On December 20, 2019, changes to the minimum tobacco-sale age were signed into law, increasing the federal minimum age for tobacco sales from 18 to 21. The U.S. Food & Drug Administration (“FDA”), the Agency responsible for enforcing age-related sale prohibitions at the federal level, immediately updated its website, proclaiming that “[i]t is now illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21.” Unsurprisingly, the updates to the law and FDA’s pronouncement prompted widespread confusion among industry groups and retailers with respect to current requirements and how to comply with FDA regulations moving forward.
Under Section 603 of what is now Public Law 116-94 (“Law”), Congress set forth sweeping changes to federal tobacco laws, which will serve to bring quick change to daily sales practices. To fully understand the breadth of the changes, it helps to look at the previous state of the law and the amendments that were enacted.
Unlike the original Family Smoking Prevention and Tobacco Control Act (“Act”), the changes to the law are self-executing, meaning that further FDA action is not required in order to implement the change. Namely, the original law permitted FDA to enact minimum age restrictions while limiting the Agency to enacting a minimum age no higher than 18.[1] FDA then promulgating regulations establishing 18 as the minimum age for tobacco sales. 21 CFR part 1140. With the most recent law, Congress has effectively taken FDA’s ability to set the minimum age requirements for tobacco sales and has inserted minimum age restrictions into the law. Language was added to establish a minimum age for the sale of tobacco products within the law itself, reading:
It shall be unlawful for any retailer to sell tobacco to any person younger than 21 years of age.
Public Law 116-94, Section 603(a)(2).
In addition to inserting a federally mandated minimum age restriction into the law, Congress also made key changes that extend existing penalties for violations of the newly established minimum age requirement. Public Law 116-94, Section 603(d). Accordingly, any violation of the new minimum age restriction may result in civil money penalties, tobacco-no-sale orders, and misbranding charges.
As explained above, no further changes must be made by FDA in order to bring the congressionally mandated minimum age into effect. However, FDA will need to change its regulations in order to conform with the federal law. In addition to changing references from 18 to 21, Congress is also requiring FDA to update its regulations to require age verification for all individuals under the age of 30.[2] Currently, 21 CFR 11.40.14 provides that no verification is required for persons over 26.
Although the law does not require
further action from FDA in order to implement minimum age requirements or
associated penalties, it is unclear when FDA will begin enforcement of these
new restrictions, if they have not already. As of December 31, 2019, FDA’s website
notes that the Agency “will provide additional details on this issue as they
become available.” For now, we will have to wait to see what the New Year
brings with respect to FDA tobacco enforcement.
[1] Act at Section 906 (2009).
[2] Public Law 116-94, Section 603(b).