Editor's note: This story was updated on Aug. 26, 2014.
April 25, 2014 -- The American Heart Association is urging the FDA to avoid delay in imposing regulations on e-cigarettes proposed in April. Those rules include banning the sale of e-cigarettes to kids under 18.
That ban would 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. The association is asking that all rules be in place by year’s end.
“Recent studies raise concerns that e-cigarettes may be a gateway to traditional tobacco products for the nation’s youth, and could renormalize smoking in our society,” says Nancy Brown, the association’s CEO, in a statement. “These disturbing developments have helped convince the association that e-cigarettes need to be strongly regulated, thoroughly researched and closely monitored.”
The World Health Organization (WHO) also released a report on e-cigarettes Aug. 26, calling them an “evolving frontier filled with promise and threat for tobacco control.” Regulations are needed to address the health concerns they pose, the organization said.
E-cigarettes have a nicotine solution that is heated to create a vapor the user breathes in, or “vapes.” Before the FDA’s announcement in April, 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 e-cigarettes and the proposed 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: The AHA and the WHO are urging the FDA to ban flavors and curb marketing of e-cigarettes.
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 75-day comment period on the rules began in April. It's tough 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.
In that case, he says, e-cigarettes are not helping them stop smoking, but merely serving as a bridge from the last regular cigarette to the next.
Some studies have suggested that the use of e-cigarettes to help smokers quit may be equal to or slightly better than nicotine patches, the AHA says. If repeated quit attempts using proven strategies fail, or if a person rejects those strategies and wants to use e-cigarettes to quit, doctors “should not discourage” e-cigarette use, the association says.
Still, the association says doctors should tell patients that e-cigarettes aren’t regulated or FDA-approved as a quit-smoking strategy, and they “may contain low levels of toxic chemicals.” Also, since long-term studies haven’t been done on the safety of e-cigarettes, doctors should suggest that patients set a quit date for use of e-cigarettes, the recommendations say.
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.
Governments “must restrict e-cigarette advertising, promotion and sponsorship, to ensure that it does not target youth and non-smokers or people who do not currently use nicotine,” the WHO said in a statement accompanying its report. The regulations outlined in its report would include a ban on flavored e-cigarettes. There are nearly 8,000 different flavors, “and there is concern they will serve as a gateway to nicotine addiction and, ultimately, smoking, particularly for young people.”
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 review of 81 studies on the use and safety of e-cigarettes, published in June, concluded their strict regulation isn’t warranted – and that allowing e-cigarettes to compete with regular cigarettes may cut tobacco-related deaths and illnesses.
But a study published the previous month suggested e-cigarettes may not be as harmless as they seem -- their vapor may produce tiny particles that users suck into their lungs. That, researchers say, could potentially cause or worsen respiratory diseases.
In April, 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.
Also, the WHO said, e-cigarettes pose risks to adolescents and the fetuses of pregnant women who use the devices.
Q: What are public health groups saying about e-cigarettes?
“In the years since the FDA first announced it would assert its authority over e-cigarettes, the market for these products has grown dramatically,” Brown says in the American Heart Association statement Monday. ”We fear that any additional delay of these new regulations will have real, continuing public health consequences.”
The AHA’s guidance also examines state smoke-free laws in relation to e-cigarettes. “Unregulated e-cigarettes could potentially turn back the clock to the days when smoking in public was normal behavior, undoing years of work on smoke-free laws and hampering current enforcement,” the association says.
A number of local and state governments are examining current laws in regard to e-cigarettes.
In July, the Forum of International Respiratory Societies, which has more than 70,000 members worldwide, issued a position statement saying governments should ban or limit the use of e-cigarettes until more is known about their health effects and safety.
“Nicotine is central to lifelong addiction, and [e-cigarettes] are nicotine-delivery devices,” statement author Dean Schraufnagel MD, past president of the American Thoracic Society, says in a society news release.
The American Lung Association, in a policy statement posted on its web site, has also urged the FDA to impose regulations.
“There is no government oversight of these products and absent (FDA) oversight, there is no way for the public health, medical community, or consumers to know what chemicals are contained in e-cigarettes or what the short- and long-term health implications might be,” the statement says.
The WHO calls for “legal steps” to end the use of e-cigarettes indoors in public places, saying, “evidence suggests that exhaled e-cigarette aerosol increases the background air level of some toxicants, nicotine, and particles.”
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 FDA’s proposed ruling?
A: Many public health organizations, including the American Lung Association, welcome the FDA’s plan.
“It's a major step," says Roy S. Herbst, MD, PhD, chief of medical oncology at Yale Cancer Center and chair of the American Association for Cancer Research Tobacco and Cancer Subcommittee.
"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.''