On Friday, the Food and Drug Administration granted authorization for menthol-flavored electronic cigarettes to be sold to adult smokers. This marks the first occasion in which the agency has allowed vaping companies to market non-tobacco flavored products.
Recently, the FDA granted clearance to Njoy, a vaping brand that was recently acquired by tobacco giant Altria, to market four menthol e-cigarettes. However, regulators also stated that they would be reviewing applications for authorization of flavored e-cigarettes on a case-by-case basis. It is important to note that the FDA’s actions only apply to Njoy’s four products.
The FDA declared that menthol-flavored e-cigarettes could potentially decrease the risks associated with traditional tobacco smoking. However, it’s important to note that the authorization does not imply approval of menthol vaping products, as this would entail a thorough evaluation of the product’s safety and effectiveness for its intended use. Rather, the FDA’s authorization signifies that Njoy has met the regulatory requirements to market its products to the public.
Matthew Farrelly, director for the FDA’s Center for Tobacco Products, stated that their agency relies on data and science to evaluate premarket tobacco applications. He emphasized that their scientific review is thorough and evidence-based. In this case, the benefits of completely switching to a less harmful product for adult smokers outweighed the risks to youth. The agency remains committed to following the science in their future decisions.
Vaping companies’ assertion that their products can aid in reducing the harmful effects of smoking has gained further validation with this decision. Smoking is responsible for a staggering 480,000 deaths in the United States every year, primarily due to lung disease, heart disease, and cancer.
The decision to allow the sale of menthol and other flavored tobacco products has drawn swift criticism from parent groups and anti-tobacco advocates. They have been advocating for years to keep such products off the market, as they can easily attract teenagers.
Meredith Berkman, co-founder of Parents Against Vaping E-cigarettes, expressed concern about the decision, stating that it may result in the youth vaping epidemic becoming uncontrollable. She feels that the FDA has let down American families by permitting the e-cigarette industry to exploit the next generation of loyal customers, namely America’s children. According to Berkman, this is a predatory move that will have long-term negative consequences on the health of young people.
Over the past few years, there has been a decline in youth vaping, which had previously reached all-time highs. Last year, only about 10% of high schoolers reported using e-cigarettes. Among those who vaped, 90% used flavored e-cigarettes, including menthol.
Young people who vape are not commonly using tobacco, which is the only type of e-cigarette that has been authorized by the FDA thus far.
Only three companies, including Njoy, have been granted FDA approval for vaping products. The menthol options are available in the form of cartridges that can be inserted into a reusable vaping device. These cartridges contain liquid nicotine that is heated to produce an inhalable aerosol.
According to Nielsen’s retail data, Njoy’s products only made up for less than 3% of e-cigarette sales in the US within the past year. Reynolds American’s Vuse and Juul dominate the market with approximately 60% of the market share, while the remaining percentage is comprised of numerous disposable brands.
A majority of teenagers who engage in vaping tend to opt for disposable e-cigarettes, with popular brands like Elf Bar offering an array of flavors like watermelon and blueberry ice.
As part of the FDA’s comprehensive review to apply scientific scrutiny to the multibillion-dollar vaping market, the Njoy has received approval. Despite being technically illegal, thousands of fruit- and candy-flavored vapes are readily available in convenience stores, gas stations, and vape shops across the U.S.