Edward Carmines, Ph.D., member of Charlie's Board of Directors and accomplished scientist and regulatory affairs expert, is spearheading Charlie's development of patented "age-gating technology" for Charlie's and potential licensees of the Company.
Charlie's seeks to develop what the FDA may recognize as a "product of merit" so that the Agency could allow the Company and its licensees to market flavored Electronic Nicotine Delivery System ("ENDS") products to adult consumers across the United States.
Aiming to prevent underage access in the $7 billion U.S. e-cigarette market, Charlie's has engaged Fish & Richardson, one of the largest patent law firms in the world, to expand the Company's intellectual property portfolio with key "age-gating" patents.
COSTA MESA, CA / ACCESSWIRE / January 25, 2023 / Charlie's Holdings, Inc. (OTCQB:CHUC) ("Charlie's" or the "Company"), an industry leader in the premium, nicotine-based, vapor products space, today announced a new strategic imperative: developing patented "age-gating" technology to address significant concerns raised by U.S. Food and Drug Administration ("FDA") over the use of Electronic Nicotine Delivery System ("ENDS") products by underage consumers. Charlie's is determined to address this issue. If the Company's "age-gated" nicotine disposable e-cigarettes-in-development are recognized as "products of merit" by the FDA, Charlie's e-cigarettes could emerge among the select minority of flavored e-cigarettes able to be sold legally in the $7 billion U.S. market.
Project leader, Dr. Edward Carmines, is a world-renowned expert in the technical aspects of all types of e-cigarettes, oral tobacco, tobacco-free products, cigars, and cigarettes. Having successfully navigated the FDA's Substantial Equivalence, Premarket Tobacco Application ("PMTA") and Modified Risk Tobacco Product Application ("MRTPA") pathways for literally hundreds of products, Dr. Carmines is developing proprietary technology with Charlie's Research and Development team to enable the Company, upon receipt of an FDA marketing order, to offer a controlled e-cigarette device that is made operable only upon activation by an age-verified adult consumer.
By launching this strategic initiative, Charlie's has endeavored to make the Company's PACHA™ disposable e-cigarette products among the select few - or the only - flavored e-cigarettes able to be sold legally in the United States.
"It is universally acknowledged that adult smokers in the United States who wish to stop using combustible cigarettes show an overwhelming preference for flavored products," explained Dr. Carmines. "However, public health officials and the FDA believe that flavored ENDS products are preferred by the majority of underage ENDS product users as well. Herein lays the greatest challenge - and the greatest opportunity - for the e-cigarette industry."
Charlie's patent-pending technology employs a proprietary "smart activation manager and user verification service." The Company's novel e-cigarette may only be activated after a proprietary "age-gating" technology and procedure enable an age-verified adult consumer to operate the device. In order to pursue the Company's "age-gating" and related Intellectual Property patent initiatives, Charlie's has engaged Fish & Richardson, one of the largest patent law firms in the world.
"At a time when the FDA has issued thousands of Marketing Denial Orders for countless flavored electronic nicotine delivery system products, and Refuse-to-File letters for many millions of other products, we believe the time has come for the proactive development of a truly game-changing solution to the problem of underage vaping," explained Ryan Stump, Chief Operating Officer of Charlie's Holdings, Inc. "In this light, we believe our proprietary 'age-gating' technology will, indeed, enable Charlie's PACHA flavored nicotine e-cigarettes to meet the FDA's statutory standard of 'appropriate for the protection of the public health.'"
"In December, Juul Labs agreed to pay $1.2 billion to resolve approximately 10,000 lawsuits targeting the e-cigarette maker as a major cause of the U.S. youth-vaping epidemic," said Henry Sicignano, Charlie's President. "On the other hand, keeping tobacco products out of the hands of youth is a top priority for the FDA and for Charlie's. Charlie's substantial investments in ‘age-gating' technologies will prevent youth access to e-cigarette products… and, in so doing, will create lucrative sales and licensing opportunities for our Company."
About Charlie's Holdings, Inc.
Charlie's Holdings, Inc. (OTCQBCHUC) is an industry leader in the premium, nicotine-based, vapor products space. 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 hemp-derived products and brands.
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SOURCE: Charlie's Holdings, Inc.