By Amie Dahnke
The U.S. Food and Drug Administration (FDA) on Friday gave the green light for NJOY LLC to bring its four menthol-flavored e-cigarette products to market in the United States.
“Today’s authorizations mark the first non-tobacco flavored e-cigarette products to be authorized by the FDA,” the FDA wrote in its press release.
“Based upon our rigorous scientific review, in this instance, the strength of evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth,” said Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products.
The approved products include the NJOY Ace Pod Menthol 2.4%, NJOY Ace Pod Menthol 5%, NJOY Daily Menthol 4.5%, and NJOY Daily Menthol 6%.
The Ace products are prefilled, non-refillable e-cigarette vape fluid carriers, called pods, that are to be used with already authorized Ace vaping devices, while the Daily products are prefilled, non-refillable disposable e-cigarettes.
NJOY is an e-cigarette company based out of Scottsdale, Arizona, and was one of the first companies to sell e-cigarettes in the United States.
The company was initially highly successful with its NJOY KING, a disposable e-cigarette that looked like a cigarette. It received its first FDA approval to market e-cigarettes in 2022.
Limiting Youth Intake
The agency highlighted that its approval is specific to the four products, and “the authorizations do not apply to any other menthol-flavored e-cigarette products.”
Since early 2020, to prevent youth consumption, the FDA enforced a temporary measure that banned the sale of all flavored e-cigarettes with the exception of menthol and tobacco.
The FDA added that it still remains concerned about the risk that e-cigarette use poses to American youth, particularly flavored e-cigarettes.
The agency said that it will continue to monitor how NJOY’s products are marketed and will take action if the company fails to comply with any applicable rules or regulations, including suspending or withdrawing authorization if the marketing or advertising is no longer appropriate for the protection of the public health.
“It is the responsibility of the applicant to provide the necessary evidence to obtain marketing authorization, and the FDA has made clear what’s needed to successfully achieve that outcome,” said Brian King, director of the FDA’s Center for Tobacco Products.
“This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it.”
According to the U.S. Centers for Disease Control and Prevention, e-cigarettes were the most commonly used tobacco products among middle and high students in the United States, with 2.1 million student users.
E-cigarettes are believed to be a healthier alternative to smoking since their aerosols contain fewer contaminants than cigarette smoke. Nevertheless, e-cigarette use has been linked with several health risks.
E-cigarettes expose people to nicotine, the same addictive drug that is present in tobacco. Nicotine can increase blood pressure and harden artery walls.
Inhalation of nicotine can cause coughing, mouth and throat irritation, heartburn, and indigestion. Frequent e-cigarette use has been linked to alteration to the outer eye surface and can impair vision.
