FDA Rescinds Marketing Ban on Juul Vaping Products, Returns Applications to Review Status
Key Insights
The FDA rescinded its 2022 marketing denial orders for Juul Labs (search) vaping products on Thursday, returning the applications to pending review status rather than granting authorization.
The reversal follows nearly two years of additional scientific review across multiple disciplines including toxicology, engineering, and clinical pharmacology since the initial ban.
Juul products remain on the market during the ongoing FDA review process, despite continued concerns from health organizations about the company's role in youth vaping epidemic.
The US Food and Drug Administration announced Thursday it had rescinded marketing denial orders for vaping products from Juul Labs (search) Inc., returning the company's applications to pending review status nearly two years after initially banning the products from the market.
The FDA had initially blocked Juul's application to sell its vaping device and tobacco- and menthol-flavored pods in June 2022, after completing a nearly two-year review of the manufacturer's application. The agency found that the applications "lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that the marketing of the products met the public health standard required by law."
The company subsequently appealed the decision, and the FDA paused the block just weeks later in July 2022 to conduct additional scientific review. Juul products remained on store shelves pending the appeal process.
Expanded Scientific Review Process
Since the initial ban, the FDA said Thursday it has "conducted additional substantive review of the applications in a number of disciplines, including toxicology, engineering, social science, and clinical pharmacology." The reversal is based on a "review of information provided by the applicant" as well as new case law stemming from court decisions involving marketing denial orders for e-cigarette products.
The FDA emphasized that court decisions since the original ban "establish new case law and inform the FDA's approach to product review to maintain the agency's commitment to issuing final decisions that are appropriate on both the scientific merits and the law."
"Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied," the FDA said in a statement. "Rescission of the MDOs returns the applications to pending status, under substantive review by the FDA."
Company Response and Market Position
Juul Labs (search) said in a statement Thursday that they "appreciate the FDA's decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for JUUL products."
"We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health," the statement continued.
Juul has remained one of the most popular e-cigarette products on the market despite regulatory challenges. The company's pods contain nicotine strengths of 5% or 3%, and the company says its products are designed for adult smokers, ages 21 and up.
Health Organizations Express Concerns
The American Lung Association (search) said Thursday it was "deeply troubled" by the FDA's announcement and urged the agency to deny all Juul products, citing the company's role in the "youth e-cigarette epidemic from 2017-2019."
"Juul is largely responsible for the youth e-cigarette epidemic from 2017-2019. These products and its manufacturer clearly do not meet the standard for protecting the public health," said Erika Sward, the association's assistant vice president of nationwide advocacy.
The Campaign for Tobacco-Free Kids (search) also criticized the decision, with CEO and president Yolonda Richardson stating that "the FDA's continuing delays in reviewing Juul's marketing applications are unacceptable and harmful to America's kids."
Richardson cited Juul's history, noting that the company "fueled this epidemic by introducing a sleek, easy-to-hide product that was sold in appealing flavors including menthol, marketed in ways that appeal to kids, and delivered massive doses of nicotine that can quickly addict kids."
Youth Usage Trends
According to the US Centers for Disease Control and Prevention (search), more than 2 million American middle and high school students used e-cigarettes in 2023, with nearly 9 in 10 students saying they use flavored e-cigarettes. Use of e-cigarettes among high school students declined from 14.1% to 10% from 2022 to 2023, though they remained the most commonly used tobacco product among youths.
The 2023 National Youth Tobacco Survey found Juul was the fourth-most popular e-cigarette brand used by adolescents, down from the most popular in the 2020 survey.
Regulatory Context
As of the end of May, the FDA says it has only authorized 23 e-cigarette products and devices after the products have undergone what the FDA describes as "rigorous scientific review" that includes toxicologic assessments. To receive authorization, products must also be appropriate by the FDA's product standard.
The agency's authority to regulate e-cigarette products stems from 2009 legislation that gave the FDA authority to regulate the manufacturing, distribution and marketing of tobacco products. E-cigarette manufacturers, including Juul, were required to submit their products to the FDA for review by September 2020 but were able to sell products while the FDA review was underway.