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Juul products would be completely removed from the market if the company's application to the FDA prior to its marketing was not approved.
ASSOCIATED PRESS
For years, Juul and his competitors have been operating an electronic cigarette market without FDA approval. This will end in May, when electronic cigarette manufacturers will have a new shortened deadline for submitting their applications for market approval.
The Food and Drug Administration had previously set a 2022 deadline for companies to submit applications explaining why they should be able to continue selling e-cigarette products. A strong increase in vaping among young people has prompted the FDA to propose reducing the time of one year. This was not enough for a multitude of anti-smoking groups, whose lawsuit against the FDA resulted in a court order issued Friday by US District Judge Paul Grimm in Maryland.
During the trial, the judge criticized both the FDA and the electronic cigarette sector, the first for allowing companies to illegally sell unapproved e-cigarettes. The industry has always been dodging federal regulations, which has created a "public health emergency," wrote Grimm.
The FDA is ready to use "all available regulatory tools" to prevent youth vaping, said Acting Commissioner Ned Sharpless in a statement released Monday. Grimm, in his order, clearly stated that the FDA's tools were not enough to attract the manufacturers of electronic cigarettes. The industry had managed to put in place regulations "deliberately avoiding" "despite the FDA's orders," he wrote.
Successful companies should have no reason to deplore the new deadline given their "big handbags" and the years they have had to voluntarily submit applications, wrote Grimm. Juul, which according to the Nielsen market study, would control three-quarters of the US e-cigarette market, rises to $ 38 billion after Altria's 35% equity stake in the company in December latest.
Juul is confident in the "content and quality" of its planned application, said company spokesman Ted Kwong Forbes. "More and more evidence, as well as our leading actions in the sector to fight against the access and use of minors, will allow adult smokers to continue to have a real alternative to cigarettes, the leading cause of preventable death in the world. "
Until 2016, electronic cigarettes could freely enter the market without prior authorization for sale. The FDA has announced its presumption rule that May has expanded its regulatory jurisdiction over tobacco products to include electronic cigarettes and anti-vaping pens as well. The policy required existing electronic cigarette manufacturers to submit applications by 2018, but FDA Commissioner Scott Gottlieb extended the deadline until 2022.
The court order dismisses the FDA review process. The agency proposed the ten-month deadline itself, but did so only as part of the lawsuit: the anti-smoking plaintiffs suggested four months. In its previous actions in regulating electronic cigarettes, the FDA had considered "as far as an organization can go to industry," said Desmond Jenson, a lawyer at the Public Health Law Center (Public Health Law). Center), which focuses on tobacco control policy. Jenson said the reduced time should not surprise Juul and his rivals because "the specter of pre-market review has always been imminent".
Former FDA chief Gottlieb doubts the chances of Juul
Nevertheless, Juul and the electronic cigarette manufacturers will experience the backlash sooner than they would have liked. Tobacco control experts are divided on whether companies can survive the process. Gottlieb, who made the crackdown on vaping companies a benchmark of his two-year tenure prior to his resignation in April, speculated on CNBC last month that Juul would have trouble getting his products approved. He was receiving a 10 month delay due to the unsavory conditions of the company. history of the use of youth. A CDC report found that more than one in five high school students and about 5% of college students were using electronic cigarettes in 2018, up 11.7% and 3.3% last year.
Gottlieb's statements have sparked significant interest in the tobacco control community, said Eric Lindblom, an FDA official under the Obama administration. Lindblom, who runs the tobacco control program at Georgetown Law, says the hurdle might be easier: what Juul needs to do is prove that he has changed. "The trick for Juul is to say," we have our product, we have reconfigured it, we are going to market it in a totally different way. "
Juul, more than other electronic cigarette manufacturers, has voluntarily complied with the FDA's marketing, Lindblom said. The company, which had attracted early criticism for its seemingly teen-based marketing, closed its Facebook and Instagram accounts last November.
The success of the application will depend on a company's ability to prove that its e-cigarette products bring more benefits than damages to public health. Some tobacco control experts do not think Juul can do it. "For the FDA to see that Juul's products have an advantage, all the damage they have done to youth initiation should be erased by benefits for adult users – and that's simply not the case, "Jenson said.
FDA approval is only the first step towards sufficient regulation of the e-cigarette industry, experts confirmed. According to Jenson, sales on the Internet remain poorly regulated, while Lindblom pointed out that the problem of youth vaping could be solved by nicotine reduction and a ban on flavored vaping. "I would not hold your breath while waiting for one of these rules," Lindblom said.
