But unfortunately, there are several fundamental flaws in both the statute and the FDA’s subsequent implementation of it. These have directly contributed to today’s chaotic marketplace and have had a detrimental impact on public health—particularly on the lives of adults who are unable or unwilling to quit smoking.

The primary flaw in the statute lies with the premarket authorization process for new tobacco products, a term used to include nicotine vapes. The Tobacco Control Act’s one-size-fits-all premarket review requirement is based entirely on a product’s market availability at a particular point in time. Only a “new” tobacco product—considered anything introduced to the US market or modified after February 15, 2007—is subject to premarket review.

Preexisting products, including the combustible cigarette, can mostly escape FDA scrutiny. But new and potentially reduced-harm products have an enormous regulatory hurdle.

That of course sets up a system where “preexisting” products, including the deadliest—the combustible cigarette—can mostly escape FDA scrutiny. But new, innovative and potentially reduced-harm products have an enormous regulatory hurdle to enter the market (or remain on the market, as is the case for many companies).

The premarket pathways themselves further entrench this system favoring preexisting harmful products. This is because the type of marketing application one files—a Premarket Tobacco Product Application (PMTA), Substantial Equivalence (SE) report or minor modification SE Exemption request—also depends entirely on whether the applicant already has a preexisting version of the new product. The premarket pathway does not depend on the type of product, or the characteristics of the product, such as whether it is combusted or non-combusted, or contains tobacco leaf or just nicotine. 

A cigarette company that has been selling cigarettes for years likely has preexisting products entirely exempt from premarket review (or “provisional” products that are allowed to remain on the market despite not being available before 2007). Those companies have the option of utilizing the much less onerous (compared to the PMTA) SE report pathway to introduce modifications or new versions of their combustible products, and even streamlined pathways for product quantity changes or minor modifications.

An e-cigarette or electronic nicotine delivery system (ENDS) manufacturer, on the other hand, is stuck with the PMTA process, and the overwhelming task of demonstrating that its products are “appropriate for the protection of the public health.” Even companies with the financial resources and scientific acumen to navigate the PMTA and obtain a marketing granted order (currently limited to tobacco-flavored ENDS), must go through the time-consuming “supplemental” PMTA process to make even minor product changes (even if those changes will not have any meaningful impact on risks or how the product is consumed).

The Tobacco Control Act isn’t all bad. Yet the FDA’s implementation has also been fundamentally flawed from the beginning.

But the Tobacco Control Act isn’t all bad. Despite its severe limitations, Congress did give FDA enough wiggle-room to use its authority to regulate in a flexible manner that, among other things, considers the needs of adults seeking reduced-harm alternatives.

Yet aside from the statute itself, the FDA’s implementation of the premarket review process has also been fundamentally flawed from the beginning. When the deeming rule was going through the rulemaking process, numerous comments suggested alternative premarket review frameworks. The FDA could have taken an approach similar to its own regulation of over-the-counter drugs; or the European Union’s Tobacco Products Directive for products like e-liquids which all contain the same basic ingredients; or tailored application requirements based on where a product falls on the continuum of risk. None of those alternatives made it into the final rule, even though they could have been justified under the Tobacco Control Act.

The bottom line is that the FDA failed to adjust to the realities on the ground. By the time the deeming rule came into effect, as a practical matter, the agency was no longer dealing with a true premarket situation for the vast majority of deemed products. When Congress was contemplating the premarket review process in the late 2000s, it could not have envisioned that less than a decade later, there would be entirely new categories of products on the market, including hundreds of millions of e-liquids alone. And while the FDA created a deferred compliance policy delaying premarket deadlines for a few years, the agency failed to utilize its rulemaking authority to establish foundational rules and product standards that would have taken at least some of the guessing out of the application process for both industry and regulator. 

There was a glimmer of hope following FDA’s announcement of the comprehensive plan for tobacco and nicotine regulation in 2017, but the spike in youth past-30 day vaping rates that occurred between 2018 and 2019 (which has thankfully subsided) appears to have hindered any real implementation of that plan—along with meaningful discussion of tobacco harm reduction within the agency and on Capitol Hill.

