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FDA seeks new regulatory framework for use of CBD products

The FDA plans to develop a new regulatory framework with Congress to ensure the safe use of CBD products.

A selection of assorted cannabidiol oil products. Credit - Jeoy Pena, CC SA 4.0.
A selection of assorted cannabidiol oil products. Credit - Jeoy Pena, CC SA 4.0.

The FDA plans to develop a new regulatory framework with Congress to ensure the safe use of CBD products.

It has been four years since Congress legalized hemp, spawning a nearly $6 billion vast unregulated market for cannabidiol-infused beverages, gummies, and lotions. The FDA on Thursday said it lacks the authority to regulate such products, reports the New York Times.

The federal agency is now calling on Congress to give it a stronger regulatory framework to address the health claims and safety concerns that have dogged the prolific CBD industry. Current safety standards for supplements and additives don’t work for cannabidiol, the FDA said.

We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” FDA Principal Deputy Commissioner Janet Woodcock said in a statement, according to WebMD.

“The use of CBD raises various safety concerns, especially with long-term use,” Woodcock said in the statement. “Studies have shown the potential for harm to the liver, interactions with certain medications, and possible harm to the male reproductive system.”

Unlike tetrahydrocannabinol, or THC, the cannabis component that gets users high, CBD is not psychoactive. But there is little data to back up marketing claims that CBD can prevent diabetes, soothe anxiety or ease menstrual cramps.

Dr. Woodcock said an internal committee that she led at the agency was concerned about the overall paucity of scientific literature on CBD and that some research suggested long-term use might be associated with liver toxicity and damage to men’s reproductive systems.

Also unclear, she said, was whether CBD was safe for pregnant women and children. “For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” she said.

The FDA generally hasn’t done much to enforce rules regarding CBD, Reuters reported. Instead, the organization has focused on food and beverage products that make unproven health claims.

CBD products also can’t meet safety standards for substances in animal food, the FDA said, and it will not give new rules allowing it to be used in animal food.

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