The 2022 omnibus spending bill signed by President Joe Biden Saturday calls on the U.S. Food and Drug Administration (FDA) to set rules for CBD, and asks the U.S. Department of Agriculture (USDA) to review the possibility of increasing the allowable level of THC in hemp plants from the current threshold of 0.3%.
Under a “Cannabis and Cannabis Derivatives” section in the appropriations bill, which is non-binding, FDA is urged to fund the establishment of a regulatory framework for CBD and all other other “cannabis-derived substances.”
Cooperation suggested
USDA should work with the Department of Health and Human Services and the Drug Enforcement Administration to review the scientific basis for the current 0.3% THC barrier for industrial hemp, and suggest an alternate limit, the bill suggests. Hemp stakeholders have urged the limit be increased to prevent their crops from going “hot,” or over the current limit.
FDA is asked to set CBD enforcement policies within 90 days of the package’s adoption. Those policies would be in effect pending the establishment of “a process for stakeholders to notify the FDA of use of CBD in products that include safety studies for intended use per product and makes a determination about such product,” under language inserted by the Senate appropriations committee.
The measure, which is non-binding, also asks the FDA to consider advancing medical research of CBD, and encourages the agency to partner with academic institutions to expand sampling studies of CBD products currently on the market.
Data lacking
In the absence of federal regulations, CBD makers and consumers have been faced with inconsistent rules – or no rules at all – in individual states, creating problems for legitimate CBD vendors and endangering public health.
Producers have long called for the FDA to set CBD rules, with some suggesting the only way to do that is to pass a law requiring the agency to do so.
FDA has said data about CBD safety and efficacy is insufficient, but the agency has done little to help fill in the knowledge gaps between the risks and benefits of using CBD and other cannabinoids.
The FDA is authorized to run clinical trials on human foods, drugs, dietary supplements, food additives, cosmetics, animal foods and tobacco products, but the agency has failed to incentivize CBD studies; nor has the FDA invested in internal CBD research.
The agency has already acknowledged the benefits of cannabis use for seizure disorders with the approval of a single drug, Epidiolex, which has helped patients who suffer Dravet Syndrome and Lennox-Gastaut Syndrome, two debilitating forms of epilepsy. The product, which contains high levels of CBD (100 milligrams per milliliter), was the first cannabis-derived prescription drug to gain FDA approval.
In other provisions in the cannabis section of the 2022 spending bill:
- USDA’s Agricultural Research Services (ARS) is to receive $2.5 million in funding to develop hemp varieties, germplasm, and production systems through research partnerships.
- The USDA Marketing and Regulatory Program will get $1.5 million to support the industrial hemp sector.
- The government’s Financial Conduct Authority (FCA) is directed to support the process of clearing the way to guaranteed loans for hemp producers and businesses.
