FDA Finally Issues Tobacco 21 Rule

When Donald J. Trump signed H.R. 1865 into law in late 2019, the massive $1.4 trillion spending bill contained a provision that increased the minimum to purchase tobacco products from 18- to 21-years-old federally. However, Trump’s signature wasn’t all that was needed.

The bill clearly stated that the Secretary of Health and Human Services (HHS) needed to publish a finalized rule that would state as much in the federal register, the U.S. government’s official books. Per the bill, that was supposed to happen within 180 days of H.R. 1865 being published, i.e. before the end of May 2020.

Tomorrow, some 1,700 days later, that will finally happen.

The U.S. Food & Drug Administration (FDA) announced that the rule will be officially published in the federal register tomorrow, Aug. 30. It will officially go into effect 30 days after being published, Sept. 29, 2024.

In practical terms, the change will have almost zero effect. The vast majority of states already have increased the minimum age to purchase tobacco products to 21-years-old though five states still have not done so. If anything, the one change might be that the rule will no longer allow tobacco vending machines in places that aren’t age-restricted to those under 21 years old; previously, the federal law restricted tobacco vending machines to 18 and over establishments.

It’s also unlikely to change FDA’s underage tobacco enforcement policy. Each year, the agency and contracted vendors perform tens of thousands of age compliance checks at retailers around the country. In total, FDA says there have been 1.5 million checks that have resulted in 134,000 warning letters and 33,000 civil monetary penalties. In addition, there have been 230 no-tobacco-sale orders, which prevent a retailer from selling tobacco.

Numerous parties have complained about the prolonged delay in issuing this final rule, but FDA’s announcement provided no explanation for why it took so long. Beyond the lack of practical changes, few people have been pedantic enough to realize that HHS never completed this final step and FDA has widely touted its authority to enforce the federal Tobacco 21 standard.