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.
Bbc news – cigarette packaging: ministers launch fresh review
Best place to buy cigarettes in toronto
For Labour, shadow public health minister Luciana Berger demanded to know why the government was delaying the introduction of plain packaging “still further” having already held a consultation on the issue in 2012.
Opposition leader Ed Miliband added “The government should have introduced plain packaging earlier this year we want them to act swiftly, we want them to act now. We don’t need another review.
“Every major public health expert agrees this would help the battle against cancer, against young people taking up smoking.”
The government has never officially ruled out changes to cigarette packaging laws, but BBC political editor Nick Robinson said that private briefings from Downing Street had previously suggested the idea was “dead”.
He said ministers were likely to have been defeated on Lords amendments to the Children and Families Bill, which enjoyed cross party support, and would have given the government the power to regulate cigarette packaging.
Ms Ellison confirmed that the government would table its own amendment to the legislation, giving ministers the power to introduce regulations “quickly” when Sir Cyril’s review is complete in March 2014 if they decide to proceed with the policy.
‘Rise in counterfeiting’
She rejected suggestions the rethink had been prompted by fears of defeat in the Lords, saying “It’s a year this weekend since the legislation was introduced in Australia. It’s the right time to ask people to look at this.
“This is fundamentally about children’s health. Two thirds of people start smoking when they’re children and it’s one of the most important public health issues we face in this country.”