On January 13, 2020, U.S. House Committee on Agriculture chairman, Representative Collin Peterson (D-MN), introduced a bill to respond to one of the most troublesome issues in the rising hemp industry – the regulation of cannabidiol (“CBD”). H.R.5587 proposes to amend current federal legislation to grant specific considerations to the already immense CBD market and establish a federal study on regulatory and market obstacles for farmers.
Potentially the most significant item in the bill’s described changes would be the addition of hemp-derived CBD products – or similarly infused products – as dietary supplements under the Federal Food, Drug, and Cosmetic Act (“FD&C”). Currently, existing law maintains that CBD and hemp-derivatives cannot be sold as dietary supplements. A commonly cited item of contention between the industry and U.S. Food and Drug Administration (“FDA”), if a substance is an active ingredient for a drug product that has previously received FDA approval – or has been authorized publicly for substantial clinical investigations – products containing said substances are then banned from being classified as dietary supplements.
Aside from expanding the definition of dietary supplement to cover “hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance,” H.R.5587 includes provisions to remove some of the limitations on interstate commerce for hemp and CBD products. Referring to the established prohibited acts and penalties outlined in the FD&C, Rep. Peterson’s bill would remove some of the transportation restrictions placed on CBD when it was initially assessed as a pharmaceutical drug.
Beyond effects on the FD&C, the new bill could also provide a way to ensure a broader level of market supervision for farmers. Section 2 of H.R. 5587 would establish a study to be led by the Secretary of Agriculture on regulatory and market challenges on known or potential obstacles including:
- Operating costs required for new and existing hemp testing programs;
- Fees and conditions for a hemp crop’s destruction if determined to be in excess of 0.3% delta-9 tetrahydrocannabinol (“THC”);
- Feasibility of producer compliance with sampling timetables; and
- Practicality of producer compliance with reporting prerequisites
“The last two Farm Bills were landmark successes for hemp, but we are still very early in this process, and growers need regulatory certainty,” Peterson explained in a recent press release.
“This bill will allow FDA to regulate CBD that comes from hemp as a dietary supplement, providing a pathway forward for hemp-derived products. It would also identify barriers to success for hemp farmers, informing growers and policy makers of the challenges facing this new industry.”
While the bill must undergo significant legislative review in the coming months – currently awaiting evaluation from the Agriculture and Energy and Commerce Committees – the bill’s introduction indicates increasing congressional pressure on the FDA. Co-sponsored by Reps. Thomas Massie (R-KY), James Comer (R-KY) and Chellie Pingree (D-ME), H.R. 5587’s bipartisan support appears to be a direct response to the lack of action by the FDA in producing appropriate guidelines for the industry.
To date, the last major FDA action concerning the substance was a revised Consumer Update on CBD and subsequent distribution of warning letters to fifteen companies in late November 2019. Cautioning that lack of data on the safety of ingestible CBD products prevented the substance from being deemed generally recognized as safe (“GRAS”), the initial announcement charged the fifteen companies in receipt of warning letters with “illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).”
If H.R. 5587 were to successfully pass through Congress, the bill could spur further dialog in reassessing hemp and CBD’s place within the FD&C to create clear industry regulations. “Businesses have suffered due to murky regulations on banking, insurance, marketing, and generally operating above ground,” Rep. Pingree wrote in a statement on Tuesday. “With this bill, we’re providing a pathway forward for hemp farmers by allowing hemp-derived CBD products to be marketed like any other dietary supplement.”
As is the case for most legislation introduced this early in the year, only time will provide indicators on H.R. 5587’s likelihood of passing. That said, the response from industry stakeholders has been generally positive. The U.S. Hemp Roundtable, a union of hemp companies and organizations, is currently advocating to secure additional bill co-sponsors, while advocacy group Vote Hemp has also publicly announced their support. “We urge Congress to pass this legislation quickly and FDA to regulate hemp-derived CBD the same as any other supplement under existing regulations,” President Eric Steenstra stated.1
Our view of the proposed legislation is a bit more nuanced. Yes, we believe that this is a step in the right direction and that legislation is the best way to force FDA to act; however, the bill as written is largely impotent as it contains no specifications or guidelines regarding CBD content in products and no timeline for FDA approval. If passed it would, in effect, simply pass responsibility for setting such standards right back to FDA, whose biggest concern is the lack of scientific data on the safety of CBD.
The only such data currently accepted by FDA is the information derived from the clinical trials of Epidiolex, something industry stakeholders have repeatedly pointed out is not applicable to the dosage level of non-Epidiolex level dosage levels. In other words, even if passed, H.R. 5587 may do very little to expedite FDA acceptance of CBD. If the bill were amended to be more specific that could change significantly.
Alternatively, The Rodman Law Group recently became aware of a potentially monumental development for the industry that could be instrumental in changing FDA policy regardless of whether this bill passes. Patrick McCarthy, the CEO of ValidCare, recently approached the Firm with the details of a multi-brand CBD safety study that the company is conducting with the University of Kentucky to establish the general safety profile of CBD. This is not a “wish and a prayer” project, according to McCarthy, “FDA has agreed to provide ValidCare with the study design and data required to address their concerns of potential liver toxicity from hemp-derived CBD.” In our opinion, this study is far more likely to result in a more sensible CBD policy at FDA than anything else currently being discussed.
If you are interested in participating in the study, which has a 20 company participant limit – please click here for more info.
- Jaeger, Kyle. “FDA Would Be Required To Allow CBD Product Marketing Under New Bipartisan Bill.” Marijuana Moment. Marijuana Moment LLC, January 14, 2020. https://www.marijuanamoment.net/fda-would-be-required-to-allow-cbd-product-marketing-under-new-bipartisan-bill/
The information in this blog post (the "Blog" or "Post") is provided as news and/or commentary for general informational purposes only. The information herein does not, and shall never, constitute legal advice and therefore cannot be relied upon as a legal opinion. Nothing in this Blog constitutes attorney communication and is not privileged information. Nothing in the Post or on this website creates any kind of attorney-client relationship or privilege of any kind.
Originally published Jan. 23, 2020, at https://therodmanlawgroup.com