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Scott Gottlieb, Commissioner of the Food and Drug Administration, has issued a strong warning on the consumption of electronic cigarettes by young people – the second in six days – to manufacturers of electronic nicotine delivery systems.
Calling the rate that young people use tobacco products – especially electronic cigarettes – "unacceptable", Gottlieb said the FDA "can not allow these trends to continue" and that manufacturers "need to better account for these trends ".
The FDA said on September 12 that it had sent letters to electronic cigarette manufacturers asking them to submit plans within 60 days describing how they would treat what they called widespread youth access to their products. their usage.
In his most recent statement, Gottlieb said he would not be "deterred or hindered" by these trends and recalled that "by law, electronic cigarette manufacturers will have to demonstrate a net health benefit in order to To obtain FDA approval to market their products. "
"How difficult will this be for electronic cigarette products widely used by children and with all the evidence of adolescence?" Said Gottlieb in the statement released Sept. 18.
He added, "These companies need to better reflect these trends."
Gottlieb added that the FDA was "in possession of data showing a worrying increase in the number of teens using e-cigarettes only last year". While saying that the data will be "made public very soon", he said that there was "an obligation to act on what we know".
"And what we know is very disturbing," said Gottlieb.
"We have data showing that the use of electronic cigarettes, although potentially less harmful than burning tobacco, is not benign.It causes its own health effects.Nicotine consumption by children is dangerous, their brains. "
He added: "Not to mention the risk of dependence for life."
"These products generate a large number of nicotine users in these children, some of whom run the risk of ending up and risking addiction to smoking," Gottlieb said.
"The report from the National Academy of Medicine this year has shown that children who use electronic cigarettes are more likely to try combustible cigarettes.
In 2010, a federal court of appeal upheld an injunction against the FDA's attempt to ban electronic cigarettes or regulate them more strictly in terms of any therapeutic use as an alternative to combustible cigarettes. .
Gottlieb said he continues to believe that "electronic cigarettes could be an important opportunity for adult smokers to stop using flammable tobacco products" and they heard about those smokers who had opted for e-cigarettes.
He added, however, he was more and more "hearing from parents of children who are addicted – telling me how easy it is for teenagers to buy these e-cigarettes, how do the images e- cigs are on social media, how their kids tell their high school peer group are using them. "
He said, "The number of children now using these products is so important, it's hard for me to understand how manufacturers do not know what we know now."
"It's not just the numbers I'm looking at, it's the American families who are facing a life of addiction and serious health risks for their children."
Gottlieb added that "the manufacturers have a narrow window to act, or be acted upon," said that he "would meet me the biggest manufacturers" and called for solving the problem "the most important thing" as a commissioner.
"I am very much in favor of the measures I am taking, I will not be deterred or blocked," Gottlieb said.
"And I am committed to seeing these actions come to an end, and I will not stop until this problem is solved, perhaps the most important thing I can do." in my role as commissioner of the agency. "
Electronic cigarettes, which use a battery to heat the liquid – usually in cartridges containing nicotine and a flavoring – aerosol or inhalation vapor, would be less harmful for individual smokers who substitute them for conventional cigarettes.
However, their use among students has risen sharply in recent years with surveys showing that in 2015, one in six students had used e-cigarettes in the last month and worry could lead to cigarette smoking. long term.
The FDA cited dating showing that more than two million high school and high school students were current users of electronic cigarettes in 2017, and that the most common reasons were mint and the belief that they are less harmful than conventional cigarettes.
Electronic cigarettes include e-pens, e-pipes and e-cigars.
Nicotine is highly addictive and smoking would cause nearly one in five deaths each year in the United States. Nicotine is absorbed into the bloodstream through the lining of the mouth and lungs and travels to the brain.
Tar, from burning tobacco in fuel cigarettes, is believed to be one of the leading causes of lung cancer. More than 200 chemicals are found in this tobacco smoke.
On its website, the Centers for Disease Control and Prevention notes: "In addition to nicotine, the electronic cigarette spray can contain substances harmful to the body."
The FDA is proposing regulations around the flavoring of tobacco products, and Gottlieb's statement noted.
"The problems seem to mainly concern closed cartridge systems, which have become popular among children," Gottlieb said.
"To be clear, the FDA remains committed to the idea that e-cigarettes have the potential to help adult smokers avoid combustible cigarettes. But we may have to reduce the ramp for adults and close the ramp for children. We make tough compromises all the time. We will do it again if necessary. "
In 2016, the FDA introduced nicotine delivery products electronically by expanding its definition of tobacco products.
Last summer, Gottlieb extended the deadline from 2016 to 2022 for electronic cigarette manufacturers to obtain authorization to sell any product marketed after February 15, 2007. The FDA has put in place a The long process of approving tobacco products would have allowed some 500 brands to remain on the market without a full evaluation of their product by the FDA.
The FDA said the delay was part of a comprehensive strategy encouraging tobacco companies to reduce nicotine levels in tobacco products.
In May, seven public health groups filed a complaint against the FDA for the delay.
In his statement of 12 September, Gottlieb said that "the use of electronic cigarettes by young people has reached an epidemic proportion".
He stated that the FDA had sent more than 1,300 warning letters and civil fines to retailers – including about three dozen in Masschusetts – who claimed to have illegally sold electronic cigarettes to minors during what he said. they called mortar stores and online this summer. "
According to the statement, the vast majority of the violations involved the illegal sale of five electronic cigarette products – Vuse, Blu, Juul, MarkTen XL and Logic – which it says "currently account for over 97% of the US electronics market" . cigarettes. "
The statement also states that the FDA has sent letters to the manufacturers of these brands asking each company to submit to the FDA, within 60 days, plans outlining how the FDA
The FDA has indicated that failure to meet this requirement could result in at least a temporary removal of the market for some or all of the flavored products considered to be contributing to market popularity.
The American Academy of Pediatrics, which is among those who are pursuing the FDA, said the FDA should "immediately regulate all electronic cigarettes".
In its response to the FDA's September 12th statement, JUUL Labs, the Californian start-up that would have captured 68% of the US e-cigarette market since its launch in 2015, issued a statement in which: with the FDA in response to our request, we are committed to preventing the minor use of our product and we want to be part of the solution to keep electronic cigarettes out of the reach of young people. "
September 18, Gottlieb's statement was made as part of the FDA's launch of the "The Real Cost" electronic cigarette prevention campaign, described as a "fundamental component of the Youth Smoking Prevention Plan, particular electronic cigarettes. "
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