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FDA announces rules that could upend e-cigarette industry
E-cigarettes will face new regulations by the U.S. Food and Drug Administration, including requirements that affect manufacturing, ingredient labeling and not selling the product to those under the age of 18, the agency announced today. The result is that e-cigs and the other products will now be subject to the same federal regulations as regular cigarettes. The new regulations would ban the sale of e-cigarettes to Americans under 18 and would require that many people buying them show photo identification to prove their age, measures already mandated in a number of states.
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This review process “gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users”, said the FDA in a statement. Products on the market before February 2007 will be permitted to circumvent FDA approval. When he was named to lead the FDA this year, Robert Califf, a cardiologist, said that the rules were needed and forthcoming.
E-cigarettes are battery-powered devices that turn nicotine into an inhalable liquid vapor.
A recent government-sponsored survey found that e-cigarette use among high school students has soared more than 900 percent in recent years, from 1.5 percent in 2011 to 16 percent in 2015.
E-cigarettes have grown into a $3 billion industry, as their use rises among middle- and high school students. 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. The agency’s new rules ban flavors in cigars, in another effort to prevent youth use.
The Campaign for Tobacco Free Kids president Matthew Myers called the FDA move a “critical first step”, but warned it “falls short in protecting kids from e-cigarettes”, he said in a statement. While almost all states already ban sales of e-cigarettes to minors, federal officials said they will be able to impose stiffer penalties and deploy more resources for enforcement.
The FDA said in 2014 that it would create rules whereby electronic cigarettes would have to pass a review to stay on the market.
E-cigarettes were originally touted as stepping stones for smokers on the road away from addiction, and they afford the undisputed benefit of providing the nicotine of traditional cigarettes without the attendant chemicals and tar of burning tobacco.
The rules will go into effect in three months, the FDA announcement said, and will also govern cigars and hookah products.
‘The premium cigar industry is made up of dozens of small, family-owned cigar makers, like us, along with thousands of small, independent specialty cigar stores across the country, ‘ they wrote.
But the regulations also require that e-cigarette manufactures register with the agency and put any new devices through a pre-market regulatory approval process.
However, there are other aspects to the historic federal regulations that may leave the industry suffering, as USA Today reports.
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“This would provide assurance on the safety, quality and efficacy to consumers who want to use these products as quitting aids, especially in relation to the flavorings used, which is where we know least about any inhalation risks”, Dame Sally told the Guardian, cautioning that “there continues to be a lack of evidence on the long-term use of e-cigarettes”, and they should only be used by smokers seeking to quit.