cbdMD Requests the Meals and Drug Administration (FDA) Take away the Drug Exclusion for CBD and Assessment cbdMD’s Intensive Security Submission

CHARLOTTE, N.C., February 22, 2022–(BUSINESS WIRE)–cbdMD, Inc. (NYSE American: YCBD, YCBDpA) (the “Firm”), one of many world’s main and most extremely trusted and acknowledged well being & wellness CBD corporations, at this time introduced that the Pure Merchandise Affiliation (NPA) filed a Citizen’s Petition on cbdMD’s behalf with the Meals and Drug Administration (FDA) requesting the FDA to take away the drug exclusion for CBD and to assessment the Firm’s in depth file of id, security and high quality information.

Eradicating the drug exclusion for CBD will obtain readability available in the market and create a degree enjoying subject for all individuals. The ultimate final result of this course of is anticipated to consequence within the potential of the Firm to submit and obtain acknowledgement for a New Dietary Ingredient Notification (NDIN). This can lastly enable the Firm to tell shoppers of the advantages of its cannabinoid merchandise and broaden its gross sales in the US by opening up mass retail channels. Since passage of the Farm Invoice 2018, the FDA has not supplied any clear regulation on the CBD market. The shortage of a transparent, regulated framework has allowed an increasing pool of producers, producers and entrepreneurs to flood the market with substandard merchandise and an abundance of questionable promoting ways. Creating and imposing industry-wide requirements would assist create a mandatory roadmap for all CBD merchandise and produce group to an {industry} that has in any other case been working with out order.

“FDA has requested for good science and strong security information. We supplied it to them in our pre NDI submission assembly and the FDA was excited to assessment our information, however fell again on the drug exclusion. We would like them to assessment our science, which we consider accommodates the requisite research to obviously reveal the protection of our merchandise for shoppers. We would like a scientific path to market per the Dietary Complement Well being and Training Act (DSHEA), one that doesn’t bureaucratically reward corporations that aren’t placing shoppers first with security and science. Our science is so sturdy that we’re assured after we are given the chance to submit an NDIN we are going to obtain one other first, the primary acknowledgment letter for a NDIN for CBD,” stated Sibyl Swift, Ph.D., Vice President of Scientific & Regulatory Affairs for cbdMD.

For extra info on NPA’s submitting, https://www.npanational.org/information/npa-files-citizens-petition-with-fda-on-specific-cbd-relief-requests-enforcement-discretion-on-drug-exclusion-clause-for-a-single-product-to-review-premarket-notifications-of-cbd-consistent/

The Firm submitted its file of id, high quality and security information as a novel meals ingredient for the European Union (EU) Meals Security Authority (EFSA) and the UK (UK) Meals Requirements Company (FSA). The UK FSA has already begun to assessment this information and EFSA is on monitor to start shortly. “cbdMD is an {industry} chief with distinctive high quality and scientific requirements. We consider that our research will stand up to the rigorous assessment within the EU and UK. We’re asking for the FDA to provide us the identical alternative as different authorities businesses have executed. cbdMD units the bar throughout the {industry} for security and high quality. This citizen’s petition is one more instance of why cbdMD is the market chief. We stand behind our science and our high quality and look ahead to the day after we are now not precluded from sharing our information with our prospects,” says Martin A. Sumachrist, Chairman & co-CEO of cbdMD.

About cbdMD, Inc.

cbdMD, Inc. is likely one of the main and most extremely trusted and acknowledged cannabidiol (CBD) manufacturers with a complete line of U.S.-produced, THC-free1 CBD merchandise. The cbdMD model at present contains over 130 SKUs of high-grade, premium CBD merchandise together with CBD tinctures, CBD gummies, CBD topicals, CBD capsules, CBD bathtub bombs, CBD bathtub salts, CBD sleep aids, CBD drink mixes and full spectrum CBD choices. Our Paw CBD model of pet merchandise contains over 45 SKUs of veterinarian-formulated merchandise together with tinctures, chews and topical merchandise in various strengths, and our cbdMD Botanicals model of magnificence and skincare merchandise options 15 SKUs, together with facial oil and serum, toner, moisturizers, facial masks, exfoliants and physique care. To be taught extra about cbdMD and their complete line of U.S.-grown, THC-free1 CBD oil and full spectrum merchandise, please go to www.cbdmd.com, comply with cbdMD on Instagram and Fb or go to one of many 6,000 stores that carry cbdMD merchandise.

Ahead-Wanting Statements

This press launch accommodates sure forward-looking statements which are primarily based upon present expectations and contain sure dangers and uncertainties throughout the which means of the U.S. Non-public Securities Litigation Reform Act of 1995. Such forward-looking statements will be recognized by means of phrases equivalent to ”ought to,” ”might,” ”intends,” ”anticipates,” ”believes,” ”estimates,” ”initiatives,” ”forecasts,” ”expects,” ”plans” and ”proposes.” These forward-looking statements will not be ensures of future efficiency and are topic to dangers, uncertainties, and different elements, a few of that are past our management and troublesome to foretell and will trigger precise outcomes to vary materially from these expressed or forecasted within the forward-looking statements, together with, with out limitation, statements made with respect to outcomes of evaluations by the FDA, EFSA, and FSA; our potential to extend our market share; our potential to broaden our enterprise and considerably improve our revenues; our potential to successfully leverage our model partnerships and sponsorships, our potential to successfully compete in our market; and our potential to report worthwhile operations sooner or later. You might be urged to fastidiously assessment and contemplate any cautionary statements and different disclosures, together with the statements made underneath the heading “Threat Elements” in cbdMD, Inc.’s Annual Report on Kind 10-Okay for the fiscal yr ended September 30, 2021 as filed with the Securities and Alternate Fee (the “SEC”) and our different filings with the SEC. All forward-looking statements contain important dangers and uncertainties that would trigger precise outcomes to vary materially from these within the forward-looking statements, lots of that are typically outdoors the management of cbdMD, Inc. and are troublesome to foretell. cbdMD, Inc. doesn’t undertake any responsibility to replace any forward-looking statements besides as could also be required by regulation. The data which seems on our web sites and our social media platforms, together with, however not restricted to, Instagram and Fb, isn’t a part of this press launch.

1 THC-free is outlined as beneath the extent of detection utilizing validated scientific strategies.

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Contacts

PR:
cbdMD, Inc.
Robert Pettway
Director of Paid Media
[email protected]
(423) 503-5225

Buyers:
cbdMD, Inc.
John Weston
Director of Investor Relations
[email protected]
(704) 249-9515