Novel Food Submission

Rhea-AI Summary

Sativa Wellness Group has submitted its Novel Food application to the Food Standards Agency (FSA) before the 31 March 2021 deadline, aiming for high regulatory compliance and product quality. The application was prepared with the assistance of Global Regulatory Services and covers a variety of products, including oil-based supplements and CBD ingredients. The Company also intends to submit similar applications to the EU FSA. This milestone is seen as crucial for the Company as the CBD market may consolidate, benefiting companies prioritizing quality.

Positive

• Submission of Novel Food application to FSA is a significant regulatory compliance step.
• Led by experienced consultancy Global Regulatory Services, enhancing credibility.
• Plans to submit to EU FSA indicates potential market expansion.

Negative

• No guarantees on the success of applications to FSA or EU FSA, creating uncertainty.
• Potential market consolidation may disadvantage smaller players.

VANCOUVER, BC / ACCESSWIRE / February 15, 2021 / Sativa Wellness Group Inc. (CSE:SWEL) ("Sativa Wellness" or the "Company") wishes to announce that it has submitted its Novel Food application for validation by the Food Standards Agency ("FSA") ahead of the 31 March 2021 deadline, as part of the Company's ongoing commitment to continually deliver the highest level of regulatory compliance and product quality - 'CBD you can trust'.

The submission, led by award winning Life Sciences Regulatory and Quality Compliance consultancy, Global Regulatory Services ("GRS") and supported by Group's in-house team of scientist and quality/compliance professionals, incorporates an extensive array of products under its Goodbody brands and on behalf of white label customers. Products include oil-based food supplements, gummies, soft gel capsules and sports recovery gels, as well as wholesale bulk CBD ingredients.

Further to the Company's press release dated 25 September 2020, Sativa is also a member of the Association for the Cannabinoid Industry (ACI) Novel Food consortium and its landmark toxicology study, providing the necessary safety data required by the FSA.

The Company plans to submit the same application to the European Food Safety Authority ("EU FSA"), once it has collated the pre-requisite consumer product stability, toxicology and genotox data.

Geremy Thomas, Executive Chairman, said: "This is a significant milestone for the Company. The CBD market is likely to consolidate around the major players that put product quality and regulatory compliance at the forefront. Sales channels in the UK will open up and smaller players will likely fall away".

The Directors of the Company accept responsibility for the contents of this announcement.

On behalf of the Board of Directors,

Geremy Thomas
Chief Executive Officer
Sativa Wellness Group Inc.
+44 (0) 20 7971 1255
enquiries@sativawellnessgroup.com
www.sativawellnessgroup.com

Joseph Colliver
Chief Financial Officer
Sativa Wellness Group Inc.
+44 (0) 20 7971 1255
enquiries@sativawellnessgroup.com
www.sativawellnessgroup.com

Neither the Canadian Securities Exchange nor its Market Regulator (as defined in the policies of the Canadian Securities Exchange) accept responsibility for the adequacy or accuracy of this release.

This news release contains certain "forward-looking information" within the meaning of applicable Canadian securities legislation and may also contain statements that may constitute "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current condition, but instead represent only the Company's beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of Sativa Wellnesses' control. Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as "plans", "expects" or "does not expect", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes" "plan is" or variations of such words and phrases or may contain statements that certain actions, events or results "may", "could", "would", "might" or "will be taken", "will continue", "will occur", "will be achieved" or "shortly". The forward-looking information and forward-looking statements contained herein include, but are not limited to information concerning the European Commission classification of CBD as a food, the intention to submit applications to the EU FSA, whether the Company will collect the pre-requisite consumer product stability, toxicology and genotox data, the acceptance by the UK FSA of the Company's Novel Foods dossier, the Company's operation of CBD extractions and production in the UK and EU, the likely consolidation around the major players, whether sales channels will open up, smaller players may fall away, the interpretation of legal judgements and Government policies.

Although Sativa Wellness believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements. In particular, there is no guarantee that the Company will be successful in their applications to the UK and/or EU FSA or be allowed to market CBD products in the European Union or that Association for the Cannabinoid Industry (ACI) Novel Food consortium and its landmark toxicology study will be successful or that the market will consolidate around the major players. The forward-looking information and forward-looking statements contained in this news release are made as of the date of this press release, and Sativa does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws.

SOURCE: Sativa Wellness Group Inc.

View source version on accesswire.com:
https://www.accesswire.com/629670/Novel-Food-Submission

FAQ

What is the significance of Sativa Wellness Group's Novel Food application submitted on February 15, 2021?

The application is crucial for regulatory compliance, allowing Sativa to market its CBD products legally in the UK.

What products does the Novel Food application from Sativa Wellness cover?

It includes various CBD products such as oil-based supplements, gummies, and soft gel capsules.

Which consultancy assisted Sativa Wellness in its Novel Food application?

The application was prepared with the help of Global Regulatory Services.

What future plans does Sativa Wellness have regarding its Novel Food application?

They plan to submit a similar application to the European Food Safety Authority (EU FSA).

What challenges does Sativa Wellness face regarding the Novel Food application?

There is uncertainty about the success of the applications to the FSA and EU FSA, as well as potential market consolidation risks.