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OPINION

FDA's New Guidance Recognizes What Law Enforcement Already Knows

The opinions expressed by columnists are their own and do not necessarily represent the views of Townhall.com.
FDA's New Guidance Recognizes What Law Enforcement Already Knows
AP Photo/Jose Luis Magana, File

The federal tobacco regulatory system was built to create a legal, science-based pathway for products and enforce the law against bad actors. Today’s vaping marketplace shows how far reality has drifted from that goal.

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For years, the Food and Drug Administration (FDA) has taken an overly restrictive posture toward new vaping products, denying American adult consumers access to safer, regulated alternatives to cigarettes and driving them instead toward a thriving illicit market. Now, it appears the agency may finally be embracing a more pragmatic approach to nicotine regulation with new enforcement guidance for flavored vaping products. As a retired police lieutenant who works at the intersection of public health and safety, the FDA’s change in course is a welcome development.

The Food and Drug Administration’s new enforcement guidance matters. It recognizes a basic reality: enforcement works best when it distinguishes between companies engaged in the regulatory process and bad actors operating outside it.

The FDA made clear that new tobacco products still need premarket authorization to be legally marketed. But the agency also said it should focus limited enforcement resources on products and companies that pose the greatest risk, including illegal imports, counterfeit products, and youth-appealing products.

That is not a retreat from regulation. It is what effective regulation requires.

The real choice facing the FDA is not between regulation and no regulation. It is between a legal marketplace of products that have gone through agency review and an illicit marketplace dominated by unknown products that have bypassed the FDA entirely.

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Congress did not create the tobacco regulatory framework so illegal products could overwhelm legal ones. When Congress passed, and President Barack Obama signed, the bipartisan Family Smoking Prevention and Tobacco Control Act in 2009, the goal was to create a science-based system: the FDA would review products, legal products would have a pathway to market, and enforcement would target those violating the law.

The law was also designed to recognize that not all nicotine products carry the same risks. A science-based system should evaluate those differences while keeping youth prevention and enforcement against illegal products at the center of the strategy.

That is the balance the FDA must restore.

The FDA recently authorized four vaping products it had previously rejected, despite favorable scientific reviews from agency staff. Now, with this guidance, the agency is drawing a line between products engaged in the regulatory process and companies that ignore the law entirely.

From a law enforcement perspective, that distinction matters. A product that has submitted data to the FDA and is moving through review is not the same as an illegal disposable product shipped into the country, marketed in kid-friendly flavors, and sold without oversight.

Treating those products the same wastes limited resources and lets the worst actors benefit from the confusion. It also makes the job harder for agencies and officers trying to identify supply chains that pose the greatest threat to consumers and communities.

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Preventing youth access must remain central to any regulatory strategy. But protecting youth and creating a lawful, regulated marketplace for adults are not opposing goals. They are connected. A marketplace dominated by unregulated products makes youth prevention harder, not easier. Bad actors thrive when legal options are limited, enforcement is inconsistent, and consumers are pushed toward products with unknown ingredients, unclear origins, and no accountability.

The FDA’s guidance recognizes a basic truth: the agency cannot pursue every unauthorized product with equal intensity. That makes prioritization essential. The agency should focus enforcement on products and companies causing the greatest harm: illegal imports, counterfeit products, products designed to appeal to minors, and companies that have not tried to comply with federal law.

At the same time, the FDA should apply clear scientific standards to authorize products that meet the public health standard. A viable legal marketplace gives adult consumers access to regulated products with clear labeling and quality standards. It also gives regulators and law enforcement a clearer target: those who refuse to follow the rules.

That is how enforcement should work: reward compliance, create consequences for evasion, and focus public resources on the conduct causing the greatest harm.

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For too long, this debate has been driven by old arguments that do not reflect the marketplace today. The FDA’s new guidance should be the beginning of a more durable system, one that distinguishes between products trying to follow the law and products that evade it completely.

If the agency gets this right, it can protect consumers, reduce illicit-market harms, and restore the science-based framework Congress intended. If it does not, the illicit market will keep filling the vacuum.

Lt. Diane Goldstein (Ret.) is a 21-year police veteran and executive director of Law Enforcement Action Partnership (LEAP), a nonprofit group of police, judges, and other law enforcement professionals who support policies that improve public safety and police-community relations.

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