By Kathy Knutson
The cannabis industry is currently experiencing explosive growth, both in the United States and internationally. Yet the current landscape is murky, states operate independently from the federal government. There is federal regulation by the Drug Enforcement Administration where marijuana is a Schedule I listed drug. Also, the federal Farm Bill legalized the growing of hemp. While 33 US states have legalized the use of marijuana and marijuana edibles for patients with medical cards and for recreational use in eleven states. Each of the states with legal marijuana has created legislation independently of each other.
The cannabis industry is struggling without federal oversight and its focus is on meeting state regulations. The industry encompasses all aspects from growing to processing, manufacturing, packaging, transportation and sales operations, with the quality manager wearing many hats in the seed to sale process.
The cannabis industry is struggling without federal oversight and its focus is on meeting state regulations.
The FDA will be the federal agency with oversight over the cannabis-infused edibles when marijuana is de-scheduled. Until the FDA regulation is applied to edibles, manufacturers must meet their state code for Good Manufacturing Practices (GMPs).
One thing everyone can agree on is that cannabis-infused edible manufacturers must be trained in and follow GMPs. GMPs represent quality management programs in support of food safety. As edibles are sold to patients with medical cards as part of a therapy regime, manufacturers must control hazards rigorously as the consumer is typically immunocompromised.
Resources for GMPs at the federal level include the 21 CFR 111 for dietary supplements and 21 CFR 117 for food items. Dietary ingredient manufacturers are required to meet 21 CFR 117, and this would include cannabis concentrate processors. The FDA recognizes the food safety systems of Canada; if that extends, the Cannabis Act is another source of GMPs for US manufacturers.
As many quality managers are short on time, time to travel and receive training to employees may not be a priority. Wholly online training is currently available for Preventive Controls Qualified Individual as required by the FDA for food facilities and dietary ingredient manufacturers by ImEpik. Cannabis-infused edible manufacturers looking to last through the cannabis boon should go beyond what is required in state code to implement both GMPs and food safety plans as required of food facilities.
About the Author
Dr. Kathy Knutson consults internationally with food and cannabis manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she has delivered over 20 PCQI workshops to the food industry and works as a Project Manager to write online curriculum for ImEpik LLC. ImEpik has a history of meeting the training needs of the food industry and is working to support the cannabis industry.