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Juul products would be completely removed from the market if the company's application to the FDA prior to its marketing was not approved.
ASSOCIATED PRESS
For years, Juul and his competitors have been operating an electronic cigarette market without FDA approval. This will end in May, when electronic cigarette manufacturers will have a new shortened deadline for submitting their applications for market approval.
The Food and Drug Administration had previously set a 2022 deadline for companies to submit applications explaining why they should be able to continue selling e-cigarette products. A strong increase in vaping among young people has prompted the FDA to propose reducing the time of one year. This was not enough for a multitude of anti-smoking groups, whose lawsuit against the FDA resulted in a court order issued Friday by US District Judge Paul Grimm in Maryland.
During the trial, the judge criticized both the FDA and the electronic cigarette sector, the first for allowing companies to illegally sell unapproved e-cigarettes. The industry has always been dodging federal regulations, which has created a "public health emergency," wrote Grimm.
The FDA is ready to use "all available regulatory tools" to prevent youth vaping, said Acting Commissioner Ned Sharpless in a statement released Monday. Grimm, in his order, clearly stated that the FDA's tools were not enough to attract the manufacturers of electronic cigarettes. The industry had managed to put in place regulations "deliberately avoiding" "despite the FDA's orders," he wrote.
Successful companies should have no reason to deplore the new deadline given their "big handbags" and the years they have had to voluntarily submit applications, wrote Grimm. Juul, which according to the Nielsen market study, would control three-quarters of the US e-cigarette market, rises to $ 38 billion after Altria's 35% equity stake in the company in December latest.
Juul is confident in the "content and quality" of its planned application, said company spokesman Ted Kwong Forbes. "More and more evidence, as well as our leading actions in the sector to fight against the access and use of minors, will allow adult smokers to continue to have a real alternative to cigarettes, the leading cause of preventable death in the world. "
Until 2016, electronic cigarettes could freely enter the market without prior authorization for sale. The FDA has announced its presumption rule that May has expanded its regulatory jurisdiction over tobacco products to include electronic cigarettes and anti-vaping pens as well. The policy provided for the requirement for existing electronic cigarette manufacturers to submit their applications by 2018, but the then FDA Commissioner, Scott Gottlieb, extended the time limit until the end of the year. in 2022.
The court order dismisses the FDA review process. The agency proposed the ten-month deadline itself, but did so only as part of the lawsuit: the anti-smoking plaintiffs suggested four months. In its previous actions in regulating electronic cigarettes, the FDA had considered "as far as an organization can go to industry," said Desmond Jenson, a lawyer at the Public Health Law Center (Public Health Law). Center), which focuses on tobacco control policy. Jenson said the reduced time should not surprise Juul and his rivals because "the specter of pre-market review has always been imminent".
Former FDA chief Gottlieb doubts the chances of Juul
Nevertheless, Juul and the electronic cigarette manufacturers will experience the backlash sooner than they would have liked. Tobacco control experts are divided on whether companies can survive the process. Gottlieb, who made the crackdown on vaping companies a benchmark of his two-year tenure prior to his resignation in April, speculated on CNBC last month that Juul would have trouble getting his products approved. He was receiving a 10 month delay due to unsavory conditions history of youth use. A CDC report revealed that more than one in five high school students and about 5% of college students were using electronic cigarettes in 2018, compared to 11.7% and 3.3% the year before.
Gottlieb's statements have sparked significant interest in the tobacco control community, said Eric Lindblom, an FDA official under the Obama administration. Lindblom, who runs the tobacco control program at Georgetown Law, says the hurdle might be easier: what Juul needs to do is prove that he has changed. "The trick for Juul is to say," we have our product, we have reconfigured it, we are going to market it in a totally different way. "
Juul, more than other electronic cigarette manufacturers, has voluntarily complied with the FDA's marketing, Lindblom said. The company, which had attracted early criticism for its seemingly teen-based marketing, closed its Facebook and Instagram accounts last November.
The success of the application will depend on a company's ability to prove that its e-cigarette products bring more benefits than damages to public health. Some tobacco control experts do not think Juul can do it. "For the FDA to see that Juul's products have an advantage, all the damage they have done to youth initiation should be erased by benefits for adult users – and that's simply not the case, "Jenson said.
FDA approval is only the first step towards sufficient regulation of the e-cigarette industry, experts confirmed. According to Jenson, Internet sales remain poorly regulated, while Lindblom pointed out that the problem of vaping in young people could be solved by nicotine reduction and a ban on flavored spraying.
