What’s Next for Nicotine? The Coming Legal and Political Battles over an FDA Proposal

BACKGROUND

On January 16, 2025, the FDA proposed limiting nicotine levels in cigarettes to 0.70 mg per gram of tobacco .a dramatic reduction from current averages (17.2 mg/g) to curb addiction. Tobacco use remains the leading preventable cause of U.S. deaths (480,000 annually), with nicotine addiction sustaining smoking despite users’ desire to quit. The rule could save millions of lives and generate trillions in economic benefits over 40 years.

METHODS

The proposal leverages the FDA’s statutory authority under the 2009 FDCA (Section 907), which permits nicotine yield regulation if "technically achievable" and "appropriate for public health." The rule avoids First Amendment challenges (unlike graphic warning mandates) but faces industry lawsuits likely targeting statutory interpretation. The authors analyze legal vulnerabilities, including post-Loper Bright erosion of agency deference and the "major questions" doctrine, concluding the rule is legally sound.

RESULTS

Technical feasibility is demonstrated by existing low-nicotine products (e.g., Philip Morris’s Next). Evidence shows minimal-addiction nicotine levels would reduce youth uptake and aid quitting. Political hurdles remain: industry opposition may mirror tactics used against menthol bans, including claims of illicit trade (though alternatives like e-cigarettes mitigate this risk). The Trump administration’s stance is uncertain, despite prior FDA support for nicotine reduction under Gottlieb.

CONCLUSIONS

The FDA’s proposal is legally defensible and transformative for public health. Researchers can bolster its adoption by submitting evidence during the comment period and countering industry arguments.

BACKGROUND

On January 16, 2025, the FDA proposed limiting nicotine levels in cigarettes to 0.70 mg per gram of tobacco .a dramatic reduction from current averages (17.2 mg/g) to curb addiction. Tobacco use remains the leading preventable cause of U.S. deaths (480,000 annually), with nicotine addiction sustaining smoking despite users’ desire to quit. The rule could save millions of lives and generate trillions in economic benefits over 40 years.

METHODS

The proposal leverages the FDA’s statutory authority under the 2009 FDCA (Section 907), which permits nicotine yield regulation if "technically achievable" and "appropriate for public health." The rule avoids First Amendment challenges (unlike graphic warning mandates) but faces industry lawsuits likely targeting statutory interpretation. The authors analyze legal vulnerabilities, including post-Loper Bright erosion of agency deference and the "major questions" doctrine, concluding the rule is legally sound.

RESULTS

Technical feasibility is demonstrated by existing low-nicotine products (e.g., Philip Morris’s Next). Evidence shows minimal-addiction nicotine levels would reduce youth uptake and aid quitting. Political hurdles remain: industry opposition may mirror tactics used against menthol bans, including claims of illicit trade (though alternatives like e-cigarettes mitigate this risk). The Trump administration’s stance is uncertain, despite prior FDA support for nicotine reduction under Gottlieb.

CONCLUSIONS

The FDA’s proposal is legally defensible and transformative for public health. Researchers can bolster its adoption by submitting evidence during the comment period and countering industry arguments.