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On January 26, the Food and Drug Administration essentially threw up its hands and announced that Congress needs to create a new regulatory pathway for cannabidiol (CBD) products because the existing pathways are inadequate to mitigate possible health risks. The agency simultaneously denied three long-pending requests to allow marketing of CBD products as dietary supplements. The move came as a major setback to industry stakeholders that have waited years for clear guidelines on CBD from FDA.

Governor Gavin Newsome recently signed California Assembly Bill 45 (AB 45) into law, which, among other things, allows hemp-derived cannabidiol (CBD) to be included in any food, beverages, and dietary supplements sold in California. This is not only a break from California’s prior position prohibiting CBD from being included in such products even as the State began to tax and regulate its cannabis industry, but it is also in stark contrast with the U.S. Food and Drug Administration’s (FDA’s) current position on the issue.

On December 22, 2020, we blogged about the omnibus 2021 Consolidated Appropriations Act passed by Congress, which included legislation extending the applicability of the Prevent All Cigarette Trafficking (“PACT”) Act to electronic nicotine delivery systems or “ENDS.”  The legislation, called the ‘‘Preventing Online Sales of E-Cigarettes to Children Act,’’ sweeps ENDS into the PACT Act by amending the PACT Act’s definition of a cigarette to include electronic nicotine delivery systems, thereby subjecting remote sales of these products to various requirements and restrictions.  Another important feature of this new law is that the defined term “ENDS” in this new legislation actually covers more than electronic nicotine delivery systems.

Relying on the regulatory and legal uncertainty surrounding cannabidiol (CBD), Food and Drug Administration statements and state laws, several class actions have been filed since late 2019 against companies selling CBD products, a number of which have been filed in California federal courts. In at least two cases, courts have adopted defendants’ requests to delay the cases while the FDA continues to study CBD and how it should be federally regulated. These cases could represent a developing “wait and see” approach by federal courts dealing with CBD class action lawsuits.

The U.S. Food and Drug Administration continues to be concerned about the proliferation of products containing CBD that are marketed for therapeutic or medical uses that have not been approved by the FDA.  On Tuesday, July 23, 2019, FDA issued a press release announcing it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, alleging the company illegally sold unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.

House Representatives Morgan Griffith (R-VA) and Brett Guthrie (R-KY) recently sent a letter to FDA Commissioner Robert Califf expressing “continued concerns involving systemic problems within the” Center for Tobacco Products (CTP). The first half of the letter asks FDA to explain its continued failure to issue meaningful regulations for CBD products, while the second half focuses on issues within CTP that have been echoed across the tobacco industry.