The US Food and Drug Administration is cracking down harshly on manufacturers and retailers who are e-cigarettes who are allowing sales to minors.
US Health and Human Services Secretary Alex Azar is “completely in support” of the US Food and Drug Administration’s proposed crackdown on e-cigarettes. He is quoted in a Reuters Health report as saying: “We are not going to permit e-cigarettes to become a pathway to nicotine dependency or the use of combustible tobacco.”
He said he disagreed with a belief that banning e-cigarettes would push youth towards traditional cigarettes.
The FDA order was part of a sweeping government action that targeted both makers and sellers of e-cigarettes, reports The New York Times. If Juul Labs and four other major manufacturers fail to halt sales to minors, the agency said, it could remove their flavoured products from the market. It also raised the possibility of civil or criminal charges if companies are allowing bulk sales through their websites.
According to the report, the agency said it was sending warning letters to 1,100 retailers – including 7-Eleven stores, Walgreens, Circle K convenience shops and Shell gas stations – and issued another 131 fines, ranging from $279 to $11,182, for selling e-cigarettes to minors. The report says federal law prohibits selling e-cigarettes to anyone under 18 but FDA commissioner, Dr Scott Gottlieb, said that more than 2m middle and high school students were regular users of e-cigarettes last year.
But the government’s tactics underscore a dilemma in the public health community, the report says: In addressing one public health problem – cigarette smoking, which kills 480,000 people in the US each year – e-cigarettes are creating another – hooking teenagers who have never smoked nicotine. E-cigarette users inhale far fewer toxic chemicals than do smokers of traditional cigarettes. But they can take in higher levels of nicotine, which is addictive.
“The developing adolescent brain is particularly vulnerable to addiction,” the FDA said. In particular, the agency has been watching the wildly popular Juul, which offers especially potent nicotine hits. Juul Labs launched the sleek device, which looks like a flash drive, in 2015. It comes with “pods” in eight flavours, among them mango, menthol and creme. In a short time, Juul has become the dominant seller of e-cigarettes and a fad among students. According to Nielsen data, Juul controls 72% of the market, and is valued by investors at $16bn.
A Juul spokesperson is quoted in the report as saying: “Juul Labs will work proactively with FDA in response to its request. We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people.”
Gottlieb said the FDA would look closely at whether Juul and the other manufacturers were allowing bulk purchases of products through their own websites – a practice where the buyer could then sell to minors. If such “straw sales” are happening, it should be readily apparent to the manufacturers, he said. “If the companies don’t know, or if they don’t want to know, we’ll now be helping to identify it for them.”
The report says the other four products facing the 60-day deadline are RJR Vapor Co’s Vuse, Imperial Brands’ blu and devices made by Logic. They said they were working with the FDA as well.
RJR, Imperial and Altria are all major tobacco companies. The report says as smoking rates have declined, the industry sees e-cigarettes as an important piece of its survival, a fact that makes some in public health mistrustful. “They say they’ve changed from the days of Joe Camel,” Gottlieb said. “But look at what’s happening right now, on our watch and on their watch. They must demonstrate that they’re truly committed to keeping these new products out of the hands of kids.”
According to the report, Gottlieb has said many times he believes that e-cigarettes and similar products known as electronic nicotine delivery systems may be effective options for adults who want to stop smoking but still crave nicotine. But he said teenage vaping has become so concerning that regulators may have to curb the availability of the devices to keep them out of the hands of youths.
“Inevitably what we are going to have to contemplate are actions that may narrow the off-ramp for adults who see e-cigarettes as a viable alternative to combustible tobacco in order to close the on ramp for kids,” Gottlieb said. “It’s an unfortunate trade-off.”
The report says Gottlieb’s aggressive approach against private industry is unusual for an official in the business-friendly Trump administration which has sought to roll back numerous environmental and health regulations. But critics said that his decision last summer to extend a deadline for e-cigarette manufacturers to demonstrate that their products comply with public health concerns helped perpetuate the current problem. “It’s nice they want to do something but realistically, what are they going to accomplish this way when they could be so much more effective by following the regulatory plan that had been ready to put into place and that the commissioner postponed?” said Diana Zuckerman, president of the National Centre for Health Research – a non-profit health policy group.
She also pointed to the popularity of vaping among young adults. Researchers generally believe that the adolescent brain continues to develop through age 26. “It’s a big epidemic among people ages 18 to 30, too,” she said.
And while the FDA’s announcement struck many as tough, the report quotes legal experts as saying that the agency could face a protracted legal fight if it follows through on its threats to ban flavours and curtail marketing. Marc J Scheineson, a health care lawyer and a former associate FDA commissioner, said that the agency was relying on public opinion and its own bully pulpit to push the targeted manufacturers into “voluntary compliance.”
Some anti-smoking groups, while encouraged by the FDA’s actions, expressed caution: “Asking the tobacco industry to come up with solutions is the proverbial case of asking the fox to guard the hen house,” said Robin Koval, the president and CEO of Truth Initiative. “After decades, there is no evidence that the tobacco industry is able to regulate itself.”
But the attorney general of Massachusetts, Maura Healey, who recently began an investigation into the marketing and sale of e-cigarettes to minors, praised the FDA’s action. “We’ve worked too hard over the past 50 years to reduce smoking rates among young people to let these companies profit off of getting them hooked on nicotine,” Healey said. “This move by the FDA is a good first step to shut down companies targeting minors.”
A Juul spokesperson, Victoria Davis, said recently that the company had already stepped up its own patrol of retailers who advertise to youths or who don’t enforce age requirements, as well as social media posts. But it’s not always easy. From 1 January through 28 July Davis said, Juul asked Instagram to remove over 5,500 posts, and the social media company complied on 4,562. Facebook Marketplace was less agreeable. The company agreed to remove 45 of 144 posts. Amazon took down 13 of 33.
Gottlieb said he was not impressed by the measures Juul and the other companies have taken. “It didn’t have the intended impact or I wouldn’t be viewing the statistics I’m now seeing,” he is quoted in the report as saying.
[link url="https://www.reuters.com/article/us-usa-fda-ecigarettes/u-s-health-secretary-backs-proposed-fda-crackdown-on-e-cigarettes-cnbc-idUSKCN1LU21Y"]Reuters Health report[/link]
[link url="https://www.nytimes.com/2018/09/12/health/juul-fda-vaping-ecigarettes.html?emc=edit_th_180913&nl=todaysheadlines&nlid=425053800913"]The New York Times report[/link]