Cannabis testing violations are running rampant from state-to-state, and awareness of this issue continues to grow. Recently, the Nevada Cannabis Compliance Board (NCBB), as well as Florida regulators, have taken action to discipline bad actors in their states.
With these recent actions from states, it is clear that regulators are beginning to take consumer safety more seriously. In Arkansas, four medical marijuana companies in the state were in the crosshairs of a federal civil lawsuit alleging that they conspired to defraud MMJ patients by illegally lying about cannabis potency testing results, according to MJBiz Daily. The suit was filed against testing lab Steep Hill Arkansas and growers Bold Team, Natural State Medicinals and Osage Creek Cultivation. Businesses need to be aware of the risks to avoid costly legal issues.
Regulatory Violations Running Rampant
“Violations are a big problem today due to issues such as lab shopping and potency inflation, alongside increased awareness and action from regulatory agencies,” Kim Stuck, CEO and Founder of Allay Consulting, said. “If you get violations from a regulatory agency, you run the risk of fines, recalls, disposals, cease and desist orders on operations, and the potential loss of a license. I would say that being in compliance with all regulations is the most important thing if you want to have a business at all.”
Out of all 50 states, Stuck says the main issue she sees is the lack of preparedness regarding product quality assurance. Being ready to properly conduct a recall, record corrective action, and take steps to protect your consumers is very important, but is overlooked by most companies in this industry. The majority of cannabis businesses are not prepared when the FDA starts to regulate them. That is why cGMP Certification is such a great thing to do before-hand to prepare for an emergency.
Different Certifications for Your Cannabis Business
In order to be compliant with consumer safety and quality assurance, here are the different certifications you should look into for your cannabis company, or to be on the lookout for when purchasing products from a manufacturer:
• cGMP (Current Good Manufacturing Practices)
The main regulatory standard for ensuring pharmaceutical quality is the cGMP regulation for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Referring to the regulations enforced by the FDA, cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.
After a facility submits an application for certification, the process begins with the arrival of an auditor. Once on site, the auditor performs a gap analysis to define how the facility should be operating versus how it is currently performing. This analysis involves a series of evaluations conducted by the auditor such as a quality systems analysis, computer systems analysis, facilities analysis, an equipment log review, and a personnel review.
• GACP (Good Agricultural and Collection Practices)
GACP is a set of guidelines covering areas of cultivation (from seeds and propagation material), collection, harvest, processing, packaging, personnel, equipment, documentation, and others for the sake of satisfying the minimum required quality assurance in plant cultivation. Together with GMP, these guidelines completely define the entire process from seed to sale of all plants with Active Pharmaceutical Ingredients (APIs) to which cannabis belongs to. In order to be GACP compliant, the World Health Organization (WHO) lists a set of guidelines to follow.
• ISO 9001/22000
ISO 9001 and ISO 22000 are two different standards. ISO 9001 is a quality management system standard that can be used by any organization, regardless of size or industry. ISO 22000 is a food safety management system standard that can be used by organizations in the food and beverage industry.
The two standards have some similarities, but also have some key differences. For example, ISO 9001 contains requirements related to quality management, while ISO 22000 contains requirements related to food safety. Additionally, the two standards have different scopes and applications. ISO 9001 is used to assess the quality management system of an organization, while ISO 22000 is used to assess the food safety management system of an organization. ISO offers standards for both 9001 and 22000 that cannabis businesses can follow.
• USDA Organic Certification
USDA certified organic foods are grown and processed according to federal guidelines addressing, among many factors, soil quality, animal raising practices, pest and weed control, and use of additives. Organic producers rely on natural substances and physical, mechanical, or biologically based farming methods to the fullest extent possible.
The best way to find out if your farm or product is eligible for USDA organic certification is to contact a reputable organic certifying agent. An organic certification agent is accredited by the National Organic Program (NOP). Choosing the right one is a big deal, as your agent will help you with the planning process, inspect your product, and license you to use the term “organic” to sell your product.
How to Avoid Getting a Regulatory Violation
Stuck advises cannabis business leaders to learn from others’ mistakes and be proactive with compliance, not reactive. Look at other companies’ violations and recalls as well as cease and desist orders so that you do not repeat their mistakes. If you know where the industry is going and you want to stay compliant for the long term, then be proactive and become compliant with the next set of regulations that you need to follow.
Right now, Stuck recommends implementing FDA cGMP and OSHA requirements, since those agencies eventually will regulate the industry. It also takes a lot of time to implement those processes and procedures. The companies that are not ready will surely get left behind once federal legality comes into play.
As regulators continue to crack down on companies who are committing violations, we will see more cannabis businesses strive for compliance. Whether you are a dispensary who needs to be aware of the products you are purchasing, or a manufacturer looking to be more compliant, this is your sign to strive for better consumer protection.