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PMTA authorization will dramatically increase Charlie's sales, profits, and market share
COSTA MESA, CA / ACCESSWIRE / June 8, 2021 / Charlie's Holdings, Inc. (OTC PINK:CHUC)("Charlie's" or the "Company"), an industry leader in both the premium, nicotine-based, e-cigarette space and the hemp-derived CBD wellness space, announced today that all of Charlie's best-selling e-liquids were included on the list recently released by the U.S. Food and Drug Administration's ("FDA") of deemed new tobacco products for which a Premarket Tobacco Product Application ("PMTA") was submitted to the FDA prior to the September 9, 2020 deadline for currently marketed products.
Under the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA must approve PMTA's for "newly deemed tobacco products" ̶ including e-liquid derived from tobacco ̶ in order for these products to remain on the market in the United States. According to the FDA's Center for Tobacco Products, since January 2021, the FDA has issued 122 warning letters to firms selling or distributing more than 1,280,000 unauthorized electronic nicotine delivery systems ("ENDS") and that did not submit PMTA's by the September 9 deadline.
In contrast to the firms that received FDA warning letters, Charlie's submitted its PMTA in August 2020, passed the FDA's filing review phase, and has already entered the "Substantive Review" phase with the FDA.
"Because we made the conscious decision ̶ years ago ̶ to demonstrate that the Company's products are "Appropriate for the Protection of Public Health," Charlie's invested substantial human and financial resources necessary to complete the extensive PMTA process," explained Ryan Stump, Charlie's Chief Operating Officer. "As a result, when others are forced to withdraw their products from the market, Charlie's will likely be one of a very select group still legally allowed to operate in the flavored nicotine product space."
Mr. Stump concluded, "We look forward to the major competitive advantage - and to the corresponding increase in sales, profits, and market share - that will result from our steadfast commitment to providing our customers with a trusted product portfolio in full regulatory compliance."
About Charlie's Holdings, Inc.
Charlie's Holdings, Inc. (OTC PINK:CHUC) is an industry leader in both the premium, nicotine-based, e-cigarette space and the hemp-derived, CBD wellness space through its subsidiary companies Charlie's Chalk Dust, LLC and Don Polly, LLC. Charlie's Chalk Dust produces high quality vapor products currently distributed in more than 90 countries around the world. Charlie's Chalk Dust has developed an extensive portfolio of brand styles, flavor profiles and innovative product formats. Launched in 2019,Don Polly creates brands and products in the hemp-derived marketplace aimed to meet the needs of the ever-evolving wellness consumer.
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding the Company's overall business, existing and anticipated markets and expectations regarding future sales and expenses. Words such as "expect," "anticipate," "should," "believe," "target," "project," "goals," "estimate," "potential," "predict," "may," "will," "could," "intend," variations of these terms or the negative of these terms and similar expressions are intended to identify these forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company's control. The Company's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: the Company's ability to successful increase sales and enter new markets; the FDA's decision with respect to the Company's PMTAs; the Company's ability to manufacture and produce product for its customers; the Company's ability to formulate new products; the acceptance of existing and future products; the complexity, expense and time associated with compliance with government rules and regulations affecting nicotine and products containing cannabidiol; litigation risks from the use of the Company's products; risks of government regulations; the impact of competitive products; and the Company's ability to maintain and enhance its brand, as well as other risk factors included in the Company's most recent quarterly report on Form 10-K, Form 10-Q and other SEC filings. These forward-looking statements are made as of the date of this press release and were based on current expectations, estimates, forecasts and projections as well as the beliefs and assumptions of management. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.
SOURCE: Charlie's Holdings, Inc.
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