Different firms have acquired 168 FDA “Advertising and marketing Denial Orders” for greater than 992,000 flavored digital nicotine supply system merchandise, and “Refuse-to-File” letters for roughly 4.5 million different merchandise
COSTA MESA, CA / ACCESSWIRE / September 13, 2021 / Charlie’s Holdings, Inc. (OTCQB:CHUC) (“Charlie’s” or the “Firm“), an business chief in each the premium, nicotine-based, e-cigarette house and the hemp-derived CBD wellness house, in the present day introduced Charlie’s Premarket Tobacco Product Functions (“PMTA’s”) for the Firm’s best-selling e-liquids stay among the many choose minority of functions submitted to the U.S. Meals and Drug Administration (“FDA”) which have not acquired Advertising and marketing Denial Orders or Refuse-to-File designations. Together with product-specific scientific information, thorough notion research, and detailed environmental assessments, Charlie’s PMTA’s value greater than $5 million and are among the many most complete PMTA’s in all the business. The Firm has publicly expressed its dedication to full regulatory compliance and youth entry prevention and believes its submissions to the FDA will probably be acknowledged as each distinguished and appropriate for approval.
Beneath the 2009 Household Smoking Prevention and Tobacco Management Act, the FDA should approve PMTA’s for “newly deemed tobacco merchandise,” together with digital nicotine supply programs (“ENDS”) resembling e-cigarettes and e-liquids derived from tobacco, to ensure that the merchandise to stay in the marketplace in america. As required by statute, a key consideration within the FDA’s evaluate of a PMTA is to find out whether or not allowing the advertising and marketing of the product could be “applicable for the safety of the general public well being,” taking into consideration the dangers and advantages to the inhabitants as a complete. This dedication relies on the evaluate of product-specific, scientific proof asserting a profit to grownup people who smoke to beat the chance posed to youth, in addition to the potential for the product(s) to maneuver grownup people who smoke away from flamable tobacco merchandise.
Within the tens of millions of instances the place PMTA’s submitted by different firms didn’t embrace FDA-required content material, or the place ample product-specific, scientific proof was not included, the FDA couldn’t permit merchandise to proceed within the PMTA evaluate course of. Accordingly, one 12 months after the September 9, 2020 PMTA submission deadline, the FDA has issued 168 Advertising and marketing Denial Orders for greater than 992,000 flavored ENDS merchandise and has issued Refuse-to-File Letters for roughly 4.5 million different merchandise. Any product topic to a Advertising and marketing Denial Order or a Refuse-to-File designation will not be launched or delivered for interstate commerce. Additional, if a product is already in the marketplace, the product have to be faraway from the market or threat enforcement motion (together with civil financial penalties, seizure, and/or injunction).
In distinction to the businesses that acquired FDA Advertising and marketing Denial Orders or Refuse-to-File designations, Charlie’s handed the FDA’s submitting evaluate section, and has already entered the “Substantive Overview” section.
Ryan Stump, Charlie’s Chief Working Officer, defined, “Along with human medical trials that measured the nicotine supply effectivity of the Firm’s merchandise through pharmacokinetic research, Charlie’s PMTA’s embrace product-specific, scientific proof that demonstrates the advertising and marketing of Charlie’s merchandise meets the statutory commonplace of ‘applicable for the safety of the general public well being.’ This is a vital cause why we are extremely assured that the FDA will acknowledge Charlie’s PMTA submissions as each distinguished and appropriate for approval.”
Mr. Stump continued, “On account of the painstaking efforts we invested in our PMTA’s, when others are pressured to withdraw their merchandise from the market, Charlie’s will probably be one in all a really choose group nonetheless legally allowed to function within the flavored nicotine product house. We stay up for the aggressive benefit – and to the corresponding will increase in gross sales, earnings, and market share – that may outcome from our steadfast dedication to offering Charlie’s clients with a trusted product portfolio in full regulatory compliance.”
About Charlie’s Holdings, Inc.
Charlie’s Holdings, Inc. (OTCQB:CHUC) is an business chief within the premium, nicotine-based, vapor merchandise house and the hemp-derived CBD wellness market. The Firm’s merchandise are offered all over the world to pick out distributors, specialty retailers, and third-party on-line resellers by way of subsidiary firms Charlie’s Chalk Mud, LLC and Don Polly, LLC. Charlie’s Chalk Mud, LLC has developed an in depth portfolio of name types, taste profiles, and revolutionary product codecs. Don Polly, LLC creates revolutionary wellness merchandise and types within the hemp-derived CBD market.
Secure Harbor Assertion
This press launch comprises “forward-looking statements” inside the that means of the “protected harbor” provisions of the Non-public Securities Litigation Reform Act of 1995, together with however not restricted to statements concerning the Firm’s general enterprise, present and anticipated markets and expectations concerning future gross sales and bills. Phrases resembling “anticipate,” “anticipate,” “ought to,” “consider,” “goal,” “challenge,” “targets,” “estimate,” “potential,” “predict,” “might,” “will,” “may,” “intend,” variations of those phrases or the adverse of those phrases and comparable expressions are supposed to establish these forward-looking statements. Ahead-looking statements are topic to plenty of dangers and uncertainties, a lot of which contain components or circumstances which are past the Firm’s management. The Firm’s precise outcomes may differ materially from these acknowledged or implied in forward-looking statements attributable to plenty of components, together with however not restricted to: the Firm’s ongoing means to cite its shares on the OTCQB; whether or not the Firm will meet the necessities to uplist onto a nationwide securities change sooner or later; the Firm’s means to efficiently improve gross sales and enter new markets; whether or not the Firm’s PMTA’s will probably be permitted by the FDA, and the FDA’s selections with respect to the Firm’s future PMTA’s; the Firm’s means to fabricate and produce merchandise for its clients; the Firm’s means to formulate new merchandise; the acceptance of present and future merchandise; the complexity, expense and time related to compliance with authorities guidelines and laws affecting nicotine and merchandise containing cannabidiol; litigation dangers from the usage of the Firm’s merchandise; dangers of presidency laws; the affect of aggressive merchandise; and the Firm’s means to keep up and improve its model, in addition to different threat components included within the Firm’s most up-to-date quarterly report on Type 10-Q, annual report on Type 10-Ok, and different SEC filings. These forward-looking statements are made as of the date of this press launch and have been based mostly on present expectations, estimates, forecasts and projections in addition to the beliefs and assumptions of administration. Besides as required by regulation, the Firm undertakes no obligation or obligation to replace any forward-looking statements contained on this launch because of new info, future occasions or modifications in its expectations.
SOURCE: Charlie’s Holdings, Inc.
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