The U.S. Food and Drug Administration (FDA) has announced it will be creating a new regulatory path for CBD products as current regulations are not suitable.
Safety concerns have been raised regarding risks associated with CBD products such as harm to children and pregnant women, harm to the liver, interactions with certain medications and possible harm to the male reproductive system.
The FDA says that, currently, food and dietary supplement authorities provide limited tools for managing many of the risks associated with CBD products, and that CBD must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive.
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FDA Principal Deputy Commissioner Janet Woodcock, M.D., states in a press release on the day of the announcement: “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.
“The agency is prepared to work with Congress on this matter. Today, we are also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.”
Woodcock notes that the organisation has suggested that risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures such as minimum purchase age,to mitigate the risk of ingestion by children, and could provide access and oversight for certain CBD-containing products for animals.
“The working group, which I chair, has closely examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies both conducted and commissioned by the agency,” state Woodcock.
“Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.
“CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.”
Woodcock concluded: “The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.”