Will Trump Administration Result in a New Approach to Tobacco and Nicotine Regulation?

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In the early days of President Trump’s Administration, there have already been significant developments with the approach to proposed tobacco-related regulations. 

Within the first week after taking office, the administration withdrew two proposed rules, one banning menthol in cigarettes and the other banning flavored cigars. The Biden Administration delayed final adoption of these delayed last April because the rules “garnered historic attention and the public comment period has yielded an immense amount of feedback, including from various elements of the civil rights and criminal justice movement,” according to a statement from former U.S. Health and Human Services Secretary Xavier Becerra. This decision was a result of the more than 250,000 public comments that were received, the overwhelming majority of which were in opposition to the proposed rules.

In the week prior to President Trump’s inauguration, the Food and Drug Administration (FDA) announced the first premarket tobacco product application (PMTA) authorizations for nicotine pouches when it issued marketing granted orders (MGO) for 20 Zyn pouch products. The FDA cited that Zyn’s PMTA applications demonstrated substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products and provided evidence from a study showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products.

Only time will tell what is next in the landscape of tobacco and nicotine regulation from the White House and the FDA. Currently, the FDA is being led by an interim commissioner until President Trump’s nominee, Dr. Marty Makary goes through the confirmation process. This has resulted in a short-term communications freeze from the agency. 

One of the biggest opportunities for the federal government is to support tobacco harm reduction policies by authorizing more PMTA vapor and nicotine pouch product applications that provide adult smokers with more choices of less risky tobacco products. 

During his campaign, President Trump said on his social media platform he would “save vaping again.” The best way to achieve this campaign pledge is by having the FDA authorize more than the current 34 vapor products that have MGOs. 

It is important that further authorizations also include flavored products that adult vaping consumers have used to migrate from combustible cigarettes. A similar regulatory approach is encouraged in the nicotine pouch space. As a category, these products have tobacco harm reduction benefits for adults and low youth usage as evidenced by in the 2024 National Youth Tobacco Survey.

Coupled with additional PMTA authorizations, the FDA needs to continue its stepped-up enforcement against illicit vapor and nicotine pouch products. Last year, the FDA and the U.S. Department of Justice (DOJ) announced the formation of a multi-agency task force to combat the illegal distribution and sale of e-cigarettes. 

The task force brings together multiple law enforcement partners, including the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), the U.S. Marshals Service (USMS), the U.S. Postal Inspection Service (USPIS), and the Federal Trade Commission (FTC), to coordinate and streamline efforts to bring all available criminal and civil tools to bear against the distribution and sale of illicit e-cigarettes. 

Additionally, the FDA and the Department of the Treasury (DOT) announced a proposed rule that would require an importer of vapor/e-cigarette products to submit the FDA-issued Submission Tracking Number (STN) into the electronic imports system operated by U.S. Customs and Border Protection. The STN number is the application number that FDA assigns to submissions such as PMTA applications.  

Under the proposed rule, if a STN is not submitted for a vapor product, it may be denied entry into the U.S. NATO filed comments in support of the proposed rule as it is a reasonable and relatively low-cost mechanism to help ensure that only those vapor products permissible for sale in the United States enter domestic commerce and to help eliminate the influx of illicit, foreign-manufactured vapor products (especially those from China). NATO also recommended expanding this proposal to other emerging tobacco product categories that require marketing authorization via the PMTA pathway, such as nicotine pouches or other modern oral products.

NATO will continue to be engaged with federal regulators in efforts to promote federal tobacco harm reduction policies that support selling tobacco and nicotine products responsibly, and in compliance with all applicable laws. 

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