F.d.a. will propose new regulations for e-cigarettes – nytimes.com
But the new blueprint was also notable for what it did not contain any proposal to ban flavors in e cigarettes and cigars, like bubble gum and grape, that public health experts say lure children to use the products, or any move to restrict the marketing of e cigarettes, as is done for traditional cigarettes, which are banned from television, for example.
F.D.A. officials said the new regulations were the first major step toward asserting the agency s authority and eventually being able to regulate flavors and marketing. But doing so will require further federal rulemaking, they said.
For example, to restrict the use of flavors, the agency would have to establish a factual record that they pose a health risk for young people. The same goes for marketing, an area that has been vulnerable to litigation from industry. The agency tried to impose graphic warning labels on cigarette packaging, for example, only to have tobacco companies fight the measure in court and win on grounds that it violated their First Amendment right to free speech.
You can t get to the flavors until you have regulatory authority over them, said Mitchell Zeller, director of the Center for Tobacco Products at the F.D.A. He called the blueprint foundational.
The regulations establish federal authority over tobacco products that were not named in the 2009 tobacco control law, including certain dissolvable tobacco products, water pipe tobacco and nicotine gels. E cigarettes are considered a tobacco product because their main ingredient, nicotine, is derived from tobacco.
One exception is sure to worry antismoking activists Mr. Zeller said the agency was asking for public comment on whether premium cigars hand rolled with a tobacco leaf as a wrapper should be placed in a special separate category not subject to F.D.A. authority. The cigar industry has lobbied Congress furiously for exemption to the rules, garnering some support from both Democrats and Republicans.
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.
Under the new rules, companies would no longer be able to offer free samples, and e cigarettes would have to come with warning labels saying that they contain nicotine, which is addictive. Companies would also not be able to assert that e cigarettes were less harmful than real cigarettes unless they got approval from the F.D.A. to do so by submitting scientific information.
In the proposed restrictions on sales to minors, vending machines in public places where minors are allowed would no longer be able to carry them. A ban on Internet sales to minors, already in place for cigarettes, would extend to e cigarettes and cigars.
E cigarette consumption is rising fast, and in the absence of federal regulations, many states have already passed laws that ban e cigarettes from public places, regulate their sale, and in some cases tax them. More than half of states already enforce bans on their sale to minors.
Under the new rules, companies would have to apply for F.D.A. approval for their products, but would have two years after the new rules are finalized to do so. Companies can keep their products on the market in the meantime. Eventually, the companies would have to adhere to F.D.A. standards for manufacturing their products, not unlike how drug companies and food companies do now, but the agency has yet to write those rules.
Some experts have cautioned that too high a regulatory bar could stifle smaller e cigarette producers and help deep pocketed tobacco companies, which have also gotten into the e cigarette business. Innovation to make e cigarettes better would also slow if regulations were too burdensome, they say. Meeting such requirements includes the expenses of application costs, user fees that industry pays the agency, and assembling a scientific case to show that a product should be approved.
Fda to regulate e-cigarettes – abc news
The U.S. Food and Drug Administration announced this morning plans to regulate electronic cigarettes.
The proposed regulations will require that the manufacturers disclose to the FDA what is in their products and will require that the devices come with a warning label. Although e cigarette sales to minors will be prohibited, there are currently no advertising restrictions.
VIDEO FDA Wants Warning Label on E Cigarettes, Ban on Sales to Minors
The regulation has been long anticipated as millions of Americans have started using e cigarettes. The devices are battery operated nicotine inhalers.
Dr. Richard Besser, ABC News’s chief health and medical editor, said public health officials are concerned that e cigarettes could be a gateway to further tobacco use.
“Data show use of e cigarettes by high school and junior high school students is on the rise,” Besser said. “Once addicted to nicotine, will users move on to using tobacco with all the inherent health risks?
“Countering the view are those who view e cigarettes as an important step towards risk reduction for current cigarette smokers,” he added. “They do not deliver the carcinogens that are the cause of so many health problems.”
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There are more than 250 brands of e cigarettes and an estimated 4 million Americans use them, according to the Tobacco Vapor Electronic Cigarette Association. However, whether the small devices are “safer” than traditional cigarettes remains unproven. Without FDA regulation it’s unclear how much nicotine or other chemicals each brand of e cigarette holds.
A widely publicized study into the safety of e cigarettes was done when researchers analyzed only two leading brands and concluded the devices did contain trace elements of hazardous compounds, including a chemical that is the main ingredient found in antifreeze.
Despite today’s announcement, it will be months to years before concrete regulation is implemented. First there will be a six month review process after the 75 day comment period. It will be another two years before current products need to be approved by the FDA and 25 months before they need to display warning labels.
ABC News’ Liz Neporent contributed to this article.