June 21, 2024

• 51 months from submission to authorization

June 21, 2024

• 51 months from submission to authorization

The authorization of the NJOY ACE Menthol APPH designation was based on several key considerations, as outlined in the TPL document:

• The PMTAs contained sufficient evidence to show that the new products have the potential to benefit adults who smoke combustible cigarettes (CC) and who switch completely or significantly reduce their CC use p. 8.

• The applicant proposed robust marketing plans that include restrictions beyond those required with PMTA authorization, such as limiting youth exposure to the new products by not engaging in social media promotions, using models over the age of 45 in marketing materials, and prohibiting the sale of NJOY ACE ENDS on third-party websites p. 8.

• The scientific review found that the new products' aerosols have fewer harmful and potentially harmful constituents (HPHCs) than CC mainstream smoke, and many of the HPHCs present in the aerosols have comparatively lower potencies than those present in CC smoke p. 16.

• The applicant submitted brand-specific data from an online, observational study that contained evidence to suggest that the menthol-flavored new products will promote switching or CC reduction among adults who smoke CC relative to tobacco-flavored ENDS p. 37.

• The TPL concluded that the PMTAs contain sufficient evidence demonstrating that the menthol-flavored new products have the potential to benefit adults who smoke CC, who switch completely or significantly reduce their CC use, that outweighs the risk to youth p. 41.

These points collectively contributed to the rationale behind the authorization of the NJOY ACE Menthol APPH designation.

The NJOY Daily Menthol product was deemed appropriate for the protection of public health (APPH) based on the evidence provided in the premarket tobacco product application (PMTA) and other scientific data. The review found that the new products have the potential to benefit adults who smoke combustible cigarettes (CC) and who switch completely or significantly reduce their CC use. The applicant proposed robust marketing plans that include restrictions beyond those required with PMTA authorization, which were determined to help further limit youth exposure to the new products and the potential for youth initiation. Additionally, the review concluded that the new products are associated with significantly higher smoking cessation rates than tobacco-flavored NJOY Daily products, and the added benefit of these new products to adults was found to be highly beneficial to public health p. 9, p. 44, p. 45, p. 61.