The federal government is about to begin regulating the booming e-cigarette market

Laurie McGinley and Brady Dennis
May 5, 2016
The Washington Post
The Food and Drug Administration, for the first time, imposed far-reaching regulations on e-cigarettes, cigars and other tobacco products, requiring manufacturers to disclose their ingredients and submit their products for government approval, and barring retailers from selling the items to anyone under 18 years old.
Federal health officials billed the new rules as critical to taming a “Wild West” atmosphere involving a multi-billion-dollar industry whose products have surged in popularity in recent years, especially among young people. They say there is little control over — or even basic information about — the manufacturing, distribution and marketing of the products, and that action is needed to protect young people from nicotine addictions and to inform adults about what exactly they are inhaling.
Industry officials reacted angrily, predicting that the new regulations would decimate small businesses and prompt some consumers to return to more-harmful conventional cigarettes. Public health advocates praised the administration effort as an important step in the nation’s long-term battle against tobacco use, but several called for additional steps, including an outright ban on flavors in e-cigarettes and sharp curbs on advertising.
In announcing the new rules at a press conference Thursday, Sylvia Mathews Burwell, secretary of health and human services, said, “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.”
She said the new regulations “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.”
The youth-access restrictions, which take effect in 90 days, compel retailers to verify the age of purchasers by photo identification, to put health warnings on their labels and to bar sales of the products in vending machines that are accessible to minors. Many states have such restrictions, but federal officials said enforcement wasn’t always consistent. The rules also ban the distribution of free samples, and the use of flavors in cigars. Officials suggested they would favor banning flavors in e-cigarettes, but said the topic needs more research.
The new regulations also generally require manufacturers whose products went on sale after Feb. 15, 2007, to get approval from the agency to continue selling their products. These reviews will allow the FDA to scrutinize ingredients, product design and health risks, the agency said. It added that it will allow the companies to keep selling their products for two years while they submit their applications and then for an additional year while the FDA reviews the submissions.
The requirements, which have been the focus of intense lobbying from the industry on one side and tobacco-control advocates on the other, are likely to only intensify the debate over whether the devices are a dangerous gateway to traditional tar-laden, chemical-filled cigarettes or a helpful smoking-cessation tool.
E-cigarettes are battery-powered devices that heat flavored, nicotine-laced liquid, turning it into a vapor that the user inhales, or “vapes.” The flavors can come in a wide range, from mango to margarita to mocha.
Chris Hansen, president of the American Cancer Society Cancer Action Network, praised the FDA’s action, and said he was especially glad that the agency decided to include premium cigars — an issue of intense lobbying — because “these products pose no less a health risk than other cigars.”
But Benard Dreyer, present of the American Academy of Pediatrics, said the “FDA passed up critical opportunities in this rule by failing the prohibit the sale of tobacco products coming in flavors like cotton candy, gummy bear and grape.”
Representatives of the e-cigarette industry said the rules will endanger the market for products that have the potential to help people move away from traditional tobacco.
“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,” Cynthia Cabrera, executive director of the Smoke-Free Alternatives Trade Association, the largest industry trade group, said in a statement Thursday. “These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers. It also limits access to the 40 million adult smokers in the U.S. yet to make the switch to vaping and cripples a multi-billion dollar, job-creating industry, the majority of which are made of small businesses.”
The FDA’s authority to regulate the products stems from a 2009 law that gave the agency broad power over traditional cigarettes, as well as jurisdiction over other tobacco-related products.
In recent weeks, the e-cigarette industry has gotten support from some public health experts. In late April, a group of tobacco-control experts, writing in the journal Addiction, urged the FDA to be “open-minded” about e-cigarettes, saying that the products are more beneficial than harmful and can result in a reduction in traditional smoking.
“We’re concerned the FDA, which has asserted its right to regulate e-cigarettes, will focus solely on the possibility that e-cigarettes and other vapor nicotine products might act as a gateway to cigarette use,” David Levy, the lead author and a professor in the department of oncology at the Georgetown Lombardi Comprehensive Cancer Center, said at the time.
He added that the “big picture tells us that these products appear to be used mostly by people who already are or who are likely to become cigarette smokers.”
And recently, the Royal College of Physicians concluded that e-cigarettes were likely to be beneficial to public health in Britain.
But many anti-smoking advocates disagree. They say that e-cigarettes could be harmful, that the long-term health risks are unknown and that companies are marketing their products to younger and younger teens. They say the companies are using the same tactics and themes that the traditional cigarette makers used years ago.
The number of middle and high school students using electronic cigarettes tripled between 2013 and 2014, according to a study by the Centers for Disease Control and Prevention.
Roy Herbst, chief of oncology at Yale Cancer Center and Smilow Cancer Hospital, applauded the rules, saying, “I think it’s good, it’s about time that we stem the tide of these e-cigarettes. The momentum has been so much in favor of their use.”
Herbst, who chairs the American Association for Cancer Research tobacco and cancer subcommittee, added, “Would we have wanted to see more restrictions on flavorings and advertising? Perhaps, but this is a good start.”