FDA Wants $5 Million Extra in 2021 Budget to Regulate CBD Products

Photo: Pexels

Originally Appeared in Let’s Talk Hemp Newsletter, March 2020
By Steven Hoffman

Even though the production and sale of all products derived from hemp was made legal in the United States under the 2018 Farm Bill, the U.S. Food and Drug Administration (FDA) in November questioned the safety of hemp-derived CBD in dietary supplements and food and beverages, causing disruption and uncertainty in the booming market for CBD and hemp extract products. Additionally, the Trump administration in a 2021 budget plan announced in February it is asking for an additional $5 million in the next fiscal year for FDA to regulate cannabis and its derivatives, including CBD, Hemp Industry Daily reported.

The request for additional funding to regulate hemp-derived CBD products comes shortly after legislation was introduced in January in the U.S. Congress to require FDA regulators to treat hemp-derived CBD as dietary supplements, Hemp Industry Daily reported.

FDA said the extra $5 million requested would help advance regulation of products containing CBD while allowing the agency to enforce the law against companies making unsubstantiated medical claims about the products, according to Hemp Industry Daily. “New funding will enable FDA to better regulate the usage of cannabis-derived substances, such as cannabidiol (CBD), in FDA-regulated products such as dietary supplements and when used as unapproved food additives, FDA said in its budget proposal. “The initiative will support regulatory activities, including developing policy, and continue to perform its existing regulatory responsibilities including review of product applications, inspections, enforcement and targeted research,” the agency said.

Included among the activities that would be supported under FDA's FY2021 budget request would be inspections of facilities manufacturing cannabis-derived products, additional research and funds for processing product-review applications, Natural Products Insider reported. The additional $5 million would be allocated as follows: $2 million for the Office of Regulatory Affairs; $500,000 for the Center for Veterinary Medicine; $2 million to the Center for Food Safety and Applied Nutrition; and $500,000 for FDA headquarters.

Dietary supplement industry trade associations were cautiously supportive of the budget request. “This is a step in the right direction and is an indication that the agency has the resources to regulate the industry. However, this does not go far enough to specifically address the issue of setting safe level 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,” said Daniel Fabricant, Ph.D., President and CEO of the Natural Products Association (NPA).

NPA supports legislation passed by the U.S. House of Representatives that would appropriate $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, NPA said in a statement. According to the World Health Organization, CBD oil is generally recognized as safe.