Industry urges US Congress to demand FDA regulates CBD as a supplement

21 Aug 2023 --- US industry stakeholders call for cannabidiol (CBD) products to be regulated as a supplement instead of developing a new regulatory pathway as the US Food and Drug Administration (FDA) has decided. Stakeholders are responding to a Congressional Request for Information (RFI) on creating a “regulatory pathway for non-intoxicating hemp-derived CBD products that prioritizes consumer safety and provides certainty to the US markets.”

The RFI for stakeholders included questions on market dynamics, regulatory pathways and scope, federal-state regulatory and enforcement interactions, public safety and risk, consumer protections and quality controls, plus inquiries related to product form, packaging, accessibility and labeling.

“Congress is asking the right questions because they created in DSHEA (Dietary Supplement, Health and Education Act) a framework that could accommodate CBD and their reasonable expectations for the FDA around this ingredient were not met,” says Steve Mister, president and CEO at the Council for Responsible Nutrition (CRN).

“Meanwhile, despite an overwhelming amount of safety data the industry has already presented to FDA. The agency continues to place an entire industry in innovation-stifling limbo, and consumers at continued risk in a needlessly unsupervised environment.”

“Patchwork of laws”
Though the CBD market has grown substantially in the last five years, industry stakeholders see that the industry has languished due to a lack of national standards.

CRN notes that it initially anticipated that CBD products would be regulated under DSHEA, as this provides for the legal marketing of other botanical ingredients.

However, the FDA concluded that a new regulatory pathway would be needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency warned that marketing CBD without proper approvals could have far-reaching health implications, potentially putting patients at risk.

Industry stakeholders stress that FDA’s existing pathways are adequate to regulate CBD products.As the FDA has not established a regulatory pathway for CBD, CRN stresses this has forced individual states to set up their policies to protect consumers, adding: “This has resulted in a patchwork of laws that is detrimental to the industry and should be unified by federal intervention.”

CRN’s response to the RFI states that if the FDA had worked on a regulatory pathway to legally market CBD in the last five years, “the questions raised in this RFI would already have been addressed.”

Adequate framework in place
Joining industry organizations, Sibyl Swift, chief science officer and VP of regulatory affairs at CBD supplier CBDMD, sees that the FDA’s existing pathways are “adequate to address any concerns about product safety/daily consumption limits, manufacturing quality and labeling on CBD.”

“We urge Congress to mandate that the FDA, with what’s left of 2023, use its current authorities to stabilize the market by setting a daily consumption limit ensuring safety for all US citizens and stabilizing the market for American Hemp Farmers, small businesses and brands that make up the entire domestic supply chain.”

The Natural Products Association (NPA) also submitted a response to the RFI. Daniel Fabricant, Ph.D., president and CEO of the NPA, adds that over the last five years, the organization has worked with Congress to establish appropriate measures and “even petitioned the FDA to exercise enforcement discretion in a specific and selective manner consistent with the premarket safety review of a new dietary ingredient notification.”

“Our proposal demonstrates that putting a clock on FDA to use existing authority is the most efficient and straightforward pathway for public health and to stabilize a robust marketplace for dietary supplements and foods containing CBD.”

Consumer safety
In response to the RFI, NPA estimates that over 3,000 CBD products have come to the US market in the past five years. In a poll the organization commissioned, seven in ten US citizens believe the FDA is overdue to establish safety standards for CBD products.

Moreover, 41% of poll respondents assumed the FDA had already developed these safety standards.

“For more than five years, US citizens have been asking the FDA to make a safety determination for CBD,” adds Fabricant.

CRN warns that FDA’s inaction “creates safety risks for consumers by creating a market which many current, knowledgeable supplement companies are hesitant to enter, and in which FDA oversight is limited.”

Meanwhile, in the UK, the Association for the Cannabinoid Industry (ACI) received formal notification from the UK’s Food Standards Agency that its application for CBD distillate and isolate is within the scope of authorization as a novel food.

“The validation of thousands of products is a major milestone for the industry,” Tom Risby, business R&D manager at ACI, previously told us. “This will increase consumer confidence, de-risk the category for investors and create the important foundations that will lead to increased product innovation in the coming years.”

By Jolanda van Hal

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