In a landmark move, the U.S. Food and Drug Administration passed the first federal measure regulating e-cigarettes and the vaping industry on Thursday. The new ruling will go into effect in 90 days.
On the surface, the ruling, which was finalized today, bans the sale of e-cigarettes, cigars, pipe tobacco, and hookah tobacco to people under the age of 18 in line with current cigarette regulations. The FDA says this is aimed at preventing a new generation of minors from getting addicted to nicotine. In practice, the category “tobacco product” has now controversially been expanded to include e-cigarettes and vaping pens, smokeless electronic devices that vaporize flavored liquids called e-juice, which contain nicotine, that is then inhaled in a process called “vaping.” Vaping has exploded in popularity in recent years and is now a $3 billion industry.
However, there are other aspects to the historic federal regulations that may leave the industry suffering, as USA Today reports. Under the new rules, the FDA will need to approve all e-cigs and vaping devices that hit stores after February 2007. Since the vaping industry was virtually nonexistent before that date, this would essentially mean all vaping devices.
“The Tobacco Control Act of 2009 sets Feb. 15, 2007, as the latest date by which all tobacco products would have to have to be grandfathered in. Mitch Zeller, head of the FDA’s Center for Tobacco Products, has said publicly that he couldn’t choose a later date, although industry officials disagree. That means nearly every e-cigarette on the market — and every different flavor and nicotine level — would require a separate application for federal approval. Each application could cost $1 million or more, says Jeff Stier, an e-cigarette advocate with the National Center for Public Policy Research and industry officials.”
An amendment is currently in the House that would change the date so that more e-cigarettes would be “grandfathered in,” as USA Today noted.
The new FDA regulations were highly anticipated and have been in the works ever since they were proposed in April 2014. The agency said these products must submit applications for review and approval, submit a list of ingredients, and place health warnings prominently on all product packaging. The industry will have two years to comply and may continue to sell their products for another year while under review, but stores will have to comply with the rule in three months. Mitch Zeller, the head of the FDA’s Center for Tobacco Products, says that enforcement will be ready “on day 91.”
WHNT News reported that the FDA’s control will also extend to “the ‘parts’ and ‘components’ of tobacco. For e-cigarettes, that would include e-liquids, atomizers, batteries, flavors, vials that contain e-liquids and programmable software.”
E-cigarette use has increased enormously in recent years, which has raised questions about the possible health concerns with vaping and caught the attention of the federal government. According to the U.S. Centers for Disease Control and Prevention (CDC), three million American teens used e-cigs in 2015, and their use among high school students increased from 1.5 percent in 2011 to 16 percent in 2015. The agency estimates that e-cigs are now the most commonly used “tobacco product” among youth.
Ellen Hahn, a professor at the University of Kentucky College of Nursing and co-chair of the UK Tobacco-free Task Force, told USA Today that she believed the new rule is an important first step in controlling e-cigarettes.
“From a health perspective, to reduce the social acceptance of them is good because frankly, it’s the wild, wild West out there,” she said. “Vape stores are everywhere.”
However, the same report indicates that not everyone is happy with the new regulations.
“Industry experts say treating e-cigarettes, which don’t contain tobacco, the same as cigarettes could lead to such onerous and costly approval that all but the largest tobacco companies would be forced out of the market — and possibly those companies too. Zeller says he expects consolidation in the number and type of products and vape shops.”
Electronic cigarettes were invented in 2003 by 52-year-old Beijing pharmacist Hon Lik, himself a three-pack-a-day smoker, after his father died of lung cancer following years of heavy smoking. By 2007, vaping devices were marketed in Europe and the United States as a less harmful alternative to smoking.
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