The Enforcement Theater: When Regulators Perform Toughness Without Actually Changing Anything

In January 2024, the FDA issued warning letters to 22 retailers for selling unauthorized e-cigarettes—specifically, the popular Elf Bar brand, a Chinese-made disposable vape that has been the dominant youth product since Juul's decline. The FDA press release noted that the agency had issued 'more than 1,100 warning letters' to retailers and manufacturers since the PMTA deadline. The press release was picked up by several media outlets. The narrative was established: FDA is cracking down. **Now walk into any convenience store in any American city and count how many Elf Bars—or their rebranded cousins, EB Design and EB Create—are still on the shelves.** The answer, in most places, is: all of them. The warning letters have not removed a single product from a single store. They are enforcement theater—public performances of regulatory authority that create the appearance of action without achieving the substance. The gap between what the FDA says it's doing and what's actually happening on the ground is not an accident. It's a feature of a regulatory system that has more authority on paper than capacity in reality.

**The enforcement theater has a predictable structure.** Step one: a regulatory agency identifies a product or practice that violates the rules. Step two: the agency issues a warning letter or other administrative action. Step three: the agency issues a press release about the action. Step four: media outlets report on the press release. Step five: nothing changes. The product remains on the market. The retailer continues selling it. The consumer continues buying it. The agency has performed regulatory authority—the warning letter, the press release, the media coverage—but has not achieved regulatory effect. **The performance satisfies the agency's institutional need to be seen as 'doing something.' It does not satisfy the public health need for products that are actually being regulated.**

**The reasons for the enforcement gap are structural, not individual.** The FDA's Center for Tobacco Products has approximately 1,100 employees and a budget of roughly $700 million—adequate for a traditional tobacco market of a few hundred cigarette and smokeless products, but wildly inadequate for a market of millions of vaping products sold through hundreds of thousands of retail outlets. The FDA does not have the inspectors, the lawyers, or the enforcement infrastructure to remove unauthorized products from the market at scale. The agency can target the largest manufacturers and the most egregious violators. It cannot police the retail environment for a product category that is sold at every gas station, convenience store, and vape shop in the country. **The enforcement gap is not a failure of will. It's a failure of design—a regulatory system built for a market that no longer exists.**

**The enforcement theater also serves a political function** that is less visible but equally important. The FDA is under constant pressure from two directions: public health advocates demand aggressive enforcement against unauthorized products, while the industry (and its Congressional allies) demand regulatory restraint and accuse the agency of overreach. Warning letters are the perfect institutional response to this pressure: they demonstrate 'toughness' to the advocates (the agency is taking action) while avoiding the political and legal risks of more aggressive enforcement (product seizures, injunctions, criminal referrals). The warning letter is a gesture that satisfies both constituencies—or, more precisely, that fails to satisfy either but provides the agency with a defensible middle ground. **The enforcement theater is not just about public perception. It's about institutional survival—the art of navigating between competing political pressures while maintaining the appearance of effective regulation.**

**The consequences of enforcement theater for the regulated market are corrosive.** When the industry observes that warning letters don't lead to meaningful consequences, the deterrent effect of regulation evaporates. The retailer who receives a warning letter and continues selling the product learns that the warning letter is the cost of doing business—not a genuine threat to their operation. The manufacturer whose products are subject to warning letters learns that the letters signal to consumers which products the FDA is concerned about—which, perversely, can function as a marketing signal ('the FDA tried to ban this, it must be good'). **Enforcement theater doesn't just fail to achieve compliance. It undermines the legitimacy of the regulatory system by demonstrating that the system's threats are empty.**

**The solution requires a realistic assessment of enforcement capacity** and a regulatory strategy that matches the capacity to the market. The FDA cannot enforce against every unauthorized product at every retail outlet. It can enforce against the largest manufacturers, the largest distributors, and the products with the largest youth-appeal risk—and it can invest in the enforcement infrastructure (inspectors, technology, interagency coordination) that would allow it to expand its reach over time. But the fundamental mismatch between regulatory ambition and enforcement reality will not be resolved by more warning letters. It requires a regulatory framework that reduces the size of the unauthorized market by expanding the authorized market—making the PMTA pathway navigable for more products, authorizing a wider range of products that meet safety standards, and accepting that a legal, regulated market with diverse products is better than the current reality of an unauthorized market that the regulatory system is performing against but cannot actually control.

**💬 Have you seen the gap between what regulators announce and what actually happens on the ground?** Warning letters, press releases, 'crackdowns' that don't seem to change what's on the shelves—is this just how regulation works, or is there something particularly broken about nicotine enforcement?