USA: FDA refuses to regulate CBD due to safety concerns

The Food and Drug Administration (FDA) has rejected starting the process of regulating CBD in food products, as its safety concerns have not been satisfied. The agency, which drew its conclusions from the Epidiolex drug information, has shown itself willing to move towards robust regulation with the US Congress.

The article has been edited to include reaction from the National Cannabis Industry Association (NCIA)

the FDA announced, in a statement signed by Janet Woodcock, Deputy Chief Commissioner, that a new regulatory paradigm for CBD is needed that balances individuals' desire for access to CBD products with the oversight needed to manage risks. The agency claims to be prepared to work on the issue, but passes the buck to Congress. According to the American regulator, the use of CBD raises several safety concerns, especially in long-term use, which makes the regulation of CBD incompatible with current legislation.

The agency also denied petitions from citizens that asked the agency to conduct the regulation itself that would allow CBD products to be marketed as dietary products. With the decision, the FDA passes the responsibility to Congress, which will depend on the initiative to develop a strategy among the various agencies for the regulation of these products.

FDA reviews risks through Epidiolex bulletin

The FDA argues that a new regulatory strategy is needed that provides consumers with the necessary safeguards and oversight to manage and minimize risks related to CBD products. Some of these risk management tools can include clear labeling, contaminant prevention, limits on CBD percentages and prohibitions, such as minimum purchase age, to mitigate the risk of ingestion by children.

It should be noted that the rampant increase in CBD consumption in the United States (increased from 8% to 26% in 2022), stems from the approval of the Farm Bill, which promoted and boosted the exploitation of industrial hemp and the consequent appearance of these products. Despite this, the agency claims to have drawn on existing literature, as well as the public bulletin for Epidiolex, a CBD-based drug used for refractory epilepsy. Despite the concerns of the FDA about the consumption of CBD by children, the recipients of Epidiolex prescriptions are precisely children (from two years old).

The working group, which closely examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted in the public bulletin, as well as other studies conducted and commissioned by the FDA. Given the available evidence, and knowing that the consumption of CBD is reaching proportions never seen before in the USA, the FDA guarantees that it is not apparent that CBD products can live up to the safety standards for dietary supplements or food supplements.

FDA abdicates creating regulation for CBD

The FDA thus abdicates from proceeding with the creation of rules that allow the use of CBD in dietary supplements or conventional foods, as it does not find adequate evidence to determine how much CBD can be consumed and for how long before it causes harm.

The FDA will continue to take action regarding CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners where appropriate. The agency says it will continue diligently in monitoring the market, identifying products that pose risks and acting within its remit.

disillusioned industry 

The National Association of the Cannabis Industry, showed its disillusionment, through release, with the result of this extended FDA study, which dates back to 2019, but they expect the decision to put more pressure on Congress to sensibly regulate CBD and other cannabis products.

“Today's FDA announcement underscores the urgent need for Congress and the administration to take swift action to modernize federal cannabis policy and regulate CBD and other products appropriately and in harmony with the vast majority of states that have already legalized cannabis. cannabis in any way," said Aaron Smith, CEO and co-founder of the National Cannabis Industry Association (NCIA), who said "moving forward with bipartisan federal cannabis reform this year would be good public health policy and good politics."