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Monday, April 28, 2014

FDA to announce long-awaited regulations on e-cigarettes, other tobacco products.

Today the FDA is set to announce “sweeping” regulations for electronic cigarettes, news which generated heavy coverage across print and web media, with at least three major papers featuring the story on their front page. Beyond e-cigarettes, some sources also note that the FDA has also proposed new rules on cigars and other tobacco products that are less heavily regulated like shisha and pipe tobacco. The main proposals in the Federal rules include banning the sale of e-cigarettes and cigars to minors, especially on the Internet, and also requiring e-cigarette and cigar makers to disclose to FDA the list of ingredients used in their products. At the same time, the new rules do not ban any flavors in e-cigarettes or cigars, as this would require FDA to quantify how flavoring introduces children to smoking or e-cigarette use, and also do not affect e-cigarette marketing for the most part.
        In a front-page story, the New York Times (4/24, A1, Tavernise, Subscription Publication) reports that the FDA’s new rule proposals will “extend its regulatory authority” to e-cigarettes “for the first time” in an environment where the “popular” devices have exploded “into a multibillion-dollar business with virtually no federal oversight or protections for American consumers.” The article notes that the new rules “will take at least another year” before coming into effect, but could be held up by litigation. The FDA Center for Tobacco Products Director Mitchell Zeller comments in the article on the agency’s accommodation of flavors, saying that “You can’t get to the flavors until you have regulatory authority over them,” further noting that FDA’s regulatory blueprint is “foundational.” The article also mentions how industry observers have “cautioned that too high a regulatory bar could stifle smaller e-cigarette producers and help deep-pocketed tobacco companies.”
        The Wall Street Journal (4/24, Burton, Esterl, Subscription Publication) reports that the blueprint of regulations is far less restrictive than rules on traditional cigarettes, but consumer groups are supporting the rules for their protections for consumers with respect to Federal monitoring of the ingredients used in e-cigarette liquids. FDA Commissioner Margaret Hamburg calls the regulations an important step in the FDA’s history and for the national interest of public health, saying that the agency is concerned with children having access to both e-cigarettes and flavored cigars.
        Reuters (4/24, Clarke) reports that warnings will be required on e-cigarettes noting that nicotine is an addictive drug but stipulate no further warnings related to health. In advertising, furthermore, e-cigarette companies cannot claim their products as a healthy alternative to smoking. There is a 75-day period of public comment on the FDA’s collection of proposals.
        On its front page, the Washington Post (4/24, A1, Dennis) reports that rules limiting e-cigarette flavors “might come eventually,” but the FDA will first have to have “more rigorous research” proving “a scientific basis for tougher rules.” Like many of the other articles, the Washington Post notes that big tobacco companies have been entering the e-cigarette market.
        The Los Angeles Times (4/24, A1, Clozel) reports on its front page that “in addition to concern about the effect on users, opponents of” e-cigarettes “have warned about secondary risks, particularly from the liquid nicotine that consumers can buy to refill some devices.” Over “the last few years, poison centers across the country have reported a sharp increase in nicotine poisoning, particularly of small children.”
        CNN (4/24, Young) quotes Hamburg as saying, “It’s really the wild, wild west out there.” She added that “e-cigarettes are increasingly in the marketplace. They’re coming in different sizes, shapes and flavors in terms of the nicotine in them, and there’s very worrisome data that show that young people in particular are starting to take up e-cigarettes, especially the flavored ones and that might be a gateway to other harmful tobacco products.”
        Bloomberg News (4/24, Edney) reports that “the industry may choose to sue the FDA to fight the proposal,” but “Zeller said he’s confident the agency would be able to back up their regulatory attempt with science.”
        FDA is expected to release its proposed rules at 9 a.m. EST today. Among the outlets also reporting are USA Today (4/24, Koch),NBC News (4/24, Fox) online, the AP (4/24, Felberbaum), Politico (4/24, Villacorta), the New York Daily News (4/24, O'Connor), and theNPR (4/24, Stein) “Shots” blog.

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