Happi Staff02.11.20
President Trump has requested $5 million dollars to regulate the CBD industry in its new FY2021 budget. 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. 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 US 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.
Not Enough?
“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,” Fabricant added.
On Oct. 17, 2019, NPA published a poll that shows 70 percent of registered voters believe the FDA should have already established safety standards for CBD products. Recently, NPA led a legislative effort to secure language in the FY 2020 House Agriculture Appropriations bill to appropriate $100,000 for the FDA to perform an HHE. The association continues to urge the Senate to act.
“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 US 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.
Not Enough?
“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,” Fabricant added.
On Oct. 17, 2019, NPA published a poll that shows 70 percent of registered voters believe the FDA should have already established safety standards for CBD products. Recently, NPA led a legislative effort to secure language in the FY 2020 House Agriculture Appropriations bill to appropriate $100,000 for the FDA to perform an HHE. The association continues to urge the Senate to act.
