• Madison County Record
    • Madison Living
    • Living 50 Plus
    • Explore
    • Classifieds
    • Public Notices
      • Public Notices
      • Alabama Public Notices
    • E-editions
    • Contact Us
    • Services
      • About Us
      • List of Locations
      • Subscribe
      • Policies
      • Terms of use
      • Submit a news tip
      • Submit a photo
      • Birth announcement
      • Engagement announcement
      • Wedding announcement
      • Submit a Classified Ad
      • Letter to the Editor
    • Madison County Record
    • Madison Living
    • Living 50 Plus
    • Explore
    • Classifieds
    • Public Notices
      • Public Notices
      • Alabama Public Notices
    • E-editions
    • Contact Us
    • Services
      • About Us
      • List of Locations
      • Subscribe
      • Policies
      • Terms of use
      • Submit a news tip
      • Submit a photo
      • Birth announcement
      • Engagement announcement
      • Wedding announcement
      • Submit a Classified Ad
      • Letter to the Editor

Hartselle Enquirer
  • Home
  • News
  • Sports
  • Obits
  • Opinion
  • Public Records
  • Madison County Record
  • Madison Living Magazine
  • Classifieds
  • Public Notices
  • Contact Us
  • Services
  • About Us
  • List of Locations
  • Subscribe
  • Policies
  • Terms of use
  • Submit a News Tip
  • Submit a Photo
  • Birth Announcement
  • Engagement Announcement
  • Wedding Announcement
  • Submit a Classified Ad
  • Letter to the Editor
    Hartselle Enquirer
      • Site logo
      • Home
      • News
      • Sports
      • Schools
      • Opinion
      • Events
      • Lifestyles
      • Business
      • Records
      • Special Sections
      • Site logo
      • Home
      • News
      • Sports
      • Schools
      • Opinion
      • Events
      • Lifestyles
      • Business
      • Records
      • Special Sections
    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
    Exclusive: Movie planned on life of baseball’s Jose Canseco
    Madison County Record, News, Sports, ...
    Exclusive: Movie planned on life of baseball’s Jose Canseco
    Bob Labbe 
    July 2, 2025
    Editor’s note: Former Major League Baseball superstar Jose Canseco spoke exclusively with Bob Labbe of the Madison Record about the former All-Star’s ...
    Madison Stake of LDS Church hosted Make Music Huntsville
    Madison, Madison County Record, News, ...
    Madison Stake of LDS Church hosted Make Music Huntsville
    Gregg Parker 
    July 2, 2025
    MADISON – “Make Music Huntsville 2025” offered a full day of live music, worship and community connection. The Church of Jesus Christ of Latter- day S...
    {"epopulate_editorials_prism":"epopulate_editorials_prism", "madison-record":"Madison Record"}{"madison-record":"Madison Record"}
    Heidi Clemons feels ‘out of this world’ as Midtown’s Teacher of the Year
    Madison, Madison County Record, News, ...
    Heidi Clemons feels ‘out of this world’ as Midtown’s Teacher of the Year
    Gregg Parker 
    July 2, 2025
    MADISON – When Heidi Clemons hears a student say, “That was so fun, Senora Clemons!,” she knows all her planning for that lesson paid off. She is “Tea...
    {"epopulate_editorials_prism":"epopulate_editorials_prism", "madison-record":"Madison Record"}{"madison-record":"Madison Record"}
    Madison Elementary picks Beth Massey as ‘Teacher of the Year’
    Madison County Record, News, Schools, ...
    Madison Elementary picks Beth Massey as ‘Teacher of the Year’
    Gregg Parker 
    July 2, 2025
    MADISON – When Beth Massey started working for Madison City Schools in 2019, she immediately felt at home. Massey is “Teacher of the Year” at Madison ...
    {"epopulate_editorials_prism":"epopulate_editorials_prism", "madison-record":"Madison Record"}{"madison-record":"Madison Record"}
    As ‘Mrs. Alabama America,’ Brianna Sistrunk focuses on national title
    Bob Jones High School, Living, Madison, ...
    2025 Mrs. Alabama America
    As ‘Mrs. Alabama America,’ Brianna Sistrunk focuses on national title
    As ‘Mrs. Alabama America,’ Brianna Sistrunk focuses on national title
    Gregg Parker 
    July 2, 2025
    MADISON - Brianna Sistrunk of Madison has been crowned 2025 Mrs. Alabama America and soon will compete at the national level. The Mrs. Alabama America...
    {"epopulate_editorials_prism":"epopulate_editorials_prism", "madison-record":"Madison Record"}{"madison-record":"Madison Record"}
    Journey Middle agrees on Chelsea Young as ‘Teacher of the Year’
    Madison, Madison County Record, News, ...
    Journey Middle agrees on Chelsea Young as ‘Teacher of the Year’
    Gregg Parker 
    June 25, 2025
    MADISON – When Chelsea Young moved to Madison in 2016, Madison City Schools held “a reputation for academic excellence and for one of the best distric...
    {"epopulate_editorials_prism":"epopulate_editorials_prism", "madison-record":"Madison Record"}{"madison-record":"Madison Record"}
    Columbia recognizes Annabel Richter as ‘Staff Member of the Year’
    Madison, Madison County Record, News, ...
    Columbia recognizes Annabel Richter as ‘Staff Member of the Year’
    Gregg Parker 
    June 25, 2025
    MADISON – Annabel Richter’s work can confirm that a student has a solid path to a well-rounded education. Columbia Elementary School’s faculty and sta...
    {"epopulate_editorials_prism":"epopulate_editorials_prism", "madison-record":"Madison Record"}{"madison-record":"Madison Record"}
    ‘Because of Jesus’ summer camp nurtures 130 youth in The Church of Jesus Christ of Latter-day Saints
    Madison, Madison County Record, News, ...
    Summer camp
    ‘Because of Jesus’ summer camp nurtures 130 youth in The Church of Jesus Christ of Latter-day Saints
    Gregg Parker 
    June 25, 2025
    MADISON - A local church’s special event connected on a personal level with 130-plus children who celebrated faith and friendship. Starting summer in ...
    {"epopulate_editorials_prism":"epopulate_editorials_prism", "madison-record":"Madison Record"}{"madison-record":"Madison Record"}

