, , , ,

By Robert G. Bell

Robert BellAnd you thought we were through! Or is this just déjà vu?

We continue our never-ending High Hopes? Or Smoke and Mirrors? marijuana blog series with the legalization and business of marijuana. The first part of the blog series focused on the pharmacology, clinical uses, abuses, and safety of medical and recreational marijuana use. The Marijuana 200 series will discuss the legalization efforts and associated regulations as well as the emerging businesses associated with the recreational and medical marijuana industry. It is estimated the combined sales of legal recreational and medical marijuana in the United States is projected to reach more than $8 billion by 2018. And this number will increase as additional states legalize both medicinal and recreational marijuana.

The marijuana industry has the ability to conduct the appropriate good manufacturing and quality practices (GMPs) for their products. However, it is the opinion of this blogger that the marijuana industry will not be proactive with quality until forced to comply. For instance, many of the marijuana edibles are made in kitchens that may not possess the appropriate food grade hygiene and controls, which could result in microbial contamination of the edibles, potentially resulting in an outbreak of food poisoning. Marijuana product testing is becoming a standard requirement for legalized marijuana markets, but universally accepted standards and methods for testing have not been established. Furthermore and for various reasons, the labels on many of the marijuana products may not be accurate, and batch production documentation and quality practices may be lacking. It is suggested that official practices and monographs be established to harmonize the analysis and standardization of the marijuana components and labeling. The pharmaceutical industry can provide many applicable guidelines for the marijuana industry, including the FDA’s guideline for botanical products and process validation, as well as the International Conference on Harmonization Quality guidances ICH Q1-12.

shutterstock_201106769Some Colorado and Oregon companies produce 100% cannabis oil from a supercritical fluid extraction of the marijuana plant and utilize devices to atomize the extracted oils. The concentrated plant extracts should have specific release and stability criteria and should be examined for impurities including pesticides, fungicides, fertilizers, residual solvents, extractable, leachates, etc. The oils are delivered through an electronic delivery device (similar to an e-cigarette) that atomizes the oil to a vapor that is inhaled by the user. Assurances that the device is safe (e.g., extractables, leachates, heating elements, reservoir compatibility, metered, etc.) and delivers a reproducible amount with a uniform particle size during shelf live should be demonstrated by the producers. The cannabis oils and delivery devices are recent advances in marijuana drug formulation and delivery, and we have little experience (in terms of use, safety, and efficacy) with these formulations and devices. From this scientist’s perspective, we basically have an unapproved drug (cannabis oil) in an unapproved delivery device (electronic vaporizers) treating indications not supported by clinical data. The marijuana industry has an opportunity to be proactive regarding the safe and efficacious use of their product. They should further cannabis research and put the appropriate controls and quality in place proactively, rather than reacting to quality issues and adverse events that may have been prevented.

The High Hopes? Or Smoke and Mirrors? Marijuana 200 blog series will also discuss the legalization efforts occurring throughout the country. As discussed in a prior post, marijuana is classified by the U.S. government as a Schedule 1 narcotic with currently no known medical use, making use and possession a serious crime in most states. Some have argued that the marijuana laws (and drug laws in general) disproportionately and negatively affects young people and people of color, results in violence and corruption, and fails to curb youth access. Others argue that laws discouraging drug use do have an effect in keeping rates relatively low compared to rates for other drugs that are legal and therefore more available. This is one of the many topics in the series that will spark some debate.

So believe it or not, there is still much to discuss regarding the pros and cons of pot. Next up, whether to legalize or not.

Robert G. Bell, Ph.D., is president and owner of Drug and Biotechnology Development LLC, a consultancy to the pharmaceutical industry and academia for biological, drug, and device development.