FDA Rescinds Previously Disclosed Marketing Denial Order for Turning Point Brands’ Vapor Products
11 October 2021 - 10:30PM
Business Wire
The Company’s portfolio of proprietary vapor products remains
under review
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Administration (“FDA”) that the agency had rescinded its September
14 Marketing Denial Order (“MDO”) for certain of its vapor products
with pending Premarket Tobacco Product Applications (“PMTAs”) under
review. All of TPB’s proprietary vapor products, including its
Solace™ branded e-liquids, will continue to be marketed while they
remain under review.
In its rescission letter to TPB, the FDA stated, “Upon further
review of the administrative record, FDA found relevant information
that was not adequately assessed. Specifically, your applications
did contain randomized controlled trials comparing tobacco-flavored
ENDS to flavored ENDS as well as several cross-sectional surveys
evaluating patterns of use, likelihood of use, and perceptions in
current smokers, current ENDS users, former tobacco users, and
never users, which require further review.” The letter further
clarified that “at present, in light of the unusual circumstances,
FDA has no intention of initiating an enforcement action against”
the products.
In response to the September 14 MDO, the Company had filed a
petition for relief and motion to stay the decision in the 6th
Circuit Court of Appeals. On October 8, as a result of the
rescission letter, TPB withdrew both the petition and motion.
“We are encouraged by the FDA’s decision to reconsider our
product applications and look forward to engaging the agency as our
PMTAs are reviewed,” said Larry Wexler, President and CEO, Turning
Point Brands. “It is important that the PMTA process is
transparent, purposeful, and evidence-based. Our organization
dedicated significant time and resources in filing our applications
in accordance with agency guidance. We remain hopeful that the
depth and range of our studies and data will persuade the FDA that
the continued marketing of our vapor products is appropriate for
the protection of the public health and that the agency will
ultimately preserve a diverse vapor market for the more than 30
million American adult smokers who may wish to transition from
combustible cigarettes to lower risk alternatives.”
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/20211011005139/en/
Media Contacts Turning Point Brands, Inc.: Raquel Cona
KCSA Strategic Communications 212.896.1204 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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