    Leave a Reply Cancel reply

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

    ❮ ❯
    Get Legals or Public Notices Published
    Latest Local News
    Exclusive: Movie planned on life of baseball’s Jose Canseco
    Exclusive: Movie planned on life of baseball’s Jose Canseco
    Editor’s note: Former Major League Baseball superstar Jose Canseco spoke exclusively with Bob Labbe of the Madison Record about the former All-Star’s ...
    July 2, 2025
    Madison Stake of LDS Church hosted Make Music Huntsville
    Madison Stake of LDS Church hosted Make Music Huntsville
    MADISON – “Make Music Huntsville 2025” offered a full day of live music, worship and community connection. The Church of Jesus Christ of Latter- day S...
    July 2, 2025
    Heidi Clemons feels ‘out of this world’ as Midtown’s Teacher of the Year
    Heidi Clemons feels ‘out of this world’ as Midtown’s Teacher of the Year
    MADISON – When Heidi Clemons hears a student say, “That was so fun, Senora Clemons!,” she knows all her planning for that lesson paid off. She is “Tea...
    July 2, 2025
    Madison Elementary picks Beth Massey as ‘Teacher of the Year’
    Madison Elementary picks Beth Massey as ‘Teacher of the Year’
    MADISON – When Beth Massey started working for Madison City Schools in 2019, she immediately felt at home. Massey is “Teacher of the Year” at Madison ...
    July 2, 2025
    As ‘Mrs. Alabama America,’ Brianna Sistrunk focuses on national title
    As ‘Mrs. Alabama America,’ Brianna Sistrunk focuses on national title
    MADISON - Brianna Sistrunk of Madison has been crowned 2025 Mrs. Alabama America and soon will compete at the national level. The Mrs. Alabama America...
    July 2, 2025

