FDA Issues Final Rule for Tobacco 21

PCA | August 29, 2024

At long last, the U.S. Food & Drug Administration’s Center for Tobacco Products (CTP) has released its Final Rule for implementing T-21, including requirements for age verification of patrons appearing to be under the age of 30 and removal of tobacco vending machines from locations where patrons are permitted to enter under the age of 21.  

Since Congress mandated T-21 in December 2019, the PCA has pressured the CTP to complete this regulatory process to prevent the ensuing compliance limbo.  Over the nearly five-year interim, the FDA shifted its T-21 focus towards conducting over 1.5 million enforcement actions despite never completing the regulatory requirements.  Rather than completing the regulation, the FDA diverted its regulatory resources towards more politically expedient efforts aimed at limiting consumer choice.

“The government’s data has continued to support the reality that the premium cigar industry is not an issue related to youth access or overall public health,” says Joshua Habursky, Executive Director of PCA. “This rule is long overdue and will hopefully return CTP’s focus to specific issues in its statutory mandate.”

The PCA worked aggressively after the passage of T-21 to get CTP to acknowledge that premium cigars and pipe tobacco were not a priority, given their lack of youth appeal nor evidence of addiction.  In addition to succeeding in making these products the lowest priority in FDA’s enforcement guidance, many of the undisputed data points were included in legal arguments that led to the vacatur of the FDA’s deeming rule concerning premium cigars.

PCA continues to ask CTP to work with the industry to update their compliance resources, such as the “This is our Watch” program.  CTP has yet to do so, but Director Brian King did agree to engage with retailers and manufacturers at the PCA 2025 trade show in New Orleans.  Last updated in 2023, “This is our Watch” has yet to incorporate the current T-21 regulations. Still, a statement on the CTP website promises to do so.