E-cigarette manufacturers face an existential danger. They must prove to the U.S. Food and Drug Administration that their products are beneficial to public health by May. The FDA can order a company to remove its product from the market if it fails to prove its case.
The agency will evaluate this benefit using a two-part assessment: Can e-cigarettes help smokers quit? If so, is this benefit greater than the harm caused to the health of new e-cigarette users, including teenagers, who have never smoked before?
According to a Reuters’ analysis of the most recent data available from the U.S. Centers for Disease Control and Prevention on trends in cigarette and e-cigarette use, this is a high hurdle for Juul Labs Inc.
Data shows that e-cigarettes have little effect on reducing U.S. smoking. The growth in vaping has been driven by users younger than 25 years, including teenagers. These trends are a problem for Juul because it dominates the U.S. tobacco market and is extremely popular among teenagers. More than a dozen tobacco researchers and doctors who evaluated the data on RReuters ‘behalf said that these trends pose a particular challenge to Juul.
Suzanne Colby said, “do not see it as an insurmountable obstacle” when referring to the FDA standard on public health benefits. The data shows that their product is attracting youth in greater numbers than adults.
According to the CDC, between 2017 and 2018, the period during which Juul grew rapidly to become the U.S. leader in the e-cigarette market, e-cigarette usage among the U.S. adult population grew from 2.8 to 3.2 percent. The CDC says that the rate of adult cigarette smokers barely changed, falling from 14 to 13.7 percent. This is not statistically significant. For a graph showing the vaping trends in different age groups, please see Here.
The use of e-cigarettes among high-school students has increased by 78 percent in the same period, from 11.7 to 20.8 percent of students. Data from the CDC & FDA shows this. Juul is the most popular e-cigarette brand among teens. In surveys conducted by the CDC or FDA, more than half of students in high school and middle schools named it their favorite.
The CDC statistics show that the use of e-cigarettes by adults has grown the most among those aged 18-24. The CDC statistics show that e-cigarettes are used by young adults four times as often as those aged 45-64.
The large number of dual users is another factor that undermines the case for cigarettes in terms of public health. According to the most recent federal statistics, 41 percent of adult users continue smoking cigarettes while using e-cigarettes.
Some studies suggest that dual use is more harmful than just smoking. In a survey conducted in December, people who use both products were found to have higher levels of volatile organic compounds (VOCs) and other toxins linked with tobacco-related diseases. In a separate study conducted last year, dual use of e-cigarettes was found to be ” more harmful than using either product by itself.”Brian King, a CDC deputy director in the Office on Smoking and Health, stated that the data for the industry casts serious doubts on the benefits of e-cigarettes among adult smokers.
“you have to look at both ends when it comes to the net impact on public health,” King said. Right now, it appears that youth use is greater than adult use.
Juul declined interviews with its executives, including CEO K.C. Crosthwait,e who was a Marlboro maker Altria Group Inc. veteran and took over the company in September, and spoke about how the company plans to pass regulatory tests. Crosthwaite, who took over the company in September, has set the FDA application as a priority. He laid off 650 workers, many of whom were in marketing, in order to restructure it and focus on regulatory approval.
According to written answers to questions by Reuters, Juul believes that its products are “already playing a crucial role in transitioning adults from combustible tobacco cigarettes and have the potential to convert tens of millions of smokers” in the U.S. The company cited commissioned studies showing between 30 to 50 percent of adult smokers using Juul “witch entirely from smoking cigarettes in six months.”Juul said that its customers were “the 1 billion smokers of the world,” but did not directly address questions regarding the disparity between youth and adult adoption in the United States. Juul has acknowledged that it must consider the impact of e-cigarettes on nonsmokers. It stated that it was “committed” to working with regulators, health officials, and other stakeholders in order to convert adult smokers and combat underage smoking.
Crosthwaite hired Joe Murillo in October to help him navigate a successful FDA submission for IQOS. Phillip Morris International Inc. and heats manufactures this product but does not burn tobacco packages. Altria and Philip Morris have an agreement to market IQOS within the United States. IQOS is only one of two tobacco products to have passed the FDA approval process.
Competitors in the U.S. marketplace face the same regulatory challenges. Japan Tobacco International says that it has confidence in the FDA application for its Logic product line it submitted in August because the data contained in it shows the brand is used overwhelmingly among older adults, unlike Juul.
