Carmines has submitted hundreds of PMTAs to the FDA and successfully led the MRTPA submitted by 22nd Century Group (NASDAQ: XXII) which won a marketing order from the FDA in December 2021.
COSTA MESA, CA / ACCESSWIRE / March 2, 2022 / Charlie’s Holdings, Inc. (OTCQB: CHUC) (“by charlie“or the”Company“), an industry leader in premium nicotine-based electronic cigarettes, today announced the appointment of Edward Carmines, Ph.D., to its Board of Directors. Dr. Carmines is an accomplished scientist and regulatory affairs expert with extensive experience working with the United States Food and Drug Administration’s Center for Tobacco Products (“FDA”). In addition to an extraordinary record of success with tobacco pre-marketing applications (“PMTA”), applications for modified risk tobacco products (“MRTPA”) and FDA substantial equivalence and waiver submissions, Dr. Carmines maintains collaborative relationships with tobacco industry leaders and public health advocates around the world.
“At a time when the FDA has issued hundreds of Marketing refusal orders for over one million tobacco flavorless electronic nicotine delivery system products, and Refuse to deposit letters for approximately 4.5 million other products, we are very fortunate to welcome Ed Carmines to Charlie’s Board of Directors. After successfully navigating FDA’s substantial equivalence, PMTA and MRTP regulatory pathways to literally hundreds of products, Ed Carmines is a world-renowned expert in the technical aspects of all types of e-cigarettes, oral tobacco, non-tobacco products, cigars and cigarettes,” explained Ryan Stump, Chief Operating Officer and Charlie’s manager. “By layering Ed Carmines’ skills and experience with Charlie’s existing PMTAs – which are among the most comprehensive in the entire industry and undergoing ‘substantive review’ with the FDA – we believe that our company’s submissions will ultimately be recognized by the FDA as both distinguished and eligible for approval.
Jeff Fox, Independent Director of Charlie’s Holdings, commented, “Ed has an incredible ability to understand complex scientific problems and develop business-relevant solutions. He was the principal scientist and principal architect of the 22nd Century Group’s reduced nicotine VLN® cigarettes, which in December 2021 became the third product in history to receive an MRTP marketing order from the FDA. We look forward to benefiting from Ed’s scientific leadership as Charlie’s moves forward with the company’s existing PMTAs and special IP-related projects that we believe could represent a significant portion of sales and profits. of Charlie in the years to come.
Dr. Carmines is currently Chief Scientific Officer of Chemular, Inc., where he designs and leads scientific and regulatory programs for PMTAs for a multitude of contract customers across a wide range of tobacco product categories. He is also currently a member of the advisory board of Sparq Life, Inc, which specializes in the science of inhalation of non-tobacco products, and a director of Carmines Consulting, LLC, where Dr. Carmines is a consultant to the tobacco industry. regulated in the field of toxicology. and regulatory affairs. Previously, Dr. Carmines managed the safety of novel and oral tobacco products as a scientist at RJ Reynolds Tobacco Co. From 1996 to 2009, Dr. Carmines was a senior scientist for Philip Morris USA (Altria Client Services, Inc.), where he developed guidelines for safely testing cigarette ingredients and components based on the FDA Red Book. Dr. Carmines earned a BSc in Chemistry and a Ph.D. degree in toxicology from the Medical College of Virginia (Virginia Commonwealth University).
About Charlie’s Holdings, Inc.
Charlie’s Holdings, Inc. (OTCQB: CHUC) is an industry leader in premium vaping nicotine products. The Company’s products are sold worldwide to selected distributors, specialty retailers and third-party online resellers through Charlie’s Chalk Dust, LLC and Don Polly, LLC subsidiaries. Charlie’s Chalk Dust, LLC has developed an extensive portfolio of branded styles, flavor profiles and innovative product formats. Don Polly, LLC creates innovative hemp-derived products and brands.
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 overall business of the company, existing and anticipated markets and expectations regarding future sales and expenditures. Words such as “expect”, “anticipate”, “should”, “believe”, “target”, “project”, “goals”, “estimate”, “potential”, “predict”, “may” , “will”, “could”, “intend”, variations of these terms or the negative form of these terms and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances beyond the Company’s control. The Company’s actual results could differ materially from those expressed or implied by the forward-looking statements due to a number of factors. , including, but not limited to: the Company’s continued ability to list its shares on the OTCQB; whether the Company will meet the requirements for listing on a national stock exchange in the future; the ability to the Company to successfully increase its sales and to penetrate new to markets; whether the Company’s PMTAs will be approved by the FDA, and the FDA’s decisions regarding the Company’s future PMTAs; the Company’s ability to manufacture and produce products for its customers; the Company’s ability to formulate new products; acceptance of existing and future products; the complexity, expense and time associated with complying with government rules and regulations regarding nicotine and cannabidiol-containing products; the risk of litigation related to the use of the Company’s products; government regulatory risks; the impact of competing products; and the company’s ability to maintain and improve 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 documents filed with the SEC. These forward-looking statements are made as of the date of this press release and are based on current expectations, estimates, forecasts and projections as well as management’s beliefs and assumptions. Except as required by law, the Company assumes 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.
THE SOURCE: Charlie’s Holdings, Inc.
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