    More Local News

    Our Latest E-edition
    Read the most recent edition
    Latest Stories
    Little Booths Market Day to premiere for young retailers
    Little Booths Market Day to premiere for young retailers
    MADISON – A special event for young, aspiring entrepreneurs and vendors will debut with Little Booths Market Day on July 12. Little Booths Market Day ...
    June 25, 2025
    TARCOG asks for input on services that benefit senior citizens
    TARCOG asks for input on services that benefit senior citizens
    HUNTSVILLE - Top of Alabama Regional Council of Government or TARCOG wants your input. Affiliated with TARCOG, the Area Agency on Aging is conducting ...
    June 25, 2025
    Heart of the Valley YMCA hires Rob Gray as president
    Heart of the Valley YMCA hires Rob Gray as president
    By GREGG PARKER MADISON COUNTY -- Heart of the Valley YMCA has appointed a new president to lead the organization. Rob Gray has accepted the position ...
    June 25, 2025
    Mitch Daly on the move: Former Bob Jones standout moving from Trash Pandas to 66ers
    Mitch Daly on the move: Former Bob Jones standout moving from Trash Pandas to 66ers
    MADISON- The Rocket City Trash Pandas has made a series of player moves including Mitch Daly. The Bob Jones High graduate and only local player to sui...
    June 18, 2025
    School leaders urge parents for feedback about rezoning
    School leaders urge parents for feedback about rezoning
    MADISON – With their continuous honors, Madison City Schools students have proven their mastery of the ‘three Rs – Reading, ‘Riting and ‘Rithmetic.’ H...
    June 18, 2025
    poll
    Latest Sports
    Exclusive: Movie planned on life of baseball’s Jose Canseco
    Exclusive: Movie planned on life of baseball’s Jose Canseco
    Editor’s note: Former Major League Baseball superstar Jose Canseco spoke exclusively with Bob Labbe of the Madison Record about the former All-Star’s ...
    July 2, 2025
    Mitch Daly on the move: Former Bob Jones standout moving from Trash Pandas to 66ers
    Mitch Daly on the move: Former Bob Jones standout moving from Trash Pandas to 66ers
    MADISON- The Rocket City Trash Pandas has made a series of player moves including Mitch Daly. The Bob Jones High graduate and only local player to sui...
    June 18, 2025
    Daly returns home to play for Trash Pandas
    Daly returns home to play for Trash Pandas
    MADISON - Since birth, Mitch Daly has always been on the move as his father, Ed, is a four-star general in the U.S. Army causing him to pack up his wi...
    May 26, 2025
    Thousands expected for Memorial Day’s Cotton Row Run
    Thousands expected for Memorial Day’s Cotton Row Run
    HUNTSVILLE - The Cotton Row Run is a community event. The annual Memorial Day extravaganza, held in downtown Huntsville, again this year will attract ...
    May 20, 2025
    Madison Academy girls surge into soccer finals
    Madison Academy girls surge into soccer finals
    HUNTSVILLE – Madison Academy entered the state soccer tournament scoreless in three previous games at John Hunt Park, including against Donoho last se...
    May 9, 2025

    More Sports Stories

    x

    Sections

    • Home
    • News
    • Sports
    • Opinion
    • Lifestyles
    • Obits
    • Business
    • Sponsored Content
      • Home
      • News
      • Sports
      • Opinion
      • Lifestyles
      • Obits
      • Business
      • Sponsored Content

    Other Publications

    Madison Living Logo Living 50 Plus Logo

    Services

    • About Us
    • Subscribe
    • Advertise With Us
    • Policies
    • Terms of use
    • Submit a news tip
    • Submit a photo
    • Birth announcement
    • Birthday announcement
    • Engagement announcement
    • Wedding announcement
    • Sign Up For Our Free Newsletter
      • About Us
      • Subscribe
      • Advertise With Us
      • Policies
      • Terms of use
      • Submit a news tip
      • Submit a photo
      • Birth announcement
      • Birthday announcement
      • Engagement announcement
      • Wedding announcement
      • Sign Up For Our Free Newsletter

    Follow Us

    Copyright

    © , The Madison Record