The U.S. Food and Drug Administration issued a stern warning this week about the potential dangers of cannabidiol, the cannabis-derived compound sweeping the nation.
Commonly known as CBD, the non-psychoactive cannabinoid has been the subject of a wellness craze that has credited it with everything from treating acne and joint pain to cancer and neurological conditions. The CBD movement went mainstream late last year, when Congress included amendments to the Farm Bill to federally legalize industrial hemp and CBD, paving the way for CBD balms, ointments and tinctures to show up on shelves from pharmacies to gas stations. The stuff has even made its way into tampons ("This is Not a Weed Tampon," June 13) and fast food ("The CBD Burger and the Evangelist Editor," April 25) .
The problem, as the FDA notes, is that there is an absolute dearth of science to support claims of CBD's health benefits or even the notion that it isn't harmful.
"The FDA is concerned that people may mistaken believe that trying CBD 'can't hurt,'" the FDA warning reads. "The agency wants to be clear that we have seen only limited data about CBD's safety and these data point to real risks that need to be considered."
First and foremost, the agency warns that CBD can cause liver injury. When the FDA approved a form of CBD for treatment of two seizure disorders in 2018 — the only CBD treatment thus far to get the FDA's seal of approval — the agency identified the risk of liver injury as a concern. But the FDA ultimately determined that if taken under medical supervision, the treatment's benefits outweighed its risks and approved it for use.
"This serious risk can be managed when an FDA-approved CBD product is taken under medical supervision, but it is less clear how it might be managed when CBD is used far more widely, without medical supervision and not in accordance with FDA-approved labeling," the warning states, adding that it found liver damage through blood tests of patients, some of whom weren't taking other drugs known to impact liver function.
Further, the FDA notes that studies of the two CBD treatments approved by the agency also show there is a risk of CBD interacting with other medicines.
"Taking CBD with other medications may increase or decrease the effects of the other medications," the warning states. "This may lead to an increased chance of adverse effects from, or decreased effectiveness of, the other medications. ... We are concerned about the potential safety of taking other medicines with CBD when not being monitored by a healthcare provider."
If all that weren't warning enough, the FDA says studies in lab animals have linked CBD with male reproductive toxicity, including but not limited to a decreased testicular size, inhibition of sperm growth and development and a decrease in circulating testosterone. This toxicity, the FDA warns, was also found in the male offspring of "CBD-treated pregnant females."
The FDA believes there are also just a ton of unstudied questions at this point.
"What happens if you take CBD daily for a sustained period of time? What is the effect of CBD on the developing brain (such as children who take CBD)? What are the effects of CBD on the developing fetus or breastfed newborn? How does CBD interact with herbs and botanicals?" the FDA asks.
These are all good questions, ones that would have been answered already if not for the long-standing folly of federal prohibition. But we are where we are and we don't know what we don't know.
What we do know is there's a lot of anecdotal evidence that CBD is or can form the basis of effective treatments for a range of maladies. But personal anecdotes and clinical trials are very different things. And to hear the FDA tell it, you might want to wait for these trials to come back before making CBD a regular part of your health and wellness regimen.
At the very least, talk to your primary healthcare provider about the stuff before you start slathering it all over your skin, dropping it under your tongue or sticking it in your hamburgers (or anywhere else).
's news editor and prefers he/him pronouns. He can be reached at 442-1400, extension 321, or email@example.com. Follow him on Twitter @thadeusgreenson.