Regulate Smarter Concludes “Smarter Regulation Now” Video Series

As Regulate Smarter continues its work supporting the modernization of the U.S. Food and Drug Administration (FDA) approach to smoke-free nicotine products, the Coalition is releasing the final installment in its multi-part video series, “Smarter Regulation Now.”

Watch the video here.

Featuring insights from voices across the law enforcement community and Coalition Chairman Richard Burr, this episode underscores the scope of the illicit nicotine product market and the consequences of delayed authorizations.

Sandalio Gonzalez, a former U.S. Drug Enforcement Administration (DEA) special agent highlights how colorful, unregulated products from China are widely available and poorly understood by young people. He stresses that enforcement alone is not enough: broad public education must be part of the equation.

Tom Lesnak, a retired agent at the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), emphasizes the federal government’s responsibility to disrupt the major importers and large-scale illegal distributors.

Rana Saoud, a retired special agent at Homeland Security Investigations (HSI), explains that illicit nicotine products generate substantial untaxed revenue that flows into broader criminal enterprises.

To close the episode and the series, Chairman Burr returns to a core point: Congress directed the U.S. Food and Drug Administration (FDA) to act on product applications within 180 days, a deadline the agency has never met. He warns that the same pattern that created today’s massive illicit vape market risks repeating itself with nicotine pouches if authorizations continue to lag.

Together, these perspectives reinforce Regulate Smarter’s central message: the FDA must pair rigorous enforcement against illicit products with an authorization process that delivers lower-risk options to adult smokers within the timelines Congress established.

Watch the full video here.

SANDALIO GONZALEZ: The products are colorful, and, you know, you see them all over the place. Kids don't realize that it's unregulated. They don't realize that they're coming from China. They don't know what's inside these products. So as much as my career was about enforcing the law, and I think there's a place for that here. A big part is educating as many people in the United States as possible.

TOM LESNAK: The feds have to do their job. They have to take out the importers that are illegally importing this stuff. They have to take out the big distributors that are illegally distributing it across the country. That's where the federal government has to do their job. That's not complicated. They know who they are. They have the paperwork.

RANA SAOUD: If there's one illicit product being sold, there's multiple. So when it comes to the illicit nicotine products, illicit vapes, you're looking at revenue that will impact the United States, but that revenue is going to their pockets are not paying tax on it. They're using it to generate and fuel other criminal activity.

FORMER SENATOR RICHARD BURR: The key message to regulators is that Congress set up an architecture that gave them 180 days to respond to applications. Not once have they met the 180 days. And as we saw, a vapor market that because of the lack of approvals, created an illicit market, we're on the verge of nicotine pouches … since 2023, we're going to create a second illicit market, if in fact, the FDA won't begin to do approvals in the 180 days that they were given time to do it. That's not necessarily a good stewardship of the 8 to $9 billion that the industry has paid the FDA to review these applications.