We believe a marketplace of FDA-authorized, smoke-free alternatives that appeal to adult smokers presents a significant public health opportunity to reduce the harm caused by combustible tobacco products.
Where We Stand: Flavors in Smoke-free Products
Tobacco harm reduction requires adult smoker access to appealing and satisfying smoke-free tobacco products. Published data demonstrate that flavors are critical in adult smokers' trial and adoption of smoke-free products. To advance tobacco harm reduction, it is imperative to create a diverse marketplace of products to meet adult smokers' preferences.
As part of a Premarket Tobacco Product Application (PMTA), manufacturers must provide data and evidence, including related to flavors, to support marketing authorization for a new product and to demonstrate that marketing the product is "appropriate for the protection of public health" as required under the Tobacco Control Act. This rigorous review considers both tobacco consumers and non-tobacco consumers, including increased likelihood of adult smokers switching products completely and risks of non-users initiating tobacco product use.
Manufacturers of products on the market as of August 8, 2016 had to submit pre-market applications by September 9, 2020 to remain on the market pending a 1-year FDA review period.
On September 9, 2021, FDA announced it had taken action on approximately 93 percent of applications it received and was committed to reviewing the remaining 7 percent as quickly as possible. In the meantime, FDA is prioritizing enforcement efforts on products for which no application was filed or that have received Marketing Denial Orders.
Addressing Youth Use of E-vapor Products
Youth use of flavored e-vapor products risks undermining the tobacco harm reduction opportunity that e-vapor products present for adult smokers. No one under 21 should use any tobacco product, and we remain committed to continuing to address underage tobacco use.
Many stakeholders have taken actions to help address underage use of e-vapor products. For example, FDA implemented youth prevention communications and public education, invested in research, and continued to pursue its rigorous, science-based approach to regulation. Congress passed legislation to raise the legal age to purchase all tobacco products to 21, which Altria supported. Manufacturers submitted PMTAs to FDA to demonstrate their products are "appropriate for the protection of public health."
We believe many of these actions helped contribute to the 2020 National Youth Tobacco Survey results which indicated significant declines in youth use of e-cigarettes. While these results are encouraging, more work remains to be done to further reduce youth use of any tobacco product.
Currently, FDA is prioritizing enforcement of flavored e-vapor products while also initiating enforcement actions against manufacturers that did not submit a required PMTA by the September 9, 2020 deadline.