Recent reports on the consumption of delta-8 Tetrahydrocannabinol (THC) have led to a qualmish riddle. Delta-8 THC is an isomer of delta-9 THC, that some believe is legal to synthesize under the 2018 Hemp Farm bill. The U.S. Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) websites list delta-8 THC as schedule 1 drug. Despite this conundrum and a lack of safety data, delta-8 THC products have exploded into the market. We explored the only known national adverse event reporting system: FDA Adverse Event Reporting System (FAERS), a US database originally designed to support the FDA's post marketing safety surveillance program for approved drugs and biologics. Repeated FAERS queries have been performed. Product names (aka search terms): delta-8 THC; delta- 9 THC, cannabis sativa (CS), and cannabidiol (CBD) were searched. FAERS Data as of March 31, 2021, showed a total of 160 cases reporting delta-8 THC, 56 delta-9 THC cases, 591 CS and 7274 CBD reported as “suspect product active ingredient” Respiratory events were most common in the Delta-8 suspect cases compared to cannabidiol and cannabis sativa. Most cases occurred in 18 to 64 year-old males. Our results suggest a potentially different safety profile for delta-8 THC containing products. It is unclear if delta-8 THC or another factor, such as an adulterant or contaminant, is the cause of these events. Understanding the limitations of FAERs and our experience analyzing the AE data, we have designed a data collection tool for collecting more granular information on cannabis-derived products www.budsinfo.com. Learning objectives: 1. Define the lack of and importance of collecting adverse events on cannabis-derived products. 2. Discuss cannabis-derived products that are available outside of the medical /regulated cannabis market that may not be that safe.

Although more than half of U.S. states have legalized the use of medical marijuana, the U.S. Food and Drug Administration (FDA) has not yet recognized or approved the cannabis plant for therapeutic use. This presentation will provide an overview of FDA’s framework for regulating drugs and explain the process of FDA review and approval of new drugs. Special attention will be given to discussing the unique regulatory challenges and opportunities associated with developing cannabis therapies in the U.S., e.g., navigating the requirements of multiple federal regulatory agencies (FDA, NIDA, and DEA), developing botanical drug products, and FDA programs that grant expanded access to, and expedited review of, drugs intended to treat serious or rare diseases. Learning Objectives: Understand the requirements and process for obtaining FDA approval of new drugs, including phases of research and development, protocol development, approval of investigational new drug (IND) applications and new drug applications (NDAs) Understand unique regulatory challenges associated with developing cannabis therapeutics in the U.S.

Cannabis sativa is an herbaceous plant of high interest, with applications of the plant and its products varied and ripe with investment. The Cannabis industry experienced a new surge of business as each state within the US moves toward more relaxed regulations for medicinal and recreational use. While the economic impacts are worthy of study, the fundamental fact doesn’t change: Cannabis sativa is a plant to be maximized for yield with improved desired agronomic and compositional characteristics. Therefore, it is appropriate to consider Cannabis sativa as a crop plant worthy of research not only for direct improvements, but also for the crop industry worldwide. As more places in the US are permitted to grow and cultivate Cannabis and the investor pool expands, the crop industry can expect to see multiple benefits of accelerating knowledge in farming practices, genetics, physiology, harvesting, processing and labor. Learning Objectives: 1. Agricultural management of Cannabis today 2. New avenues of research that will advance crop research

For a plant that has been medically legal in some states for over 20 years and recreationally legal in some states since 2014, there has been an attitude that “cannabis never killed anyone.” While we don’t have the necessary research to prove that the plant hasn’t killed anyone, we do have evidence that the contaminants on the cannabis plant have caused severe harm, especially in cases of immune-suppressed patients . With no FDA or USDA to oversee consumer product testing, US States, growers and manufacturers are on their own to ensure properly labeled and safe product for patients and consumers are released in the marketplace. The best science and technology is available today, so whether or not the government is watching over you, learn why safety testing for cannabis products will insure correct potency labelling, reliable brands and products, prevent product recalls and lead to an industry that can meet global standards for safety and health. Learning Objectives: As States and Countries Legalize, learn why Cannabis Testing is Integral to a successful cannabis industry - the what and why Like other consumer industries, consumers will demand safe, tested and properly labeled cannabis. Advanced science and technology is here and available today to insure accurately labeled and safe products. Learn how to be ahead of consumer demand as this industry grows out of infancy and into maturity

