Will a New Administration Result in a New Approach to Tobacco & Nicotine Regulation?
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 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 an April 26 statement from the U.S. Department of Health & Human Services. 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 U.S. 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. 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 that 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 MGO. 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 last fall's "National Youth Tobacco Survey" conducted by the FDA and the Centers for Disease Control and Prevention.
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 announced the formation of a multiagency taskforce to combat the illegal distribution and sale of e-cigarettes. The taskforce brings together multiple law enforcement partners, including the Bureau of Alcohol, Tobacco, Firearms and Explosives, the U.S. Marshals Service, the U.S. Postal Inspection Service and the Federal Trade Commission 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 U.S. Department of the Treasury 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 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 United States.
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 U.S. 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.
David Spross is executive director of the National Association of Tobacco Outlets (NATO), a national retail trade association that represents more than 66,000 stores throughout the country.
Editor's note: The opinions expressed in this column are the author's and do not necessarily reflect the views of Convenience Store News.
