Wednesday, February 5, 2025
2/5/2025
Project Summary Cannabidiol (CBD) products have rapidly gained popularity, with more than 46 million US adults reporting use, primarily to treat medical ailments. The growing CBD market spans the range of products that the US Food and Drug Administration (FDA) regulates including drugs, dietary supplements, food/beverages and cosmetics. CBD cannot be marketed as having therapeutic benefits, be false or misleading to consumers, or convey the products are approved or endorsed by the FDA. In addition, CBD cannot be marketed as a food additive or dietary supplement since it is an active ingredient in an approved drug, Epidiolex. Despite this, CBD products have been unlawfully advertised online to consumers with these claims including unsubstantiated health claims that promote benefits including curing cancer, preventing Alzheimer’s disease and providing chronic pain relief. This a public health concern as these claims may reduce perceptions of harm, increase perceived benefits and influence consumers to delay medical treatment. Coupled with lacking scientific evidence on CBD’s safety and efficacy and uncertainty about product quality, consumers are at risk for unintended consequences including liver toxicity and adverse drug interactions with existing medications if they are misled about CBD’s risks and benefits by illicit health claims. This project, focused on informing regulatory actions for CBD, aims to document the types of health claims being made by brick and mortar CBD retailers, evaluate consumer perceptions of them, and assess their impact on consumer purchase of CBD. First, we will document health claims displayed in a large sample of CBD retailers from three states with contrasting cannabis policies. Our team and experts in cannabis, public health regulation and health communication will content analyze the health claims to identify potential FDA-prohibited claims. Next, we will assess consumer perceptions of the real-world CBD health claims by conducting a web-based survey with a nationally representative sample of 3,000 adult CBD users and non-users. Participants will assess if the claims indicate a FDA-prohibited category, share their interpreted meaning of each claim, and interest in trying CBD. Finally, in Aim 3, we will examine the impact of CBD health claims on consumer purchase behavior using a simulated retail environment. We will conduct a two-arm (CBD claims, no claim control) randomized controlled trial (RCT) in a simulated CBD retailer with 400 adult CBD users and susceptible non-users to evaluate the impact of CBD health claims on the purchase of CBD products (primary), willingness to try, perceived benefits, product safety, and outcome expectancies. The proposed study, informed by multiple disciplines including tobacco regulatory science and food and nutritional claims, will be the first to document health claims made by CBD retailers, assess consumer perceptions of those claims, and test the impact of claims on consumer behavior in a real-world RCT. This study will directly inform regulatory actions, assisting FDA in determining which claims consumers interpret in ways prohibited by law and ensuring consumers are not misled about CBD.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).