Anthony Hemsley is an executive with Japan Tobacco International’s U.S. Division. He acknowledged that a large population uses e-cigarettes and cigarettes. Hemsley did point out, however, that the FDA will make its decision about net public health benefits on a per-product basis and not for the entire industry. He said that Juul faces a “significant challenge in overcoming concerns that are out there.”
The FDA has declined to interview Mitch Zelle,r who is the head of tobacco regulation for the agency. He was asked about their oversight of electronic cigarettes. The FDA did not address population-level trends in smoking or vaping directly when answering questions. However, it said that they are “asked” to “threading a needle of public health” to craft regulations for e-cigarette companies.
In a November investigation by Reuters, it was revealed that developers had used tobacco industry patents and research to create its potent but smooth “nicotine-salts” liquid nicotine blend. This is a major factor in JJuul’s popularity among teenagers. The report revealed that company leaders knew about the product’s popularity with teenagers shortly after its launch in 2015. This contradicts statements that Juul had been caught by surprise last year.
Scott Gottlieb, former FDA commissioner, told Reuters he agreed that benefits for cigarette users are outweighed by the fact that it attracts children who would not have otherwise tried other tobacco products. Gottlieb and his staff considered the possibility of stopping sales of Juu and other high-nicotine products if teens continued to use them.
He said, “We could remove these products from the market tomorrow.”““” We need applications.”For a graph tracking the growth of vaping amid regulatory delay, please see Here.
Juul and the FDA have not responded to questions regarding GGottlieb’s assertions that the FDA should remove Juul and similar products from the market immediately.
The FDA is under increasing pressure.
E-cigarettes have been available in the United States since 2007, but the FDA didn’t gain formal authority over the industry for nine years, in 2016.
Initially, the agency tried to regulate electronic cigarettes as drugs, which would have imposed more stringent requirements on e-cigarette companies, such as extensive animal testing or clinical trials. E-cigarette manufacturers sued the FDA and won. The agency now regulates the devices as tobacco products.
FDA officials began drafting a regulation to regulate electronic cigarettes in 2011. However, the industry successfully fought back and delayed the rule till May 2016, the last months of President Barack Obama’s administration. Juul, along with dozens of other competitors, introduced products into the market that were grandfathered in because they had already been sold before the rule took effect.
The rule extended some cigarette restrictions to electronic cigarettes, such as requiring health warning labels, setting an age minimum of 18 for sales, and prohibiting free samples.
The new rule required that e-cigarette manufacturers submit their applications by August 2018, demonstrating how their products benefit the public, along with data and studies on the potential toxins of the products.
Gottlieb, who was appointed to head the agency by Donald Trump in 2017, delayed that deadline for four years. This was a move that public health advocates criticized. Only a few months later, school officials, parents, and politicians began to raise alarms over the rapid growth of vaping among teenagers, especially those who were captivated by the Juul device.
After a three-month deal, some public health advocates were concerned about the commitment of the new administration to the Obama-era rules, especially as the FDA was facing litigation from the industry. Gottlieb refused to comment on the question of whether some members of the administration were trying to kill the Obama-era regulations. Still, he said that his efforts to move them forward had been ” ot an easy process.”
He said, ” hey, wwould’vesued me, and I wwould’velost.”Gottlieb stated that the FDA could and should remove Juul and similar products from the marketplace today.
He said, ” thought the agency would be located there.”Gottlieb, shortly before leaving the FDA, said in March that the FDA would consider banning the sale of cartridge-based electronic cigarettes like Juul if teenage usage rates increased for the second consecutive year. In September, federal youth tobacco survey results showed that teen usage was on the rise. The percentage of teens reporting that they had used e-cigarettes in the past 30 days grew from almost 21 percent to over 27 percent.
The FDA released a statement in which it said that they have sent over 1,100 letters of warning to retailers who sell to minors. They also issued letters to companies selling teen-friendly electronic cigarettes, like those with sweet flavors, and have launched campaigns to prevent e-cigarette use among students.
The agency stated that “taken together, these efforts have had an extensive impact” on the manufacture, marketing, and sale of e-cigarettes. The FFDA’s efforts to keep these products away from children are constant.