The Rational Argumentator. Although many nonsmokers have absolutely no attraction to e-cigs or tobacco products of any sort, for some individuals, e-cigs may work as a substitute for traditional tobacco products or as a part of a transitional approach toward the cessation of smoking.

E-cigs lack the high levels of more than 40 carcinogenic byproducts found in traditional tobacco smoke, and they also minimize the harm caused by secondhand smoke, says Stolyarov. If somebody wishes to smoke, it is better for that person’s health and the health of others if the person smokes an e-cigarette.

Concerns About Young People

Many advocates of greater regulation and higher taxes on e-cigarettes say they are concerned young people are using the products and may eventually transition to using more harmful tobacco products, but Stolyarov says these claims are largely unfounded and that additional regulations will not solve that problem.

“It is well-known many teenagers under the age of 18 will find ways to access tobacco products in spite of existing prohibitions,” said Stolyarov.

“Furthermore, if [an e-cigarette] black market … for young people emerges, that market would be characterized by much less transparency in the composition of e-cigarette products, thereby putting the safety of young people at risk, as well as all of the perils of physical violence and cultural degeneration that black markets … have produced throughout history,” Stolyarov said.

Cleaner Than a Prius

Since e-cigarettes emit water vapor, it’s not clear what the federal agency will be regulating, says Seton Motley, president of the public policy organization Less Government.

“This is absurd,” Motley said. “Either they’re ignorant and don’t know it’s not tobacco, which means they’re colossal fools, or they know and don’t care and are using this as an excuse to gather more power.

“The tailpipe of your average [Toyota] Prius emits more water vapor than an e-cigarette,” Motley said. “Maybe the FDA needs to regulate them as well?”

Matthew Glans ([email protected]) is a senior policy analyst at The Heartland Institute.