Rutgers Health experts issue a call to action for the FDA to grant marketing orders for nicotine pouch products that meet its standards faster than it had e-cigarettes

In a commentary published in JAMA, experts at the Rutgers Institute for Nicotine & Tobacco Studies have issued a call to action to head off the proliferation of nicotine pouches based on lessons learned from electronic-cigarette regulation.

Authors Cristine Delnevo, director of the institute, and Mary Hrywna, associate professor, argue the U.S. Food and Drug Administration should act swiftly now to exercise its regulatory authority – both by granting marketing orders for nicotine pouch products that meet its standards and penalizing those who violate the law – to prevent the newest segment of the market from mutating as uncontrollably as e-cigarettes did. 

Delnevo and Hrywna discuss the health impacts. 

What are nicotine pouches and how popular are they? 
Delnevo: Nicotine pouches are a noncombustible or smokeless product that contain nicotine, but no tobacco and are intended for oral consumption. They are sold in a variety of nicotine strengths and flavors and the leading brands on the market, including Zyn, the No. 1 oral smokeless tobacco or nicotine product in the U.S., are manufactured by large tobacco companies. In fact, sales in nearly all commercial tobacco and nicotine product categories are declining except for oral nicotine products, the fastest-growing product on the market. 

Hrywna: While sales of nicotine pouches have grown, the use of these products among youth and adults in the U.S. remains low. For now, it seems that people who use nicotine pouches are more often older and have a history of cigarette, e-cigarette or smokeless tobacco use. That said, Zyn’s commercial success and cultural prominence may have prompted a surge in new brands; the pace of new nicotine pouch brands entering the market has accelerated in the past year.  

We should always keep a watchful eye on youth tobacco use behaviors, including use of multiple products, substitution with other products or alternative methods of finding and using flavored tobacco and nicotine products.

Cristine Delnevo

Director, Rutgers Institute for Nicotine & Tobacco Studies

What has the FDA done about nicotine pouches? What can it do about these pouches?Hrywna: Like with all tobacco products deemed under its authority, the FDA requires that manufacturers submit premarket tobacco product applications [PMTAs], which many of the most popular nicotine pouch brands appear to have done. However, the FDA has not made a final decision on any application for a nicotine pouch brand, either by issuing a marketing authorization or a marketing denial order. 

Delnevo: We think that the recent history with the FDA’s regulation of e-cigarettes, particularly in the context of Juul, offer lessons to learn from. In many ways, the evolution of the e-cigarette market, with fast-to-market companies exploiting the opportunity to stay under the radar while a market leader like Juul or some other new and popular illicit brand were subject to increased scrutiny or enforcement actions has great potential to be repeated, just in a different product category. 

During the FDA’s slow and lengthy regulatory process, the e-cigarette category grew and evolved, and by 2017, it was dominated by Juul. While the FDA was concerned with reining in Juul, the e-cigarette category mutated over the next several years and disposable flavored e-cigarette brands flooded the market, leading to an avalanche of PMTA applications. Unfortunately, the FDA took enforcement action against one brand while other brands materialized, and the turnover among popular brands in the illicit e-cigarette market made effective enforcement extremely difficult. 

Should we be concerned about nicotine pouches? How do nicotine pouches fit into the tobacco and nicotine marketplace?
Delnevo: We should always keep a watchful eye on youth tobacco use behaviors, including use of multiple products, substitution with other products or alternative methods of finding and using flavored tobacco and nicotine products. Nicotine, even in pouches containing no tobacco leaf, is an addictive substance, and we should discourage nicotine use among young people who are uniquely at risk for nicotine dependence and associated health effects. We also need to comprehensively evaluate the effects of any marketing authorization by the FDA on product sales and use. 

Hrywna: The risk profile of a nicotine pouch appears to be more similar to pharmacological nicotine replacement therapy products than traditional tobacco products. Therefore, nicotine pouches have great potential to reduce harm if people who use more dangerous forms of tobacco such as cigarettes and cigars could completely switch to these types of products. We should do what we can to nudge people who use more dangerous products to switch to products that can reduce harm. Public health policies, including federal, state and local regulations, offer ways to encourage these people to select less harmful products. 

Why is it important to issue marketing authorizations for these products? Why has it taken so long for the FDA to act?
Hrywna: The FDA must evaluate the scientific evidence base regarding the risks and benefits to the public, including those who use and don’t use tobacco before it acts on any tobacco product. They must carefully consider the information provided by the manufacturer’s application as well as population surveillance such as use among youth and adults. Of course, we must remain vigilant about youth uptake of the product but if the marketing, formulation, such as the flavors or nicotine levels, or use of the products become problematic, then FDA may have a stronger legal basis to take action after a product is authorized. 

Delnevo: We believe that the FDA should act swiftly to exercise its regulatory authority by granting marketing orders for nicotine pouch products that meet its standards because it will allow the FDA to penalize those who violate the law and may mitigate uncontrollable growth of the nicotine pouch market that make effective enforcement nearly impossible.  

By: Patti Zielinski

Date: December 9, 2024

Media Contact: Patti Zielinski, patti.zielinski@rutgers.edu