02.11.20
The White House’s $4.8 trillion budget proposal for FY2021 includes a request of $5 million to regulate the CBD industry, according to the Natural Products Association (NPA).
Specifically, the request would “allow the Food and Drug Administration (FDA) to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways…for products containing cannabis and cannabis-derived compounds.”
“This is a step in the right direction and is an indication that the agency has the resources to regulate the industry,” said Daniel Fabricant, PhD, president and CEO. “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.”
NPA said it 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. According to Fabricant, 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 U.S. are considered illegal by the federal government.
“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,” added Fabricant.
Specifically, the request would “allow the Food and Drug Administration (FDA) to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways…for products containing cannabis and cannabis-derived compounds.”
“This is a step in the right direction and is an indication that the agency has the resources to regulate the industry,” said Daniel Fabricant, PhD, president and CEO. “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.”
NPA said it 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. According to Fabricant, 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 U.S. are considered illegal by the federal government.
“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,” added Fabricant.