Currently Marketed JUUL Products Must Be
Removed from the US Market
SILVER
SPRING, Md., June 23,
2022 /PRNewswire/ -- 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.
There are many resources to help smokers who want to quit.
Quitting all tobacco products is the best possible path to good
health. Some current JUUL users who will not have access to JUUL
products following this action or current smokers who want to
transition away from cigarettes and cigars may decide to switch to
other ENDS products that have been reviewed and authorized by the
FDA based on their potential to benefit adult smokers.
To date, the FDA has authorized 23 ENDS products. Under the PMTA
pathway, applicants must demonstrate to the agency, among other
things, that permitting the marketing of the new tobacco product
would be appropriate for the protection of the public health.
The FDA continues to work to complete its review of the
remaining pending applications for deemed products submitted by the
Sept. 9, 2020, deadline.
Additional Resources:
- Tobacco Products Marketing Orders
- Premarket Tobacco Product Applications
- Quitting Smoking and Other Tobacco Public Health Resources
- Safety Reporting Portal for Tobacco Products
Media Contact: FDA Office of Media Affairs,
301-796-4540
Consumer Inquiries: Email or 888-INFO-FDA
(888-463-0332)
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.
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SOURCE U.S. Food and Drug Administration