Charlie’s Holdings Partners with Blackbriar Regulatory Services to Direct Submission of its Premarket Tobacco Product Application (PMTA)
Blackbriar Regulatory Services Ensures Charlie’s Holdings Maintains the Highest Quality Standards in the Vapor Industry
COSTA MESA, CA / ACCESSWIRE / January 21, 2020 / Charlie’s Holdings, Inc. (OTC Pink: CHUC ) (“Charlie’s” or the “Company”), an industry leader in both the premium, nicotine-only, e-liquid space and the hemp-derived, CBD wellness space, announced today that its subsidiary company, Charlie’s Chalk Dust, has engaged Blackbriar Regulatory Services (BRS), formally a division of, and now a sister company of, AVAIL Vapor, LLC, to assist in the preparation and submission of Premarket Tobacco Product Applications (PMTA) to the Federal Food and Drug Administration (FDA) for certain of its e-liquid products.
The engagement of Blackbriar Regulatory Services (BRS), experts in the tobacco products regulatory space, demonstrates the Company’s commitment to the highest standards of regulatory compliance and commitment to meet FDA’s May 2020 regulatory deadline for submission of a PMTA.
Per section 910 of the Federal Food, Drug, and Cosmetic Act (FDCA), all manufacturers of any newly deemed tobacco products (generally, meaning any tobacco product that was not commercially marketed in the United States as of February 15, 2007), including e-liquid derived from tobacco, must seek authorization approval to sell such products in the United States. In July, a U.S. District Court judge in Maryland issued an order requiring that manufacturers of newly deemed tobacco products submit premarket applications by May 12, 2020, including vape products, that were on the market as of Aug. 8, 2016. Once submitted, FDA has 180 days to review and respond to timely filed PMTA applications.
“The PMTA process is challenging and complex,” said Ryan Stump, COO of Charlie’s Holdings. “We are fortunate to have a strong relationship with the leadership team at Blackbriar, a result of prior manufacturing agreements with AVAIL Vapor, their sister company. We are confident that guidance from BRS will further ensure Charlie’s continued compliance with the regulations put forth by FDA, further supporting Charlie’s leadership in the nicotine e-liquid vape space.”
Stump further commented, “We anticipate that a successful completion of the PMTA process will allow Charlie’s to increase its already growing share of the nicotine-only, e-liquid market, and view this step as a necessary springboard for our business in 2020 and beyond.”
Charlie’s Holdings continues to lead the nicotine-only, e-liquid industry by providing adult consumers with innovative flavors, products and brands, safely distributed through vape shops worldwide. Commitment to regulatory compliance and quality is paramount to Charlie’s and its stakeholders worldwide.
“We are honored that Charlie’s Chalk Dust has added its name to the growing list of companies that trust us to help them move forward in a maturing industry,” said Russ Rogers, the newly appointed CEO of Blackbriar Regulatory Services. “We are very happy to see that they are so committed to continuing their success working with Blackbriar as vape-industry leaders start to add regulatory compliance to their list of critical strategies.”
About AVAIL Vapor
Richmond, Virginia-based AVAIL is a premium retailer that offers a broad array of products online and in its 99 stores across 12 states. The company delivers on the promise of quality and transparency. Information on AVAIL products is available through retail stores and on the web at www.availvapor.com.
About Blackbriar Regulatory Services
Richmond, Virginia-based Blackbriar Regulatory Services (BRS) specializes in helping small to mid-sized domestic and international companies navigate the United States regulatory landscape to bring their FDA-regulated products to market. BRS provides regulatory and analytical laboratory services, good manufacturing processes (GMP) and regulatory audits, as well as contract manufacturing and distribution for a range of markets regulated by the FDA. Information on BRS services can be found at www.bb-rs.com.
About Charlie’s Holdings, Inc.
Charlie’s Holdings, Inc. (OTC Pink: CHUC ) is an industry leader in both the premium, nicotine-only, e-liquid 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 June of 2019, Don Polly, LLC formulates innovative hemp-derived CBD wellness products. Don Polly’s high quality CBD products derive from single-strain-sourced hemp extract and high purity CBD isolate crystals.
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 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-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: Charlies Holdings, Inc.
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