Politics
Hemp Products Would Be Federally Regulated Instead Of Banned Under New Senate Bill
Democratic senators have introduced a new bill to create a federal regulatory framework for hemp-derived cannabinoids and allow states to set their own rules for products such as CBD.
The legislation, shared exclusively with Marijuana Moment ahead of its introduction on Wednesday, is being sponsored by Sens. Ron Wyden (D-OR) and Jeff Merkley (D-OR). It comes at a critical time for the industry, which is facing significant upheaval after President Donald Trump signed a spending bill last month that includes provisions to widely recriminalize consumable cannabinoid products.
The senators’ proposal would set THC limits on hemp products, allowing up to 5 milligrams per serving and a maximum of 50 milligrams per package across all types other than beverages. Hemp drinks could have up to 10 milligrams of THC per package.
The Food and Drug Administration (FDA) would also be empowered to ensure that certain safety standards are met in the marketplace—including making sure that products aren’t marketed to children.
“There’s no question that more needs to be done to protect kids and consumers from unsafe, untested hemp products,” Wyden told Marijuana Moment.
“We learned from the failed war on drugs that a one-size-fits all approach that bans hemp products from the market outright does nothing to protect kids and consumers, and will be a gut-punch to thousands of jobs and small businesses across the country,” he said. “My legislation takes the thoughtful and measured approach necessary to implement strong consumer protection regulations while fostering growth and innovation in this growing industry.”
Merkley said that “a blanket ban on hemp harms research and the entire industry.”
“Instead, the FDA must establish clear, commonsense guidelines—as it does for other foods, drinks, and products—to protect the health of all Americans and prevent children from purchasing these hemp products,” he said.
The new bill, the Cannabinoid Safety and Regulation Act, represents something of a compromise between both sides of the hemp policy debate. Rather than impose an outright ban as is currently set to take effect next November, it would establish a regulatory pathway that many stakeholders view as a more sensible alternative that wouldn’t threaten to dramatically undermine the industry.
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 measure would additionally create a $125 million cannabis use prevention grant program under the U.S. Department of Health and Human Services (HHS), with the intent of preventing underage consumption of intoxicating cannabinoids.
The bill specifically preserves the rights of states to set tighter regulations, including banning the products altogether as has played out in certain markets. 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.
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 further 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.
The bill is largely identical to a prior version of the hemp legislation filed last Congress, with select changes.
Arguably the most notable revision is the imposition of THC limits for hemp products, which represents a departure from the earlier iteration of the proposal and seems to serve as a compromise agains the broad ban that is set to take effect next November under the newly enacted appropriations legislation.
Under the new measure, testing facilities would need to be approved at the state level and registered with either DEA, FDA or USDA. The previous bill stipulated that testing facilities could have either state or federal approval.
The earlier version of the measure also sought to create a new Center for Cannabinoid Products at FDA, which was removed from the current legislation.
“We are deeply grateful to Senators Wyden and Merkley for their continued leadership on behalf of hemp farmers, consumers and businesses,” Jonathan Miller, general counsel at the U.S. Hemp Roundtable, told Marijuana Moment on Wednesday.
“Introduction of their bill is a key first step to developing consensus around a robust regulatory framework that can replace the impending ban,” he said. “We are hopeful that Congress will extend the ban moratorium for at least another year to provide adequate time to consider, improve upon and resolve efforts such as Wyden/Merkley.”
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Meanwhile, the Congressional Research Service (CRS) recently released a report describing the significant uncertainty around how the pending federal hemp ban will ultimately be enforced, but “divergent federal and state marijuana laws may provide some guidance,”
Hemp was federally legalized under the 2018 Farm Bill that Trump signed during his first term, with then-Senate Majority Leader Mitch McConnell (R-KY) leading the push to end criminalization of the crop at the time. But the senator has insisted that the policy change wasn’t intended to allow consumable products with THC, so he’s been determined to close what he describes as a “loophole” in the law.
Sen. Rand Paul (R-KY) attempted to remove the hemp ban language from the spending bill Trump signed last month, but a majority of members voted to table his amendment.
