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How well do we understand the benefits, side effects of CBD products?

FDA warns cannabidiol can harm liver, induce lethargy and affect appetite
As cannabidiol, better known as CBD, becomes more widely used in foods and healing products, the U.S. Food and Drug Administration is warning people that little testing has been done on benefits or side effects of CBD products.

Chefs are starting to experiment with this plant in the kitchen. Garment companies are making clothes with it. Contractors are using it to build homes. And the U.S. Food and Drug Administration says it can help treat epilepsy. The plant? Hemp.

“What other plant do you know that can feed you, clothe you, shelter you and make you healthy? That’s what hemp does,” said William Billings, co-founder of consulting company the Colorado Hemp Project.

While hemp has numerous commercial uses, it is cannabidiol – better known as CBD – that is popping up in everyday products and stores across the country, often at marked-up prices. At Sephora, customers can buy 1.69 ounces of CBD-infused body lotion for $60. For the same price, online shoppers can purchase a 12-pack of CBD “enhanced water” from Oki, a CBD oil and beverage company.

Companies often market CBD products as health supplements, claiming CBD can treat ailments such as chronic pain, or even cure cancer.

“We saw a CBD product that claimed it cured death,” said Erica Stark, director of the National Hemp Association. “So, obviously, there’s a lot of ridiculousness going on out there, and this industry needs to be regulated but it needs to be regulated in a reasonable way.”

Dr. Amy Abernethy, the FDA’s deputy commissioner, told the U.S. Senate Agriculture Committee in July that adding CBD to food or marketing a CBD product as a dietary supplement is generally prohibited by the Food, Drug and Cosmetic Act, unless the agency makes an exception.

So far, the FDA has permitted only hulled hemp seed, hemp seed protein powder and hemp seed oil for human consumption. And last year, the agency approved Epidiolex, a CBD-based drug, to treat two forms of pediatric epilepsy.

During clinical studies for Epidiolex, Abernethy said, the FDA found that CBD can have negative side effects. It can harm the liver, induce lethargy and affect one’s appetite, she said.

CBD is derived from the cannabis plant, which produces marijuana and hemp. While marijuana is still illegal at the federal level, the 2018 Farm Bill removed hemp as a controlled substance, effectively legalizing the crop if its THC content doesn’t exceed 0.3%.

But because hemp has been a legal commodity for less than a year, research on CBD’s effects is limited, Abernethy said. She listed about a dozen instances in which the FDA does not have enough data to issue science-based CBD regulations.

“What about situations where CBD is in your morning cereal, you consume a CBD lozenge or you apply CBD skin cream? What if you take these every day, together, for months, or for years?” she said. “What is the risk if you’re pregnant, breastfeeding, a child, elderly, taking other medicines or suffering a major illness? And what about pets and food-producing animals?”

Some studies suggest that CBD may be effective in treating insomnia, chronic pain, anxiety and inflammation, according to Harvard Medical School. But while clinical studies are ongoing, Abernethy said, Epidiolex is the only CBD drug the FDA has approved. Abernethy said the agency has sent warning letters to companies that make unsubstantiated claims that CBD treats cancer, Alzheimer’s disease and opioid withdrawal.

Stark agreed that research needs to be done but suspected the FDA knows CBD is safe since it has already approved Epidiolex. Either way, she acknowledged the immense amount of work facing the agency.

“I don’t envy them, to be honest with you. The industry is huge.” Stark said. “FDA has a big challenge.”

Abernethy leads an FDA working group aiming to help issue and clarify regulations on CBD products such as food, dietary supplements, cosmetics and animal feeds. The group is reviewing medical literature, meeting with governments and engaging trade associations. Though Abernethy didn’t set a deadline for issuing CBD regulations, she said the group will provide a progress report by early fall. One main component the group lacks, she emphasized, is data.

“Throughout, we have asked for any available data,” Abernethy said. “Please send it to us.”

James Marshall is a student at American University in Washington, D.C., and an intern for The Durango Herald.



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