A Democratic senator has introduced a new bill that would create a federal regulatory framework for hemp-derived cannabinoids, allowing states to set their own rules for products such as CBD while also empowering the Food and Drug Administration (FDA) to ensure that certain safety standards are met in the marketplace—including making sure that products aren’t marketed to children.
The legislation from Sen. Ron Wyden (D-OR)—titled the Cannabinoid Safety and Regulation Act—comes at a pivotal time, with debates playing out at the state and congressional levels about how to address public health concerns related to the proliferation of largely unregulated intoxicating cannabinoid products since hemp and its derivatives were federally legalized under the 2018 Farm Bill.
Rather than impose an outright federal ban on hemp products containing traceable amounts of THC, as has been proposed in two major Republican-led pieces of legislation on the House side in recent months, Wyden’s bill offers a regulatory pathway that many hemp stakeholders view as a more sensible alternative that wouldn’t threaten to pull the rug out from under the industry.
“It’s unacceptable to slap fun cartoons and glitzy candy wrapper packaging on cannabis products meant for adults,” Wyden said. “That’s why I’m introducing the Cannabinoid Safety and Regulation Act—to set a floor to regulate consumer hemp products. It’s non-negotiable to ensure that consumers aren’t put at risk by untested products of unknown origin. My legislation will ensure that adult consumers know what they’re getting, and that hemp-derived products are never sold or marketed to children.”
Under the proposal, businesses selling hemp cannabinoid items meant for human consumption would need to register with FDA and comply with the agency’s safety regulations. Such products could not be sold to people under 21, and they would need to adhere to federal labeling requirements.
The bill specifically preserves the rights of states to set tighter regulations, including banning the products altogether as has played out in certain markets—most recently California, where controversial emergency regulations took effect on Monday prohibiting the sale of products with with any “detectable amount of total THC.” Hemp stakeholders—including Cheech and Chong’s cannabis company—filed a lawsuit challenging the California policy on Tuesday.
As far as the Senate proposal is concerned, states that allow the products would need to abide by federal packaging and labeling rules and they could not prevent companies from transporting hemp cannabinoids through their state regardless of their individual laws.
As part of the labeling requirement proposed under the measure, all products would need to feature an internationally recognized symbol and statement identifying them as containing cannabinoids. States could use different symbols for intoxicating vs. non-intoxicating items.
FDA would be required to promulgate rules on the remote sale, marketing and distribution of hemp cannabinoids to prevent youth use within 18 months of the measure’s enactment. Within nine months, the agency would need to establish good manufacturing processes for such products. In general, FDA would have the authority to enact additional regulations on the sale and production of hemp cannabinoids if they serve public health interests.
Additionally, the legislation would allow FDA to create and mandate the inclusion of a “nutrition facts-like” label for cannabinoids, according to a summary from Wyden’s office. It could also decide to require tamper-proof packaging through the rulemaking process.
Hemp cannabinoids could be considered as, or included in, food items if they meet Federal Food, Drug, and Cosmetic (FFD&C) Act standards laid out in the bill. However, businesses couldn’t sell cannabinoid products if they contain alcohol, tobacco or nicotine.
Vapes containing cannabinoids could not have natural or artificial flavors, and they could contain no more than 6 percent terpenes.
The bill states that synthetically derived cannabinoids would be banned, which is consistent with existing law but has generally gone without federal enforcement. For example, delta-8 THC products are commonly synthesized from legal CBD—something the Drug Enforcement Administration (DEA) has said violates statute—but those products are still widely available in loosely regulated state markets.
Wyden’s measure also adds a definition for what constitutes total THC content, a measurement that determines whether a product is considered federally legal hemp or illegal marijuana. The Farm Bill defines hemp as cannabis containing up to 0.3 percent THC by dry weight, and that’s conventionally been understood to refer to the most commonly known intoxicating cannabinoid delta-9 THC. The new legislation stipulates that THC refers to the total content of the cannabinoid in all forms, including delta-8, delta-9, delta-10, THC-A and HHC, for example.
Additionally, the heads of the U.S. Department of Agriculture (USDA), FDA, Justice Department and Alcohol and Tobacco Tax and Trade Bureau (TTB) would be required to work together to create a report with recommendations on regulating the sale of beverages containing THC.
The legislation also provides for mandatory recalls of any hemp cannabinoid products that FDA determines to be unsafe.
On top of the regulatory provisions, the Cannabinoid Safety and Regulation Act also calls for a series of agency directives and appropriations and grant initiatives to support relevant public health objectives.
That includes $200 million in annual appropriations over five years for the Centers for Disease Control and Prevention (CDC) to support data collection on cannabis use trends and evidence-based prevention programs, mandatory data collection on impaired driving and $40 million in grants over five years for state agencies to combat driving under the influence and $30 million for research development to create a device capable of detected impaired driving.
“We strongly support Senator Wyden’s efforts here to promote robust regulation for hemp products, as opposed to misguided prohibition,” Jonathan Miller, general counsel of the U.S. Hemp Roundtable, told Marijuana Moment. “This is precisely what the hemp industry has been urging” since hemp was legalized under the 2018 Farm Bill.
