FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth

Agency sends additional letter requesting more information on several issues, including outreach and marketing practices, as part of ongoing investigation

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U.S. Food and Drug Administration

Sep 09, 2019, 10:45 ET

SILVER SPRING, Md., Sept. 9, 2019 /PRNewswire/ -- Today, the U.S. Food and Drug Administration 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. These letters are the latest in a series of actions the agency has taken as part of its continued commitment to providing strong oversight of e-cigarettes and other electronic nicotine delivery systems (ENDS) and the latest development in the FDA's ongoing investigation related to JUUL.

"Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation's youth," said Acting FDA Commissioner Ned Sharpless, M.D. "In addition, we're troubled about several issues related to JUUL's outreach and marketing practices that came to light in a recent Congressional hearing. We will continue to scrutinize tobacco product marketing and take action as appropriate to ensure that the public is not misled into believing a certain product has been proven less risky or less harmful. We remain committed to using all available tools to ensure that e-cigarettes and other tobacco products aren't being marketed or sold to kids. We've also put the industry on notice: If the disturbing rise in youth e-cigarette use continues, especially through the use of flavors that appeal to kids, we'll take even more aggressive action."

As stated in the warning letter, the 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. According to that testimony, a JUUL representative speaking with students at his presentation in a school stated that:

JUUL "was much safer than cigarettes" and that "FDA would approve it any day."
JUUL was "totally safe."
A student "…should mention JUUL to his [nicotine-addicted] friend…because that's a safer alternative than smoking cigarettes, and it would be better for the kid to use."
"FDA was about to come out and say it [JUUL] was 99% safer than cigarettes…and that…would happen very soon…."

Additionally, a "Letter from the CEO" that appeared on JUUL's website, and also in an email that JUUL sent to a parent in response to her complaint that the company sold JUUL products to her child, states: "[JUUL's] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it."

The FDA has requested that JUUL provide a written response within 15 working days describing its corrective actions and its plan for maintaining compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), including its plan to prevent the same or similar violations. Failure to ensure compliance with FD&C Act may result in the FDA initiating further action, including, but not limited to, civil money penalties, seizure, and/or injunction.

Further, the agency sent an additional letter to JUUL that notes that despite commitments JUUL has made to address this epidemic, JUUL products continue to represent a significant proportion of the overall use of ENDS products by children. Some of this youth use appears to have been a direct result of JUUL's product design and promotional activities and outreach efforts.

The letter outlines 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, such as:

"'[JUUL is] a smart, really well thought-out alternative to smoking.' Make the switch."
"I think [JUUL is] an amazing invention…I don't know how we lived without that. The alternative for adult smokers."
"Elimination of combustible cigarettes is crucial to reduce risk of harm"
"Improve the lives of the world's one billion adult smokers"

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 poses less risk or is less harmful than cigarettes. The FDA is requesting documents and information about these practices, including any and all scientific evidence or data, such as consumer perception studies, related to whether these statements and representations explicitly or implicitly convey that JUUL products pose less risk, are less harmful, present reduced exposure, are safer than other tobacco products or that the products are smoking cessation products.

The FDA is also asking JUUL to explain why it uses nicotine salts, which was described at the Congressional hearing as masking the harshness of nicotine. The agency further asks JUUL why it uses a nicotine concentration of 5% in its products, which the agency is concerned could potentially increase their addictiveness. The FDA is requesting documents and information on, among other things, JUUL's use of nicotine salts in its e-liquids and the concentration of nicotine in its products.

The FDA has requested that JUUL provide the requested documents and information to the agency within 30 days of the date of the letter.

The agency previously requested documents from JUUL Labs in April 2018 to examine the reportedly high rates of youth use and the youth appeal of JUUL products. The FDA has also conducted an unannounced inspection of JUUL's corporate headquarters. Additionally, the agency has conducted inspections of several of JUUL's contract manufacturing facilities to determine compliance with all applicable FDA laws and regulatory requirements

As part of the agency's Youth Tobacco Prevention Plan, the FDA continues work on all fronts to tackle the troubling epidemic of youth e-cigarette use through all available regulatory tools. This includes taking action against manufacturers and retailers who illegally market or sell these products to minors, investigating counterfeit e-cigarette products, educating youth about the dangers of e-cigarettes, and implementing the policies necessary to keep them out of the hands of America's kids.

Separately, the FDA continues to work closely with the U.S. Centers for Disease Control and Prevention and state and local public health partners to investigate the recent respiratory illnesses associated with vaping as quickly as possible and the agency is committed to taking appropriate actions as the facts emerge.

For more information:
CTP Letters to Industry
FDA's Youth Tobacco Prevention Plan
How FDA is Regulating E-Cigarettes

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Stephanie Caccomo, 301-348-1956, [email protected]
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration