31 July 2022 | Cannabis
Cannabis can’t wait on federal legalization to implement quality standards.
By Kaitlin Domangue
80% of American cannabis consumers think cannabis products are produced with consistent safety product standards – regardless of the legal state they’re in. Yikes.
Good Manufacturing Practices (GMP) don’t apply to the cannabis industry right now. But, the long-anticipated Senate bill tackling federal legalization that was filed on July 21st might change that.
The Cannabis Administration and Opportunity Act (CAOA) establishes federal regulatory framework and ends the federal prohibition of cannabis.
It also loops in federal agencies like the Alcohol and Tobacco Tax and Trade Bureau (TTB), the Bureau of Alcohol Tobacco Firearms and Explosives (ATF), and the Food and Drug Administration (FDA).
- The bill allows the FDA to restrict the sale and distribution of cannabis if the FDA determines its “appropriate for the protection of public health”
- The FDA would have a Center for Cannabis Products that sets product & labeling standards and marketing & advertising rules
- Vape flavors would be banned – including menthol, chocolate, and various fruit flavors
- Among other things
(I wrote about the CAOA after the bill was filed, you can read my thoughts here. I’ve since developed additional opinions and stances on this bill. But that’s for another day! :-))
The CAOA bill won’t pass right away. But it’s vital for cannabis businesses to adhere to and familiarize themselves with Good Manufacturing Practices (GMP) starting now.
Cost is the biggest problem. It’s hard for cannabis businesses to justify the cost of establishing Good Manufacturing Practices (GMP). We all know most cannabis operations are bleeding cash – only 42% of cannabis businesses reported being profitable according to a survey published a few months back.
Adhering in compliance with GMP can be expensive. But, not transitioning to a compliant operation is even more expensive. It can lead to:
Loss of loyal customers
83% of cannabis consumers support requiring retailers to validate safety and potency testing through verified certificates. And you might only have one chance to do that. 1 in 3 customers (across all industries, not just cannabis) would ditch a brand after just one bad experience with them.
Increase product recalls
In May, a cannabis testing lab’s license was suspended in Oklahoma after 33 cultivation and processing operations had to issue recalls for 99 total products. The cannabis products were contaminated with yeast, aspergillus, mold, salmonella, and E. coli.
Health hazards
At least 18 people complained of “mild allergic reactions” after Michigan’s Marijuana Regulatory Agency (MRA) recalled an estimated 64,000 pounds of cannabis worth almost $230 million in November last year. The products had aspergillus.
Criminal charges
Johnson & Johnson was ordered to pay more than $2 billion in 2013 to resolve criminal and civil investigations. The health care giant pleaded guilty to misbranding an antipsychotic drug. Cannabis operators might be responsible for medical patients and products, food & beverage products, and more. This industry comes with a great risk of potential GMP errors.
Thankfully, there are less expensive steps to start with as cannabis businesses transition to a GMP-compliant facility, like:
Document/record keeping
The facility must have documented procedures to manage records.
CSQ says to write documents only in ink, not pencil. That’s a cheap and easy switch to implement right now. Have all staff members do the same. Also, don’t use white out on any records or documents.
Employee training
All employees need to be trained on “current Good Manufacturing Practices (cGMPs), HACCP, Security/Food Defense, Allergen Management, and any specialized training required to complete job duties (e.g., CCP Monitoring) by a qualified individual”
Operators need to maintain a training matrix that includes what each employee has been trained on and their most recent date of training. That also includes providing refresher courses at appropriate intervals, at least once a year.
Good hygiene practices
All employees must be informed of the signs and symptoms associated with infectious diseases. A system for employees to report symptoms must be included. People with exposed cuts, sores, and lesions also can’t handle any products.
Fingernails must be kept short and ocean, smoking, eating, and drinking can only be in designated areas away from handling products, and employees must be trained on proper handwashing techniques.
What I’m Thinking 🧠
All operations can afford to start small, like polishing the recordkeeping process or revamping hygiene requirements.
CSQ has an in-depth list of cGMP standards to dive into. Find what feels manageable to you and start there. Other area of focus include security plans, the process for hosting visitors on site, and shipping & receiving.
Operators should also invest in a cGAP Audit from CSQ. It’s the first step to running a GMP-compliant facility when you’re taking CSQ’s pathway and provides a step-by-step approach to best optimize facilities for future accreditation. Here’s everything you need to know about the cGAP Audit.
Cannabis operators should also research potential business partners like crazy. One bad testing lab impacted 33 operators. Whether they knew the details or not, their customer’s health and brand’s reputation were damaged by that one testing lab’s choices.
The time is now to stockpile cash for future audits, renovations, and certifications. In the meantime, CSQ has several free resources to get the process started in small doses.