Cannabis and the necessity for USP standards

The United States Pharmacopeia (USP) is a non-profit, non-governmental organization that provides official standards for identity, strength, quality, and purity in medicines. As well, they also produce standards for food ingredients and dietary supplements.1 For medicine, food, and dietary supplements, the USP publishes reference standards to ensure accuracy and reproducibility of laboratory procedures. For cannabis, the USP has published a scientific paper on cannabis standards to help provide safety and accuracy to the cannabis community.2 They have not, however, published a USP monograph to officially record these findings, as the US government still does not recognize cannabis as a legal medical product. The need for standards is extremely important for the safety of consumers as well as to protect the growers, processors, and other parts on the cannabis production industry.

              The first and foremost reason that the cannabis industry needs USP reference standards is the question of safety.  USP standards are enforced by the FDA. Again, because cannabis is still on the Schedule I drug list and therefore federally illegal, the FDA does not recognize it as a type of medicine or supplement. In fact, there are actually no monographs or general chapters produced by the USP on cannabis for laboratories to follow.3 Instead, they have published a scientific paper to help get the references standards out to the laboratories that need them. The USP’s recommendation includes standardizing methods and attributes for the ensured quality of a cannabis product.4 This standardization is vital to a cannabis product that is properly labeled and free of any contaminants.  Unfortunately, with cannabis, it is difficult to produce homogenous and identical plants from the same grower, let alone from multiple locations throughout the globe. The content of the plants will be different, including THC and CBD potency, as well as terpene content. The need for a standard way of testing these differences is vital for the growth of the cannabis industry.

With a USP reference standard, labs can standardize their procedures for identifying and quantitating the important compounds and contaminants in cannabis. For instance, the mold, Aspergillus fumigatus, can survive in the cannabis flower after smoking and vaporization. If inhaled, Aspergillus can cause serious damage to the lungs and can also be fatal in patients with compromised immune systems.2 Unfortunately, there is no decent test for Aspergillus. The USP must work with other international standards group to help formulate a standardized test which can then be distributed to the cannabis industry for use with identification and purification.2 Along with microbial contamination, formulation processes and adulteration could add contaminants to the cannabis flower.5 The USP can help by providing lists of materials that are safe for cannabis processing.

With USP standards in place, there would be little question about lab techniques and procedures, therefore, in theory, every lab could produce similar results for the same sample.  By having labs work with the same standards, potencies should be the most accurate, as they can be calculated by multiple labs.  This would also discourage “lab shopping” in which cannabis processors use different labs to create the outcome they want instead of the actual reproducible scientific results. “Lab shopping” has been a particular problem in the industry, as cannabinoid potency can be labeled at something significantly different than the product actually has. It is important to know the cannabinoid and terpene contents of cannabis in order to produce the most reliable medicine. Quantification of cannabinoids is also extremely important to the legality of hemp as well.  If a grower’s hemp tests above 0.3%, it is no longer hemp, but rather psychoactive cannabis that could lead to significant legal problems in the future.

Using their experience with other botanical products, the USP has published guidelines for the identification and quantification of the components of cannabis.4 While not an official monograph, the cannabis standards are extremely important for labs to follow in order to ensure accuracy of identification and quantification. Unfortunately, because of the federal status of cannabis, the USP’s hands are somewhat tied in producing and enforcing standards. Labs can have bad techniques, wrong materials, or sometimes even malicious intent which can badly skew the results of cannabis analysis. The FDA usually enforces the USP standards, but the FDA has only approved monographs for dronabinol, a synthetic form of THC, that is the only FDA approved medication associated with cannabis.4 More standards and monographs need to be developed, as the reliability of a lab’s ability to refine, purify, analyze, identify, and quantify cannabis can be seriously compromised.

References

  1. Supporting the quality of cannabis for medical use. USP website. https://www.usp.org/dietary-supplements-herbal-medicines/cannabis. Accessed on November 22, 2020.
  2. Cannabis for medical use: consistent quality to help protect patients. USP website. https://www.usp.org/dietary-supplements-herbal-medicines/cannabis. Accessed on November 22, 2020.
  3. Everything old is new again: cannabis returns to USP. Cannabis Science and Technology website. https://www.cannabissciencetech.com/view/everything-old-new-again-cannabis-returns-usp. Accessed on November 22, 2020.
  4. Cannabis for medical use FAQ. USP website. https://www.usp.org/sites/default/files/usp/document/our-work/DS/Cannabis_FAQ.pdf. Accessed on November 22, 2020.
  5. Giancaspro GI, Kim NC, Venema J, et al. The Advisability and Feasibility of Developing USP Standards for Medical Cannabis. In Pharmacopeial Forum 2016;42(1).

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