Blog

In recent years, hemp-derived cannabinoid products have become increasingly popular for their potential therapeutic benefits. These products, which include CBD oils, tinctures, and edibles, have been embraced by patients seeking alternative treatments for various conditions. However, the legal and regulatory landscape surrounding these products has been complex and often confusing. The introduction of the Farm, Food, and National Security Act of 2024, an amendment to the House Farm Bill, aims to address some of these complexities by redefining what constitutes hemp and hemp-derived products. This legislative change could significantly impact the availability and regulation of these products, highlighting the ongoing debate over how best to balance consumer safety, market certainty, and access to cannabinoid-based therapies.

I. What Just Happened?

In a significant development, the U.S. House of Representatives has introduced an amendment to the Farm Bill aimed at addressing the loopholes related to cannabinoid products derived from hemp. The Farm, Food, and National Security Act of 2024 (H.R. 8467), introduced by Rep. Thompson [R-PA-15] on May 21, 2024, seeks to redefine hemp and hemp-derived products to exclude those with synthesized cannabinoids or those marketed for intoxicating effects. It reflects growing concerns about the unregulated market of hemp-derived products that often contain intoxicating compounds similar to THC.

H.R. 8467 The Farm, Food, and National Security Act of 2024

www.Congress.gov/bill/118th-congress/house-bill/8467/text

Introduced by Rep. Thompson [R-PA-15] 05/21/2024

www.Congress.gov/bill/118th-congress/house-bill/8467/text

Referred to House Agriculture Committee:  05/21/2024

Passed Agriculture Committee with amendments: 05/23/2024

• 1639o. Definitions

(1) HEMP- The term "hemp" means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.

(2) INDUSTRIAL HEMP.—The term ‘industrial hemp’ means hemp—

(A) grown for the use of the stalk of the plant, fiber produced from such a stalk, or any other non-cannabinoid derivative, mixture, preparation, or manufacture of such a stalk;

(B) grown for the use of the whole grain, oil, cake, nut, hull, or any other non-cannabinoid compound, derivative, mixture, preparation, or manufacture of the seeds of such plant;

(C) that is an immature hemp plant intended for human consumption;

(D) that is a plant that does not enter the stream of commerce and is intended to support hemp research at an institution of higher education (as defined in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001)) or an independent research institute; or

(E) grown for the use of a viable seed of the plant produced solely for the production or manufacture of any material described in subparagraphs (A) through (D).

The bill, referred to the House Agriculture Committee on the same day it was introduced, swiftly passed the committee with amendments on May 23, 2024. Notably, Rep Mary Miller’s  [R-IL-15] amendment “changes the definition of hemp in the Agricultural Marketing Act of 1946 to include only naturally occurring, naturally derived, and non-intoxicating cannabinoids.”

“(1) HEMP.

• IN GENERAL.-The term "hemp" means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a total delta-9 tetrahydrocannabinol concentration (including tetrahydrocannabinolic acid) of not more than 0.3 percent in the plant on a dry weight basis.

(B)  EXCLUSIONS.-Such  term  does  not include-

(i) any viable seeds from a Cannabis sativa L.plant that exceeds a total tetrahydrocannabinol concentration (in­cluding tetrahydrocannabinolic acid) of 0.3 percent in the plant on a dry weight basis; or

(ii) any hemp-derived cannabinoid products containing-

(I) cannabinoids that are not capable of being naturally produced by Cannabis sativa L. plant;

(II) cannabinoids that-

(aa) are capable of being naturally produced by a Cannabis sativa L. plant; and

(bb) were synthesized or manufactured outside the plant;

(III) quantifiable amounts (as determined by the Secretary) of-

(aa) tetrahydrocannabinol (including tetrahydrocannabinolic acid); or

(bb) any other cannabinoids that have similar effects (or are marketed to have similar effects) on humans or animals as tetrahydrocannabinol (as determined by the Secretary).”;

(2) HEMP-DERIVED CANNABINOID PRODUCT.- The term ‘hemp-derived cannabinoid product’ means any intermediate or final product derived from hemp, excluding industrial hemp, that-

“(A) contains cannabinoids in any form; and

(B) is intended for human or animal use through any means of application or administration, such as inhalation, ingestion, or topical application.

II. Why Is This Happening?

The Agriculture Improvement Act of 2018, known as the 2018 Farm Bill, broadened the definition of hemp to include all derivatives, extracts, cannabinoids, and isomers, provided they contained no more than 0.3% delta-9 THC. This change removed hemp from the Controlled Substances Act's (CSA) definition of marijuana, effectively de-scheduling hemp-derived CBD. However, the broad definition also inadvertently created loopholes that have allowed for the proliferation of synthetically modified cannabinoid products that mimic the effects of THC.

Regulatory Challenges:

The 2018 Farm Bill preserved the FDA's authority over CBD in regulated products. The FDA has maintained that hemp-derived CBD cannot be marketed as a food additive or dietary supplement, citing safety concerns and the "exclusionary clause" that prevents articles approved as drugs from being marketed as food or dietary supplements. This has led to a regulatory void where state governments have tried to step in to regulate these products.

Many states have attempted to implement their own regulations on hemp-derived cannabinoid products. These state regulations have often resulted in legal challenges, with businesses suing states over restrictions they argue are inconsistent with federal law. This patchwork of state regulations has led to further confusion in the market and has highlighted the need for clear federal guidelines.

Congressional Efforts:

In response to the regulatory challenges and market confusion, the FDA has urged Congress to establish a new regulatory pathway with extended authority. In July 2023, a bicameral Request for Information (RFI) was announced by House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Ranking Member Frank Pallone, Jr. (D-NJ), Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-VT), and Ranking Member Bill Cassidy, M.D. (R-LA). The RFI sought expert and stakeholder input on potential regulatory pathways for hemp-derived CBD products.

ASA (Americans for Safe Access) responded by advocating for a comprehensive federal regulatory approach that addresses all cannabinoid hemp products. ASA emphasized the need for an Office of Medical Cannabis and Cannabinoids Control (OMC) within HHS and the creation of a new Schedule VI for cannabis and cannabinoid products, allowing Congress to define "hemp products" within existing FDA and USDA regulations. They highlighted the need for consistency across states to prevent ongoing legal battles and ensure safe access for consumers.

III. What’s Next?

With the House's amendment passed, attention now turns to the Senate version of the Farm Bill. The current Continuing Resolution (CR) expires on September 30, and another CR is likely. The ongoing legislative process will determine the future of hemp-derived cannabinoid products and their regulation.

For patients and stakeholders, these developments underscore the need for continued advocacy and engagement to ensure that regulatory changes prioritize consumer safety and provide clarity in the hemp-derived product market.