Online announcement declares that new tobacco age restrictions are effective immediately.
To the surprise of many tobacco retailers, the U.S. Food and Drug Administration (FDA) recently declared on its website that “it is now illegal” to sell any tobacco product “to anyone under 21.” The announcement followed a presidential tweet proclaiming that the recently enacted Further Consolidated Appropriations Act, 2020 “raises smoking age to 21! BIG!”
The Appropriations Act, which funded the federal government until September 2020, did include a bill to increase the minimum age for tobacco purchases from 18 to 21. But the change was not expected to be implemented for several months, and so far no rules or guidance have been published to put the change into effect. Retailers are therefore in the dark as to whether they must comply with FDA’s online announcement.
Section 603(b) of the Appropriations Act provides up to 180 days for the Secretary of Health and Human Services to publish “a final rule to update the regulations” of the Federal Food, Drug, and Cosmetic Act (FDCA) to increase the tobacco sales age from 18 to 21. Then that final rule would “take full effect not later than 90 days” after publication. All told, the Appropriations Act allocates up to nine months for a final rule to increase the minimum tobacco purchasing age from 18 to 21.
Despite all this time allotted in the statute to implement the age change, FDA announced its change was legally binding after fewer than nine days.
Perhaps FDA took its cue from section 603(a) of the Appropriations Act, which specifies in the present tense that the FDCA “is amended” to include a provision that retailers may not sell tobacco products to any person under the age of 21. A spokesperson for FDA reportedly stated that the change “was able to go into effect immediately” because it “simply increased the age limit in existing law.” But this view contradicts the provisions of section 603(b), which lay out the nine-month timeline and the required regulatory steps for the age increase to take effect.
FDA’s digital website banner declaring the age change was labeled as a “Note” and promised that “FDA will provide additional details on this issue as they become available.” But the rest of agency’s website and the text of the FDCA still state that the federal minimum age for tobacco sales is 18. Not one of the relevant regulations of the FDCA has been formally amended to reflect the new minimum age of 21. The Secretary of Health and Human Services, responsible under section 603(b) for publishing a final rule to update the FDCA regulations, has not issued any press release corroborating or denying the age change as effective immediately.
All of this leaves an open question: What is the law right now?
The issue is not merely academic—it has serious consequences for retailers that sell tobacco products. FDA assesses retailer compliance with current tobacco laws and regulations through undercover compliance checks in which a “trained minor” works with a commissioned FDA inspector to attempt a tobacco purchase. Tobacco retailers that fail a compliance check by selling to an underage purchaser are subject to FDA enforcement measures, including warning letters, monetary penalties, prohibitions on future tobacco sales, and even criminal prosecution.
If retailers attempt to adhere to a new age limit of 21 that is not legally binding, they will miss out on legal sales revenue. If they continue to sell to purchasers between 18 and 21 in contradiction of FDA’s online announcement and the President’s tweet, they may expose themselves to FDA enforcement action. Clarity on the effective date of the minimum age change would eliminate this confusion and help tobacco purchasers and retailers comply with the new regulations.
The push to increase the tobacco sales age to 21 has enjoyed widespread bipartisan support, and the bill contained within the Appropriations Act was co-sponsored by Senator Mitch McConnell (R-Ky.) and Senator Tim Kaine (D-Va.). Advocates argue that raising the tobacco age to 21 will reduce usage of cigarettes and vaping products among high school students, particularly by preventing 18- and 19-year-old students from supplying their younger friends with tobacco products. This past year’s vaping crisis, which hospitalized more than 2,500 e-cigarette users with acute lung illness and claimed the lives of 54 victims nationwide, ignited further calls to raise the tobacco purchase age. More than half of those hospitalized for vaping-related lung illness were under the age of 24.
Far from opposing a change in the minimum age for tobacco purchases, major tobacco companies like Juul and Altria have supported the increase from 18 to 21. Still, anti-tobacco advocates like the Campaign for Tobacco-Free Kids argue that, for tobacco companies, supporting the increased age limit is “a shield to fight efforts to prohibit flavored e-cigarettes” which are at the root of the teen vaping epidemic.
Despite some concerns that the changes do not go far enough, all sides agree that increasing the tobacco purchasing age to 21 is at least an initial step in the right direction. Perhaps the next step will be a proposed rule from FDA that will bring greater clarity about the effective date of the age change.