Industry stakeholders, advocates and lawmakers are stressing the urgency of the situation. While the hemp ban won’t take effect until one year after enactment, that still leaves little time in the congressional calendar to reverse course or create an alternative regulatory framework for products set to be banned.
Paul, meanwhile, said last month that he’ll soon file a bill to protect the hemp industry from the impending hemp ban. And he also called out alcohol and marijuana interests for allegedly “join[ing] forces” to lobby in favor of the prohibitionist policy change, which will restrict access to a plant and its derivatives that are often used therapeutically.
The senator said the forthcoming legislation would make it so state policy regulating hemp cannabinoid products—with basic safeguards in place to prevent youth access, for example—”supersedes the federal law.”
On the other end of the debate, Rep. Andy Harris (R-MD), who helped secure the hemp re-criminalization language, said last month that he’s not concerned about attempts to undercut the enacted law, brushing off arguments about the possible consequences of the policy change as “desperate mistruths from an industry that stands to lose billions of dollars by selling intoxicants to children.”
Overall, there’s been widespread outcry over the pending hemp re-criminalization law, drawing criticism from parents of cannabis patients, veterinarians and influencers like Joe Rogan, for example.
In response to the hemp ban, Rep. Nancy Mace (R-SC) filed a bill that would strike the contested provisions of the appropriations legislation. But some stakeholders worry that approach could backfire, and they’re hoping to see bipartisan bills introduced in he near future that would provide a robust regulatory model for intoxicating hemp products as a viable alternative to blanket prohibition.
Meanwhile, GOP political operative Roger Stone said last month that Trump was effectively “forced” by Republican lawmakers to sign the spending bill with the hemp THC ban language.
However, a White House spokesperson said prior to the bill signing that Trump specifically supported the prohibition language.
The Democratic governor of Kentucky said last month that the hemp industry is an “important” part of the economy that deserves to be regulated at the state level—rather than federally prohibited, as Congress has moved to do.
Also, a leading veterans organization is warning congressional leaders that the newly approved blanket ban on consumable hemp products could inadvertently “slam the door shut” on critical research.
While many hemp stakeholders say the ban would effectively eradicate the industry–even applying to nonintoxicating CBD products that people use for medical reasons—there’s latent hope that they can strike a compromise deal with lawmakers before the prohibition is implemented this time next year.
Lawmakers such as Sen. Chris Van Hollen (D-MD) also say that window could provide an opportunity to advance legislation to create an alternative regulatory model for consumable hemp products.
Since 2018, cannabis products have been considered legal hemp if they contain less than 0.3 percent delta-9 THC on a dry weight basis.
The new legislation specifies that, within one year of enactment, the weight will apply to total THC—including delta-8 and other isomers. It will also include “any other cannabinoids that have similar effects (or are marketed to have similar effects) on humans or animals as a tetrahydrocannabinol (as determined by the Secretary of Health and Human Services).”
The new definition of legal hemp will additionally ban “any intermediate hemp-derived cannabinoid products which are marketed or sold as a final product or directly to an end consumer for personal or household use” as well as products containing cannabinoids that are synthesized or manufactured outside of the cannabis plant or not capable of being naturally produced by it.
Legal hemp products will be limited to a total of 0.4 milligrams per container of total THC or any other cannabinoids with similar effects.
Within 90 days of the bill’s enactment, the Food and Drug Administration (FDA) and other agencies will need to publish list of “all cannabinoids known to FDA to be capable of being naturally produced by a Cannabis sativa L. plant, as reflected in peer reviewed literature,” “all tetrahydrocannabinol class cannabinoids known to the agency to be naturally occurring in the plant” and “all other known cannabinoids with similar effects to, or marketed to have similar effects to, tetrahyrocannabinol class cannabinoids.”
The language slightly differs from provisions included in legislation that had previously advanced out of the House and Senate Appropriations panels, which would have banned products containing any “quantifiable” amount of THC, to be determined by the HHS secretary and secretary of agriculture.
Read the full text of the new Senate bill below:
Photo courtesy of Brendan Cleak.
