Nearly five years after the federal government legalized hemp-derived CBD, the U.S. Food and Drug Administration announced today that it won’t be issuing guidelines for the inclusion of CBD in food and beverages.
Instead, Principal Deputy Commissioner Janet Woodcock said the FDA will work with Congress to develop a “cross-agency strategy” for the regulation of CBD-infused products “to protect the public’s health and safety.”
According to Woodcock, an internal working group concluded that the existing regulatory framework for food and beverages is not appropriate for CBD.
“Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks,” Woodcock said in a press release.
“The agency is prepared to work with Congress on this matter.”
Among the FDA’s concerns are determining whether CBD can be safely ingested every day for a long period of time during pregnancy and how the substance might impact fertility, as The Wall Street Journal reported last month.
Marketing Daily reached out to the FDA for clarity on the meaning of a “cross-agency strategy” but had not heard back by deadline.
“This news isn’t shocking to me,” says Griffen Thorne, an attorney with the Harris Bricken Sliwoski law firm.
“What is shocking is that if they were going to reach this conclusion and it was kind of destined to be this way, why is it only happening now after so many years?
“I think you have to be careful reading this because they’re not saying it’s unsafe. They’re just saying we don’t know if it is safe.”
The FDA’s announcement isn’t likely to surprise many people on Wall Street, who have long expressed doubt that the agency would come up with its own guidelines.
In a Dec. 28 report, Cowen & Company analyst Eric Assaraf said the investment firm was “skeptical that a new regulatory pathway for CBD will be settled any time soon.”
The FDA’s concerns over the ingestion of CBD derive from the 2018 approval of the prescription drug Epidiolex, which contained CBD for the treatment of seizures associated with two forms of epilepsy.
Studies at the time showed a significant potential risk of liver disorder and other side effects from ingesting CBD.
The same year that Epidiolex was approved, hemp-derived CBD containing a maximum of .3% of THC by weight became legal to grow and distribute under the Agriculture Improvement Act—also known as the Farm Bill.
However, because of the Epidiolex approval, the FDA considers food and beverages containing CBD to be unapproved drugs.
In addition to liver injury, the FDA says CBD “can affect the metabolism of other drugs, causing serious side effects” and when used with alcohol or other central nervous system depressants “increases the risk of sedation and drowsiness—which can lead to injuries.”
Even though CBD ingestibles have exploded onto the market, the FDA has chosen to devote most of its resources to going after companies making blatant health claims regarding CBD.
Thus far this month, the agency has issued warning letters to three businesses selling CBD products the companies claim can prevent or mitigate COVID-19.