On March 22, 2021, the U.S. Food and Drug Administration (FDA) released two warning letters to U.S. companies selling products containing cannabidiol (CBD). These warning letters highlight the FDA’s continuing vigilance on marketing of products containing CBD. Without having undergone rigorous testing and FDA review and approval, it remains a violation of the Federal Food Drug and Cosmetics Act (FD&C Act) to sell products containing CBD that make specific health claims related to the treatment or prevention of disease or other conditions or the function or structure of the body. This includes claims on a product’s label and applies to any marketing material in any form.
In these letters, the FDA highlights that “a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient.” In other words, a drug manufacturer cannot add CBD to a non-prescription over-the-counter (OTC) pain cream, even if CBD is listed as in “inactive ingredient.”
The FDA made clear that the products targeted in the warning letters portrayed CBD as “active” even if the ingredient labeling categorized it otherwise (e.g. “Pain Relief Cream with Rejuvenating CBD”). The labeling of a drug may be considered misleading, and thus a violation of the FD&C Act, if it features “inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation.” (21 CFR 201.10(c)(4)).
The FDA has generally been less interested in so called “wellness language” such as “rejuvenating”, and, for this reason, industry participants often carefully craft marketing material to include similar word and concept choices. However, these letters illustrate that it is not acceptable to combine (A) the health claim related to an OTC product with (B) wellness language related to CBD that has been added to that product.
The warning letters indicate the FDA intends to challenge efforts to sneak CBD through the regulatory cracks as an “inactive ingredient”. According to the FDA, CBD has not been proven “safe” nor is it considered “suitable” as an inactive ingredient as it has no known functional role (e.g. as a preservative or to improve product delivery). In addition, inactive ingredients cannot have pharmacological effects and, as the FDA points out, CBD “has known pharmacological activity with demonstrated risks” pointing to Epidiolex®, an FDA approved prescription drug containing CBD as an active ingredient, which lists risks such as liver injury.
The FDA’s latest warning letters serve as an important reminder that the agency continues to monitor the marketplace. The FDA has signaled that it intends to widen CBD-related enforcement efforts with a focus on the inclusion of CBD in otherwise legally marketed OTC products as an “inactive ingredient” and creative labeling attempts to avoid the provisions of the FD&C Act and its regulations.