Leaders in the House are doubling down against non-compliant CBD products. Earlier this week, a key House committee called on the Food and Drug Administration (FDA) to “continue and increase” enforcement against CBD companies making unsanctioned claims about the benefits of the cannabinoid, Marijuana Moment reports.
This is just the latest in a series of moves from U.S. leadership and government organizations, with the FDA currently working with Congress to finally develop regulatory solutions for CBD products.
House Doubles Down on Non-Compliant CBD Products
Leaders addressed the ongoing conversation in new reports attached to annual spending legislation, which the House Appropriations Committee approved last week. The bill focuses on funding for the U.S. Department of Agriculture (USDA) but also codifies protections for state-regulated hemp programs.
In regard to CBD, the spending bill report for USDA and FDA says appropriators are “concerned about the proliferation of foods and dietary supplements marketed in violation of the [federal Food Drug, and Cosmetic Act], including products containing derivatives of the cannabis plant.”
The
also states that non-compliant CBD products pose health and safety risks to consumers, “through misleading, unsubstantiated, and false claims that cannabis and cannabis derivatives can treat serious and life-threatening diseases and conditions, including COVID–19.”
In the report, the committee recognizes the FDA’s intention to work with Congress to create a regulatory framework permitting CBD in consumer products.
“FDA indicated that such a framework could safeguard consumers by providing risk management tools to the agency to manage CBD risks, including labeling requirements, prevention of contaminants, content limits, and other public health protections, such as minimum purchase age, to mitigate the risk of ingestion by children,” it continues.
Regulating CBD: An Ongoing Saga
Earlier this year, the FDA determined that it would not be able to develop regulations allowing for the marketing of CBD products as food items or dietary supplements, at least not on its own. Instead, it’s indicated that it’s up to Congress to make the call and facilitate further rules around CBD regulation.
Appropriators also said that they recognize that the FDA uses existing authorities to tackle cannabis-related efforts, like research, data requests, consumer education, issuing cannabis guidance and policy around cannabis-based product development and enforcement against wrongdoers. They indicated that they wanted the FDA to continue and increase such efforts, given the amount of non-compliant CBD products out on the market.
“The Committee also expects FDA to take enforcement action against the manufacturers of any cannabis products marketed with unlawful therapeutic claims to preserve the integrity of the drug development and approval processes, which ensures that products, including cannabis-containing products, marketed as drugs have undergone a rigorous scientific evaluation to assure that they are safe, pure, potent, and effective for the diseases and conditions they claim to treat,” the report says.
It also notes the importance of the FDA continuing to exercise its existing authority, “to preserve incentives to invest in robust clinical study of cannabis so its therapeutic value can be better understood.”
Last year’s spending bill report expressed similar concerns, but the call to increase enforcement and work with Congress on regulations is unique to this year’s.
One of Many Trials in the Hemp-Derived Cannabinoid Industry
The conversation surrounding CBD and other hemp-derived cannabinoid products has already been quite the whirlwind this year, even looking beyond the potential action on behalf of the FDA and Congress.
Namely, the DEA has also thrown its hat into the ring. Terrence Boos, chief of the DEA Diversion Control Division’s Drug & Chemical Evaluation section,
that the DEA will propose a new THC limit for hemp products, cutting it from the current 0.3% limit to just 0.1%. It’s far from the first time we’ve seen pushback toward hemp-derived cannabinoids, especially psychoactive compounds like delta-8 THC, which is already banned in a number of states.Opponents believe that the production and sale of psychoactive, hemp-derived cannabinoid products goes against the intent of Congress when it legalized hemp, taking advantage of a loophole.
However, it’s still unclear whether or not the DEA will actually move ahead with this new proposal.
Earlier this month, the DEA
on the legal status of other lesser-known cannabinoids, like THCA, delta-8 THC and hydrogenated CBD. Specifically, the DEA said that delta-9 THC must be accounted for in a post-decarboxylation test for “total THC” when assessing whether a plant can be classified as legal hemp or cannabis.Attorney Rod Kight analyzed the letter and said that the DEA pronouncement is bound to create more confusion in an already confusing area of law; however, it should properly be read as simply restating the fact that hemp producers must comply with the total THC test in order to harvest their hemp.”
This all comes before the long-awaited 2023 Farm Bill, which is expected to include potential updates surrounding hemp cultivation and could provide more clarity surrounding the future of the hemp-derived cannabinoid industry.
