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FDA sets out a road to regulation for CBD products

Article-FDA sets out a road to regulation for CBD products

© iStock/Stefan Tomic FDA sets out a road to regulation for CBD products
The US Food and Drink Administration (FDA) recently announced that it will not regulate products containing cannabinoid (CBD) as marketable dietary supplements. How might this decision impact the future of the sector?

In a hit to the sector, on 26 January 2023, the FDA announced a refusal to regulate CBD products following a consumer petition calling for their approval to be marketable as dietary supplements. In a statement, the FDA’s principal deputy commissioner, Janet Woodock, expressed concerns about the long-term safety risks associated with the consumption of CBD.

Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system,” Woodock said.

CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant.

To mitigate the risks surrounding the use of CBD in food and drink products and safeguard consumers from potential harm, the FDA revealed plans to work alongside US Congress to craft a new regulatory pathway for the ingredient. Potential risk management tools may include clear labels, prevention of contaminants, CBD content limits, and measures, such as a minimum purchase age, to mitigate the risk of ingestion by children, Woodock said.

Industry stakeholders call for standardised CBD regulation

To certain food and beverage industry stakeholders who were eagerly awaiting an approval, the recent FDA announcement came as an “extreme disappointment”.

When it comes to the safety of CBD, the FDA gets it wrong. Contrary to the FDA’s continued assertions regarding the safety of CBD, there is clear, established evidence of safety over the years. CBD products have been sold at retail for nearly a decade with no significant safety issues,” Jonathan Miller, general counsel of the US Hemp Roundtable, said in a statement.

© AdobeStock/Kimberly BoylesIndustry stakeholders call for standardised CBD regulation

We therefore see no need for FDA to go through the lengthy, burdensome exercise of establishing a new regulatory pathway for CBD, or other hemp-derived cannabinoids. This action would be unprecedented and is unnecessary given the existing dietary supplement and food pathways provided under the Federal Food, Drug, and Cosmetic Act.

US CBD sector stuck in a legal grey area

For now, the US CBD industry is stuck in a legal grey area as states have differing regulations surrounding what can and cannot be sold. To date, CBD is fully legal in 18 states, and conditionally legal in a further 33 states, according to Forbes. Industry leaders have called for standardisation in regulation across states to protect consumers and producers from deceptive marketing and low-quality standards.

Today’s announcement by the FDA underscores the urgent need for Congress and the Administration to take swift action to modernise federal cannabis policy and regulate CBD and other products appropriately and in harmony with the vast majority of states that have already legalised cannabis in some form,” Aaron Smith, CEO and co-founder of the National Cannabis Industry Association (NCIA), said.