Following deeming, and in the aftermath of the July 2019 decision from the federal district court in Maryland (which accelerated the premarket review deadline to September 9, 2020), while trying to scramble together applications, several ENDS industry and small business trade associations met with the FDA and the Department of Health and Human Services to again propose potential streamlined PMTA processes for open-system ENDS and e-liquids. These have a much lower youth-use concern than certain closed-system products.

This was on the heels of then-HSS Secretary Alex Azar’s public statement that the administration was planning on creating a streamlined pathway for vape shops and small e-liquid manufacturers. Those industry proposals contemplated allowing eligible manufacturers, who were otherwise compliant with the Tobacco Control Act and the FDA’s deferred compliance policy, to submit abbreviated applications— containing, among other things, product-specific information, as well as environmental assessments, manufacturing details, marketing plans, proof that they were age-verifying and not contributing to illegal underage use, and plans for controlled distribution networks to ensure adequate postmarket surveillance. If manufacturers could provide this information, under the proposals, then the FDA would accept the applications and allow additional time to complete more extensive behavioral and perception studies, while allowing the products to remain on the market for adults.

But the FDA rejected those opportunities as well.

The calculus must be different when the FDA knows a denial could have an adverse public health impact on people already using the product as a replacement for cigarettes.

With respect to the FDA’s review of PMTAs, it appears that the agency is not properly balancing the potential public health impact of denying applications and ultimately forcing widely used products off the market. Again, that is because in reality we are not dealing with true premarket review in most cases. Rather, we are dealing with products that are already being used by millions of adults who might otherwise be smoking. 

The FDA’s “fatal flaw” review of PMTAs for non-tobacco flavored ENDS obviously did not consider that, and neither did FDA’s attempted denial of Juul, a product that has 2 to 3 million documented adult consumers, or the agency’s recent denial of Logic Technology’s menthol-flavored ENDS. Rather, it seems that the FDA is in some ways reviewing these applications in a vacuum and ignoring the real-world evidence, at least with respect to potential benefits to adults.

But considering the potential benefits of ENDS (particularly non-tobacco flavored products) for adults who smoke, it is difficult to understand a review process that determines it is “appropriate for the protection of the public health” to deny Juul, say, with its significant adult consumer base, based on apparently insufficient or conflicting information on product chemistry or toxicology.

Of course, these are key questions that must be addressed before authorizing a product. In a true premarket review scenario, it would certainly make sense to prevent the introduction of a new product that does not have adequate toxicology data, for example. But the calculus must be different when the FDA knows a denial could have an adverse public health impact on people already using the product as a replacement for cigarettes. And plenty of real-world data back that up (including the FDA’s own PATH study).

So now what? Getting Congress to amend the legislation is unlikely. But as the Reagan-Udall Foundation completes its review of the FDA’s tobacco program in the next few weeks, it should know that the FDA might still be able to rectify the situation.

The agency should consider re-tooling its PMTA review process. The FDA must consider the totality of the evidence in a PMTA (including the applicant’s marketing and sales-access-restrictions plans) and not conduct reviews in silo. This means the potential negative consequences of denying authorization to existing products must be appropriately considered. For such products, the FDA should focus on postmarket surveillance and strict enforcement of age-verification and youth access prevention plans. It is also critical that the FDA hamper the spread of counterfeit products, which may be riskier for consumers and are drowning out the small businesses and vape shops that continue to bear the brunt of FDA enforcement. Finally, the FDA should shift more resources to developing reasonable safety, quality and marketing product standards.

Although the system is fundamentally flawed, if measures like these are implemented, the ultimate goal of the Tobacco Control Act—to protect public health—might still be realized.

Photograph by Felton Davis via Flickr/Creative Commons 2.0

The Influence Foundation, which operates Filter, has received grants from Juul Labs, Inc. Filter‘s Editorial Independence Policy applies.

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