Labeling & Testing for Medical Cannabis
It is funny how what is happening with medical cannabis seems to mimic what I often deal with in my life sciences career. As a Quality Assurance professional, I am often found in the precarious situation of having to tell someone they did something wrong. Sometimes, it is received well and other times...not so much. One thing I discovered that increases my success and avoids the tough conversations is to create a partnership - work together from the beginning to ensure that we get to a mutually-agreed upon endpoint. It is amazing to me how many companies don't have time to do something right but end up finding the time to do it over.
Very few states have managed to get it right the first time. Most, like Florida, have legalized medical cannabis and are now struggling to create standards, laws, and regulations for product testing and oversight of laboratories.
Here are some direct quotes from the 2018 Florida Statutes:
"The department shall determine by rule which contaminants must be tested for and the maximum levels of each contaminant which are safe for human consumption."
"The Department of Agriculture and Consumer Services shall assist the department in developing the testing requirements for contaminants that are unsafe for human consumption in edibles."
"The department shall also determine by rule the procedures for the treatment of marijuana that fails to meet the testing requirements of this section..."
In other words, go ahead and start doing stuff and we'll see if we agree with it later. In the meantime, here are the Florida requirements as they stand today:
What is on the label?
- Name of medical marijuana treatment center (MMTC)
- Product name
- Dosage form
- THC & CBD concentration
- Batch # & harvest #
- Date dispensed
- Name of physician
- Name of patient
- Recommended dose
- Warning statement(s)
- Edibles must also contain: ingredients, storage instructions, and expiration date
How is product quality ensured?
- Processed marijuana must be tested before being dispensed
- No definition on contaminants to be tested or limits that must be met
- Test lab must perform audits of the MMTC
- Biennial and surprise inspection by the state as needed
- Test lab must be accredited or certified
Strengths
- Cultivation, processing, and retail occurs all at the same facility which reduces handling and the potential for contamination
- A patient package insert is required for all dispensed marijuana that includes: clinical pharmacology, indications, dosage & administration, dosage forms & strength, contraindications, warnings & precautions, adverse reactions
Flaws
- No requirement to dispose of batches that fail testing since no limits have been established
- The state has not set rules for certification/accreditation of test lab
- The state has not established required testing or contaminant limits
- No requirement for terpene testing or identification on the label