As a society, we have been conditioned to believe “Big Tobacco” is out to get everyone addicted to dangerous, toxic products. Many picture a boogeyman using its money and influence to skirt the barriers the US Food and Drug Administration (FDA) has put in place to keep us safe. But what if the FDA is actually the villain in this story?

That might sound preposterous. After all, the FDA exists to protect consumers from large corporations whose only concern is profit — or so we’ve been told.

In truth, the FDA causes a lot of harm. From delaying lifesaving drug rollouts to allowing unsafe and ineffective products on the market, the federal agency has a long list of errors under its belt. When it comes to tobacco and nicotine, the FDA’s reputation is less than spotless.

Helix Innovations and NJOY, two subsidiaries of the large tobacco company the Altria Group, have joined forces to sue the FDA in the hopes of bringing safer nicotine products to market. The companies argue the FDA’s Premarket Tobacco Product Application (PMTA) process — which all new tobacco and nicotine products must complete before they can legally be sold or distributed in the United States — violates the Tobacco Control Act (TCA). The TCA sets a 180-day deadline for the FDA to review new product applications — but the FDA rarely meets this timeline. Applications routinely wait years for decisions.

In their filing, Helix Innovations and NJOY note that rulings on all their new product applications took between 361–1,564 days — far longer than the 180 days the TCA sets as the legal maximum. Because of the FDA’s slowness, safe nicotine products cannot reach customers, and illegal, unregulated alternatives — often from China — flood the market instead.

The FDA faces no consequences for its routine failure to meet the statutory deadline for PMTA review. But the same cannot be said for the companies applying for the privilege of competing in our country’s supposed free market. When the FDA fails to do its duty, they lose out.

The bureaucratic bottleneck: how delays stifle competition

Large companies like JUUL Labs can eventually squeak through the bureaucracy to take novel products to market. But even with their seemingly endless resources, they still suffer trials and tribulations. JUUL2, an e-cigarette with age verification and pod-authenticity safeguards, took three years to get its PMTA from the FDA to sell in the United States. This comes nearly five years after JUUL2 launched in the United Kingdom, a country known for its anti-Big Tobacco policies.

Smaller companies that compete with Big Tobacco do not have the luxury of endless time and legal resources. NOAT, a boutique nicotine pouch company that prides itself on creating an environmentally sustainable and healthier alternative to tobacco products, was forced to shut its doors in the United States because the FDA refused to issue the company a PMTA. Similar to JUUL2, NOAT received the equivalent approval in the United Kingdom, where the product is still available for purchase.

Because the FDA failed to approve new product applications in a reasonable timeframe, consumers are left with fewer options in the legal market. But limited options do not change consumers’ desire for more choice, and the illicit market has gladly worked to serve that demand.

When the FDA effectively pushed JUUL off the shelves in the early 2020s, the disposable vape market exploded to fill the void. Consumers still wanted e-cigarettes. The market, as always, was willing to meet that demand. But this wasn’t a one-for-one substitution: JUUL’s vapes and pods were FDA-regulated, while the disposable vapes that flooded gas station and convenience store shelves were not. There was no telling what was in those mystery illicit products. State and local governments responded in a predictable way — by banning legal flavored nicotine products outright. Predictably, those bans failed to change consumers’ habits.

A few years later, the same pattern repeated with nicotine pouches. Rather than keeping pace with surging consumer demand through timely PMTA review, the FDA let its backlog grow — and the illicit market stepped in to fill the gap. Just as with flavored vapes, counterfeit and illicit nicotine pouches have taken over large segments of the American market, often without consumers realizing.

The illicit market fills the void

Prohibition is not the answer to our tobacco problems — innovation is. Consenting adults should have access to the best, safest products available. JUUL2 addresses two of the main concerns surrounding tobacco products: underage use and counterfeits. Yet the FDA withheld it from the American market for years, for no apparent reason.

By creating an endlessly complicated bureaucratic approval process, the FDA has made consumers less safe while entrenching the very “Big Tobacco” incumbents it claims to be checking. When the United Kingdom has a more functional free market, one must admit the United States is doing something wrong. And yes — a lawsuit from a tobacco company against a federal agency might be part of the solution.

[Kaitlyn Diana edited this piece.]

The views expressed in this article are the author’s own and do not necessarily reflect Fair Observer’s editorial policy.