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By Robert G. Bell

Robert BellA medicinal label should mean something. As per 21 CFR § 201.56, the general requirement for prescription drug labeling is to provide a summary of the safe and effective use of the drug product, and that the information is accurate, not promotional, false, or misleading. The purpose of the Fair Packaging and Labeling Act (FPLA) is to facilitate value comparisons and to prevent unfair or deceptive packaging and labeling of many household consumer commodities and to make sure the Food and Drug Administration administers the FPLA with respect to foods, drugs, cosmetics, and medical devices.

However, a recent analysis of 75 edible marijuana products sold to patients in Seattle, San Francisco, and Los Angeles demonstrated that only 17% of the labels accurately described their levels of tetrahydrocannabinol (THC), the main psychoactive ingredient in edible marijuana products. Edible marijuana products with too little THC may fail to deliver symptom relief to those patients in need, and those with too much THC may overwhelm and debilitate the users. In some situations, the differences between what is stated on the label versus the laboratory results were extreme. In one instance, the label claim was 108 mg THC, but laboratory testing revealed only 3 mg in the product.

So why aren’t these labels accurate or in compliance with prescription drug labeling or FPLA? In broad terms, it is a quality control and assurance oversight problem on the part of the cannabis industry. And don’t forget THC’s stability and the shelf life of the active ingredient and final product. However, the cannabis industry is hampered by inconsistent and conflicting laws between the states and federal government regarding the legality of marijuana (to this day, marijuana is listed as a DEA schedule I compound with no currently accepted medicinal use). Unless you hold a DEA schedule I license, the current non-harmonized federal and state laws prevent the exchange of important analytical needs such as cannabis analytical standards to be transported. In addition, there are multiple analytical methods that can be used to analyze cannabis, including spectroscopy and gas, liquid, and thin layer chromatography (PDF). Harmonization of the analytical methodology and an understanding the stability of the multiple cannabis actives (cannabidiol (CBD), cannabinol (CBN), cannabavarin (THCV), cannabigerol (CBG), cannabichromene (CBC), delta-8-THC, cannabicyclol (CBL), cannabitriol (CBT), cannabielsoin, etc.) in the multiple dosage forms (edibles, tinctures, oils, hash, joints, etc.) is needed for accurate determination of potency and stability in these products.

The many available analytical methods for cannabis testing add to the confusion. The methods are mostly chromatographic in nature (thin-layer chromatography [TLC], gas chromatography [GC], high/ultra-high pressure liquid chromatography [U/HPLC]), each with their own advantages and disadvantages. For example, TLC is usually not sensitive or quantitative, and GC has issues with decarboxylation efficiency at the injection port and measuring acidic and neutral cannabinoids. The United Nations (PDF) and the American Herbal Products Association (PDF) have determined HPLC to be the preferred method of analysis for quantitatively determining cannabinoid concentration. Both of these documents provide excellent guidance for the cannabis industry for the quality oversight for cannabis product development, release, and stability testing. The cannabis industry needs to step to the plate and proactively assure the quality of their products and compliance to labeling requirements on both the medicinal and recreational marijuana products, or the government will. This is no time for smoke and mirrors.

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.