FDA says new regulatory pathway is needed for CBD products

The US Food and Drug Administration has announced that, with there being a growing cannabidiol (CBD) market in the US, a new regulatory pathway is needed to manage risks.

What’s more the FDA has that it is prepared to work with Congress on this matter as well as announcing that it is denying three citizen petitions that asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements. 

The Mayo Clinic has noted that CBD products, though often “well tolerated” following human consumption, can cause side effects, such as dry mouth, diarrhoea, reduced appetite, drowsiness.

In addition, the FDA has highlighted that the use of CDB raises various safety concerns, especially with long-term use. It says that studies have shown the potential harm to the liver, interactions with certain medications and possible harm to the male reproductive system.

What’s more, the FDA has said that CBD exposure is “concerning” when it comes to certain vulnerable populations such as children and those who are pregnant.

Explaining that a new regulatory pathway would “benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products”, the FDA has noted that “some 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”.

In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals, according to the FDA.

Currently, the Federation’s existing foods and dietary supplement authorities only provide limited tools for managing many of the risks associated with CBD products. Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive.

“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,” said Janet Woodcock, Principal Deputy Commissioner at the FDA.

“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. “

The challenges of being a CBD business

Woodcock has also explained that CBD also poses risks to animals and has highlighted that 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.”

The FDA has said that it will continue to take action against CBD and other cannabis-derived products in order to protect the public. It has said that it will work in coordination with state regulatory partners when appropriate.

“We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. 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,” concluded Woodcock.