cbdMD Achieves Key Milestone in UK Novel Food Regulatory Approval

Rhea-AI Summary

cbdMD (NYSE: YCBD) has reached a significant milestone in its UK regulatory journey as its Novel Food dossier (RP793) advances to the final phase of assessment with the UK Food Standards Agency (FSA). The company's proprietary CBD isolate, with over 97% purity, received a positive safety assessment on February 28, 2025.

The FSA's evaluation confirms that cbdMD's ingredient meets UK food safety standards, is free from contaminants and controlled cannabinoids like THC, and supports safe consumption levels for adults. The company initiated this process in March 2021 and became the first U.S. brand to receive dossier validation in February 2022.

This development positions cbdMD among the few companies approaching full Novel Food authorization in the UK's £800 million CBD market. The achievement is expected to enhance consumer confidence and expand market share in the regulated CBD industry.

Positive

• Advanced to final phase of UK regulatory approval, positioning for market advantage
• Achieved positive safety assessment for proprietary CBD isolate with >97% purity
• Targeting £800 million UK CBD market opportunity
• First U.S. brand to receive dossier validation, demonstrating market leadership

Negative

• Final approval still pending, with uncertain timeline
• Significant time investment since 2021 for regulatory compliance

Insights

Regulatory Affairs Specialist

cbdMD's advancement to the final phase of the UK's Novel Food approval process represents a significant regulatory milestone in an industry where compliance creates substantial barriers to entry. This is not merely procedural progress – it's a competitive differentiator that positions cbdMD among an elite group of companies nearing full authorization in the UK's regulated CBD market.

The FSA's published safety assessment confirms several critical aspects of cbdMD's formulation: high purity (>97%), absence of THC and other controlled substances, established safe consumption parameters, and verified toxicological safety. These validations are particularly valuable in a market increasingly focused on product legitimacy and consumer safety.

What's most notable is the timing – cbdMD initiated this process in March 2021, achieved first-stage validation in February 2022, and is now positioned as one of the few companies approaching final approval. This persistence through a rigorous multi-year regulatory process demonstrates significant operational discipline.

The UK market, estimated at £800 million according to the article, presents substantial commercial potential for companies with approved Novel Food status. With many competitors likely to face extended approval timelines or potential rejection, cbdMD's regulatory progress creates a defined competitive advantage in a high-value market with substantial entry barriers.

Consumer Goods Market Analyst

This regulatory advancement positions cbdMD to capitalize on the growing consumer preference for officially sanctioned CBD products in a £800 million UK market. The completion of the safety assessment phase is particularly significant as it addresses the primary consumer concern in CBD purchases: product safety and regulatory compliance.

From a market positioning perspective, achieving one of the first fully approved Novel Food ingredients would allow cbdMD to establish premium positioning within the UK retail landscape. Retailers increasingly favor products with complete regulatory documentation, potentially giving cbdMD preferred shelf positioning and marketing support over non-approved competitors.

The FSA explicitly advises consumers to purchase only CBD products compliant with novel food regulations, effectively creating a government-endorsed marketing advantage for approved products. This regulatory endorsement serves as powerful third-party validation that typically commands premium pricing and builds consumer trust more effectively than traditional marketing.

While the final approval timeline remains undefined, the progression to this stage suggests imminent completion of the process. The CEO's statement connecting regulatory clarity to expanded market share demonstrates strategic recognition of how regulatory compliance translates to competitive advantage. Companies achieving early regulatory approval in emerging regulated markets typically capture disproportionate market share, making this development particularly valuable for cbdMD's growth trajectory.

FSA Publishes Safety Assessment for cbdMD's Proprietary CBD Ingredient

Charlotte, North Carolina--(Newsfile Corp. - April 7, 2025) - cbdMD, Inc. (NYSE American: YCBD) (NYSE American: YCBDpA), a leader in premium hemp-derived cannabidiol (CBD) products, proudly announces that its Novel Food dossier (RP793) has advanced to the last phase of regulatory assessment with the UK Food Standards Agency (FSA), nearing final approval. This milestone not only underscores cbdMD's commitment to safety, quality, and scientific excellence but also reflects its position as a trusted brand in the growing CBD market, offering consumers confidence in purchasing compliant and rigorously tested products.

cbdMD initiated this process in March 2021, with the submission of a comprehensive dossier detailing the ingredient's identity, quality, stability, hemp sourcing, extraction controls, labeling, testing requirements, usage instructions, and extensive safety data. In February 2022, cbdMD became the first U.S. brand to receive dossier validation. Since then, cbdMD has worked closely with the FSA, actively addressing inquiries to expedite the regulatory review process.

FSA's Safety Assessment: A Critical Step Toward Approval

On February 28, 2025, the FSA published its safety assessment for cbdMD's proprietary and patent-pending CBD isolate (RP793), a high-purity CBD ingredient (>97%) with trace supporting minor cannabinoids intended for food supplements. The assessment, publicly available on the FSA website (https://science.food.gov.uk/article/129715-safety-assessment-on-the-safety-of-cannabidiol-cbd-isolate-as-a-novel-food-for-use-in-food-supplements-rp793), confirms cbdMD's ingredient meets UK food safety standards and has now progressed to the final Risk Assessment stage before full authorization as a Novel Food.

