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Quality Assurance Priorities for the Medical Marijuana Industry
The Four Pillars of Quality; Product Safety, Truth in Labeling, Tamper evident Packaging, and Dosage
R.W. Martin, Ph. D.
Since its beginnings at the turn of this century, California Cannabis Testing Laboratories have been focused primarily on cannabinoid testing. The motivation for most users or dispensaries to use laboratories has been driven by the eagerness to find more potent strains and understand the potency of extant strains. The discovery of more cannabinoids and the promising data surrounding the efficacy of CBD in particular has fueled even more interest in the further understanding of these cannabinoids.
Terpenoids (aromatic compounds associated with plants) have also been gaining interest of many of the Cannabis Testing Laboratories, at least within California, even though these compounds exist at almost trace amounts. These terpenes are thought by some to be related to specific symptomatic issues relating to patient care. Others believe that the terpenes enhance aroma therapy and taste of fresh products during consumption. Preliminary investigations are underway in several laboratories to further identify and quantify these compounds in the various strains currently being commercialized.
To date, little emphasis has been placed upon the three pillars of Quality Assurance, namely 1) product safety, 2) labeling, and 3) tamper evident packaging that are usually considered major quality components in most consumer or patient-based delivery systems. Dosage is added here as the forth pillar as it becomes very important to understand the strength of a certain medicine delivery system. This emphasis is, in part, due to the fact that the experience base of most California Cannabis laboratories is primarily chemistry. Hence, these chemist led laboratories play to their strength, and offer really top notch, very impressive chemical analyses to their patients. There are labs that offer a wide range of cannabinoid and terpenoid profiling because they have the background to do so. However, these cannabinoid and terpenoid analyses don’t begin to address the quality needs of the industry. The following is a document that seeks to share existing concepts and principles of Quality Assurance and how they may relate to the medical marijuana industry in California.
1) Product Safety
First and foremost in any Quality Assurance program is the concept of product safety. In the medical marijuana industry,” products” refer to (1) the fresh prepared flowers as well as, (2) food processed with the infusion of cannabinoids:
1) Prepared Flowers
It has been shown through testing that prepared flowers can yield very high numbers of bacteria and mold spores. These high numbers, in most cases, indicate, for bacteria: poor handling or hygiene during processing and drying; and for mold the presence of a fungal species pathogenic or saprophytic on the flower. High bacterial spore counts also increase the probability for the presence of human pathogens. Pathogens such as Pseudomonas spp. have been identified on flowers grown and processed in California (CW Analytical file data). Aspergillus has also been reported, a pathogen that produces Aflatoxin, an exocellular excretion known to be toxic to all mammals.
It has also been shown that residues of pesticides and fungicides can be present on prepared flowers, especially those grown indoors. These residues are known to sequester in human tissues and are implicated in a wide range of physiological disorders.
The minimum testing for QA approval of a flowered product=Residue Testing, Bacterial Screening, and Yeast and Mold Screening with potency testing optional (AOAC 986.33, 991.14, and 997.02). Potency will be discussed in the Dosage Section below.
2) Food processed with infusion of cannabinoids
Cannabinoid infused food should be tested similarly to food processed and distributed in existing food channels. The minimum tests for acceptable Quality Assurance for edible food products infused with cannabinoids are= Bacterial Screening and Yeast and Mold Screening. (AOAC 986.33, 991.14, and 997.02) Potency will be discussed in the Dosage Section below.
2) Product Labeling
The Sherman Food, Drug, and Cosmetic Law of 2008 clearly states that all food products be labeled accurately and consistently with standardized descriptions and labels (NLEA, 1991, Sherman Food and Cosmetic Act, 2008). This should be considered appropriate for both (1) prepared flowers as well as (2) food products infused with cannabinoids:
1) Prepared flowers
Dried flowers should be tested, bagged and sealed prior to dispensing to patients. Vacuum, nitrogen flush and hermetic sealing are all options currently available. Efficient bagging will maintain freshness and guard against further contamination. Labels indicating date of bagging, level of testing (cleanliness), and potency (if desired) should be prominently displayed on each bag.
2) Food processed with infusion of cannabinoids
All food products must be labeled using the 1997 convention adopted by the NLEA*. That is, all labels must include mandatory reporting of nutritional values based on serving size. These values include calories, fat, protein, carbohydrate, cholesterol, sodium, Trans fat, fiber, sugar, with vitamins A and C, and iron. Further, all potential allergens must be clearly identified and labeled to guard against accidental ingestion. An ingredient statement in order of preponderance is also mandatory. Labels may be based on either calculated data or actual nutrition testing. Minimum requirement for label compliance= NLEA convention food label and accurate ingredient statement.
*= It is understood that some municipalities are uncomfortable with current labeling doctrine and that they seek to make packaging as different as possible to guard against mistakes with non-patients. CW Analytical strongly suggests that nutritional labels be offered at point of sale as information sheets or addendum added to the purchase of an edible in these situations.
3) Tamper Evident Packaging
Tamper evident packaging should be required for all medical marijuana products whether fresh or processed. The accidental exposure of non-patients to these medications should be taken very seriously and barriers such as these should be mandatory.
The US Code of Federal Regulations (21 CFR 211.132) defines OTC Drug tamper evidence as = – Tamper-evident packaging requirements for over-the-counter (OTC) human drug products:
“A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering have occurred. To reduce the likelihood of successful tampering and to increase the likelihood that consumers will discover if a product has been tampered with, the package is required to be distinctive by design or by the use of one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture).”
Minimum requirement for medical marijuana industry = tamper evident packaging meeting requirements listed above
Potency ranks fourth on the Quality Assurance priority as a nice to know datum point in one aspect and a need to know in another. The potency of prepared flowers and concentrates is a nice to know in terms of commercial value and psychoactive potential but becomes a need to know datum point when calculating the potency for a dosage calculation in edible form*. Whether it be prepared flower or concentrate, the accurate depiction of cannabinoid levels are necessary for dosage calculations and serving size coordination to the patient. Minimum cannabinoid testing should include THC, CBD, and CBN values.
*It should be noted that there is currently no known dosage widely accepted for this industry. Patient response to various dosages is very diverse and should be considered as a case by case basis. CW Analytical recommends 20-25 mg as a standard single dose of THC.
These opinions are respectfully submitted and based upon 30+ years within the food industry serving as a Director of Research and Quality Assurance in large multinational food corporations. This document is intended soley for educational purposes and should be considered preliminary in scope and a precursor to formal ISO and HACCP program development. All questions should be directed to:
Dr. Robert Martin
Director, CW Analytical Laboratories