The U.S. Food and Drug Administration on Thursday blocked Juul Labs Inc. from selling its e-cigarettes in the United States.
After a nearly two-year-long review of scientific and public-health data submitted by the company, the FDA said the applications “lacked sufficient evidence” to show that sale of the products would be appropriate for public health.
What are Juul e-cigarettes?
Juul is a popular brand of vaporizer, also sometimes called e-cigarette. The devices have a reservoir that contains a liquid solution, which Health Canada says most often contains nicotine and is flavoured.
Devices use battery power to heat the solution, causing vaporization. The vapour then condenses into an aerosol, which is breathed in by the user through the mouthpiece. The devices come in many shapes, colours and sizes, with most Juul products looking like small USB drives.
Why is Juul being banned?
In the U.S., Juul and other e-cigarette brands had to meet a September, 2020 deadline to file applications to the FDA showing the products provided a net benefit to public health. The FDA had to judge whether each product was effective in getting smokers to quit and, if so, whether the benefits to smokers outweighed the potential health damage to new e-cigarette users – including teenagers – who never smoked.
“The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize … many have played a disproportionate role in the rise in youth vaping,” FDA Commissioner Robert Califf said in a statement.
Teenage use of e-cigarettes surged with the rise in popularity of Juul in 2017 and 2018. Its use among high-school students grew to 27.5 per cent in 2019 from 11.7 per cent in 2017, but fell to 11.3 per cent in 2021, a federal survey showed.
Juul did not provide evidence to show that the products were up to its standards and that raised “significant questions,” the FDA said, but added it has so far not received clinical information to suggest an immediate hazard tied to the device or pods.
What are the current rules in Canada for e-cigarettes?
A report from the Public Health Agency of Canada says that prior to May, 2018, Canada had a highly restrictive regulatory framework for e-cigarettes: nicotine-containing vaping products could not be sold or marketed without premarket approval. However, as of May of that year, the Tobacco and Vaping Products Act (TVPA) permitted the sale of nicotine-containing e-cigarettes, as well as greater advertising and promotion. The e-cigarette market experienced rapid change after implementation of the TVPA, including the introduction of major international brands such as Juul and Vype/Vuse.
Currently, Canada restricts how vaping products are marketed, who they are sold to, and how much nicotine can be allowed in the products.
Vaping products can’t be sold or given to anyone under 18 years of age, and vaping products that appeal to youth with certain youth-friendly flavours are not allowed to be sold. In June, 2021, Canada announced plans to restrict flavours like ice cream, cookie dough and candy in vaping products, confining flavours to tobacco, mint and menthol. Those regulations have not yet come into effect.
In July, 2021, the Nicotine Concentration in Vaping Products Regulations set a maximum nicotine concentration of 20 mg/ml for vaping products marketed in Canada and prohibited the packaging and sale of vaping products if the nicotine concentration stated on the package exceeds that amount. This change was in line with regulations in B.C. and the European Union. By way of comparison, a cigarette contains 10mg of nicotine on average.
Is vaping harmful?
Health Canada says vaping can increase exposure to chemicals that can harm your health, and expose you to nicotine, which is addictive. Nicotine does not cause cancer, but vaping with nicotine can lead to dependence and “cause nicotine addiction among users who would not have started using nicotine otherwise.” Nicotine can affect memory and concentration and is known to alter teen brain development by reducing impulse control and contributing to cognitive and behavioural problems.
Vaping could also lead to nicotine poisoning and “popcorn lung” from the chemical diacetyl, used to give a butterlike flavour to food and vaping products.
Why is vaping particularly appealing to teenagers?
A Globe and Mail investigation in 2019 found that companies advertising vaping products were targeting teens with lifestyle advertising or kid-friendly flavours and getting the help of social-media influencers and viral marketing.
Today, public-health groups in the U.S. cheered the decision to ban the sale of Juul products, after warning that e-cigarettes were getting a new generation of teenagers hooked on nicotine after major strides in reducing youth cigarette use.
According to the 2018-2019 Canadian Student Tobacco, Alcohol and Drugs Survey, the prevalence of vaping among students doubled since 2016-17. Twenty per cent of students had used an e-cigarette (with or without nicotine) in the previous 30 days, up 10 per cent from 2016-17.
What does the FDA decision mean for Juul’s stock?
The stock for Altria Group (MO-N), which holds a 35-per-cent stake in Juul dropped 9 per cent on Wednesday. The decline came after a report stating that the FDA was readying to order Juul to pull its vapour products off the market. Marty Shtrubel of TipRanks reports that Juul can appeal the decision, but in any case, the products will be taken off the shelves immediately. Juul claims almost 26 per cent of vapour market share and is second only to BAT’s Vuse products.
With reports from Reuters
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