The world of cannabis and hemp has arrived and agencies are scrambling to determine how to regulate this new industry.
As with any new industry, growing pains are inevitable, and there is an ever-changing regulatory and enforcement landscape globally. The U.S. has significant challenges because the laws at federal and state levels aren’t congruent. The U.S. Drug Enforcement Agency still classifies cannabis as a Schedule 1 drug in the Controlled Substance Act (CSA), which puts marijuana in the same drug category for enforcement as heroin. It is at a more restricted category than Schedule 2 drugs such as meth or cocaine. In the U.S., 34 states have legalized the medicinal use of marijuana and 11 others, including Washington D.C. have legalized cannabis for recreational use, and more states are moving towards legalization every day. Canada and Uruguay have legalized the recreational use of cannabis use at the federal level, while many other countries have decriminalized its use. It is currently the wild frontier.
The U.S. Food and Drug Administration (FDA) is in the process of evaluating a regulatory framework to ensure product efficacy and safety. Also, at the federal level, the Agriculture Improvement Act of 2018 (2018 Farm Bill) was signed into law in December 2018. This bill explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act and section 351 of the Public Health Services Act. In other words, they’re subject to the same authorities and requirements as FDA-regulated products containing any other controlled substance. This is regardless of whether the cannabis is classified as hemp under the Farm Bill. However, the Farm Bill did remove hemp as a controlled substance and schedule I drug from the CSA.
Canada announced new regulations in June 2019 that will take effect in October 2019 for cannabis edibles, extracts, and topicals. The Canadian regulations are divided into two sets, Cannabis, and Industrial Hemp. These regulations cover such things as physical security, limits on contamination (Residual Solvents), and supply chain requirements, to name a few. Not surprisingly, most regulatory bodies are setting up compliance regulations to regulate cannabis and hemp, much like drug products.
What does this mean for the industry today? What this means is that regulatory health agencies are working and have the jurisdiction to regulate the cannabis and hemp industries for safety and efficacy. Compliance with the regulations is necessary, especially for quality, clinical research, validation, manufacturing, and supply chain.
USDM works closely with emerging cannabis and hemp companies, and we follow the global regulatory agencies to stay on top of the evolving regulations. We realize the cannabis and hemp industries will have many regional impacts and considerations. The earlier on your road to commercialization that you align your compliance and technology strategies, the more competitive market advantage you will have in the industry.
Guiding your Journey to Commercialization and Compliance for Cannabis
We can support and guide your journey to commercialization or compliance for your cannabis products. Some of the services we offer for emerging cannabis companies are below:
Learn more about how we help Emerging Cannabis Companies
- Regulatory education and training
- Establishing risk-based, pragmatic, phase-appropriate Quality and IT Compliance Programs
- Developing IT Strategy and Technology Roadmaps
- Accelerating vendor selection, implementation, and validation of all regulated systems
- Computer System, Process, and Equipment Validations and Qualifications
- Internal and mock audits to prepare for regulatory submission
About the Author
Joseph Cassella is a Project Management Lead at USDM Life Sciences. With over 25 years of experience in the pharmaceutical, biotech and medical device industries, Joe’s background is both broad and deep in Information Technology, Laboratory and Analytical Applications, and Quality Systems. He has led many projects inclusive of IT Infrastructure, Research & Development, QA/QC, Manufacturing, Compliance, and Sales & Marketing.