FDA proposes to crack down on e-cigarettes, other tobacco products.
By Kathleen Doheny
WebMD Health News
Reviewed by Arefa Cassoobhoy, MD, MPH
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.
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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.
Q: When do these rules take effect, if finalized?
A: The next step is a 75-day comment period. It's difficult to estimate how long it will take to review those comments and issue a final ruling, says FDA Commissioner Margaret Hamburg.
Once that happens, the ban on sales to minors and from vending machines goes into effect in 30 days. For the rest, companies will have 24 months to meet the new rules. They can continue marketing their products during that time.
Q: Who is using e-cigarettes?
A: "At this point we have far more questions than answers about who is using e-cigarettes and how they are being used," Zeller says. There is some evidence, he says, that hard-core cigarette smokers may turn to e-cigarettes when they can't light up.
Young people represent a growing group of e-cigarette users, and that concerns public health experts. Between 2011 and 2012, the number of middle and high school students who used e-cigarettes doubled, reaching 1.78 million, CDC statistics show.
Anti-tobacco experts are concerned that the e-cigarettes will lead the teens to become regular cigarette smokers. Most smoked both types of cigarettes.
Q: What are the health effects of e-cigarettes?
A: The FDA and other experts are still trying to find that out, Zeller says.
The FDA has funded numerous studies to look at the health effects of e-cigarettes, he says. Nicotine, the main ingredient, is addictive, but little research exists on its effects.
A recent study with 1,000 smokers in "real world" conditions found that e-cigarette use did not help people quit smoking.
Another study funded by The Consumer Advocates for Smoke-Free Alternatives Association says e-cigarettes pose no health concerns for the average person. They evaluated 9,000 samples from vapors of e-cigarettes.
And earlier this month, the CDC reported that calls to poison control centers about the nicotine in e-cigarettes rose dramatically in the past several years. More than half of the calls involved children under 5. The liquid nicotine is toxic, and children can be poisoned by swallowing it, inhaling it, or absorbing it through the skin.
Q: What is the industry reaction to the proposed ruling?
A: At least two makers of e-cigarettes released statements supporting the proposed regulations.
Lorillard, which produces blu eCigs, says it applauds the FDA efforts and that it has already initiated some proposed measures, such as limiting minors' access.
Q: What is the public health reaction to the proposed ruling?
A: Many public health organizations, including the American Lung Association, welcome the FDA's plan.
"It's getting a message out, even if the regulations don't start right away, about the harm these products can have in getting youngsters and others hooked on a nicotine-addictive product."
The e-cigarettes may play a role in helping people quit, he says, ''but have them be governed by the same FDA regulation.''
SOURCES: FDA press briefing, April 24, 2014. News release, American Association for Cancer Research. Roy S. Herbst, MD, PhD, chief, medical oncology, Yale Cancer Center; chair, AACR Tobacco and Cancer Subcommittee. American Lung Association statement, April 24, 2014. News release, FDA. News release, NJOY. News release, Lorillard Inc. Annals of the American Thoracic Society, February 2014. Igor Burstyn, PhD, associate professor, Drexel University School of Public Health, Philadelphia. BMC Public Health, Jan. 9, 2014. News release, CDC. CDC: "New CDC study finds dramatic increase in e-cigarette related calls to poison centers." NPR: "Despite popularity, mysteries of e-cigarettes persist."
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