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Volume X, Number 216

July 31, 2020

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Trump Administration Proposes to Remove FDA’s Authority to Regulate Tobacco Products

As our readers may recall, under the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, FDA has the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency deems to be subject to the law.

However, on February 10, the Trump administration proposed creating a new federal agency to regulate tobacco products and to remove that authority from the FDA. The administration’s plan is included in their 2021 budget proposal, but to take effect, the budget proposal must be passed by Congress, which appears unlikely given the current political landscape.

In sum, the budget proposes to move the Center for Tobacco Products out of the FDA and to create a new agency within HHS to focus solely on tobacco regulation. The new agency would be led by a Senate-confirmed Director. According to the proposal, a “new agency with the singular mission on tobacco and its impact on public health would have greater capacity to respond strategically to the growing complexity for new tobacco products. In addition, this reorganization would allow the FDA Commissioner to focus on its traditional mission of ensuring the safety of the Nation’s food and medical products supply.”

The proposal comes after the head of the White House Domestic Policy Council, Joe Grogan, told reporters last year that tobacco regulation was a “huge waste of time” for the FDA.  Grogan further stated that “tobacco has no redeeming qualities and it should not be regulated by a health agency like this.”  However, public health and policy experts have already criticized the proposal. For example, Matthew Myers, present of the Campaign for Tobacco-Free Kids state that “[i]t has taken a long time for the FDA Center for Tobacco Products to build up the staff, legal expertise and structure to do the job.” Myers elaborated further lamenting that the proposal is “yet another giveaway to the tobacco and e-cigarette industry.”

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 43


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...