Charlie's Holdings Selected for FDA Premarket Tobacco Product Applications Meeting

Company's Board Member, Dr. Ed Carmines, to Serve as Panelist at Prestigious FDA Roundtable

Published on Feb. 10, 2026

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Charlie's Holdings, Inc. (OTCQB:CHUC), a leading provider of premium vapor products, announced that the U.S. Food and Drug Administration (FDA) has selected the company's Board member, Dr. Ed Carmines, to serve as a panelist for a roundtable discussion on Premarket Tobacco Product Applications (PMTAs) for Electronic Nicotine Delivery Systems (ENDS). Dr. Carmines, an expert in regulatory submissions and product safety, will discuss pharmacokinetic studies on Charlie's PACHA products and studies on the adult benefits of flavored ENDS products.

Why it matters

This invitation from the FDA highlights Charlie's expertise in navigating the complex regulatory landscape for tobacco and nicotine products. Dr. Carmines' participation could pave the way for Charlie's to become the first company to demonstrate to the FDA that age-gated flavored vape products are 'appropriate for the protection of public health', potentially allowing the company to legally sell its flavored e-cigarette products in the U.S.

The details

Dr. Ed Carmines, Charlie's Board member and Chief Scientific Officer of Chemular, Inc., is a renowned expert in the technical aspects of e-cigarettes, oral tobacco, tobacco-free products, cigars, and cigarettes. He has successfully navigated the FDA's Substantial Equivalence, PMTA, and Modified Risk Tobacco Product Application (MRTPA) pathways for thousands of products. Carmines also spearheaded the development and licensing of proprietary technology to enable Charlie's to offer a controlled e-cigarette device that can only be activated by an age-verified adult consumer.

  • The FDA roundtable discussion will be held at 9:00am (Eastern Time) today, February 10, 2026, at FDA Headquarters in Silver Spring, Maryland.

The players

Charlie's Holdings, Inc.

An industry leader in the premium vapor products space, offering an extensive portfolio of brand styles, flavor profiles, and innovative product formats.

Dr. Ed Carmines

Chief Scientific Officer of Chemular, Inc. and independent Board Member of Charlie's Holdings, a world-renowned expert in the technical aspects of all types of e-cigarettes, oral tobacco, tobacco-free products, cigars, and cigarettes.

U.S. Food and Drug Administration (FDA)

The federal agency responsible for regulating tobacco and nicotine products, including the review and authorization of Premarket Tobacco Product Applications (PMTAs).

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What’s next

The FDA roundtable discussion will be available for viewing online, and the public can provide comments, either orally or in writing, as per the Federal Register notice.

The takeaway

Charlie's selection for the prestigious FDA roundtable on PMTA submissions highlights the company's expertise in navigating the complex regulatory landscape for tobacco and nicotine products. Dr. Carmines' participation could pave the way for Charlie's to become the first company to demonstrate that age-gated flavored vape products are 'appropriate for the protection of public health', potentially allowing the company to legally sell its flavored e-cigarette products in the U.S.