The Food & Drug Administration (FDA) decided to ban the popular vape product Juul and issued a marketing denial order (MDO) to JUUL Labs Inc. for all its products currently marketed in the United States. That’s a long-winded way of saying the products are now banned. The company must stop selling and distributing these products. The ban doesn’t mean that people who continue to use Juuls or have them in their possession will get into trouble, the product just can’t be sold.
In addition, those currently on the U.S. market must be removed or risk enforcement action. The products include the JUUL device and four types of JUULpods: Virginia tobacco-flavoured pods at nicotine concentrations of 5.0% and 3.0% and menthol-flavoured pods at nicotine concentrations of 5.0% and 3.0%.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf, M.D. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products, and many have played a disproportionate role in the rise in youth vaping.”
What triggered the FDA response was the company’s lack of data regarding the toxicological profile of the products. “In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.”
Cannabis Industry Worries
Vaping products in the cannabis industry are hugely popular, so the ban has attracted a great deal of attention among producers. Seattle-based data-analytics firm Headset recently reported that vapes were the second-largest category by revenue behind flowers in the U.S. cannabis market during 2020 and 2021. The category logged nearly $2.6 billion in retail sales across six adult-use markets last year. Vape pens are also growing, with sales rising 28% in 2021. Despite the sustainability issues, disposable vapes are proving to be very popular and are increasing by 64%. This is likely because disposable vape products tend to be cheaper.
Arun Kurichety, chief operating officer and general counsel of Petalfast, said, “ While the FDA’s decision to prohibit Juul from marketing its products in the U.S. does not directly impact the cannabis industry, it suggests we may continue to expect scrutiny on all vaping products — nicotine and cannabis alike. For licensed businesses in the highly regulated cannabis industry, this shouldn’t be huge news. Rather than prohibition, this further highlights the need for consumer education regarding the risks of obtaining vape products in the illicit markets where product testing for safety is non-existent.”
E-cigarettes were initially hailed as an effective way for nicotine-addicted consumers to inhale with fewer terrible side effects. Tobacco companies all created versions for their tobacco-smoking customers with limited success. Yet, when Juul began marketing cotton candy-flavoured nicotine vapes, teens and young adults swarmed the products. Instead of helping already addicted adults, it created a whole new generation of Juul-addicted consumers. Parents complained, and the FDA jumped in to address the situation. At first, it was just a clamp down on the flavours, but now it is banning the entire product line.
Cannabis vapes also proved to be an excellent option for consumers who didn’t want to smoke regular flowers. Cannabis vapes were discreet, easy to carry, and didn’t create the distinct smell that burned flowers did. They could be expensive, but cannabis consumers were willing to spend money for the convenience of being able to pop a vape in their pocket and ramble on.
Arnaud Dumas de Rauly, CEO and co-founder of the Blinc Group, said, “If the FDA took the time to look at the science surrounding vaping instead of having knee-jerk reactions to statistics over youth consumption, they would see that vaping has been beneficial to countless individuals looking to quit smoking. For years, the European markets have embraced vape as such a necessary tool for the cessation of smoking that they offer health insurance breaks to those who vape.”
He went on to add, “If you look down the road to what this decision could mean for the cannabis vape industry, the federal illegality of cannabis will keep the space safe for now since the FDA is unwilling to regulate the industry while it remains a schedule one drug. However, this doesn’t mean that will be the case forever. I would hope when that time comes that, the FDA will recognize that vaping is considered one of the safest consumption methods, particularly for medical patients who are looking for the purest stream of cannabinoids and terpenes. The absence of combustion means fewer hazardous substances and easier on the lungs.”
A Post-Juul World
One company that the trouble has already hit in the Juul market is Greenlane (NASDAQ: GNLN). At one point in 2019, Greenlane was selling almost $50 million worth of Juul products. With the first ban on flavoured products, sales fell over 30% to $33 million in 2020. This week, Greenlane noted that it was selling off assets to generate cash. The company has been weaning itself off its Juul dependence, but $50 million is a significant number to make up elsewhere.
In Closing
Juul has said it will appeal the ban and try to keep its products on the shelves while it fights the prohibition. Cannabis vapes may fail purely because the FDA can’t decide what to do about the federally illegal product. Since the FDA can’t seem to decide on CBD products, tackling cannabis vape pens seems unlikely. Cannabis consumers haven’t been complaining about the product, as evidenced by the growing sales. As Dumas noted, the FDA mainly was reacting to angry parents of Juul-addicted teens. In the cannabis industry, not many people are complaining and that seems to have kept the product off the radar for now.
Disclaimer: https://www.greenmarketreport.com/fda-juul-ban-has-cannabis-producers-on-alert
Posted by: Times Of Hemp, TOH, #TOH, #TimesOfHemp, https://www.timesofhemp.com