FDA Grants PMTA Approval to Four NJOY Ace E-Cigarette Products

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has approved four NJOY Ace e-cigarette products via its premarket tobacco product application (PMTA) pathway. The approved products are the NJOY Ace Device; NJOY Ace Pod Classic Tobacco 2.4%; NJOY Ace Pod Classic Tobacco 5%; and NJOY Ace Pod Rich Tobacco 5%.

The authorization allow these products to be legally marketed in the United States. However, the FDA cautioned that although this action permits these specific products to be sold in the U.S., it does not mean these products are safe, nor are they "FDA approved."

Under the PMTA pathway, the applicant must demonstrate to the agency that marketing of the new tobacco product would be appropriate for the protection of the public health.

"The authorized NJOY products were found to meet this standard because, among several key considerations, chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke," stated the FDA. "Further, data provided by the applicant demonstrated that participants who had used only the authorized NJOY Ace products had lower levels of exposure to HPHCs compared to the dual users of the new products and combusted cigarettes. Therefore, these products have the potential to benefit adult smokers who switch completely or significantly reduce their cigarette consumption."

Additionally, the FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, and importantly, youth, the government agency stated.

"This included review of available data on the likelihood of use of the product by young people," wrote the FDA. "For the authorized products, the FDA determined that the potential benefit to adult smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided that the company follows post-marketing requirements to reduce youth access and youth exposure to their marketing."

The FDA stressed this authorization imposes strict marketing restrictions on NJOY to greatly reduce the potential for youth exposure to tobacco advertising for these products.

"The FDA will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers — including youth — using these products," the agency stated.

The FDA did also issued marketing denial orders to NJOY for other Ace e-cigarette products. Applications for two menthol-flavored Ace e-liquid pods remain under FDA review.

The FDA could suspend or withdraw a marketing granted order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product is no longer "appropriate for the protection of the public health," such as if there is a notable increase in youth initiation.

In an investor note written by Jefferies, the financial firm stated the FDA approvals provide a "boost for tobacco sentiment."

"With recent IMB rejections, there was likely investor caution that other pod vapes could be denied. With NJOY approved, we are now even more confident we will also see BAT's Alto and Juul both given the go ahead. More broadly, we think these PMTA's could also prove to be a key catalyst for industry multiples overall," wrote Jefferies.