The end of the calendar year is a natural time to reflect on the previous 12 months and look toward opportunities for the new year. For the National Association of Tobacco Outlets (NATO), 2025 brought regulatory progress and promising signs of achievable objectives to come.
In Washington D.C., the change of administration in January meant not only increased commitment toward addressing the illicit nicotine market, but also meaningful action from the federal government.
Illicit vapes
In recent years, illicit vapor products—mostly from China—have flooded our streets and store shelves. Because they have not applied for authorization or presented any science to the Food and Drug Administration (FDA), these products are being sold illegally. No small part of the marketplace, an estimated 85% of the vapes in this country today are illegal. The Trump administration’s crackdown on this illicit market is a welcome change of pace. Many are imported illegally and deliberately targeted to underage users with youth-appealing features like gummy bear flavors and gaming device screens.
In reality, the FDA product reviews take years, many of which are still without resolution. Since 2009, applications for over 26 million tobacco and nicotine products have been filed, with the agency having only authorized less than 100 products.
FDA has left these consumers with far too few authorized choices, making them vulnerable to a marketplace of products that are illegal and potentially unsafe.
We are encouraged that the FDA has moved some product applications through the premarket tobacco application (PMTA) process, which manufacturers must go through to receive authorization to market and sell any new tobacco product in the United States. More action in this area can help break the logjam at the FDA and provide much-needed clarity to consumers and retailers about what can legally be sold on our store shelves.
The importance of education also cannot be overstated. Retailers must be well-versed in federal, state and local laws and policies, from preventing youth access to understanding the distinctions between product types. We work tirelessly to keep our membership informed and compliant through seminars, resources and direct guidance. Only when adult consumers have accurate information and responsible access can they make truly informed decisions about harm reduction.
Joined forces
NATO remains invested in a well-functioning federal regulatory system where FDA oversight protects against underage use and promotes harm reduction. That is one of the primary reasons that NATO was proud to join a brand-new group called the Coalition for Smarter Regulation of Nicotine, or Regulate Smarter.
Formed earlier in 2025, Regulate Smarter is chaired by former U.S. Sen. Richard Burr (R-North Carolina), and made up of a community of industry members united in their commitment to operate responsibly within the regulated marketplace and advocate for an FDA system committed to harm reduction.
Regulate Smarter shares NATO’s belief in education, compliance and advocacy for informed policies that help adult consumers make informed and better choices regarding tobacco and nicotine products. They are calling new attention to issues that we have been pushing for some time, including a belief that the current regulatory process has left millions of adult smokers, vape users and pouch consumers with few legal, properly regulated options—often leaving them with either illegal products or nothing at all.
As an industry, it is our goal to ensure lower-risk alternatives are available, properly regulated and presented to adult consumers so they have meaningful choice. Unfortunately, FDA regulation has failed to keep up with the pace of changing consumer landscape.
Regulate Smarter is committed to addressing this imbalance, not just through the sustained enforcement activities, but also by increasing the ability for adult consumers to purchase FDA authorized products.
By bridging the gap between regulators, retailers and the public, our industry can support effective and informed strategies that provide adult consumers with greater choice.
We are excited about the progress of 2025 and looking forward to even more meaningful steps forward in 2026.
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