Authorization Includes Restrictions to
Mitigate Youth Risk
SILVER
SPRING, Md., June 21,
2024 /PRNewswire/ -- Following an extensive
scientific review, the U.S. Food and Drug Administration today
authorized the marketing of four e-cigarette products in
the United States through the
premarket tobacco product application (PMTA) pathway. The FDA
issued marketing granted orders to NJOY LLC for four
menthol-flavored e-cigarette products – NJOY ACE Pod Menthol 2.4%,
NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5%, and NJOY DAILY
EXTRA Menthol 6%. The two authorized ACE products are sealed,
pre-filled, non-refillable pods that are used with the previously
authorized ACE device, and the two authorized DAILY products are
disposable e-cigarettes with a prefilled, non-refillable e-liquid
reservoir.
Today's authorizations mark the first non-tobacco flavored
e-cigarette products to be authorized by the FDA. Importantly, each
application is reviewed on a case-by-case basis and today's actions
are specific to these four products only – the authorizations do
not apply to any other menthol-flavored e-cigarette products. To
legally market a new tobacco product in the U.S., a company must
receive a written marketing order from the FDA. While this action
permits these specific tobacco products to be legally marketed in
the U.S., it does not mean these tobacco products are safe nor are
they "FDA approved." All tobacco products are harmful and
potentially addictive. Those who do not use tobacco products
shouldn't start.
"It is the responsibility of the applicant to provide the
necessary evidence to obtain marketing authorization, and the FDA
has made clear what's needed to successfully achieve that outcome,"
said Brian King, Ph.D., M.P.H.,
director of the FDA's Center for Tobacco Products. "This action is
further reinforcement that authorization of an e-cigarette product
is possible when sufficient scientific evidence has been submitted
to the agency to justify it."
The FDA evaluates PMTAs based on a public health standard that
considers, among other things, the risks and benefits of the
product to the population as a whole. After reviewing the company's
applications, the FDA determined there was sufficient evidence to
demonstrate that permitting marketing of the products would be
appropriate for the protection of the public health, which is the
standard legally required by the 2009 Family Smoking Prevention and
Tobacco Control Act. Specifically, evidence submitted by the
applicant showed that these menthol-flavored products provided a
benefit for adults who smoke cigarettes relative to that of the
applicant's previously authorized tobacco-flavored products—in
terms of complete switching—that is sufficient to outweigh the
risks of the product, including youth appeal.
"We are a data driven agency and will continue to follow the
science to inform our review of premarket tobacco applications,"
said Matthew Farrelly, Ph.D.,
director of the Office of Science in the FDA's Center for Tobacco
Products. "Based upon our rigorous scientific review, in this
instance, the strength of evidence of benefits to adult smokers
from completely switching to a less harmful product was sufficient
to outweigh the risks to youth."
The FDA remains concerned about the risk of youth use of all
e-cigarettes – particularly flavored products that are more
appealing to youth. Like previously authorized products, the FDA
has placed stringent marketing restrictions on the new products in
an effort to prevent youth access and exposure. The FDA will
closely monitor how these products are marketed and will act as
appropriate if the company fails to comply with any applicable
statutory or regulatory requirements. The agency may suspend or
withdraw authorization if the agency determines that continued
marketing is no longer appropriate for the protection of the public
health, including if there is a notable increase in use of the
products among youth or former smokers, or a decrease in the number
of current smokers who completely switch to the products.
Today's actions are among many the FDA has taken to ensure all
new tobacco products that are marketed in the U.S. undergo
science-based review and have received marketing authorizations by
the agency. The FDA has received applications for nearly 27 million
deemed products and has made determinations on more than 26 million
of these applications. To date, the FDA has authorized 27 tobacco-
and menthol-flavored e-cigarette products and devices, including
the four authorized today. The agency maintains a printable
one-page flyer of all authorized e-cigarette products; these are
the only e-cigarette products that currently may be lawfully
marketed and sold in the U.S. and those manufacturing, importing,
selling, or distributing e-cigarettes without the required
premarket authorization risk enforcement. Those seeking a list of
tobacco products—including e-cigarettes—that may be legally
marketed in the United States, can
visit the FDA's new Searchable Tobacco Products Database.
Additional Resources:
- Searchable Tobacco Products Database
- NJOY ACE: Order Letter
(PDF) and Decision Summary (PDF)
- NJOY DAILY: Order Letter (PDF)
and Decision Summary (PDF)
- Premarket Tobacco Product Applications
- Quitting Smoking and Other Tobacco Public Health Resources
Media Contact: Jim
McKinney, 240-328-7305
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, radiation-emitting electronic products, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration