Labeling of Cannabidiol Products: A Public Health Perspective

Abstract

Introduction: Interest in the therapeutic use of cannabidiol (CBD) has reached a fever-pitch in recent months, as CBD-containing products appear everywhere from online retailers to grocery stores and gas stations. The widespread availability of hemp-derived CBD products is confounding given that CBD is a U.S. Food and Drug Administration (FDA)-approved drug, and thus precluded from being added to food and beverages, or included in dietary supplements. The use by manufacturers of disease-related claims on marketing materials and product labels, along with the federal legalization of hemp in December 2018, has created political pressure on FDA to promulgate regulations. Conclusions: Accurate and informative labeling of hemp and hemp-derived CBD products is an important public health issue. FDA-regulated product labels are considered an essential tool for protecting consumers and enabling informed decision-making. Untruthful or unsubstantiated health-related claims, and unallowed Drug Claims, in marketing materials and on labels of CBD products may create harm by enticing consumers to forgo more evidence-based medical interventions. Furthermore, missing or inaccurate labeling of the amount of CBD, delta-9 tetrahydrocannabinol (THC), and potentially harmful contaminants such as pesticides, naturallyoccurring yeast and mold or heavy metals may result in harm and/or lack of efficacy. Manufacturers of these products may reasonably be expected to understand and adhere to FDA regulations for labeling and marketing of food, dietary supplements and drugs, both over-the-counter (OTC) and prescription, even though FDA has interpreted federal law as excluding them from these categories. As manufacturers prepare for forthcoming regulations, a better understanding of the basic framework for FDA labeling and marketing regulations for food, dietary supplements and drugs is warranted.

Cannabidiol use and effectiveness: real-world evidence from a Canadian medical cannabis clinic

“…While recent rulings clarified that CBD is not a drug under the 1961 United Nations as Single Convention on Narcotic Drugs, regulatory status in the USA remains extremely confusing. When derived from cannabis, CBD is a schedule 1 drug but when derived from “industrial hemp” plants it may be lawful federally (Corroon and Kight 2018 ; Corroon et al 2020 ). In Canada, CBD is controlled under the Cannabis Act as are all cannabinoids, cannabis, and cannabis-derived products (Canada Go 2021 ).…”

CBD and THC: Do They Complement Each Other Like Yin and Yang?

“…67 The risks are increasingly prominent in patients seeking medicinal cannabis from dispensaries given the high potency of THC currently available on the shelves, as well as the seeming lack of regulation and unsubstantiated marketing claims. 68 Patients are unlikely to find similar ratios to the 1:2 (THC:CBD) cited in Morgan and colleagues, 31 and even more unlikely to find the concentrations administered in Dalton's study. 19 Alternatively, a low concentration 1:1 oral mucosal spray, that delivers 2.7 mg of THC and 2.5 mg of CBD per each 100 ll spray, seems to help in some pain-related clinical outcomes in chronic neuropathic pain and demonstrates low intoxication scores with euphoria reported by only 2.2% of patients.…”

“…The risks are increasingly prominent in patients seeking medicinal cannabis from dispensaries given the high potency of THC currently available on the shelves, as well as the seeming lack of regulation and unsubstantiated marketing claims 68 . Patients are unlikely to find similar ratios to the 1:2 (THC:CBD) cited in Morgan and colleagues, 31 and even more unlikely to find the concentrations administered in Dalton’s study 19 .…”

Palmitoylethanolamide: A Natural Compound for Health Management

“…Cannabidiol (CBD) has recently gained interest as a potential tool to accelerate recovery. Reports are mixed, and issues of legality, toxicity, doping risks and the limited research supporting its application in healthy populations have hindered the adoption of CBD as a recovery strategy [ 183 , 184 , 185 , 186 , 187 ].…”