Washington, D.C. - Today the U.S. Food and Drug Administration (FDA) announced it will issue marketing denial orders to all JUUL e-cigarette products. The products must be removed from shelves across the country or risk enforcement action as FDA has ruled they do not meet the public health standard required to be authorized for sale.
In 2018, the American Cancer Society Cancer Action Network (ACS CAN) joined public health and medical groups and pediatricians to successfully sue the FDA after the agency sought to extend its deadline to August 2022 for e-cigarette manufacturers to apply to the agency and demonstrate their products are “appropriate for the protection of the public health” in order to market their products. This delay would have left these products on store shelves unregulated until at least that time. In 2019, a federal judge ruled the FDA acted illegally in extending the deadline. By court order, manufacturers were given until September 9, 2020, to submit applications to the FDA and those failing to do so were subject to having their products removed from the market. FDA’s announcement today is their ruling on JUUL’s product applications – products that make up a significant portion of the market share.
ACS CAN and other public health groups submitted a letter to the FDA in April 2021, urging the agency to deny authorization of the sale of JUUL e-cigarette products since these products cannot meet the required public health standard. The groups also sent a letter in April 2022 calling on the agency to deny authorization of sale of menthol-flavored e-cigarettes, which are part of JUUL’s marketing denial order. ACS CAN has also continued working with Congressional leadership to reinforce the importance of denying authorization of sale of JUUL e-cigarettes.
The following is a statement from Dr. Karen E. Knudsen, CEO of ACS CAN:
“ACS CAN strongly supports the FDA’s decision to issue a marketing denial order to JUUL for the company’s e-cigarette products, including menthol-flavored e-cigarettes. This decision sends a strong message that public health is paramount when regulating tobacco products, especially a product which is proven to be the chief driver behind our country’s youth e-cigarette epidemic.
“There is overwhelming data to demonstrate the negative impact JUUL products have had on public health. In the time JUUL products were on the market unregulated, these products and JUUL’s marketing strategies significantly contributed to the youth e-cigarette crisis we currently face in this nation and led to new, previously unimaginable, levels of addiction among youth. Given research shows youth who use e-cigarettes are more likely to use combustible cigarettes, preventing youth addiction to these products is critical to preventing tobacco-related cancers.
“The tobacco industry has long used flavors to hook kids and e-cigarette manufacturers have taken that strategy and run with it, unregulated for far too long. FDA’s decision to deny authorization of the sale of JUUL products, including menthol products, is an important step that will protect our kids from an industry built on luring people into a lifetime of addiction. It blunts the potential for future generations to become addicted to tobacco and suffering from tobacco-related diseases like cancer.
“We commend FDA for standing up for public health and ordering the removal of JUUL e-cigarette products, including its menthol flavored products, from the market and urge the agency to enforce its decision swiftly.
“ACS CAN remains committed to working with Congress, state and local lawmakers to end the sale of all flavored tobacco products.”