The vast majority of US states and other countries require quality control testing of cannabis and cannabis processed products prior to release for distribution. The purpose of product testing is to provide patients with the assurance that the medicine is potent and pure and safe for use. Analytical testing also assures that the contents match the label claim, that there is batch to batch consistency, and the product is potent and pure throughout shelf life. Each state and country has its own set of testing requirements and regulations for the analytical laboratories. With these requirements come challenges for both the regulators and the regulated industry. Learning Objectives: 1. Participants will learn how medical cannabis products are tested and the quality standards 2. Participants will learn about the regulatory testing requirements in the US and other countries 3. Participants will appreciate the various testing challenges as state programs evolve

Many people are using CBD effectively as part of their daily treatment for various ailments across the globe, what is all the hype about CBD/THC and why is it being touted as a wonder medicine?! It is still considered controversial and there is confusion about what it is and how it can help the human body. As of now the FDA has approved just one purified form of CBD, Epilodex which can be used to treat two types of epilepsy. CBD is just one of many compounds found in the marijuana plant, known as cannabinoids. Plenty of research is currently being done regarding the therapeutic uses of CBD. CBD is the non psychoactive compound found in marijuana and does not appear to produce significant changes to the body but it does appear to have health benefits. As far as we know THC binds to CB1 receptors in the brain which relate to coordination, movement, pain, emotions, mood, thinking, appetite, memories as well as other functions. CB2 receptors are mostly found in our immune systems and they affect pain and inflammation. But instead of attaching to these receptors CBD seems to cause the body to use more of its own cannabinoids. Someone put it this way~ CBD does not make you feel good so much as it just makes you not feel bad. Learning Objectives: 1. Understanding CBD/THC ratios in medical marijuana. 2. When to utilize a high CBD low THC cannabis product to treat disease processes.

Often overlooked but critical to most cannabis laboratory operations is sample workflow and sample preparation, having these areas figured out early in the start-up process is essential – particularly in the prevention of sample cross-contamination. The primary focus of this presentation is to discuss sample workflow with an overview of sample intake and processing. Once the sample is accepted at the laboratory – how does it move from one test (or station) to another and what considerations are there to prevent cross-contamination of the sample? Are there any special storage requirements, retain procedures, and overall best sample-handling practices? Considerations will be made regarding sampling and sample size(s) which based on the regulatory jurisdiction are typically different, as well as the sample test portion size. Problem areas for contamination and how to prevent further contamination-possible test fails will also be briefly discussed. Learning Objectives: 1. Discuss sample Workflow and Sample Intake/Processing best practices. 2. Discuss sample contamination prevention.

In this session, attorney Bob Hoban will explore the current legal and regulatory landscape in the United States related to intoxicating hemp cannabinoids. Anyone who is keeping a pulse on the cannabis industry knows of the rise of products containing such cannabinoids, like delta-8 tetrahydrocannabinol, over the last 5 years after the passing of the 2018 Agricultural Improvement Act, or 2018 Farm Bill. Delta-8 - and other variations of intoxicating hemp cannabinoids like THC-O, THC-JD, and Delta-10 – represent a controversial cannabis industry segment that some industry pundits attribute to a “legal loophole” created in the definition of hemp under the 2018 Farm Bill. Regardless of legislative intent behind establishing a formal definition of hemp, the 2018 Farm Bill expressly allows for commercial activities related to products that contain under 0.3% delta-9 tetrahydrocannabinol and that are sourced from lawful hemp, including delta-8, as affirmed by the 9th Circuit of Appeals in their recent decision in AK Futures v. Boyd Street Distro. While the federal legality of such products has been confirmed by the federal judiciary, administrative agencies like the FDA and DEA have declined to issue regulations pertaining to those products. States have stepped in and passed varying versions of regulations pertaining to intoxicating hemp products. On one hand, some have approached the regulation of such products similarly as to the ways they regulate cannabis by requiring firms engaged in manufacturing or selling those products to be licensed. On the other hand, some have taken more of a free market approach and allow such products to be introduced into commerce freely, with the condition that they are sourced from lawful hemp. Bob will explore the contours of the intoxicating hemp product landscape, including a comparison of different regulatory approaches and the pros and cons of each. Further, Bob will share his personal thoughts on the future of intoxicating hemp product regulations and their role in the emerging cannabis industry. Learning Objectives: 1. Demonstrate an understanding of the federal regulatory scheme pertaining to intoxicating hemp derived products. 2. Be able to differentiate between different state frameworks currently regulating intoxicating hemp derived products. 3. Visualize the current legal landscape in the United States for intoxicating hemp derived products. 4. Explain the legal and practical differences between intoxicating hemp derived products and intoxicating marijuana derived products.