US$5 million for CBD regulation “doesn’t go far enough”, notes natural products body

12 Feb 2020 --- Despite a hazy regulatory landscape, the cannabidiol (CBD) space continues to gather pace in terms of NPD and R&D. Now US President Donald Trump has requested US$5 million, from the FY2021 budget, to regulate the CBD industry to allow the Food and Drug Administration (FDA) to continue enforcing protection laws safeguarding patients and consumers. The money would also provide potential regulatory pathways for products containing cannabis and cannabis-derived compounds.

As the CBD industry is growing, it is imperative to clear the ambiguous regulatory environment for manufacturers to be safe from a legal standpoint and consumers from a health one. Previously, Geoff Freeman, Grocery Manufacturers Association (GMA) President and CEO spoke to NutritionInsight on the matter, deeming the CBD market “the Wild West.” He explained that it is the role of federal agencies to ensure a safe and transparent consumer marketplace. “Without a uniform federal regulatory framework in place, consumers lack the basic information they need to make informed decisions about CBD,” he noted.

The US Natural Products Association (NPA), deemed the Trump administration’s request a step in the right direction. “It is an indication that the FDA has the resources to regulate the industry. However, this does not go far enough to specifically address the issue of setting safe levels of daily consumption for CBD products. Setting a safe level of consumption for CBD products is the best way to move forward with this promising new product while protecting consumers,” notes Dr. Daniel Fabricant, NPA President and CEO.

NPA supports legislation passed by the US House of Representatives that would appropriate US$100,000 for the FDA to perform a Health Hazard Evaluation (HHE) and set a safe level of CBD for consumers to use each day. The process would follow the same precedent as red yeast rice, which allows a natural product to contain a level of a drug ingredient that the FDA has determined to be safe. With the exception of Epidiolex, all CBD products in the US are considered illegal by the federal government.

The US Natural Products Association (NPA) deemed the Trump administration’s request a step in the right direction.“The President’s budget request suggests that the FDA will continue to regulate the use of CBD-containing products. The language uses the phrase ‘continue to support’ and ‘continue to regulate’ throughout, but this misses the mark. Enforcing on label claims alone does not go far enough. Instead, we encourage the FDA to use this new funding to move on to the next phase of enforcement and establish a safe level or threshold of CBD,” notes Dr. Fabricant.

Previously, the NPA led a legislative effort to secure language in the FY2020 House Agriculture Appropriations bill to appropriate US$100,000 for the FDA to perform a Health Hazard Evaluation on CBD and is leading a grassroots effort urging the Senate to act.

Developments in CBD regulations to date
The unclear regulatory situation within the CBD space is causing much confusion in both the industry and among consumers. The US Food and Drug Administration (FDA) has recognized the significant public interest in cannabis and its derived compounds and is working on answering these questions through ongoing efforts including feedback from a recent FDA hearing and information and data gathering through a public docket.

Last month, US Representative Collin Peterson, Chair of the House Agriculture Committee, introduced legislation designed to facilitate the marketing of hemp-derived CBD in dietary supplements. The new bill would also require a study and report from the US Department of Agriculture (USDA) on the regulatory and market barriers for farmers engaged in hemp production. 

The 2018 Farm Bill removed hemp from the definition of marijuana in the Controlled Substances Act and has caused a lot of new CBD-based product development. CBD products are still subject to the same laws and requirements as FDA-regulated products that contain any other substance. The federal agency is focusing its attention on monitoring products making health claims that are virtually unsubstantiated. Other than that, there is no regulation that mandates a significant intervention on CBD products. 

It is the role of federal agencies to ensure a safe and transparent consumer marketplace. So far, one prescription drug product to treat rare, severe forms of epilepsy has been cleared by the agency but the FDA has not approved any other CBD products. Moreover, there is limited available information on CBD, including its effects on the body.

Last November, FDA warned 15 companies for illegally selling products containing CBD, ranging from marketing unapproved new human and animal drugs, selling CBD products as dietary supplements and adding CBD to foods. Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.

By Kristiana Lalou