FDA offering new rules for e-cigarette oversight

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WASHINGTON -- The Food and Drug Administration will propose sweeping new rules today that for the first time would extend its regulatory authority from cigarettes to electronic cigarettes, popular nicotine delivery devices that have grown into a multibillion-dollar business with virtually no federal oversight or protections for U.S. consumers.

The regulatory blueprint -- with broad implications for public health, the tobacco industry and the nation's 42 million smokers -- would also cover pipe tobacco and cigars, tobacco products that have long slid under the regulatory radar and whose use has risen sharply in recent years.

The new regulations would ban the sale of e-cigarettes, cigars and pipe tobacco to Americans under 18, and would require that people buying them show photo identification to prove their age -- measures already mandated in a number of states.

Once finalized, the regulations will establish oversight of what has been a market free-for-all of products, including vials of liquid nicotine of varying quality and unknown provenance.

It has taken the FDA four years since Congress passed a major tobacco-control law in 2009 to get to this stage, and federal officials and advocates say it will take at least another year for the new rules to take effect -- and possibly significantly longer if affected companies sue to block them.

Today's release of the blueprint, hundreds of pages long, is sure to set off frantic lobbying in Washington, as affected industries try to head off the costliest, most restrictive regulations.

Members of the Smoke Free Alternatives Trade Association, one of the e-cigarette industry trade groups, descended on Washington in November, and reported holding nearly 50 meetings with congressional officials to help them "learn more about the negative impact inappropriate regulation could have on this nascent industry," the group said in a statement.

The industry has several trade associations, and some have met with Obama administration officials about the regulations over the past several months, according to public records and industry group statements.

FDA officials gave journalists an outline of the new rules Wednesday, but required that they not talk to industry or public health groups until after today's formal release of the document.

The agency said the 2009 law gave it the power to prohibit sales to minors of all tobacco products it has authority over, which now will include e-cigarettes and cigars. A spokeswoman said the move did not reflect a finding about these products' safety.

Perhaps the biggest proposed change would require producers of cigars and e-cigarettes to register with the FDA, provide the agency with a detailed accounting of their products' ingredients and disclose their manufacturing processes and scientific data. Producers would also be subject to FDA inspections.

But the new blueprint was also notable for what it does not contain: any proposal to ban flavors in e-cigarettes and cigars, such as bubble gum and grape, that public health experts say lure children to use the products, or any move to restrict e-cigarette marketing, as is done for traditional cigarettes, which are banned from television, for example.

FDA officials said the new regulations were the major first step toward asserting the agency's authority and eventually being able to regulate flavors and marketing. But doing so, they said, will require further federal rule-making.

The regulations establish federal authority over tobacco products not named in the 2009 tobacco control law. E-cigarettes are considered a tobacco product because their main ingredient, nicotine, is derived from tobacco.

The new regulatory proposal is open to public comment for 75 days, and then the agency will make final changes, a process that will take months.


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