This story is part of a partnership between MedPage Today and VICE News.
Issuing what it called a "historic rule," the Food and Drug Administration announced on Thursday that it will regulate e-cigarettes, federally prohibiting their sale to minors and requiring e-cig manufacturers to get FDA marketing authorization within three years.
The rule extends the FDA's authority to include hookah tobacco, pipe tobacco, and cigars as well, but only products introduced before February 2007 will be grandfathered into authorization. Because the e-cigarette industry developed after 2007, nearly all e-cigarettes will need to prove that they meet national standards by providing information on their design and ingredients. They will also have to carry health warnings on packaging and in advertisements.
"Today is milestone in consumer protection," FDA Commissioner Dr. Robert Califf, said during a conference call. "The actions being taken today will help the FDA prevent misleading claims by tobacco manufacturers, evaluate tobacco products and how they're made, as well as communicate potential risk."
The American Medical Association applauded the FDA's efforts and urged it to issue more regulations, specifically banning e-cigarette flavors, which have been attractive to minors, and addressing e-cigarette marketing.
"The AMA supports the FDA's new rule and its efforts to ensure the public — especially young people — is aware of and protected from these harmful products," AMA President Dr. Steven Stack said in a statement.
According to the Department of Health and Human Services, cigarettes kill more than 480,000 people in the US each year. Youth cigarette smoking has decreased in recent years, but e-cigarette use among high school students has "skyrocketed," increasing 900 percent between 2011 and 2015, the agency said in a press release, citing the National Youth Tobacco Survey.
E-cigarette manufacturers will be able to continue making and selling their products for up to two years while they submit applications and for an additional year during the application review process, but they could face enforcement action after that if they continue to operate without authorization.
Mitch Zeller, director of FDA's center for tobacco products, said that the estimated cost for the most extensive application process is "in neighborhood of several hundred thousand dollars per application."
Until now, the e-cigarette marketplace has been likened to the Wild West. The new rule prohibits the sale of e-cigarettes and all other previously unregulated tobacco products to minors, requiring vendors to card their customers. It also prohibits the sale of e-cigarettes in vending machines except in adult-only settings, and bars the distribution of free samples.
The FDA currently has more questions than answers about e-cigarettes, particularly with regard to whether they can help people quit smoking altogether and what their long-term health effects are, Zeller said. Several studies are underway to determine whether e-cig smokers continue to smoke tobacco cigarettes, for example, and whether e-cigarettes make quitting tobacco products less appealing. He noted that one study has shown that 70 percent of e-cigarette users continue to smoke cigarettes.
Zeller said that there isn't enough evidence to say whether first-time e-cigarette smokers turn to more harmful products.
Although anecdotal accounts have suggested that e-cigs have helped smokers quit, both the FDA and the US Preventive Services Task Force concluded that the available scientific literature and data don't support that claim.
"We looked long and hard at the comments on that particular issue," Zeller said, referring to the more than 135,000 public comments the agency received on its initial proposal to regulate the e-cigarette industry introduced in 2014.
The Smoke-Free Alternatives Trade Association (SFATA), the largest e-cigarette trade group in the country, said in a statement that the FDA rule "has pulled the rug out from the nine million smokers who have switched to vaping, putting them in jeopardy of turning back to smoking."
SFATA called on Congress to change the grandfather date from February 2007.
"These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers," it said. "It also limits access to the 40 million adult smokers in the US yet to make the switch to vaping and cripples a multi-billion dollar job-creating industry, the majority of which are made up of small businesses."
SFATA said it supports "science-based regulations" in the rule, such as banning sales to minors, but it cited a recent report by the Royal College of Physicians, Britain's leading physician organization, which concluded that e-cigarettes are more likely to benefit public health than to harm it. The report published last week urged cigarette smokers to switch to e-cigarettes.
Even if e-cigarettes don't contain the same harmful ingredients as cigarettes, health experts note that they contain nicotine, which is addictive, and a study published last year in the journal Environmental Health Perspectives found that flavored e-cigarette liquids contain harmful chemicals, including diacetyl, which is a known carcinogen.
Only a small number of smokeless tobacco products have submitted applications to the FDA for authorization, Zeller said, but eight were recently authorized.
Congress could alter the FDA rule via two additions, called policy riders, to the bill that is needed annually to fund the FDA. They did this in April in anticipation of the FDA's finalization of its long-awaited rule on this issue. The first would back up the 2007 grandfather date to include every product currently on the market, including e-cigarettes. The second would exempt certain cigars to the FDA rule. Riders are additions to bills that normally wouldn't pass on their own, often because they're controversial, but they can't become law unless they're signed into law by the president.
If either rider were to be enacted into law, Zeller said, it would have "an enormously adverse impact on public health and the ability of the FDA to do its job."
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