Turning Point Brands Provides Update on PMTA Process
September 17 2021 - 8:13AM
Business Wire
On September 14, Turning Point Brands, Inc. (“TPB” or the
“Company”) (NYSE: TPB), a manufacturer, marketer and distributor of
branded consumer products including alternative smoking accessories
and consumables with active ingredients, was informed by the Food
and Drug Administration that the agency has issued a Marketing
Denial Order (“MDO”) in response to a Premarket Tobacco Product
Application (“PMTA”) covering certain of the Company’s vapor
products.
The Company stands behind the high quality of its PMTA, which we
believe established that the products’ continued marketing would be
“appropriate for the protection of public health,” the standard
established by the Family Smoking Prevention and Tobacco Control
Act of 2009. These products are crucial to improving public health
by helping adult smokers migrate to less harmful products. TPB will
continue to engage with the FDA and other stakeholders as we
consider options moving forward, including a formal appeal of the
decision and potential legal relief.
The PMTA denied by this MDO included an in-depth toxicological
review, a clinical study, and studies on patterns and likelihood of
use. We believe the data demonstrated that TPB products do not
appeal to never users, youth, or former users and that a
significant majority of users of TPB products had completely ceased
use of combustible cigarettes. The scientific literature on
lower-risk nicotine delivery systems shows that these products can
significantly improve public health by providing alternatives that
are much less harmful than combustible cigarettes.
“While we believe the FDA’s current conclusion is misguided, we
will continue our dialogue with the agency in search of a path
forward,” said Larry Wexler, President and CEO, Turning Point
Brands. “As we explore options for appealing this decision, we are
hopeful that the agency reaffirms its commitment to science-based
decision making and to its announced Comprehensive Plan, which
includes fully transitioning adult consumers down the continuum of
risk in order to reduce the morbidity and mortality associated with
combustible cigarette use by preserving the diverse vapor
market.”
The Company continues to monitor regulatory developments and
intends to take appropriate measures to manage and mitigate any
risk exposure that may result from these and any future MDOs.
About Turning Point Brands
Turning Point Brands (NYSE: TPB) is a manufacturer, marketer and
distributor of branded consumer products, including alternative
smoking accessories and consumables with active ingredients,
through its iconic core brands Zig-Zag® and Stoker’s® and its
emerging brands within the NewGen segment. TPB’s products are
available in more than 210,000 retail outlets in North America, in
addition to sites such as www.zigzag.com, www.nu-x.com and
www.solacevapor.com. For the latest news and information about TPB
and its brands, please visit www.turningpointbrands.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the federal securities laws. Forward-looking
statements may generally be identified by the use of words such as
"anticipate," "believe," "expect," "intend," "plan" and "will" or,
in each case, their negative, or other variations or comparable
terminology. These forward-looking statements include all matters
that are not historical facts. By their nature, forward-looking
statements involve risks and uncertainties because they relate to
events and depend on circumstances that may or may not occur in the
future. As a result, these statements are not guarantees of future
performance and actual events may differ materially from those
expressed in or suggested by the forward-looking statements. Any
forward-looking statement made by TPB in this press release, its
reports led with the Securities and Exchange Commission (the “SEC”)
and other public statements made from time-to-time speak only as of
the date made. New risks and uncertainties come up from time to
time, and it is impossible for TPB to predict or identify all such
events or how they may affect it. TPB has no obligation, and does
not intend, to update any forward-looking statements after the 2
date hereof, except as required by federal securities laws. Factors
that could cause these differences include, but are not limited to
those included it the company’s Annual reports on Form 10-K,
Quarterly Reports on Form 10-Q and other reports led by the Company
with the SEC. These statements constitute the Company’s cautionary
statements under the Private Securities Litigation Reform Act of
1995.
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version on businesswire.com: https://www.businesswire.com/news/home/20210917005098/en/
Media Contacts
Turning Point Brands, Inc.: Caitlin Kasunich / Raquel Cona KCSA
Strategic Communications 212.896.1241 / 212.896.1204
ckasunich@kcsa.com / rcona@kcsa.com
Investor Contacts
Turning Point Brands, Inc.: Louie Reformina, Senior Vice
President, CFO Turning Point Brands, Inc. 502.774.9238
ir@tpbi.com
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