As Miller alluded to, the senator’s bill’s introduction comes as congressional lawmakers consider other controversial legislative proposals to impose a general ban on hemp-derived cannabinoids such as delta-8 THC.
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Rep. Mary Miller’s (R-IL) amendment to the 2024 Farm Bill, for example, was approved by a House committee in May and would remove cannabinoids that are “synthesized or manufactured outside of the plant” from the federal definition of legal hemp. The change is backed by prohibitionists as well as some marijuana companies, who’ve described the restriction as a fix to a “loophole” that was created under the 2018 Farm Bill that federally legalized hemp and its derivatives.
Anti-drug groups, law enforcement and some health organizations have called on Congress to embrace the ban, arguing that “trying to regulate semi-synthetic cannabinoids will not work.”
In addition to Miller’s amendment in the 2025 Farm Bill, the House Appropriations Committee in July approved a separate spending bill that contains a similar provision to prohibit cannabinoid products such as delta-8 THC and CBD containing any “quantifiable” amount of THC.
Hemp-derived cannabinoids also came up in a recent federal appeals court decision in which judges ruled that cannabinoids derived from hemp, such as THC-O-acetate, indeed qualify as hemp and are legal under the 2018 Farm Bill. In making that ruling, the court rejected the Drug Enforcement Administration’s more restrictive interpretation of the law.
How to address hemp-derived cannabinoids has caused some fractures within the cannabis community, and in some cases marijuana businesses have found themselves on the same side as prohibitionists in pushing a derivatives ban.
In a letter to congressional leaders ahead of Miller’s amendment, the U.S. Cannabis Council (USCC) proposed specific language they wanted to see included that would place hemp-derived cannabinoids containing any amount of THC under the definition of federally illegal marijuana.
While they’ve focused on the need to address public safety concerns related to unregulated “intoxicating” cannabinoid products such as delta-8 THC, some hemp industry advocates say the effect of the proposed language could be a ban on virtually all non-intoxicating CBD products as well, as most on the market contain at least trace levels of THC, consistent with the Farm Bill definition of hemp that allows for up to 0.3 percent THC by dry weight.
Meanwhile, the legislation that advanced through the House Agriculture Committee in May also contains provisions that would reduce regulatory barriers for certain hemp farmers and scale-back a ban on industry participation by people with prior drug felony convictions.
Specifically, it would make it so the U.S. Department of Agriculture (USDA), states and tribal entities could choose to eliminate a policy that prevents people with felony drug convictions in the past 10 years from being licensed to produce industrial hemp.
However, advocates had hoped to see more expansive language, such as what was described in Senate Democrats’ recent summary of their forthcoming Farm Bill draft. Under that plan, there would be a mandate to eliminate the ban, rather than simply authorizing it, and it would cover all hemp producers, not just those growing it for non-extraction purposes.
The Senate Agriculture Committee has not yet released the draft text of their bill, so it remains to be seen if the summary description matches what will ultimately be released. Bipartisan House lawmakers filed standalone legislation last year that would broadly lift the felony ban for would-be hemp producers.
Lawmakers and stakeholders have also been eyeing a number of other proposals that could be incorporated into the Farm Bill—and which could come up as proposed amendments as the proposal moves through the legislative process—including measures to free up hemp businesses to legally market products like CBD as dietary supplements or in the food supply.
The hemp market started to rebound in 2023 after suffering significant losses the prior year, according to an annual industry report from the U.S. Department of Agriculture (USDA) that was released in April.
The data is the result of a survey that USDA mailed to thousands of hemp farmers across the U.S. in January. The first version of the department’s hemp report was released in early 2022, setting a “benchmark” to compare to as the industry matures.
Bipartisan lawmakers and industry stakeholders have sharply criticized FDA for declining to enact regulations for hemp-derived CBD, which they say is largely responsible for the economic stagnation.
To that end, FDA Commissioner Robert Califf testified before the House Oversight and Accountability Committee earlier this year, where he faced questions about the agency’s position that it needed additional congressional authorization to regulate the non-intoxicating cannabinoid.
USDA is also reportedly revoking hemp licenses for farmers who are simultaneously growing marijuana under state-approved programs, underscoring yet another policy conflict stemming from the ongoing federal prohibition of some forms of the cannabis plant.
For the time being, the hemp industry continues to face unique regulatory hurdles that stakeholders blame for the crop’s value plummeting in the short years since its legalization. Despite the economic conditions, however, a recent report found that the hemp market in 2022 was larger than all state marijuana markets, and it roughly equaled sales for craft beer nationally.
Meanwhile, internally at USDA, food safety workers are being encouraged to exercise caution and avoid cannabis products, including federally legal CBD, as the agency observes an “uptick” in positive THC tests amid “confusion” as more states enact legalization.
Read the text of the Cannabinoid Safety and Regulation Act below:
Photo courtesy of Brendan Cleak.
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