Health Claims About Cannabidiol Products: A Retrospective Analysis of U.S. Food and Drug Administration Warning Letters from 2015 to 2019

Summary & key facts

The study examined 39 FDA Warning Letters about CBD products issued from 2015 to 2019. It found most violations were online (websites and social media) and that nearly all letters (97%) cited companies marketing CBD as an unapproved drug. The letters also showed widespread claims that CBD could treat many different health problems and that companies often promoted CBD as a dietary supplement or food, which current FDA rules do not allow because CBD is the active ingredient in an approved drug (Epidiolex).

Key facts:

• The researchers analyzed 39 FDA Warning Letters issued between 2015 and 2019 about CBD product marketing.
• 97% of the Warning Letters cited violations on company websites.
• 56% of the Warning Letters cited CBD claims made on social media accounts.
• 97% of the Warning Letters cited marketing CBD as an unapproved new drug.
• The letters documented claims that CBD could affect more than 125 unique health problems; for example, 87.2% of letters included cancer claims and 71.8% included diabetes claims.
• 79.5% of the Warning Letters cited companies marketing CBD as a dietary supplement or food product, which the FDA says is not allowed for CBD because it is the active ingredient in the approved drug Epidiolex.
• The letters showed CBD was promoted as having 16 different pharmacological effects; among these, 53.8% of letters mentioned anti-inflammatory effects, 43.6% mentioned anticancer effects, and 30.8% mentioned antipsychotic effects.
• The study focused on claims related to products intended for human use and excluded claims specific to animals.

Abstract

Background: Cannabidiol (CBD) products are increasingly available to consumers in the United States and are subject to regulation by the U.S. Food and Drug Administration (FDA). CBD products cannot be marketed as unapproved new drugs with claims of therapeutic benefit. In addition, because CBD is the active ingredient in a FDA-approved CBD product, Epidiolex, CBD cannot be marketed as, or in, food products or dietary supplements. The FDA has issued Warning Letters to promote voluntary regulatory compliance. These letters provide insights as to the types of violations for CBD products detected in the U.S. market. Objective: The goal of this retrospective study was to content analyze Warning Letters issued by the FDA to identify illicit marketing of CBD products. Design: Warning Letters issued by the FDA between 2015 and 2019 were content analyzed using a deductive approach. We extracted year of issuance, issuing office, and claim types that are currently prohibited by the FDA, including (i) unapproved new drug, (ii) misbranded drug, (iii) false and/or misleading, (iv) FDA-approved/endorsed, (v) dietary supplement, and (vi) adulterated food product. In addition, we documented the disease or conditions the product claimed to affect, pharmacological effects, and location of violation. Results: Of the 39 Warning Letters issued, 97% were for violations made on company websites and 56% were for social media accounts. Almost all letters (97%) cited violations of marketing CBD as an unapproved new drug. These illicit therapeutic claims were made for >125 unique health problems, including cancer (87.2%), diabetes (71.8%), inflammation (66.7%), pain (66.7%), and arthritis (66.7%). The majority of letters (79.5%) also cited illicit marketing of CBD as a dietary supplement or food product. CBD was promoted as having 16 unique pharmacological effects, including anti-inflammatory (53.8%), anticancer (43.6%), and antipsychotic (30.8%). Conclusions: CBD products have been unlawfully advertised online as unauthorized drugs with health claims that promote therapeutic benefits and as dietary supplements. Efforts are needed to regulate and monitor illicit advertising so consumers are not misled about the risks and benefits of CBD use.

Topics

Alcohol Consumption and Health Effects Cannabis and Cannabinoid Research Psychedelics and Drug Studies

Categories

Health Sciences Medicine Pharmacology

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Advertising Approved drug Business Cannabidiol Cannabis Chemistry Drug Food and drug administration Food science Geometry Health claims on food labels Mathematics Medicine Pharmacology Product (mathematics) Psychiatry