Lobbyists say US CBD supplements regulation moving too slow though “pathway is clear”

28 Jul 2023 --- The US FDA is receiving criticism for its lack of regulatory action on cannabidiol (CBD), this week organizations have sent testimonies questioning how there can be a lack of CBD laws when dietary supplements became part of the FDA’s regulation three decades ago.

“The FDA will claim that they need more time. However, this assertion is deliberate and not without severe public health consequences and further confusion in the marketplace,” says Dr. Daniel Fabricant, president and CEO at the National Product Association (NPA).

The NPA says that the FDA lacks “progress on any meaningful path toward regulation of CBD” and that the agency has wasted time as “the pathway is clear.”

Meanwhile, the Council for Responsible Nutrition (CRN) urges the FDA to complete the work demanded by Congress in 2018, permitting CBD supplements and other hemp-derived cannabinoids to be marketed and sold as dietary supplements.

The CRN sent its testimony as a response to a declaration by the FDA earlier this year.

“First asserting in January that the existing legal framework was not appropriate to regulate CBD products; and subsequently stating, during a stakeholder call the agency hosted in June, that it would request an entirely new regulatory framework for all cannabis products, ignoring the distinction Congress previously made between hemp and marijuana in the 2018 Farm Bill,” states the CRN.

The lobbyists say that the FDA has been given the needed information for safe CBD regulations, but “wasting time.”Evaluating safety
Since 2018, the CRN has been calling out FDA to take action on providing a safe and legal path to CBD regulation.

CRN further says that the FDA has received a large amount of information evidencing the safety of CBD, not only from the CRN but also from other organizations and companies.

“The FDA is downplaying, underestimating and misrepresenting its enforcement capabilities and consumer protection tools it already has for dietary supplements as a justification for establishing new staff and resources within the FDA, and a regulatory category that undermines and ignores the existing structure,” says the CRN’s president and CEO, Steve Mister.

“Creation of this new framework would require substantial funding requests from Congress to set up and staff it; or, if the FDA instead decided to seek user fees on these products, doing so could ultimately raise costs for consumers. In the meantime, consumers are left to navigate the CBD marketplace without any guardrails imposed on these products when a viable framework for dietary supplements already exists,” Mister adds.

Pathway exists
In February, Nutritional associations “expressed dismay” following the US FDA’s rejection of three citizens’ petitions to legally allow the marketing of CBD in dietary supplements.

“Indecision to regulate CBD has been the decision for far too long, and as a result, a confused marketplace of unregulated CBD products has emerged that does not serve the public health,” Duffy MacKay, SVP of supplements at the Consumer Healthcare Products Association, previously told Nutrition Insight.

“Instead of collaborating with Congress and industry to use its existing legislative authority wisely, FDA is pursuing a new regulatory empire via a ‘center’ for cannabis or hemp. Based on what happened with the Center for Tobacco Products (CTP) at FDA, another new center will be another huge expense, likely costing the taxpayer hundreds of millions of dollars and more delays – and as we’ve seen with CTP, no demonstrable functionality as a regulator,” says Fabricant.

He adds: “We have spearheaded the charge to create a lawful pathway to market for foods and dietary supplements that contain CBD.”

He explains that the NPA worked with the House Appropriations Committee in 2019 on language to force the FDA to set a daily consumption level, as CBD supplements’ primary question is the safe daily dose.

Edited by Beatrice Wihlander