FDA: Currently marketed JUUL products must be removed from the US market
Madison, Madison County Record, News, Z - News Main
 By  John Few Published 
10:39 am Thursday, June 23, 2022

FDA: Currently marketed JUUL products must be removed from the US market

Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action. The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%. Retailers should contact JUUL with any questions about products in their inventory.

“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf, M.D. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”

These MDOs only pertain to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use—the FDA cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products.

After reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.

To date, the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUULpods. However, the MDOs issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the JUUL products. There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the JUUL device or using JUULpods with a non-JUUL device. The FDA recommends against modifying or adding substances to tobacco products. JUUL users are encouraged to report any unexpected health problems or product problems to the FDA through the Safety Reporting Portal and to seek medical attention as necessary.

“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”

Any products subject to an MDO may not be offered for sale or distributed in the United States, or the FDA may take enforcement action.

In addition to ensuring that JUUL complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers. Specifically, the FDA notes that all new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action.

As the FDA has stated in the past, unauthorized electronic nicotine delivery system (ENDS) products for which no application is pending, including for example, those with an MDO, are among our highest enforcement priorities. Therefore, the FDA encourages retailers to discuss products in their inventory with their suppliers including the current status of any particular tobacco product’s marketing application or marketing authorization. Manufacturers will be the best source of that information and retailers should rely on manufacturers directly to inform decisions about which products to continue selling.

Also on The Madison Record
Rocket City Marching Invitational set for Saturday, Sept. 20 at stadium
Bob Jones High School, Madison, Madison County Record, ...
Gregg Parker 
September 17, 2025
MADISON – Bob Jones High School Bands, in collaboration with title sponsor KODA Technologies, will present the third annual Rocket City Marching Invit...
Mayor Paul Finley bids farewell, reflects on accomplishments at 2025 Madison Update
A: Main, Madison County Record, News, ...
Maria Rakoczy 
September 17, 2025
MADISON - Madison Mayor Paul Finley will be leaving the office of mayor this Nov. after sitting out the Aug. 26 election. Finley addressed the busines...
District 6 seat to be decided Tuesday in runoff election
A: Main, Madison County Record, News, ...
Maria Rakoczy 
September 17, 2025
MADISON - There is one final race to be decided from Madison’s municipal Aug. 26 election. The representative for District 6 on the Madison City Counc...
Heart of the Valley YMCA exits Chapter 11 bankruptcy, renews mission focus
A: Main, Business, Madison County Record, ...
Gregg Parker 
September 17, 2025
HUNTSVILLE – On Sept. 8, Heart of the Valley YMCA announced its successful emergence from Chapter 11 bankruptcy. This development marks a new chapter ...
MCDAB presents check to Parks and Recreation, chairperson steps down
Madison County Record, News, The Madison Recor, ...
Maria Rakoczy 
September 17, 2025
MADISON - After serving as the chairperson for the Madison City Disability Advocacy Board (MCDAB) for nine years, Janessa Crosswy is moving and steppi...
State lawmakers, local city leaders meet with Space Command leader to discuss transition
Madison County Record, News, The Madison Recor, ...
By ALEX ANGLE Alabama Daily News 
September 17, 2025
WASHINGTON — Space Command is moving quickly to bring the headquarters to Huntsville through meetings with members of the state’s congressional delega...
Best-Selling Author Jen Hatmaker to share memoir on Oct. 21
Events, Madison County Record, News, ...
Gregg Parker 
September 17, 2025
MADISON – Jean Hatmaker, “New York Times” Best-Selling Author, speaker and podcaster, will share thoughts from her memoir, “Awake,” at Blue Apple Book...

Leave a Reply

Your email address will not be published. Required fields are marked *