In the weeds: An update on the hemp regulatory landscape

USA cannabis map: Image by gwendolyn salas / MJH Life Sciences using AI

In December 2018, the U.S. hemp industry experienced a monumental change with the passing of the Agriculture Improvement Act of 2018, commonly referred to as the Farm Bill, which removed hemp from the list of federally controlled substances.1 Subsequently, it enabled the cultivation, processing, and sale of hemp and hemp-derived products, with cannabidiol (CBD) being a significant cannabinoid in the new marketplace.¹ It also enabled transportation of legal products across state lines.²

Importantly, the 2018 Farm Bill provided this definition for hemp1: “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.” This definition differentiated hemp from marijuana and allowed it certain qualifications. For example, only hemp and hemp products are eligible to receive organic status from the U.S. Department of Agriculture.³

Passed every five years by Congress, the legislation in the Farm Bill governs agricultural and other programs in the country. In 2023, through the Further Continuing Appropriations and Other Extensions Act, 2024, programs in the Farm Bill were allowed to continue until September 30, 2024.⁴ Even though in many ways it seems like little has changed since last year, the implications of the 2024 Farm Bill, including currently proposed amendments, are expected to be wide-reaching for the hemp industry.

A Standstill with Past Legislation

The years since the 2018 Farm Bill have resulted in frustration across the industry from a lack of definitive regulatory action regarding hemp-derived cannabinoids. In January 2023, Dr. Janet Woodcock, the then principal deputy commissioner of the Food and Drug Administration (FDA), released a statement regarding FDA’s position on regulatory oversight on CBD.⁵ Essentially, FDA stated it would not regulate the CBD market, but rather work alongside Congress to create a regulatory framework. In the meantime, FDA stated it will “continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate.” That has mostly taken the form of sending warning letters to companies making illegal and unsubstantiated health claims with their CBD products.⁶ 

Kim Stuck, founder and CEO of Allay Consulting, covered FDA’s announcement in 2023 and offered suggestions for companies to still remain compliant with their cannabis products.⁷ “We suggest following FDA’s established current good manufacturing practices (cGMP) for food and dietary supplements, get cGMP certification from an accredited third-party company, follow tetrahydrocannabinol (THC) potency restrictions, be cautious when making health claims for hemp products, make friends with the state or local authority who has jurisdiction over your establishment, and work with a third-party compliance firm. Someday we will look back on this and laugh, but right now it feels like a scary place to be for the cannabinoid industry. Only time will tell how it will all shake out.”

In a recent statement to Nutritional Outlook, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN) explained, “More than five years ago, Congress purposefully removed hemp-derived CBD from the Controlled Substances List to jumpstart a market, yet FDA refuses to recognize that directive. While FDA delays, a sizable market has grown for CBD, and lack of a regulatory scheme punishes the companies making legitimate product from the bad actors. FDA owes it to consumers to follow the direction from Congress and create a legal pathway to market for non-intoxicating hemp-derived CBD.”

In the midst of this situation, there has been legislation created that would enable the regulation of hemp-derived CBD products through already-existing legal pathways. For example, in July 2023, Senators Ron Wyden, Rand Paul, Jeff Merkley, and Representative Earl Blumenauer, reintroduced S. 2451, the Hemp Access and Consumer Safety Act, intending to provide consumer safety by regulating hemp-derived CBD products by the FDA.⁸ Currently, the Federal Food, Drug, and Cosmetic Act prohibits substances studied or approved as a drug to enter the market as a dietary supplement; however, FDA could establish exemptions.⁹ At its core, S. 2451 intended: “To allow for hemp-derived cannabidiol and hemp-derived cannabidiol containing substances in dietary supplements and food.” As a result, these products would be used in food, beverages, and supplements; would comply with federal regulations on manufacturing; and would be properly labeled.⁹ The legislation gained support from over a dozen organizations including American Herbal Products Association (AHPA) and the U.S. Hemp Roundtable, however it was not passed.¹⁰

On September 25, 2024, Senator Wyden introduced the Cannabinoid Safety and Regulation Act (CSRA), which was co-sponsored by Senator Merkley.¹¹ With this legislation, FDA would be required to recall or ban unsafe hemp products, set the minimum age for purchasing products to 21, require testing for safe production and clean manufacturing, and require truth in labeling.As Wyden explained, this bill intends to create a “federal regulatory floor” for hemp products.

Jonathan Miller, U.S. Hemp Roundtable’s general counsel, noted in the press release, “The hemp industry is united behind a simple, common-sense proposition: Hemp products should be robustly regulated, not the subject of a misguided prohibition.” He also further explained in an interview with Nutritional Outlook, “a Wyden bill, if it passes, would have a tremendous impact. It would hopefully bring all of these different regulatory regimes together, and particularly on an issue like labeling, to have some federal standards, as opposed to having to have 50 different state standards.”

