The U.S. Food and Drug Administration (FDA) has recently taken drastic action against two disposable vape brands, EB Design (formerly Elf Bar) and Esco Bar, by ordering import inspectors to detain shipments of their products at U.S. ports of entry.
This move has raised the question: why is the FDA targeting only two brands out of thousands with pending PMTAs?
In this article, we will explore the controversy surrounding the FDA’s decision and what it could mean for the future of the vape industry.
We will examine how RJ Reynolds petitioned for enforcement discretion and what exactly is on the FDA’s Red List. Finally, we will discuss how this decision could affect other companies in the vaping industry.
Table of Contents:
FDA Red List
The recent addition of certain products to an import red list has sparked debate about why this action was taken and what implications it may have for the future of such products.
The FDA’s import crackdown on EB Design and Esco Bar disposable vapes from China and Korea is based on the agency’s concern over the use of synthetic nicotine in these products, which are unauthorized for sale by the FDA and technically illegal.
This issue has been pushed forward by anti-vaping organizations such as the Campaign for Tobacco-Free Kids, as well as one major tobacco company that also sells vaping products, who have pressured the FDA to prioritize enforcement against “illegally marketed disposable electronic nicotine delivery system (‘ENDS’) products” to “better protect public health.”
With disposables grabbing 5.7 billion of the market size in 2021 and expected to grow by 11.2% through 2030, many are questioning whether this crackdown is a sign that other PMTAs submitted during a short window last year will come under further scrutiny.
Unless Congress or Supreme Court steps in, it seems likely that FDA will continue with its current enforcement strategy.
RJ Reynolds Petition
R.J. Reynolds has submitted a petition to the U.S. Food and Drug Administration requesting an emphasis on enforcement of illegally marketed disposable electronic nicotine delivery systems to protect public health better.
The petition cites pressure from Congress, one major tobacco company that sells vaping products, and anti-vaping organizations like the Campaign for Tobacco-Free Kids as the impetus for the import crackdown.
In particular, R.J. Reynolds is asking the FDA to prioritize enforcement against “illegally marketed disposable electronic nicotine delivery system (‘ENDS’) products” to “better protect public health.”
The petition raises questions about whether or not FDA “enforcement discretion” allows the agency to pick two brands (out of thousands) with pending PMTAs to enforce against.
Since early 2020, disposable vapes such as EB Design and Esco Bar have gained significant popularity. In just two years after, the FDA altered its enforcement priorities, with disposables capturing a third of the convenience store segment in the vape market.
This rapid growth has led some to question whether the recent crackdown on these products is another instance of regulators employing a whack-a-mole enforcement strategy. They argue that regulators may not adequately consider the broader implications for individuals relying on disposable vapes for their nicotine needs.
Furthermore, critics argue that regulators may be solely focusing on data related to youth usage rates, disregarding adult use cases when making decisions about regulation.
Enforcement Discretion
Regulators are faced with whether their enforcement discretion allows them to choose certain brands with pending applications for market authorization to protect public health better.
The FDA has ordered import inspectors to detain EB Design and Esco Bar disposable vapes from China and Korea. These have been added to an “import red list” that allows detention without a physical examination.
While the FDA has allowed products with pending PMTAs to remain undisturbed, R.J. Reynolds filed an FDA citizen petition in February asking for prioritization against “illegally marketed disposable electronic nicotine delivery system (‘ENDS’) products.”
This presents a dilemma regarding the FDA’s discretion limitations: if it chooses these two brands, what implications could this have on other companies? Furthermore, what impact would this have on the vaping industry as a whole?
If enforcement is made arbitrarily, it could confuse vape manufacturers navigating through the complex PMTA process or attempting to comply with premarket requirements.
Therefore, regulators must take into consideration all stakeholders involved before making any decisions so as not to impede innovation or disrupt consumer access to high-quality products while ensuring public health remains protected.
Conclusion
The FDA’s decision to detain shipments of EB Design and Esco Bar products has caused a stir among the vaping community. Despite requests from many stakeholders, the FDA has chosen to exercise its enforcement discretion by targeting just two brands out of thousands with pending PMTAs.
The implications of this move are yet to be seen, but it could signal a shift in how the FDA regulates e-cigarettes and other tobacco products in the future. As the debate over vaping continues, one thing is clear. All parties involved must ensure that any regulation applied is grounded in science and evidence-based research for the safety of consumers everywhere.
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