Following an exploration of potential regulatory pathways for cannabidiol (CBD) products by an internal Food and Drug Administration (FDA) working group, the FDA concluded on January 26, 2023, that a new regulatory pathway for CBD is needed to provide the regulatory oversight necessary to manage risk. The Agency is prepared to work with Congress on this issue.
Indeed, the FDA has denied three citizen petitions asking the agency to develop rules to allow CBD to be marketed as a dietary supplement.
The working group thoroughly reviewed the studies related to the Epidiolex drug approved in the US for the treatment of seizures associated with two rare and severe forms of epilepsy, the scientific literature, the information submitted to the public file and the studies conducted and commissioned by the agency. It concludes that:
– based on the available evidence, it is not possible to determine how much CBD can be consumed and for how long without harm,
– CBD products may not meet the level of safety required for food ingredients and supplements,
– the Agency does not intend to pursue the development of rules to allow the use of CBD in food or dietary supplements.
The use of CBD raises safety issues related to its long-term use, potential harm to liver, interactions with drugs and possible damage to the male reproductive system. The exposure of children and pregnant women to CBD also needs to be monitored and controlled. Therefore, the use of a new regulatory pathway offering consumers health protection and safety is necessary.
To know more.
Orchidali can organize a regulatory watch for you.
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CBD in the U.S.: Food and dietary supplement status not appropriate
Following an exploration of potential regulatory pathways for cannabidiol (CBD) products by an internal Food and Drug Administration (FDA) working group, the FDA concluded on January 26, 2023, that a new regulatory pathway for CBD is needed to provide the regulatory oversight necessary to manage risk. The Agency is prepared to work with Congress on this issue.
Indeed, the FDA has denied three citizen petitions asking the agency to develop rules to allow CBD to be marketed as a dietary supplement.
The working group thoroughly reviewed the studies related to the Epidiolex drug approved in the US for the treatment of seizures associated with two rare and severe forms of epilepsy, the scientific literature, the information submitted to the public file and the studies conducted and commissioned by the agency. It concludes that:
– based on the available evidence, it is not possible to determine how much CBD can be consumed and for how long without harm,
– CBD products may not meet the level of safety required for food ingredients and supplements,
– the Agency does not intend to pursue the development of rules to allow the use of CBD in food or dietary supplements.
The use of CBD raises safety issues related to its long-term use, potential harm to liver, interactions with drugs and possible damage to the male reproductive system. The exposure of children and pregnant women to CBD also needs to be monitored and controlled. Therefore, the use of a new regulatory pathway offering consumers health protection and safety is necessary.
To know more.
Orchidali can organize a regulatory watch for you.
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