Critics Say FDA Out to Ruin the E-Cigarette Industry

Published April 29, 2014

E-cigarettes have no tobacco smoke but that hasn’t stopped the Food and Drug Administration from proposing rules to treat e-cigarettes much like tobacco-based cigarettes. The draft regulations also cover cigars, pipe tobacco and other tobacco products that have not been regulated like cigarettes.

Those in the e-cigarettes industry are none too happy about the proposal, which gave the public just 75 days to comment. Some independent tobacco policy researchers and policy experts also have complaints.

“The FDA is overreaching as they always do. They’re doing this to benefit Big Pharma. They leave nicotine strength out [of the proposed rules], and everyone knows toxicity depends on the amount. This is going to be a nasty battle I hoped to avoid,” said Ray Story, chief executive of the Tobacco Vapor Electronic Cigarette Association and former chief executive of Smoking Everywhere, a Florida-based e-cigarettes company.

‘Biased Toward Big Pharma’

“The sad part about it is when we look at the FDA and their past, we know we’re going to have an issue because they’re biased toward Big Pharma,” Story said. Sales of nicotene gums, patches, lozenges and other quit-smoking pharmaceuticals have been falling as e-cigarettes have risen in popularity.

Story added producers of medical marijuana do not have to jump through the regulatory hoops through which e-cigarette makers would have to jump under the FDA proposal. He said this is “because they [the FDA] control the field already. They’re not okay with e-cigarettes because they don’t have control over the manufacturing process.”

He said the FDA could end up ruining the industry. FDA officials say they their proposal is due to safety concerns.

“The proposed rules would give the FDA additional tools to protect the public health in today’s rapidly evolving tobacco marketplace, including the review of new tobacco products and their health-related claims,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a statement.

Heavy Reporting, Sales Ban

E-cigarette companies would have to register with the FDA and submit detailed lists of all ingredients and descriptions of manufacturing procedures. The rules also call for a ban on e-cigarettes sales to minors.

Manufacturers bill e-cigarettes as a safer alternative to actual cigarettes because no smoke is inhaled. Instead, a small battery powers a heater that heats a mixture of nicotine, flavorings and water into vapor. Many people who want to quit smoking are turning to e-cigarettes to wean themselves off tobacco, which has numerous substances that can harm health if inhaled.

Dr. Gilbert Ross is executive director and medical director of the American Council on Science and Health. “For America’s 44 million smokers, most of whom want to quit yet cannot with the currently available FDA-approved products, the continued availability of electronic cigarettes is reassuring, as this method provides addicted smokers with their best chance of quitting,” he said.

‘Not Based on Sound Science’

He also said the rules “will stifle innovation in the e-cigarette marketplace. They are unduly onerous and are not based on sound science, requiring 99 percent of the current products to apply for FDA approval. Many smaller e-cig companies will either go under or seek ‘protection’ from the major tobacco companies” via buyout or takeover.

Ross said the big winner from the regulations would be Big Tobacco “by either absorbing small companies unable to bear the FDA approval expense, or just by waiting it out.”

Greg Conley, a research fellow in tobacco policy for The Heartland Institute, said: “By requiring the manufacturer of every single electronic cigarette product on the market to file a ‘new tobacco product’ application, the FDA has all but guaranteed the closure of tens or hundreds of small and medium-sized businesses that have no connection to Big Tobacco. The FDA estimates that just one application will require over 5,000 man-hours to complete, meaning that the true cost of a single application is likely in the millions.”