angelburst29
The Living Force
It was just a matter of time, before the FDA got involved in regulating e-cigarettes.
_http://www.washingtonpost.com/national/health-science/fda-outlines-plan-to-regulate-e-cigarettes/2014/04/23/4e7c8684-ca39-11e3-93eb-6c0037dde2ad_story.html
The Food and Drug Administration will for the first time regulate the booming market of electronic cigarettes, as well as cigars, pipe tobacco and hookahs, under a proposal to be released Thursday.
The move would begin to place restrictions on e-cigarettes, a nearly $2 billion industry that for years has operated outside the reach of federal regulators. If adopted, the government’s plan would force manufacturers to curb sales to minors, stop handing out free samples, place health warning labels on their products and disclose the ingredients. Makers of e-cigarettes also would be banned from making health-related claims without scientific evidence.
The FDA’s proposal stops short of broader restrictions sought by many tobacco-control advocates. Regulators at this point are not seeking to halt online sales of e-cigarettes, curb television advertising, or ban the use of flavorings such as watermelon, grape soda and piña colada — all tactics that critics say are aimed at attracting young smokers and that have been banned for traditional cigarettes.
Those restrictions might come eventually, FDA officials said, but not before more rigorous research can establish a scientific basis for tougher rules.
“Right now, for something like e-cigarettes, there are far more questions than answers,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.
Thursday’s action is about expanding FDA’s authority to products that have been “rapidly evolving with no regulation whatsoever,” in order to create a foundation for broader regulation in the future, he said. “It creates the framework.
We’re calling this the first step. . . . For the first time, there will be a science-based, independent regulatory agency playing a vital gate-keeping function.”
Congress passed a law in 2009 giving the FDA broad power to regulate cigarettes, including requirements for new warning labels, restrictions on ads and explicit approval of new products. The law also gave the FDA the authority to broaden its jurisdiction over other tobacco-related products. While the agency has long indicated that it planned to do just that, action has been slow in coming.
Whatever changes are coming won’t happen overnight. The public will have 75 days to comment on the proposal. After the FDA sorts through a likely tidal wave of responses and finalizes its regulations, companies will have to begin complying almost immediately with the proposed age and identification restrictions. But they will have two years to submit applications to the FDA to approve their products, which can remain on the market in the meantime.
The FDA’s effort to begin overseeing the sprawling e-cigarette market comes at a critical time. Sales have doubled year after year, with no signs of slowing, according to some industry analysts. That pales in comparison with the estimated $80 billion-a-year U.S. market for conventional tobacco products, but the gap is shrinking steadily. In addition, tobacco giants such as Lorillard, Reynolds and Altria have entered the e-cigarette market in recent years, joining hundreds of smaller manufacturers.
Greg Conley, a board member of the American Vaping Association, said the e-cigarette industry supports sensible federal regulations, such as restricting sales to minors, child-resistant packaging and standardized labeling. But Conley, who had not seen the details of the proposal, said he and others fear that the FDA will drive out of business small and medium-size manufacturers, as well as many bricks-and-mortar vape shops, if it regulates too overzealously in coming years.
“They could completely wipe out the growth in e-cigarettes. . . . They could destroy a big part of the industry and send a lot of it underground,” he said. “I’m cautiously pessimistic.”
_http://www.washingtonpost.com/national/health-science/fda-outlines-plan-to-regulate-e-cigarettes/2014/04/23/4e7c8684-ca39-11e3-93eb-6c0037dde2ad_story.html
The Food and Drug Administration will for the first time regulate the booming market of electronic cigarettes, as well as cigars, pipe tobacco and hookahs, under a proposal to be released Thursday.
The move would begin to place restrictions on e-cigarettes, a nearly $2 billion industry that for years has operated outside the reach of federal regulators. If adopted, the government’s plan would force manufacturers to curb sales to minors, stop handing out free samples, place health warning labels on their products and disclose the ingredients. Makers of e-cigarettes also would be banned from making health-related claims without scientific evidence.
The FDA’s proposal stops short of broader restrictions sought by many tobacco-control advocates. Regulators at this point are not seeking to halt online sales of e-cigarettes, curb television advertising, or ban the use of flavorings such as watermelon, grape soda and piña colada — all tactics that critics say are aimed at attracting young smokers and that have been banned for traditional cigarettes.
Those restrictions might come eventually, FDA officials said, but not before more rigorous research can establish a scientific basis for tougher rules.
“Right now, for something like e-cigarettes, there are far more questions than answers,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.
Thursday’s action is about expanding FDA’s authority to products that have been “rapidly evolving with no regulation whatsoever,” in order to create a foundation for broader regulation in the future, he said. “It creates the framework.
We’re calling this the first step. . . . For the first time, there will be a science-based, independent regulatory agency playing a vital gate-keeping function.”
Congress passed a law in 2009 giving the FDA broad power to regulate cigarettes, including requirements for new warning labels, restrictions on ads and explicit approval of new products. The law also gave the FDA the authority to broaden its jurisdiction over other tobacco-related products. While the agency has long indicated that it planned to do just that, action has been slow in coming.
Whatever changes are coming won’t happen overnight. The public will have 75 days to comment on the proposal. After the FDA sorts through a likely tidal wave of responses and finalizes its regulations, companies will have to begin complying almost immediately with the proposed age and identification restrictions. But they will have two years to submit applications to the FDA to approve their products, which can remain on the market in the meantime.
The FDA’s effort to begin overseeing the sprawling e-cigarette market comes at a critical time. Sales have doubled year after year, with no signs of slowing, according to some industry analysts. That pales in comparison with the estimated $80 billion-a-year U.S. market for conventional tobacco products, but the gap is shrinking steadily. In addition, tobacco giants such as Lorillard, Reynolds and Altria have entered the e-cigarette market in recent years, joining hundreds of smaller manufacturers.
Greg Conley, a board member of the American Vaping Association, said the e-cigarette industry supports sensible federal regulations, such as restricting sales to minors, child-resistant packaging and standardized labeling. But Conley, who had not seen the details of the proposal, said he and others fear that the FDA will drive out of business small and medium-size manufacturers, as well as many bricks-and-mortar vape shops, if it regulates too overzealously in coming years.
“They could completely wipe out the growth in e-cigarettes. . . . They could destroy a big part of the industry and send a lot of it underground,” he said. “I’m cautiously pessimistic.”
