The Argument for Establishing USP and Compendia Guidelines for CBD Products

The market for over-the-counter cannabidiol (CBD) products continues to grow rapidly as seen at the 2019 NACDS TSE conference. PHSL identified roughly 50 different CBD companies with booths at this conference to promote different oils, tinctures, creams and lotions, capsules and tablets, and edibles. The FDA has not evaluated CBD products but has stated that they may not be sold as dietary supplements.  A 2017 JAMA article on label accuracy of CBD products reported that only 30% of CBD products were labeled accurately.  The mislabeled products either contained less product than labeled (26% of products tested) or more product than labeled (43% of products tested).1 This year the FTC, FDA and legal cases have all been in the news regarding CBD promotional statements, claims, label accuracy, and the existence of Tetrahydrocannabinol (THC) above the legal limit. For example, this past November the FDA acted by issuing warning letters to 15 companies for promoting their CBD products in ways which violate the Federal Food, Drug and Cosmetic Act (FD&C Act).2 Many of these letters were related to CBD companies marketing their products as preventative, diagnostic, therapeutic, and/or curative for certain diseases.

As more consumers use CBD products in the hope of alleviating various health conditions, there is a growing need for healthcare professionals to record CBD products in their respective EMR/EHR and pharmacy systems along with other patient medication history. This is a critical step to assure accurate clinical screening including identification and reporting of adverse effects, drug interactions and allergies.  There are multiple steps and processes for CBD products to follow to be listed in the respective EMR/EHR and pharmacy systems. United States Pharmacopeia (USP) has been hampered by prior rules and regulations surrounding cannabis, but with the Hemp Farming Act of 2009 and the 2014 Farm Bill, federal law allows cannabis derived products to contain no more than 0.3% of THC. Moreover, a growing number of CBD products are being promoted with 0% THC.

USP needs to establish standards to measure cannabis derived products for identity, strength, quality, and purity. CBD products would be required to be labeled appropriately. These standards would then enable the respective drug compendia to group and categorize CBD products in their drug databases. Absent USP standards, there are too many CBD products with varying claims of ingredients, purity and standards for the drug compendia to sufficiently group/categorize these products.  The absence of standards results in insufficient information to identify, categorize, and perform clinical screening for physicians, nurses, pharmacists, and other health professionals with ultimate potential of patient harm,

The growth of CBD products is like the days when many once prescription-only drugs became available OTC.  For example, when ibuprofen became available OTC, there was data available to accurately identify its use on patient profiles and allow for screening against other anti-coagulants.  This does exist yet for CBD.  As the order of information becomes more important to prove legitimacy, the market will mature and progressive leaders in this space will recognize that following agreed upon standards that can be tested, measured and reported objectively will help all stakeholders, including patients, physicians and retailers. Recognition of CBD products within USP and new standards will help move us in the right direction.

  1. https://jamanetwork.com/journals/jama/fullarticle/2661569
  2. https://www.theshelbyreport.com/2020/01/06/fda-regulating-cannabis-cbd-products/?MessageRunDetailID=1147119967&PostID=10404678&utm_medium=email&utm_source=rasa_io

 

Posted February 2020

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