FDA Seeks Regulatory Framework for CBD


CBD Logo | Image by brandmix/Shutterstock

The U.S. Food and Drug Administration (FDA) has decided to explore new pathways to regulate CBD products.

The FDA made this announcement on January 26 in a statement from Janet Woodcock, MD, the principal deputy commissioner for the FDA.

This announcement also denied three civilian petitions asking the organization to brand CBD products as dietary supplements for marketing purposes. Woodstock announced the FDA rejected these petitions after a review of the CBD-based drug Epidiolex based on studies conducted by the administration and other supplementary sources.

Cannabidiol oil, or CBD, is derived from marijuana but is distinct from THC, the psychoactive ingredient in the drug that produces a high. This oil is already used in multiple products, including foods.

CBD gummy vending machines were added to Grapevine Mills Mall in October 2022, as previously reported by The Dallas Express.

Despite widespread use, Epidiolex is the only FDA-approved prescription CBD oil. It is used to treat two forms of epilepsy.

“Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” said Woodstock. “For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.”

Instead of branding the items as a supplement, the agency has said that it will adopt a new path to regulation for CBD products that “balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”

“A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products,” said Woodcock in the release. She also said that a new path could also provide oversight to animals.

Despite not knowing the extent of consumption that elicits harm, the FDA does acknowledge that CBD poses risks to animals and that people could be exposed to CBD through products from animals with the substance in their systems.

Suggested new risk management tools include clear labels, prevention of contaminants, and CBD content limits, such as a minimum purchase age and keeping the item away from children.

Woodstock said that the FDA will continue to remain vigilant for items that may pose a risk to public health and safety. The Dallas Express requested further information from the FDA but had not received a response at press time.

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