Background: The global cannabis market, both for medical and non-medical purposes, is growing. Various countries and jurisdictions have legalized and regulated cannabis, permitting access to cannabis for medical and/or non-medical (adult-use/recreational) purposes. As regulatory affairs and quality assurance professionals, we need to have awareness of, and be prepared to understand various regulated countries and/or jurisdictions, as well as assess and support the development of legal, regulated products in specific markets.

Although cannabis is not legal at the federal level, the United States of America (USA) currently has 36 legal medical, and ten (18) legal non-medical cannabis jurisdictions (State or Territorial level legislation; See Appendix A). Even with the absence of full federal legalization, the USA is thought to be one of the largest cannabis markets in the world, with an estimated $9.9 billion in sales for both medical and non-medical purposes (2018). Furthermore, the USA is projected to be the leading cannabis market in the world in 2024, with an estimated $30.1 billion in sales making up about three-quarters of the global legal market1 . However, some experts have aptly commented that the US market is a patchwork of legislative frameworks, distinct and different mini-markets.

Assignment Description: Students will work in groups (~3-4 students/group) and apply knowledge obtained in class, as well as research and analysis of relevant regulatory frameworks and marketing strategies, to develop a mock cannabis product in their chosen US jurisdiction.

Choose a legalized medical and/or non-medical cannabis market in the United States of America (i.e. State-level or Territory-level; See list in Appendix A).

**NOTES: Develop a legal cannabis product concept, including packaging/label design and promotional strategy, based on the local regulations and market analysis of the groups chosen jurisdiction. Construct a critical analysis of the jurisdiction: o The applicable regulations pertaining to promotional provisions (prohibitions; non-applications, etc.) o Any regulatory/scientifically supported efficacy (including marketing/health) claims for your product/product format in the jurisdiction, and o Strengths/opportunities versus challenges/risks in the chosen jurisdiction. Presentation Format: The presentation will be structured as a product launch presentation and will clearly outline and provide comprehensive details on the objectives stated above. The presentation format will include up to 20 minutes for the formal presentation and 5 minutes for question and answer (maximum of 25 minutes per group). Regulatory Fact Sheet (maximum: 2 pages): Adaptation of the critical analysis of the jurisdiction into a regulatory fact sheet for the jurisdiction where the product would be launched and marketed, including: o The applicable regulations pertaining to promotional provisions (prohibitions; non-applications, etc.) o Any regulatory/scientifically supported efficacy (including marketing/health) claims for your product/product format in the jurisdiction o Information in your fact sheet must be referenced using any commonly accepted standard practice (e.g. APA) and/or embedded weblinks.

Fact sheets: Structured as a reference fact sheet. Includes all components of the critical analysis: o The applicable regulations pertaining to promotional provisions (prohibitions; non-applications, etc.). o Any regulatory/scientifically supported efficacy (including marketing/health) claims for your product/product format in the jurisdiction. Is the fact sheet visually appealing/creative and provides ease of reference for the reader? Does the format fit within the 2-page maximum?

Introduction Does the presentation clearly outline the market jurisdiction and provide history and context of the medical and/or recreational cannabis market in the jurisdiction?

Mock Product, Label Design and Promotional Strategy : Does the presentation accurately and effectively summarize i) relevant regulations and ii) market analysis of the groups chosen jurisdiction? Development of a legal cannabis product concept, including packaging and label design and promotional strategy.

Critical analysis of the jurisdiction Demonstration of understanding of the following : The applicable regulations pertaining to promotional provisions (prohibitions; non-applications, etc.). Any regulatory/scientifically supported efficacy (including marketing/health) claims for your product/product format in the jurisdiction. Strengths/opportunities versus challenges/risks in the chosen jurisdiction.

Conclusion Well-developed summary of mock product development and regulatory considerations.

Appendix A