FDA ban on Juul vaping devices, pods pending as company calls

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  • After the Food and Drug Administration banned Juul’s vaping devices and flavored pods, the company asked a federal court to extend the suspension of the ban.
  • The FDA’s ban on Juul products is part of the agency’s effort to regulate the multi-billion dollar vaping industry.
  • According to the Centers for Disease Control and Prevention the vapor from e-cigs may contain potentially harmful substances such as nicotine, lead and other heavy metals.

Vaping company Juul Labs, Inc. on June 28 asked a federal court to extend the temporary suspension of the Food and Drug Administration’s (FDA) ban on its e-cigarettes and flavored pods.

The FDA said the previous week that the company’s marketing authorization application provided “insufficient and conflicting data” on the risks of its product, including whether “potentially harmful chemicals” could leak from e-pods liquid.

As a result, the FDA ordered the San Francisco-based company to stop selling its vaping device and tobacco-menthol flavored pods.

Dr Nino Paichadzeassistant research professor at George Washington University’s Milken Institute School of Public Health, said the agency’s decision was an important step for public health.

“Given the harm that e-cigarettes cause in young people and adolescents, and the potential to lead to many health problems in adulthood, this is important,” she said.

The ban, however, was short-lived.

A Federal Court of Appeals for the District of Columbia Circuit temporarily blocked FDA ban on June 24 after Juul filed an emergency motion seeking a stay while appealing the agency’s decision.

The following Tuesday, Juul filed a motion with the same court to extend the stay.

In its filing, the company said the FDA overlooked 6,000 pages of data on aerosols created when the liquid in the pods is heated by the vaping device, reports CNBC.

The FDA’s ban on Juul products is part of the agency’s effort to regulate the multi-billion dollar vaping industry based on scientific evidence – the same way it regulates the pharmaceutical and device industries. medical.

For a company to keep its vaping products on the market, it must demonstrate that the benefits to the public outweigh the risks.

Possible benefits of e-cigarettes include helping smokers quit using tobacco products altogether or simply encouraging them to switch to vaping, which may reduce their health risks.

The vapor generated by e-cigarettes contains fewer toxic chemicals than the mixture of over 7,000 chemicals in the smoke of ordinary cigarettes. But that doesn’t mean e-cigarette vapor is completely harmless.

According to the Centers for Disease Control and Prevention, this steam may contain potentially harmful substances such as nicotine, lead and other heavy metals, organic compounds and chemicals that cause cancer.

Researchers are also concerned that particles in e-cigarette vapor could cause inflammation and damage to the lungs.

Another potential risk of e-cigarettes is that children and adolescents become addicted to them.

“Not only are these products immediately harmful to the health of the individual who consumes them,” said Dr Adnan Hyderprofessor of global health at George Washington University’s Milken Institute School of Public Health, “but they also increase the likelihood that people will become addicted to substances like tobacco and nicotine, especially young people and adolescents.”

Moreover, some to research suggests that e-cigarette use among adolescents may increase the risk that they will start smoking as adults.

“So it’s not just about health today, it’s also about the future of public health,” Hyder said.

Experts say vaping companies have targeted young people with kid-friendly marketing and vaping flavors such as fruit and dessert.

“When you have companies that make e-cigarette flavors like cotton candy and gummy bear, there’s no motive other than to get young kids hooked on those products,” he said. Hyder.

In response to these concerns, in 2020 the FDA banned the sale of electronic cigarettes based on flavored cartridges — other than menthol and tobacco flavors.

However, before that, Juul used candy and fruit flavors, along with its high nicotine e-liquid and sleek design, to gain a large share of the US vaping market, including young people.

In a study published online May 30 in the journal PediatricsResearchers from the University of California, San Diego found that in 2017, e-cigarette sales increased by 40% in the United States, thanks to Juul products.

As a result, many of the new users were young people – 64.6% of the increase in 2017 was among 14 to 17 year olds, according to the researchers.

They also estimated that around 600,000 people under the age of 21 used Juul products daily in 2019, which is 2.5 times the rate of 25-34 year olds.

“There was very little evidence that smokers were using Juul to try to quit, and there was a ton of evidence that 14 to 17 year olds were becoming addicted,” the study author said. John Pierce, Ph.D.Distinguished Professor Emeritus in the UC San Diego Herbert Wertheim School of Public Health and Human Longevity.

Since the FDA began reviewing premarket applications for e-cigarettes, the agency has cleared two more companies – RJ Reynolds and Logic — to market their e-cigarettes in the United States.

While this allows these companies to sell their products, the agency stressed that it “does not mean that these products are safe”.

“[E-cigarette companies] have not proven that their products are harmless,” Pierce said. “In fact, the more data we get on these products, the more we worry about future health consequences.”

He cites studies by other UCSD researchers that found e-cigarettes can cause inflammation and damage to the lungswith flavored electronic cigarettes also implicated in this health risk.

“All the evidence we see is that we’re going to have a lot of disease down the road,” Pierce said. “Remember, it took 20 years or more to identify that smoking caused lung cancer.”

Although the FDA has allowed two e-cigarette companies to sell their products in the United States, that could change if new data shows that vaping is more harmful than scientists currently believe.

Tobacco control experts say this kind of scientific evidence is needed not only to show the risks of vaping, but also to provide the public with accurate information about those risks.

“What’s critical is that we have really good research evidence coming from the public health community and reaching the public,” Paichadze said, “versus the so-called research that the drug industry tobacco finances itself in order to influence consumers or [regulatory] decision making.”

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