New Challenges Introduced by Intoxicating Hemp-Derived Cannabinoids

In addition, regulation of hemp and hemp-derived products has continued to face significant challenges. Since the Farm Bill, states have resorted to creating their own regulations for hemp-derived cannabinoids. For example, some states have created licensing requirements for manufacturers and retailers, testing for contaminants, and labeling and traceability.¹²

Comprehensive restrictions on certain hemp-derived cannabinoids are becoming more common as products containing intoxicating, synthetic cannabinoids, such as delta-8 tetrahydrocannabinol (delta-8-THC), emerged through a perceived loophole in the Farm Bill’s definition of hemp. Major concerns have arisen because of the availability of these products, including to minors, in retail locations other than licensed dispensaries.

In a recent example of state legislation limiting products containing intoxicating hemp-derived cannabinoids, in September 2024, California Governor Gavin Newsom introduced emergency regulations regarding hemp products.¹³ This proposal comes on the heels of California’s Assembly Bill 2223. The legislation, proposed earlier this year, would have limited the amount of THC in hemp products, but it failed to pass the Senate.¹⁴ While both the emergency regulations and AB 2223 reportedly were in response to intoxicating cannabinoids harming minors, both received criticism for their predicted negative effect on hemp products, retailers, and consumers, including medical cannabis patients, as it would severely reduce the types of products available to consumers. The introduction of legislation restricting hemp products this year mirrored similar legislation in 2023, namely, California’s AB 420, which also sought to limit THC levels in hemp products.¹⁵

In an interview with Nutritional Outlook, Jane Wilson, American Herbal Products Association’s (AHPA) director of program development, explained, “Various limitations have been introduced at the state level (ranging from no detectable THC allowed in a hemp cannabinoid product to varying limits on the amount of THC in a serving size/product package of a hemp cannabinoid product). The patchwork of different state laws introduces additional challenges to the hemp industry to comply with ever-changing regulations and in establishing efficient interstate commerce. The variation in the limits also indicate a potential lack of a scientific basis in determining these limits and whether the limits are related to specific health and safety concerns.”

AHPA also highlighted its guidance policy (introduced in 2021 and revised in December 2023) stating that delta-8-THC and other synthesized and artificial cannabinoids should be sold through channels for adult use products.16 Furthermore, the policy, “discourages labeling or marketing as ‘hemp’ any products that consist of or contain any amount of synthesized cannabinoids for consumption by any route, and encourages identification in labeling and marketing of any synthetic cannabinoid ingredient by an accurate common or usual name; and further, AHPA strongly discourages the marketing of products for consumption by any route that consist of or contain any amount of artificial cannabinoids.”

Jonathan Miller explained in a recent interview with Nutritional Outlook: “There are intoxicating cannabinoids and there are ones that are marketed to kids and are copycats, and the latter are a real problem for the industry. We encourage states and the federal government to crack down on them, but in terms of just natural intoxicating cannabinoids, they are the lifeblood of the industry, and they need to be kept away from minors. We support strong regulation. They need to be manufactured properly, but they should continue to be sold or retailed to adults under appropriate regulations.”

The Mary Miller Amendment

A recent and significant complication to future hemp regulation is the proposed amendment to the draft version of the House of Representative’s Farm Bill, known as the “Mary Miller amendment,” which was submitted by Illinois Representative Mary Miller and approved in May 2024.¹⁷ In a statement, Miller explained that the amendment intended to keep THC products packaged like candy away from minors.¹⁸ However, the amendment “would significantly impact cannabinoid products,” explained AHPA. “This amendment is intended to close the ‘delta-8 THC loophole’ in the 2018 Farm Bill by excluding from the definition of hemp any cannabinoids that are not capable of being produced by the plant and those capable of being produced, but that were synthesized or manufactured outside of the plant. It also excludes quantifiable amounts of THC/THCA and any other cannabinoids that have ‘similar effects.’”

Jonathan Miller further explained the consequences to the amendment. “If the Mary Miller amendment stays in the Farm Bill, it would devastate the industry—99 to 95% of products would be declared illegal, and there would be no real industry to speak of, if it does pass.”

As of the time of publication, Congress failed to meet the deadline for passing a Farm Bill in 2024.

Looking Toward the Future

With legislation and regulation seemingly pulling the industry in several directions at once, it may seem like it’s being pulled apart and under threat of disappearing. However, when envisioning the long-term future of hemp regulation in the U.S., a few main ideals consistently appear as necessary for the industry to thrive. As Jonathan Miller explained, the U.S. Hemp Roundtable would ideally like to see hemp-derived cannabinoids “appropriately regulated, robustly regulated, that they’re kept out of the hands of kids, that they use good manufacturing practices, truth in labeling, and that they are offered safely and legally to adults across the country.”

These ideals should be a common denominator among all stakeholders in the hemp industry. Hopefully, they can be used as a guiding set of principles to find common ground for legislation.