CEI Joins Coalition Urging FDA Not to Ban Synthetic Nicotine

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This week CEI joined a coalition of groups urging Food and Drug Administration (FDA) Commissioner Robert Califf not to prohibit synthetic nicotine (read the full letter here). Slipped into the omnibus spending package that President Biden signed in late March was a measure giving the FDA the authority to regulate synthetic nicotine as a tobacco product.

Though presented as a seemingly reasonable measure aimed at preventing e-cigarette businesses from bypassing existing regulations, it would act as a de facto ban on the use of synthetic nicotine. Such a ban would not, as promised, increase oversight of the e-cigarette industry. Instead, like nearly every other action the FDA has taken with regard to e-cigarettes, banning the use of synthetic nicotine will only push more consumers into the unregulated illicit market or back to deadly combustible cigarettes.  

As I recently wrote, the effort to solve the so-called synthetic “loophole” is an attempt to solve a regulatory problem created by our government’s dysfunctional regulation of e-cigarettes. There would be no need to close this loophole had the FDA provided legitimate businesses with a viable path to market. As it stands, the only way legitimate e-cigarette businesses can hope to earn FDA approval of their products is through a process that is onerously expensive, time-consuming, and—based on the decisions the FDA has made so far—apparently futile.

Since beginning to review pre-market tobacco applications for e-cigarette products, the FDA has received more than 6 million applications, approving just a handful from two companies. At the same time, the agency has denied thousands of applicants, seemingly without bothering to fully review their applications, often justifying denials for applicants failing to include evidence that the FDA said they need not include or for seeking approval for non-tobacco flavors, despite there being no statutory, regulatory, or scientific rationale for the FDA to reject these applications without review.

The capriciousness of the FDA’s oversight has signaled to the industry that, while there is a way for companies to earn FDA approval and bring their e-cigarette products to market legally in theory, in reality this pathway isn’t viable for 99 percent of the industry and 99 percent of the products consumers want. So, while the FDA has made it functionally impossible for companies to continue existing while complying with regulations, companies have instead looked for ways to bypass regulation altogether.

No e-cigarette company wants to use synthetic nicotine because it is far more expensive than tobacco-derived nicotine. The only reason some companies have shifted to synthetic nicotine is because they see it as their only option for survival, short of operating completely illicitly.

While the law giving the FDA regulatory authority over synthetic nicotine seeks to ensure that the e-cigarette industry complies with federal rules and that consumers are protected from unregulated products, it will not have this effect if it is enforced as written, because it requires products to file for and receive FDA approval within 120 days. As the FDA itself admits, the process of merely submitting an acceptable application takes approximately six months. In other words, as written, this measure amounts to a de facto ban on synthetic nicotine e-cigarettes.

That probably sounds like a great outcome to proponents of the measure and the anti-nicotine lobby who want to eliminate any use of recreational nicotine. But closing this loophole will not, as they may wish to believe, make these products go away. All it will do is push the e-cigarette business further into unregulated territory, forcing consumers to rely on illicit products, manufactured by overseas companies and sold by companies uninterested in complying with any of our nation’s rules and regulations.

If Commissioner Califf truly wants to protect the public, he should use his discretion to delay enforcement of this rule and give companies using synthetic nicotine a real chance to comply with the regulations. More importantly, perhaps, if the FDA wants to preserve access to potentially life-saving nicotine substitutes for the millions of adults who still smoke, ensure these products meet safety standards, and discourage youth access, he should take immediate steps to create truly viable way for e-cigarette companies to earn FDA approval and regulations that allow for the existence of a legal market for these products. Without this, the illicit market will only continue to grow, and no amount of congressional ink will be enough to close that loophole.