Members of Congress issued a bicameral Request for Information this week, asking for a wide range of data from “subject matter experts and stakeholders regarding Food and Drug Administration (FDA) regulation of cannabidiol.”
The request comes after the FDA announced in January that it would not be crafting rules to guide the CBD industry, as many expected. Instead, the FDA called for a “new regulatory pathway” and emphasized that the agency is “prepared to work with Congress on this matter.”
The request also comes as members of Congress are collecting information from a spectrum of stakeholders about their priorities as they pertain to hemp and hemp-derived cannabinoids ahead of the 2023 Farm Bill debate.
“Since hemp was descheduled five years ago, consumers, manufacturers, and policymakers have sought clarity regarding the legal status of CBD. Farmers, food and beverage groups, and state regulators have shared their policy priorities with Congress. Questions remain about the best way to provide a legal pathway to market for CBD products,” the RFI reads.
“We are assessing the potential for a regulatory pathway for hemp-derived CBD products that prioritizes consumer safety and provides certainty to the U.S. market,” the request continues.
The RFI is broken down into the following categories: Current Market Dynamics; Pathway; Scope; Federal-State Interaction; Safety; Quality; and Form, Packaging, Accessibility, and Labeling. The questions range from open-ended to specific.
Under “Pathways,” for example, the lawmakers ask for input on the FDA’s position: “Please comment on the concerns FDA has raised with regard to regulating most CBD products through existing pathways (i.e., conventional foods, dietary supplements, and cosmetics), and FDA’s view that there is a need for a new regulatory pathway for CBD products. If existing regulatory pathways are sufficient for regulating CBD products, please explain how these existing pathways can be used to address the concerns raised by FDA, as appropriate.”
Another question addresses the shapeshifting hemp-derived cannabinoid marketplace, which has created particular headaches for regulators because as soon as they understand one cannabinoid product, another appears.
“How has the absence of federal regulation over CBD created a market for intoxicating, synthetically-produced compounds, such as Delta-8 THC, THC-O, THC-B, HHC-P, and others?” one question reads.
The request addresses an elephant in the room: Epidiolex, the CBD formulation that the FDA approved in 2018 to treat severe seizures in children. As the request notes, the FDA has repeatedly pointed to existing law that “prohibits articles from being marketed as a food or dietary supplement if they are studied or approved as a drug.” However, FDA has also said that even if this weren’t the case, there are too many safety concerns to approve CBD as a food or dietary supplement.
Under the Safety category, the request asks: “FDA approved Epidiolex, a drug containing CBD, based in part on a data package that included preclinical data from rodent safety models, as well as clinical trials. FDA has received safety data on CBD products from several manufacturers also based on rodent models,” the request reads. “How should FDA consider data submitted for a CBD-containing drug as evidence to support that CBD is safe for human consumption in non-drug products, recognizing the inherent differences in the intended uses of such products?”
The request is signed by Rep. Cathy McMorris Rodger, chair of the U.S. House Committee on Energy and Commerce, and Rep. Frank Pallone, Jr., ranking member of the same committee, as well as Sen. Bill Cassidy, ranking member of the U.S. Senate Committee on Health, Education, Labor, and Pensions, and Sen. Bernie Sanders, ranking member of the same committee. They’ve asked that written comments and data be submitted by August 18.
