Other companies have received 168 FDA 'Marketing Denial Orders' for more than 992,000 flavored electronic nicotine delivery system products, and 'Refuse-to-File' letters for approximately 4.5 million other products
COSTA MESA, CA / ACCESSWIRE / September 13, 2021 / Charlie's Holdings, Inc. (OTCQB: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, today announced Charlie's Premarket Tobacco Product Applications ('PMTA's') for the Company's best-selling e-liquids remain among the select minority of applications submitted to the U.S. Food and Drug Administration ('FDA') that have not received Marketing Denial Orders or Refuse-to-File designations. Including product-specific scientific data, thorough perception studies, and detailed environmental assessments, Charlie's PMTA's cost more than $5 million and are among the most comprehensive PMTA's in the entire industry. The Company has publicly expressed its commitment to full regulatory compliance and youth access prevention and believes its submissions to the FDA will be recognized as both distinguished and suitable for approval.
Under the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA must approve PMTA's for 'newly deemed tobacco products,' including electronic nicotine delivery systems ('ENDS') such as e-cigarettes and e-liquids derived from tobacco, in order for the products to remain on the market in the United States. As required by statute, a key consideration in the FDA's review of a PMTA is to determine whether permitting the marketing of the product would be 'appropriate for the protection of the public health,' taking into account the risks and benefits to the population as a whole. This determination is based on the review of product-specific, scientific evidence asserting a benefit to adult smokers to overcome the risk posed to youth, as well as the potential for the product(s) to move adult smokers away from combustible tobacco products.
In the millions of cases where PMTA's submitted by other companies did not include FDA-required content, or where sufficient product-specific, scientific evidence was not included, the FDA could not allow products to continue in the PMTA review process. Accordingly, one year after the September 9, 2020 PMTA submission deadline, the FDA has issued 168 Marketing Denial Orders for more than 992,000 flavored ENDS products and has issued Refuse-to-File Letters for approximately 4.5 million other products. Any product subject to a Marketing Denial Order or a Refuse-to-File designation may not be introduced or delivered for interstate commerce. Further, if a product is already on the market, the product must be removed from the market or risk enforcement action (including civil monetary penalties, seizure, and/or injunction).
In contrast to the companies that received FDA Marketing Denial Orders or Refuse-to-File designations, Charlie's passed the FDA's filing review phase, and has already entered the 'Substantive Review' phase.
Ryan Stump, Charlie's Chief Operating Officer, explained, 'In addition to human clinical trials that measured the nicotine delivery efficiency of the Company's products via pharmacokinetic studies, Charlie's PMTA's include product-specific, scientific evidence that demonstrates the marketing of Charlie's products meets the statutory standard of ‘appropriate for the protection of the public health.' This is an important reason why we are highly confident that the FDA will recognize Charlie's PMTA submissions as both distinguished and suitable for approval.'
Mr. Stump continued, 'As a result of the painstaking efforts we invested in our PMTA's, when others are forced to withdraw their products from the market, Charlie's will be one of a very select group still legally allowed to operate in the flavored nicotine product space. We look forward to the competitive advantage - and to the corresponding increases in sales, profits, and market share - that will result from our steadfast commitment to providing Charlie's customers with a trusted product portfolio in full regulatory compliance.'
About Charlie's Holdings, Inc.
Charlie's Holdings, Inc. (OTCQB:CHUC) is an industry leader in the premium, nicotine-based, vapor products space and the hemp-derived CBD wellness market. The Company's products are sold around the world to select distributors, specialty retailers, and third-party online resellers through subsidiary companies Charlie's Chalk Dust, LLC and Don Polly, LLC. Charlie's Chalk Dust, LLC has developed an extensive portfolio of brand styles, flavor profiles, and innovative product formats. Don Polly, LLC creates innovative wellness products and brands in the hemp-derived CBD marketplace.
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 ongoing ability to quote its shares on the OTCQB; whether the Company will meet the requirements to uplist onto a national securities exchange in the future; the Company's ability to successfully increase sales and enter new markets; whether the Company's PMTA's will be approved by the FDA, and the FDA's decisions with respect to the Company's future PMTA's; the Company's ability to manufacture and produce products 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-Q, annual report on Form 10-K, 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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