FDA proposes to crack down on e-cigarettes, other tobacco products.
April 25, 2014 -- The big news out of the FDA’s announcement on e-cigarettes is that people under age 18 will no longer be able to buy them.
That ban will go into effect 30 days after the rules are approved. But it could take more than 2 years for many of the other rules to go into effect. And while everyone from the American Lung Association to e-cigarette makers praised the plan, others say it won’t do enough to keep the products out of the hands of teens.
E-cigarettes contain a nicotine solution that is heated to create a vapor the user breathes in, or “vapes.” Before the FDA’s announcement Thursday, no federal rules existed to regulate what’s in them, who they can be sold to, or how they are advertised.
Here are some details from experts about the proposed e-cigarette rules.
Q: In addition to banning sales to minors, what else do the proposed rules do?
A: Makers of the tobacco products that would come under the FDA’s new rules would have to:
- Register with the FDA
- Provide a list of ingredients
- Seek FDA approval to market their products
- Seek approval to make direct and implied claims of reduced risk
- Include health warnings
They could not distribute free samples or sell products in vending machines (unless the facility never allows people under 18 to enter).
Right now, "We can't even tell you what compounds are in the vapor," says Mitch Zeller, director of the FDA Center for Tobacco Products, who spoke at a press briefing about the new rules.
Q: What don't the new rules cover?
A: The new rules do not ban online sales, TV ads, or flavored e-cigarettes. Zeller says once the rules are finalized, the FDA could propose separate rules for those areas.
It's yet to be decided if cigars that are ''premium" -- hand-rolled with a tobacco leaf wrapper -- will be included. The FDA is seeking comments on that question, Zeller says.
Q: Why didn’t they include the flavors and the marketing?
A: Public health advocates worry that the sweet flavors of e-cigarettes will continue to attract teens, along with marketing.
But CDC Director Tom Frieden, MD, said in an interview with NPR that rules in those areas could be challenged in court.
"One of the challenges that the FDA has is the balance between stringent regulation and regulation that will stand up to a court challenge,” Frieden told NPR. He noted that the e-cigarette industry has already won one court case against the FDA.
“It is a real balancing act between how effective regulation can be and how sustainable it will be in court.”
Q: What other products are included in the new rules?
A: Besides electronic cigarettes, the proposed rules also cover cigars, pipe tobacco, nicotine gels, water pipe tobacco, and hookah tobacco.
The FDA already regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
source : Electronic Cigarettes: Q&A
