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.
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.
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