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The U.S. Food & Drug Administration on Thursday called for a new regulatory pathway for cannabidiol, or CBD, the non-psychoactive ingredient in the cannabis plant that is widely held to have wellness properties, and said it’s willing to work with Congress to create one.
The agency said the use of CBD raises safety concerns, in particular regarding its long-term use. It cited the potential harm to the liver, interactions with some medications and possible harm to the male reproductive system.
“We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” according to a statement from Janet Woodcock, principal deputy commissioner, of the FDA. “Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.”
The FDA also denied three petitions by citizens asking it to conduct rulemaking to allow the marketing of CBD products as dietary supplements.
The announcement is expected to further delay action on CBD such as rules around product labeling, given that the U.S. House of Representatives is now controlled by the GOP, which has been less supportive of cannabis and its byproducts. That will likely disappoint the many companies offering CBD in drinks, oils, food supplements and topical creams, who have been waiting for clarity from the FDA.
“The FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products,” the FDA said.
Given available evidence, the FDA said it’s not clear how CBD products could meet dietary supplement or food additive safety standards. The same holds true for CBD in animal products, the FDA said.
In December, The Wall Street Journal reported that the FDA would decide within months on how legal cannabis and cannabis-derived cannabidiol (CBD) should be regulated.
In 2020, the FDA released preliminary guidance on cannabis-related clinical research, outlining how companies seeking approval of drugs that contain cannabis or its derivatives must follow the traditional drug review and approval process involving clinical trials.
CBD has been in a kind of regulatory limbo since the passage of the 2018 Farm Bill that legalized hemp, a raw ingredient to make CBD.
While the bill legalized hemp, it did not legalize CBD, but rather moved enforcement of the substance away from the Drug Enforcement Administration and over to the FDA.
Because the FDA has approved a drug that contains the ingredient — Jazz Pharmaceutical Plc’s
JAZZ,
Epidiolex, a treatment for severe forms of childhood epilepsy—it has told companies that they cannot not add it to food or drink or make health claims for its use in topicals.
Also Read: FDA releases guidelines for cannabis-related research, but CBD will have to wait
“The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate,” said Woodcock. “We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities.”
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