FDA Issues New Regulations for E-Cigarettes and Other Tobacco Products

Agency announced new regulations to combat "wild, wild west" of e-cigarettes.

May 5, 2016, 1:08 PM

— -- E-cigarettes will face new regulations by the U.S. Food and Drug Administration, including requirements that affect manufacturing, ingredient labeling and not selling the product to those under the age of 18, the agency announced today.

The FDA announced a plan to regulate e-cigarettes two years ago, but these are the first concrete regulations issued. The new rules affect not only e-cigarettes but more traditional tobacco products, including cigars, pipe tobacco and hookah tobacco.

“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction,” U.S. Department of Health and Human Services Secretary Sylvia Burwell said in a statement today.

“Today’s announcement is an important step in the fight for a tobacco-free generation -- it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions," Burwell said.

Federal officials framed the new regulations as a way to take on the rapidly increasing rates of e-cigarette usage among teens. The new regulations will affect the selling, marketing and manufacturing of e-cigarettes and other tobacco products.

Newly announced prohibitions on selling e-cigarettes, hookah tobacco and cigars to people under 18 or giving free samples will start to be enforced within 90 days, according to the FDA.

Mitch Zeller, director of the Center for Tobacco Products, a part of the FDA, likened the current e-cigarette marketplace to "the wild, wild west," pointing out that there have been reports of e-cigarettes exploding in recent months, causing burns on teens.

"Today is a first step, a foundational step, to bring all these previously unregulated products into the world of being regulated," Zeller said during a news conference today.

Health officials have been concerned that teens and other young adults may view e-cigarettes as an alternative to cigarettes with a rising number of teens using e-cigarettes. A recent survey found current e-cigarette use among high school students has risen sharply, from 1.5 percent in 2011 to 16 percent in 2015, according to the FDA and the U.S. Centers for Disease Control and Prevention. An estimated 3 million middle and high school students were current e-cigarette users in 2015, according to the FDA. Data also showed high school boys smoked cigars at about the same rate as cigarettes.

To ensure compliance with new regulations, manufacturers of e-cigarettes will have to present their products to the FDA to meet public health standards. The new regulations include new requirements to report ingredients and any potentially harmful aspect of the product. Health warnings will be required on e-cigarette packages and ads and e-cigarette makers must register the places where their products are manufactured.

The new regulations will likely take time to be implemented, as the FDA expects that manufacturers will sell their products for up to two years before they submit their product for FDA review. It will take another year for the FDA to review the product the application.

Industry group Smoke-Free Alternatives Trade Association blasted the FDA for "essentially banning 99 percent of all vapor products" on the market due to requirements that any e-cigarette device introduced after Feb. 15, 2007, be submitted to the FDA for approval.

"Our industry has a long history of supporting sensible science-based regulations, including license requirements, as well as banning sales to minors and adopting child-resistant packaging," SFATA said in a statement. "Today’s final rule pulls the rug out from the nine million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year and costs the U.S. more than $300 billion in annual health care expenses."

SFATA said the FDA review process will be costly and claimed that there is growing evidence that e-cigarettes are 95 percent less harmful than combustible cigarettes.

“These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers," SFATA said.

While most of the regulations will not be implemented for years, prohibiting tobacco sales to those under 18 will start in 90 days. Burwell explained that currently "the absence of federal restriction means enforcement is uneven and sometimes non-existent" in preventing teens from buying e-cigarettes and other tobacco products.

Burwell called the regulations "common sense" actions to protect children from tobacco products.

"As a nation we have agreed for many years that nicotine does not belong in the hands of children," Burwell said during today's new conference. "Progress has been made but the context has changed, we owe it to ourselves to do better."

Zeller said his group is working with state officials on plans to enforce the ban on sales to those under 18 and that they will "hit the ground running."

While regulations addressed many concerns of health officials, the FDA has not banned flavors in e-cigarettes. Flavored cigarettes were been banned in 2009 over concerns they may lead younger teens to smart smoking. Zeller said his group is monitoring how flavors affected users.

“As a physician, I’ve seen first-hand the devastating health effects of tobacco use,” FDA Commissioner Robert M. Califf, said in a statement. “At the FDA, we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco. That includes ensuring consumers have the information they need to make informed decisions about tobacco use and making sure that new tobacco products for purchase come under comprehensive FDA review.”

Some health groups applauded by the move by the FDA, though others said they were disappointed the FDA didn't take further action.

The March of Dimes commended the FDA.

"E-cigarettes are clearly tobacco products, and they should be strictly regulated as such," March of Dimes President Dr. Jennifer L. Howse said in a statement. "Lack of regulation has allowed these products to be marketed and sold without limits, including to pregnant women and youth."

The American Society of Clinical Oncology called the regulations a "crucial step" in regulating tobacco products and understanding the risks and benefits of e-cigarettes.

"Most importantly, we are concerned that e-cigarettes may encourage nonsmokers, particularly children, to start smoking and develop a nicotine addiction. FDA regulation will minimize the potential negative consequences of e-cigarettes and other ENDS [electronic nicotine delivery systems] without undermining their potential to reduce harm as a smoking cessation tool," the group said.

The American Academy of Pediatrics also welcomed the regulations but called on the FDA to do more.

“More work must be done now as e-cigarettes become more and more common in households and communities across the country," the organization said in a statement today. "FDA passed up critical opportunities in this rule by failing to prohibit the sale of tobacco products coming in flavors like cotton candy, gummy bear and grape or to prevent marketing tactics that target children. The Academy also looks forward to a law -- the Child Nicotine Poisoning Prevention Act -- taking effect this summer that will require child-resistant packaging on liquid nicotine containers.”

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