CBD supplements? Regulatory status debate roars on

18 Jun 2020 --- The cannabidiol (CBD) sector has been filled with renewed calls for safety framework regulation in both the US and EU. In the US, the Council for Responsible Nutrition (CRN) filed a Citizen’s Petition to the Food and Drug Administration (FDA), requesting it to establish a regulatory pathway to legally market dietary supplements containing hemp-derived CBD. Alongside a long-term research project in CBD, the European Industrial Hemp Association (EIHA) has launched a Novel Food Consortium, which is projected to set a Novel Food joint application in motion. New research findings from both sides of the Atlantic also aim to bring clarity to the CBD sector.

The CRN’s Citizen’s Petition specifically requests the FDA to enforce existing dietary supplement regulations, given that CBD and its derivative products are being marketed as dietary supplements. The petition also calls for the provision of more guidance on CBD-specific definitions. Reluctance to provide clarity on this definition has contributed to the “confusion among consumers and industry alike,” says the CRN, as well as preventing firms from filing new dietary ingredient (NDI) notifications for hemp-derived products.

“With this Citizen’s Petition, CRN is urging the agency to take action by providing a legal pathway to market for responsible companies. [It also calls the FDA] to enforce existing dietary supplement requirements for companies already marketing CBD as dietary supplements, and above all else, to ensure consumer safety to the 20 million Americans who take CBD dietary supplements,” says Steve Mister, President and CEO of the CRN.

The hazy regulatory landscape surrounding CBD is causing major disruptions for big and small players alike. To speed up developments, US President Donald Trump previously requested US$5 million from the FY2021 budget to regulate the CBD industry and allow the US Food and Drug Administration (FDA) to continue enforcing protection laws safeguarding patients and consumers.

The CRN is urging the FDA to take action by providing a legal pathway to market CBD.In March, the FDA officially reopened the public comment window on cannabis and CBD products, “extending it indefinitely.” Although the extended comment period is to collect more scientific data, the Natural Products Association (NPA) pegged the move as a “huge step backward.” 

Research insights
The lacking regulatory framework in the US has given life to a new paper discussing perspectives on science, safety and potential regulatory approaches. “Possible approaches to a new framework for the regulation of CBD products as dietary supplements [include] expanded research emphasis, a robust corporate stewardship program and a rigorous adverse event reporting program,” the paper’s abstract reads.

The paper authors, from the University of Mississippi, the University of Arkansas for Medical Sciences and the University of Minnesota School of Pharmacy, are notably concerned about the “aggressive marketing of many types of products, some of dubious quality, making or implying drug-type claims” that has been facilitated by a vacuous regulation policy in the US.

In other research news, a study published in Cannabis and Cannabinoid Research found that CBD supplementation did not cause a presence of THC in blood plasma, and no psychotomimetic effects of THC occurred. The paper responds to recent studies that suggest that cannabidiol (CBD) could interconvert into Delta-8- and Delta-9-THC.

“The findings presented are consistent with previous evidence suggesting that the oral administration of CBD in a corn oil formulation is a safe route for the administration of the active substance without bioconversion to THC in humans. We found no signs of Delta-8-THC or Delta-9-THC in whole blood at three and six hours after oral administration of CBD. The results also add to the knowledge built over 40 years of research that CBD-based therapies are safe and well-tolerated in humans,” the paper affirms.

Joint novel food application
On June 15, the EIHA held an online General Meeting on the creation of a Novel Food Consortium, which aims to regulate the CBD market in Europe for both industry and customers. To guarantee its members are covered across the whole European market, EIHA will submit two Novel Food applications within the Consortium: one to the UK Food Safety Authority (FSA) for the British market and the other to European Food and Safety Association (EFSA) for the EU market.

“We only stand a chance if we jointly bear the exorbitant costs for the necessary toxicological studies and the long procedure ahead of us. This would not be affordable for a single hemp company,” states Daniel Kruse, EIHA President. 

Due to the costs of up to €500,000 (US$562,000) per product and the long approval procedure for novel foods, the Novel Food Consortium aims to act as a representative of the European hemp industry by submitting various applications for the approval of novel food ingredients and foods. 

Kadenwood unveiled Level Zzz CBD Oil Drops, an all-natural melatonin-infused CBD oil.Meanwhile, the EIHA is set to commission research to establish legal and planning security for the European hemp industry and market. Over the next two to three years, around €3.5 million (US$3.9 million) is to be invested in unprecedented studies on CBD and tetrahydrocannabinol (THC). The aim is to submit applications for approval of four so-called “novel foods“ with CBD ingredients.

Earlier this year, NutritionInsight spoke with Lorenza Romanese, Managing Director at the EIHA, who outlined that the hemp sector is asking for a clear and fair legal framework in the EU. 

“The assumption that not being classified as Novel Food means not being classified at all is simply wrong. Given rules for food, cosmetics, feed and food supplements in the EU already exist, the EIHA appeals to the EU for these rules to be applied to hemp as well. We want a real single market for hemp-derived products like any other agri-crop,” she previously asserted. 

Blossoming NPD
Despite the need for a better regulated CBD sector, NPD in this space continues to blossom. Just this week, consumer seed-to-shelf company Kadenwood unveiled Level Zzz CBD Oil Drops, an all-natural melatonin-infused CBD oil. The launch is the newest addition to the growing portfolio of performance-based personal care products under the Level Select brand. It responds to US consumers’ demand for CBD products to help achieve restful sleep.

Meanwhile, health and wellness company OMID Holdings launched several new hemp-based products including gel caps, bath bombs and gummies. These products are currently available under the Shangri-La and Naturally Peaked brands. Furthermore, the company has engaged with a prominent digital marketing firm, Volume Digital, to improve its marketing reach and expand its social media presence.

Last month, NutritionInsight delved into the latest trends in the CBD space, further progressions in regulatory frameworks and to what extent the sector is affected by the COVID-19 pandemic.

By Anni Schleicher