and something from the FDA
FDA Warns JUUL Labs for Marketing Unauthorized Modified Risk Tobacco Products; Requests Additional Documents and Information
Today, FDA issued a warning letter to JUUL Labs, Inc. for marketing unauthorized modified risk tobacco products
by engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at a school.
The agency also sent a letter to the company expressing concern, and requesting more information,
about several issues raised in a recent Congressional hearing regarding JUUL’s outreach and marketing practices,
including those targeted at students, tribes, health insurers and employers.
The warning letter to JUUL states that FDA has determined that JUUL has marketed its products as modified risk tobacco products
without an appropriate FDA order in effect. JUUL’s labeling, advertising, and/or other activities directed to consumers represent,
or would be reasonably expected to result in consumers believing, that the products
1) present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products;
2) contain a reduced level of a substance or present a reduced exposure to a substance; and/or
3) do not contain or are free of a substance or substances.
The warning letter identifies several statements, including statements discussed in testimony from a July 2019 Congressional hearing on JUUL,
and a “Letter from the CEO” that appeared on, for example, JUUL’s website.
The agency has requested that JUUL provide a written response to the warning letter within 15 working days
describing its corrective actions and its plan for maintaining compliance with the Federal Food, Drug, and Cosmetic Act,
including its plan to prevent the same or similar violations.
FDA also issued a letter to JUUL requesting documents and information regarding several additional issues of concern,
including statements and representations made as part of JUUL’s “Make the Switch” campaign
and JUUL’s “Switching Program” presentation to the Cheyenne River Sioux Tribe.
The agency is concerned these statements and representations may convey that switching to JUUL
is a safer alternative to cigarettes in that using JUUL products pose less risk or is less harmful than cigarettes.
FDA is requesting documents and information about these practices, as well as about JUUL’s product design, including the use of nicotine salts.
The agency has requested that JUUL provide the requested documents and information on the various topics,
including JUUL’s outreach and marketing practices, to the agency within 30 days of the date of the letter.
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U.S. Food and Drug Administration
10903 New Hampshire Avenue, Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)
Privacy Policy | www.fda.gov
and something from the FDA FDA Warns JUUL Labs for Marketing Unauthorized Modified Risk Tobacco Products; Requests Additional Documents and Information Today, FDA issued a warning letter to JUUL Labs, Inc. for marketing unauthorized modified risk tobacco products by engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at a school. The agency also sent a letter to the company expressing concern, and requesting more information, about several issues raised in a recent Congressional hearing regarding JUUL’s outreach and marketing practices, including those targeted at students, tribes, health insurers and employers. The warning letter to JUUL states that FDA has determined that JUUL has marketed its products as modified risk tobacco products without an appropriate FDA order in effect. JUUL’s labeling, advertising, and/or other activities directed to consumers represent, or would be reasonably expected to result in consumers believing, that the products 1) present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products; 2) contain a reduced level of a substance or present a reduced exposure to a substance; and/or 3) do not contain or are free of a substance or substances. The warning letter identifies several statements, including statements discussed in testimony from a July 2019 Congressional hearing on JUUL, and a “Letter from the CEO” that appeared on, for example, JUUL’s website. The agency has requested that JUUL provide a written response to the warning letter within 15 working days describing its corrective actions and its plan for maintaining compliance with the Federal Food, Drug, and Cosmetic Act, including its plan to prevent the same or similar violations. FDA also issued a letter to JUUL requesting documents and information regarding several additional issues of concern, including statements and representations made as part of JUUL’s “Make the Switch” campaign and JUUL’s “Switching Program” presentation to the Cheyenne River Sioux Tribe. The agency is concerned these statements and representations may convey that switching to JUUL is a safer alternative to cigarettes in that using JUUL products pose less risk or is less harmful than cigarettes. FDA is requesting documents and information about these practices, as well as about JUUL’s product design, including the use of nicotine salts. The agency has requested that JUUL provide the requested documents and information on the various topics, including JUUL’s outreach and marketing practices, to the agency within 30 days of the date of the letter. Read More U.S. Food and Drug Administration 10903 New Hampshire Avenue, Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Privacy Policy | www.fda.gov
