With its recent issuance of additional warning letters and the release of a consumer update, the Food and Drug Administration (FDA) appears to be signaling that it will continue its deliberate approach in determining an appropriate regulatory scheme for foods containing cannabidiol (CBD). Included in the announcement on the warning letters was a declaration by the FDA that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.
The agency's action is occurring during a time when CBD-infused food products continue to permeate the market, including holiday season-inspired turkey gravy. The FDA also continues to face intense political pressure to provide industry guidance with members of Congress urging the agency to act quickly in providing some certainty for the industry, especially hemp farmers.
New Warning Letters
On November 25, 2019, the FDA issued warning letters to 15 companies for illegally selling products containing CBD. The letters outlined how the companies are using online stores and social media to market CBD products in interstate commerce in ways that violate the Food, Drug, and Cosmetic (FD&C) Act, including marketing CBD products to treat diseases or for other therapeutic uses. Other violations outlined in the letters include marketing CBD products as dietary supplements and adding CBD to human and animal food.
As part of its announcement, the FDA also highlighted that some of the products involved in the warning letters raise other legal and public health concerns, including:
The announcement on the warning letters also included the notable declaration on GRAS. "Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food."
Consumer Update
On the same day it issued the warning letters, the FDA also published a revised Consumer Update that details the safety concerns about CBD products. The update reminded consumers that the FDA has seen only limited data about CBD safety and "these data point to real risks that need to be considered before taking CBD for any reason."
To emphasize this point, the FDA warned consumers that CBD has the potential to cause harm such as that it can: cause liver damage; affect the metabolism of other drugs, causing serious side effects; and increase the risk of sedation and drowsiness when mixed with alcohol.
"There are many important aspects about CBD that we just don't know"
The FDA also seemed to provide a clear signal that it intends to take a cautious approach toward developing a regulatory approach for these products, acknowledging that there are many aspects about CBD that they are not aware of, such as:
USDA Interim Hemp Rule Not Immune to Congressional Pressure
Although the U.S. Department of Agriculture (USDA) released the long-awaited interim final rule on hemp production, that has not alleviated congressional pressure on the department. Responding to several concerns expressed by the hemp industry over the interim final rule, Oregon Senators Ron Wyden (D) and Jeff Merkley (D) sent a letter to USDA Secretary Sonny Perdue requesting several changes.
The letter highlighted five concerns that should be addressed before the final rule is issued.
Wilson Sonsini Goodrich & Rosati's FDA Regulatory, Healthcare, and Consumer Products practice group is actively following developments on regulatory activity impacting CBD and hemp. For more information on the items above, please contact Brian Ronholm, David Hoffmeister, Georgia Ravitz, or Jamie Ravitz.