The recently enacted federal spending bill, H.R. 5371, introduces a new definition of hemp that reshapes the regulatory landscape for growers, extractors, manufacturers and finished product brands. The language alters THC calculations at every point in the supply chain and excludes several categories of hemp-derived cannabinoids, prompting widespread operational and compliance concerns across the dietary supplement and broader botanical industries.
Changes to hemp definition outline new compliance thresholds
The bill revises the definition of hemp in the Agricultural Marketing Act. “The term ‘hemp’ means the plant Cannabis sativa L. and any part of that plant… with a total tetrahydrocannabinols concentration… of not more than 0.3 percent on a dry weight basis,” the bill states. Such a term includes industrial hemp.
The law also identifies several exclusions. Products that exceed “0.3 percent total tetrahydrocannabinols, including tetrahydrocannabinolic acid” fall outside the definition of hemp. Additional exclusions cover cannabinoids “not naturally produced by the plant or that are synthesized or manufactured outside of the plant,” as well as final products that contain “more than 0.4 milligrams total tetrahydrocannabinols per container.”
Intermediate extracts, referred to in the statute as intermediate hemp-derived cannabinoid products, are also subject to the 0.3 percent total THC limit. Any material exceeding that limit is considered a controlled substance.
These changes are set to be implemented on Nov. 13, 2026, one year from the bill’s signing.
Legal and regulatory impacts
Rend Al-Mondhiry, partner at Amin Wasserman Gurnani LLP, said the shift to a total THC limit marks a fundamental departure from the previous focus on delta-9 THC.
The legislation redefined ‘hemp’ by moving from a 0.3% delta-9 THC concentration limit to a 0.3% total THC concentration limit, which takes into account all THCs and THCA.
This change affects farmers, extractors and brand owners because any source material above the limit “is considered a controlled substance,” Al-Mondhiry said, noting that the new 0.4 mg container limit creates significant marketplace disruption.
“Even for products that primarily contain CBD or other non-intoxicating cannabinoids, they may still contain small amounts of delta-9 and other THCs, and this new container limit is prohibitively low,” she said.
The exclusion of cannabinoids manufactured outside the plant presents additional uncertainty.
“The legislation broadly excludes cannabinoids that are naturally found in the cannabis plant but were synthesized or manufactured outside the plant,” Al-Mondhiry said. “The latter part seems very problematic, since ‘manufactured outside of the plant’ could be open to multiple interpretations.”
Primary regulatory changes for hemp industry stakeholders:
- Hemp must meet a 0.3% total THC limit, including THCA, at every stage of production or it is classified as a controlled substance.
- Final consumer products may contain no more than 0.4 mg total THC per container, affecting most tinctures, beverages and supplements.
- Cannabinoids synthesized or manufactured outside the plant are excluded from the definition of hemp, making many converted or semi-synthetic cannabinoids unlawful.
- Intermediate hemp-derived extracts must also meet the 0.3% total THC standard, effectively restricting work-in-progress materials used throughout the supply chain.
Impacts on retail operations and consumer access
CBD American Shaman Founder and President Vince Sanders noted that the manner in which the provision was added to the spending bill signals deeper policy concerns for the hemp sector.
“It was clearly slipped into a must-pass spending bill with virtually no public awareness or debate,” he said. “Powerful groups with a vested interest in eliminating competition have been pushing back against hemp because it threatens their market share.”
According to Sanders, the limits would reshape the business model for many retailers on the opeartional side.
“If this stands, it would be catastrophic for us and for the entire hemp economy,” he said. “Most hemp companies depend on the full spectrum of cannabinoids, and this kind of language strips everything out.”
He added that consumer use patterns heighten the stakes.
“Consumers report these products as alternatives to help with temporary pain, anxious feelings and sleep support,” he said. “If those products disappear, so do thousands of jobs and millions of consumers who rely on them.”
Effects on manufacturers, suppliers and product categories
The change to the hemp definition complicates operations for companies working with plant-based extracts, according to Graham Rigby, president and CEO of the American Herbal Products Association (AHPA).
“The revised definition of hemp in the H.R. 5371 bill represents a significant and concerning change that negatively impacts AHPA members and the wider industry that utilizes hemp extracts,” he said, add\ding that the exclusion of converted cannabinoids directly affects sectors built around bioconversion.
“As the CBD and hemp markets have grown in recent years, so has the importance of processors who convert naturally derived cannabinoids into other forms. The ban on these converted forms will negatively impact multiple hemp categories.”
For AHPA, the 0.4 mg container limit also has far-reaching consequences.
“For several categories, including tinctures and beverages, this extremely low threshold is viewed as an extinction-level event,” Rigby said. “AHPA is actively advocating for the adoption of science-based, category-specific THC limits as an alternative to the bill’s blanket restriction.”
On consumer safety, evidence-based standards remain central to the association’s position.
“In our view, H.R. 5371 does not reflect a science-driven approach to consumer safety,” Rigby said. “There is no clear scientific basis for the 0.4 mg total THC limit per package.”
Broader supply chain and regulatory considerations
Natural Products Association (NPA) CEO and )resident Daniel Fabricant, PhD, commented that the law’s reach extends beyond supplements.
“Economically, it’s the whole supply chain—the value chain,” he said. “Growers of hemp and cannabis play in a multitude of diversified markets.”
Dr. Fabricant pointed to functional beverages as an area of particular concern.
“Economically, the most important part of that chain right now is beverages—specifically non-alcoholic THC or hemp beverages,” he said. “Ensuring a pathway for those products is very top of mind for our membership.”
He added that existing regulatory tools could guide future policy.
“The way to do it right is to use the current pieces of the Food, Drug, and Cosmetic Act: Set caps on cannabinoids scientifically, follow existing product and labeling standards, and add any additional standards if needed,” he said.
For NPA, the path forward will require collaboration and pragmatic expectations.
“What makes good policy is being able to look at this from all the different angles,” Dr. Fabricant said. “You’re never going to get something that any one group is 100% happy with.”
New federal proposal outlines national safety standards for hemp-derived products
Following enactment of the spending bill, Oregon Senators Ron Wyden and Jeff Merkley reintroduced the Cannabinoid Safety and Regulation Act (CSRA) on Dec. 10, which would create a federal regulatory framework for hemp-derived cannabinoid products.
“The Cannabinoid Safety and Regulation Act keeps hemp legal, and creates a thorough and strict regulatory regime for hemp-derived consumer products to protect public health and safety and keep these products out of the hands of kids,” the CSRA fact sheet released by Senator Merkley stated.
The legislation would require producers to register with FDA, test products for contaminants and potency, and follow manufacturing, labeling and packaging standards, including a federal age limit of 21 and truth-in-labeling rules. It would also ban synthetic cannabinoids and impose THC serving and package limits across edible, beverage, topical and inhalable formats, according to the bill’s section-by-section breakdown.
In a press statement, Senator Wyden said the approach is intended to provide guardrails while maintaining access.
“A one-size-fits all approach banning hemp products from the market outright does nothing to protect kids and consumers,” he noted. Senator Merkley added that the bill aims to prevent unintended consequences. “A blanket ban on hemp harms research and the entire industry,” he said in the same statement.
According to Senator Merkley’s office, industry groups signaled support for a national baseline.
“The hemp industry stands firmly behind Senator Wyden’s effort to replace confusion with clarity and prohibition with practical regulation,” U.S. Hemp Roundtable General Counsel Jonathan Miller shared in the senator’s press statement.