Key Findings from the Scientific Evaluation:

• Purity & Compliance - The CBD isolate is free from contaminants and controlled cannabinoids such as THC, ensuring compliance with UK food safety regulations.
• Safe Consumption Levels - The FSA's review supports cbdMD's data on safe intake levels for the general adult population.
• Toxicological Safety - Rigorous studies confirm the ingredient's safety when consumed as directed.
• Regulatory Approval Pathway - Products incorporating cbdMD's CBD isolate align with the UK's strict novel food criteria, ensuring their legal status in the regulated market.

Ensuring Consumer and Industry Compliance

The FSA advises consumers to purchase only CBD products compliant with novel food regulations and listed on the public register. Businesses marketing CBD food supplements must ensure regulatory approval to remain on the market. cbdMD is proud to be among the legally authorized companies currently supplying CBD products in the UK, and will soon be one of only a few companies with an approved Novel Food ingredient, offering consumers a safe, trusted, and high-quality option for their wellness needs. The milestone of being published and moved to the final phase of assessment reinforces cbdMD's leadership in the CBD industry and is expected to drive increased consumer awareness and sales, as customers increasingly seek compliant and well-regulated products.

"This milestone reaffirms our commitment to delivering safe, high-quality CBD products worldwide," said Ronan Kennedy, CEO of cbdMD. "The FSA provided us with a clear framework to validate our products' safety. The UK is estimated to be a £800 million industry this year. We are excited about our progress and believe the leaders in obtaining an FSA will benefit from the regulatory clarity, and we anticipate greater consumer confidence, leading to expanded market share."

As demand for regulated CBD products continues to rise, cbdMD remains at the forefront, providing consumers with safe and effective choices backed by rigorous scientific research.

About cbdMD, Inc.

cbdMD, Inc. (NYSE American: YCBD) (NYSE American: YCBDpA) is one of the leading and most highly trusted and most recognized cannabidiol (CBD) brands with a comprehensive line of U.S. produced, THC-free¹ CBD products, and an array of Farm Act compliant Delta 9 products. Our Paw CBD brand of pet products includes veterinarian-formulated products, our ATRx brand features functional mushroom products and our Herbal Oasis brand is a fast-growing hemp-derived THC beverage. To learn more about cbdMD and our comprehensive line of U.S. grown, THC-free¹ CBD and Full Spectrum products as well as our other brands, please visit www.cbdmd.com, www.pawcbd.com, ATRxlabs.com, or Herbaloasis.com, follow cbdMD on Instagram and Facebook, or visit one of the thousands of retail outlets that carry cbdMD's products.

Forward-Looking Statements

This press release contains certain forward-looking statements that are based upon current expectations and involve certain risks and uncertainties within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements can be identified using words such as ''should,'' ''may,'' ''intends,'' ''anticipates,'' ''believes,'' ''estimates,'' ''projects,'' ''forecasts,'' ''expects,'' ''plans,'' and ''proposes.'' These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond our control and difficult to predict. You are urged to carefully review and consider any cautionary statements, including but not limited to expectations on our ability to continue as a going concern, increasing our revenues, FSA final approval, future UK sales of cbdMD products and other disclosures, including the statements made under the heading "Risk Factors" in cbdMD, Inc.'s Annual Report on Form 10-K for the fiscal year ended September 30, 2024 as filed with the Securities and Exchange Commission (the "SEC") on December 17, 2024, and our other filings with the SEC. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements, many of which are generally outside the control of cbdMD, Inc. and are difficult to predict. cbdMD, Inc. does not undertake any duty to update any forward-looking statements except as may be required by law. The information which appears on our websites and our social media platforms, including, but not limited to, Instagram and Facebook, is not part of this press release.

¹ THC-free is defined as below the level of detection using validated scientific analytical methods.

Contacts:

Investors:
cbdMD, Inc.
Ronan Kennedy
Chief Executive Officer and Chief Financial Officer
IR@cbdmd.com
(704) 445-3064

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/247545

FAQ

What milestone did YCBD achieve in UK regulatory approval in April 2025?

YCBD's Novel Food dossier (RP793) advanced to the final Risk Assessment phase with the UK FSA, following a positive safety assessment of their proprietary CBD isolate.

What are the key findings of FSA's safety assessment for YCBD's CBD isolate?

The assessment confirmed the isolate has >97% purity, is free from contaminants and THC, meets UK safety standards, and is safe for adult consumption at recommended levels.

How large is the UK CBD market that YCBD is targeting?

The UK CBD market is estimated to be worth £800 million in 2025.

When did YCBD first submit its Novel Food dossier to the UK FSA?

YCBD submitted its comprehensive Novel Food dossier to the FSA in March 2021 and became the first U.S. brand to receive dossier validation in February 2022.