FDA issues further warning to e-cigarette manufacturers

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Food and Drug Administration Commissioner Dr. Scott Gottlieb has issued a stern warning on youth e-cigarettes use - the second within six days - to manufacturers of electronic nicotine delivery systems.

Calling the rate that young people are using tobacco products - especially e-cigarettes -"unacceptable," Gottlieb said the FDA "can't allow these trends to continue" and that manufacturers "better take heed of these trends."

The FDA had said Sept. 12 that it issued letters to the manufacturers of e-cigarettes asking them to be submit within 60 days plans describing how they will address what it called widespread youth access and use of their products.

In his most recent statement Gottlieb said he won't be "deterred or obstructed" in addressing these trends and reminded that "under the law e-cig manufacturers will basically need to show a net public health benefit in order to get authorization from the FDA to market their products."

"How challenging will that be for the e-cigarette products that are now being widely used by kids and given all the evidence of teen use?," said Gottlieb in the statement released Sept. 18.

He added, "These firms better take heed of these trends."

Gottlieb added that the FDA is in "possession of data that shows a disturbingly sharp rise in the number of teens using e-cigarettes in just the last year." While saying the data will be "made public very soon," he said there is an "obligation to act on what we know."

"And what we know is very disturbing," Gottlieb said.

"We have data to show that use of e-cigarettes, while potentially posing much less harm than combusting tobacco, is not benign. It causes its own health effects. And nicotine use by kids is dangerous. It causes direct effects on their health and their brains."

He added, "Not to mention the risk of lifelong addiction."

"There's a large pool of nicotine users that's being created among kids by these products. And some portion of them are at risk of transitioning to and risking addiction to cigarettes," Gottlieb said.

"The National Academy of Medicine report from earlier this year found that kids who use e-cigarettes are more likely to try combustible cigarettes. And that jeopardizes the extraordinary public health gains we've made in reducing smoking rates in this nation."

In 2010, a federal appeals court upheld an injunction against the FDA's attempt to ban e-cigarettes or regulate them more strictly as drugs in terms of any therapeutic use as alternative to combustible cigarettes.

Gottlieb said he continues to believe "e-cigarettes may present an important opportunity for adult smokers to transition off combustible tobacco products" and hears from such smokers who have switched to e-cigarettes.

He added, however, he has been increasingly "hearing from parents of kids who are addicted - telling me how easy it is for teens to buy these e-cigarettes, how the e-cig images are all over social media, how their kids tell them so many of their peer group in high school are using them."

He said the "numbers of kids now using these products is so large; it's hard for me to understand how the manufacturers don't know what we now know."

"It's not only the numbers I'm looking at; it's the American families who are facing a lifetime of addiction and serious health risks for their kids." 

Gottlieb added that "the manufacturers have a narrow window to act, or be acted upon," said that he would be "meeting with the largest manufactures myself" and called addressing the issue possibly "the most important thing" he could do as commissioner.

"I have broad support for the steps I'm taking. I won't be deterred or obstructed," Gottlieb said.

"And I'm committed to seeing these actions to their conclusion. I won't stop until this problem is solved. This may be the most important thing I can accomplish in my role as the agency's commissioner."

E-cigarettes, which use a battery to heat liquid - generally in cartridges containing nicotine and a flavoring - into aerosol or vapor for inhaling, have been said to be less harmful for individual smokers who substitute them for conventional cigarettes.

However, their use among students has soared in recent years with surveys showing in 2015 that one in six students had used e-cigarettes in the last month and the concern is this will lead to long-term smoking of tobacco cigarettes.

The FDA has quoted dating showing that more than two million middle and high school students were current users of e-cigarettes in 2017, and common reasons  included flavors such as mint and the belief they are less harmful than conventional cigarettes.

E-cigarettes include e-pens, e-pipes e-hookah, and e-cigars.

Nicotine is highly addictive and cigarette smoking is said to be the cause of nearly one in five deaths annually in the U.S. Nicotine is absorbed into the bloodstream through the lining of the mouth and the lungs and travels to the brain. 

Tar, create from the burning of tobacco in combustible cigarettes, is said to one of the main causes of lung cancer. More than 200 chemicals are found in such tobacco smoke.

On its website, the Centers for Disease Control and Prevention notes, "Besides nicotine, e-cigarette aerosol can contain substances that harm the body."

The FDA is in the process of proposed rulemaking around the flavoring of tobacco products, and Gottlieb's statement noted this.

"The problems seem to principally involve the closed cartridge systems, which have become popular among kids," Gottlieb said.

"To be clear, the FDA remains committed to the idea that e-cigarettes have the potential to help adult smokers' transition away from combustible cigarettes. But we may have to narrow the off ramp for adults, to close the on ramp for kids. We make hard trade-offs all the time. We'll do it again if we must."

The FDA brought electronic nicotine delivery products under its regulation in 2016 when it expanded its definition of tobacco products.

Last summer, Gottlieb had extended the deadline from 2016 to 2022 for manufacturers of e-cigarettes to seek approval to sell any product that had entered the market after Feb. 15, 2007. The FDA has a lengthy process for approving tobacco products and the delay is said to have allowed some 500 brands to remain on the market without full FDA evaluation of their product.

The FDA said at the time the delay was part of an overall strategy encouraging tobacco companies to reduce nicotine levels in tobacco products.

In May, seven public health groups filed suit against the FDA over the delay.

In his Sept. 12 statement, Gottlieb said that "youth use of electronic cigarettes has reached an epidemic proportion."

He said the FDA has sent more than 1,300 warning letters and civil fines to retailers - including some three dozen in Masschusetts - that it said illegally sold e-cigarette products to minors during what it called its "nationwide, undercover blitz of brick-and-mortar and online stores this summer."

The statement said that the vast majority of the violations were for the illegal sale of five e-cigarette products - Vuse, Blu, JUUL, MarkTen XL, and Logic - brands it said "currently comprise over 97 percent of the U.S. market for e-cigarettes."

The statement also said the FDA issued letters to the manufacturers of these brands asking each company to submit to the FDA within 60 days plans describing how they will address what the FDA called the widespread youth access and use of their products.

The FDA indicated failure to do so could result in at least a temporary removal from the market of some or all of the flavored products seen as contributing to market popularity.

The American Academy of Pediatrics, which is among those suing the FDA, said in response that the FDA needed to "immediately regulate all e-cigarettes."

In its response to the FDA Sept. 12 statement, JUUL Labs, the California-based startup that is said to have captured 68 percent of the U.S. e-cigarette market since launching in 2015, issued a statement 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's Sept. 18 statement was made in conjunction with the FDA's launch of 'The Real Cost' Youth E-Cigarette Prevention Campaign, which it described as a "foundational component of the Youth Tobacco Prevention Plan, particularly in educating teens about the dangers of using e-cigarettes."

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