Tag Archives: hemp

FDA’s Report on CBD Reaffirms Status Quo

Consumers want answers from FDA on how it plans to regulate the multibillion dollar market for CBD-related products—and they’re not alone. Under the Further Consolidated Appropriations Act, 2020 (P.L. 116-94), Congress directed FDA to provide a report concerning the agency’s progress in receiving and evaluating data to help inform a policy of enforcement discretion and a process by which FDA will evaluate cannabidiol (meeting the definition of hemp) in FDA-regulated products.

On March 5, 2020, FDA submitted the requested report, painting a more detailed view of its CBD-related activities than the public has seen to date. From a high level, FDA noted that it remains concerned about the potential safety risks posed by mislabeled or contaminated CBD-infused products. At the same time, FDA stated that it “is actively working to evaluate potential lawful pathways for the marketing of CBD.”

View the full Alert on the Duane Morris LLP website.

USDA Delays DEA Registration Requirement for Hemp Testing Laboratories

On February 26, 2020, the United States Department of Agriculture (USDA) took a significant step toward allaying industry concerns by announcing that it delaying enforcement of the interim final rule (IFR) requirement that hemp producers only use testing laboratories registered with the Drug Enforcement Administration (DEA).

When the IFR was published in late October of 2019, it faced near-immediate criticism from industry participants and stakeholders who, among other things, voiced concerns that the DEA registration requirement would create a bottleneck given capacity issues. Appearing to respond to those critiques, the USDA explained that its enforcement discretion “will allow additional time to increase DEA registered analytical lab capacity.”

Notwithstanding other applicable provisions of law, the requirement that hemp testing labs be DEA-registered largely foreclosed the potential for a single laboratory facility to test both hemp and marijuana, as the DEA, which is a division of the U.S. Department of Justice, continues to treat marijuana as an illegal, Schedule I controlled substance. While this delay may provide an opportunity for labs that currently test medical and recreational marijuana pursuant to state law to also test hemp for compliance with the 2018 Farm Bill, it is not certain that the DEA registration requirement will not be reinstated. It is also not clear what further requirements states may impose.

Under the USDA’s guidance, hemp testing may be “conducted by labs that are not yet DEA registered until the final rule is published, or Oct. 31, 2021, whichever comes first.” Until that time, labs conducting hemp testing are still subject to the other compliance requirements of the IFR, including those related to methods of testing.

Spate of FDA and FTC Warning Letters Sets Stage for Wave of False Advertising Consumer Class Action Lawsuits

Since the 2018 Farm Bill passed in December 2018, removing hemp from the Controlled Substances Act and thus legalizing it under federal law, consumer goods containing the hemp-derivative cannabidiol (CBD) have become exceptionally popular. With that growing popularity among consumers has come increased scrutiny by federal regulators whose mission is consumer safety and protection, such as the Food and Drug Administration and Federal Trade Commission, and now by the plaintiffs’ bar, which files consumer class actions based on advertising. As the recent spate of warning letters and consumer class actions demonstrate, hemp-derived CBD product manufacturers and others in the supply chain for those products have to be mindful of the claims they make to consumers about their products.

View the full Alert on the Duane Morris LLP website.

With a Flurry of Warning Letters and a Consumer Update, FDA Signals Commitment to CBD Enforcement Policy

On November 25, 2019, the U.S. Food & Drug Administration (FDA) announced that it had issued warning letters to 15 U.S. businesses engaged in the sale of products containing cannabidiol (CBD); that it had published a revised Consumer Update detailing safety concerns about CBD products; and that it “cannot conclude that CBD is generally recognized as safe (GRAS)” for use in human or animal food. These actions and statements by FDA cut against industrywide hopes that FDA might soon realign its enforcement policy in light of market realities.

View the full Alert on the Duane Morris LLP website.