[MIAMI] The United States on Thursday issued a sweeping ban on sales of e-cigarettes, cigars, pipe tobacco and hookahs to those under 18, marking the first time these products have been federally regulated.
The ban will go into effect in 90 days, according to the US Food and Drug Administration, which issued the final rule after several years of study and debate.
Until now, the marketplace for tobacco products outside of traditional cigarettes has been like "the wild, wild west," said Mitch Zeller, director of the FDA's Centre for Tobacco Products.
"This final rule is a foundational step that enables the FDA to regulate products that young people were using at alarming rates - like e-cigarettes, cigars and hookah tobacco - which had gone largely unregulated," he told reporters.
Key aspects of the rule include barring the sale of e-cigarettes to minors online or in person, prohibiting the distribution of free samples and not allowing vending machines, unless they are located in an adult-only facility.
The rule also requires manufacturers to get the FDA's marketing approval for any products that were issued after February 15, 2007, to show that their "products meet the applicable public health standard set forth in the law." However, it does not place any restrictions on advertising and marketing, and does not ban flavouring ingredients, which public health experts say serve a lure to young customers.
Mr Zeller said future rules may extend the current ban on flavoured cigarettes to cover cigars and little cigars known as cigarillos. Down the road, there may also be nicotine warnings and child-resistant packaging.
The Campaign for Tobacco Free Kids president Matthew Myers called the FDA move a "critical first step," but warned it "falls short in protecting kids from e-cigarettes," he said in a statement.
"It does nothing to restrict the irresponsible marketing of e-cigarettes or the use of sweet e-cigarette flavours such as gummy bear and cotton candy, despite the FDA's own data showing that flavours play a major role in the skyrocketing youth use of e-cigarettes." The FDA gained the power to regulate a wider range of tobacco products in 2009, with the passage of the Family Smoking Prevention and Tobacco Control Act.
A preliminary rule was issued in 2014, resulting in more than 135,000 public comments, an FDA spokesman said.
About one in five Americans smokes, and the habit kills 480,000 people in the United States each year, according to health authorities.
Traditional cigarette smoking has declined in recent decades, but youths are increasingly turning to e-cigarettes, which are battery powered devices that heat a nicotine liquid - and flavoured cigars.
E-cigarette use among high-schoolers rose from 1.5 per cent in 2011 to 16 per cent in 2015 - a more than 900 per cent increase - according to the US Centers for Disease Control and Prevention.
Last year, three million middle and high school students were current e-cigarette users.
Another recent study, carried out by the FDA and the National Institutes of Health in 2013-2014, showed four out of five youths who use some form of tobacco also had tried a flavoured tobacco product in the past month.
The FDA said that studies showing e-cigarettes may help traditional cigarette smokers quit are "anecdotal," and more evidence is needed to show the impact of the devices on a wider population level.
The FDA gave no exemption for so-called premium cigars, despite lobbying efforts from the industry.
"All cigars pose serious negative health risks," said Mr Zeller.
"To exclude such a product from FDA regulation would be neglecting our duty to protect public health." Now, makers of cigars have two years to disclose to the FDA "important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users," according to the 499-page FDA rule.
"We are deeply disappointed," said a joint statement from Eric and Bobby Newman, president and executive vice president of J.C. Newman Cigar Company in Tampa, Florida.
"The premium cigar industry is made up of dozens of small, family-owned cigar makers, like us, along with thousands of small, independent specialty cigar stores across the country," they wrote.
"The cost and burdens of onerous regulations threaten the entire industry." According to Gary Giovino, chair of the department of community health and health behavior at the State University o New York at Buffalo, the FDA regulations could also prove too steep for some small businesses that make e-cigarettes.
"These companies likely will not have the resources to deliver all the information the FDA is asking for," he said.
"This could stifle innovation and hurt public health in the long run, to the extent that innovative e-cigarette products will help people move off of combusted tobacco products."