FDA Issues Consumer Update Claiming CBD Has Harm Potential

The Food and Drug Administration has issued a CBD-focused consumer update claiming that the cannabinoid “has the potential to harm” including negative effects on the metabolism of other drugs, increase risk of sedation and drowsiness when used with alcohol, changes in alertness, gastrointestinal distress, and changes in mood.

The agency also suggests that CBD can damage the liver – a claim made by Greenwich Biosciences representatives during a hearing in June. That claim has been disputed by the CED Foundation, who notes that the mice in the study were given the human equivalent of 42,050 milligrams of CBD, which they called “an unreasonable amount.”

“In the days where many people are taking 10mg pills of CBD per day, the amounts of CBD that were force-fed to these animals in this study, if translated to humans, would be 4,305mg, 12,915mg, and 43,050mg over 10 days, or 17,220mg, 51,660mg, and 172,200mg in one-shot doses.) For reference, these days, most dispensaries sell CBD in doses of 10mg, 20mg, up to 2-300mg.” – CED Foundation in a June 20 blog post.

The FDA also claims that CBD could lead to male reproductive toxicity and that animal studies found a “decrease in testicular size, inhibition of sperm growth and development, and decreased circulating testosterone.”

“Because these findings were only seen in animals, it is not yet clear what these findings mean for human patients and the impact it could have on men (or the male children of pregnant women) who take CBD,” the agency said in the update. “For instance, these findings raise the concern that CBD could negatively affect a man’s fertility.”

The consumer update coincides with the agency sending a round of warning letters to CBD companies who are making health claims about their products. The agency sent similar letters to three U.S. CBD firms in April.

The FDA said in July that the agency would release CBD regulations by the end of the summer or early fall; however, those regulations have yet to be published.

Last week, Senate Majority Leader Mitch McConnel (R) met with the agency commissioner nominee, Dr. Stephen Hahn, to discuss a framework for CBD regulations. McConnell, who was a driving force behind federal hemp legalization, said after that meeting that he is “eager” for the FDA “to create certainty for CBD products.”

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