FDA Says CBD Products Run ‘Real Risks’

Such times are ours that the cannabis industry’s bete noir at the federal government is not the cops at the Drug Enforcement Administration, but the scientists, researchers and policy wonks at the Food and Drug Administration.

The FDA is tasked with ensuring the marketed, for-profit products Americans eat, drink, and put into their bodies are safe. Lately, they haven’t been doing this — not with JUUL devices and other e-cigarettes supposedly hooking a “new generation” of teens on nicotine — and not with products containing CBD, or cannabidiol.

The FDA has been on notice to regulate products containing CBD at least since CBD of dubious provenance started turning up in cosmetics, coffee, pet treats and patent-medicine-like heal-all potions. While the FDA has done a decent job of policing at least some of the least-honest companies using false, baseless, or misleading medical claims to push their CBD products on a credulous public, on Monday the FDA also issued an updated consumer warning, in which the FDA said that CBD could be very, very bad.

FDA is quickly working to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD. We’re doing this in line with our overarching approach like for any other substance FDA regulates. https://t.co/dlxQ8Fmk0t

— Dr. Amy Abernethy (@DrAbernethyFDA) November 25, 2019

Users of CBD products run “real risks,” Dr. Amy Abernethy, a physician and the FDA’s principal deputy commissioner, said in a statement. These risks include “potential liver injury, interactions with other drugs, drowsiness, diarrhea, and changes in mood” as well as — deep breath! —  impaired sexual behavior in males. CBD products may also carry risks for “vulnerable populations” like children and women who are pregnant or breastfeeding.

On Monday the #FDA said “some of the available data raise serious concerns about potential harm from #CBD,” including liver injury, drowsiness, diarrhea and changes in mood, and raised questions about its impact on children and pregnant or breastfeeding women.” via @KristineOwram https://t.co/PmXS0XNX9Z

— Grace Maral Burnett (@BurnettGraceM) November 26, 2019

Since CBD is addictive for both a public eager to find the next new cure-all as well as the news media, many mainstream outlets including Good Morning America repeated the FDA’s new claims verbatim. Which is too bad, because what the FDA did was misleading at very best.

New CBD concern; FDA worried people mistakenly believe it won’t hurt them. @DrJAshton has the latest. pic.twitter.com/WLJKcLUgBc

— Good Morning America (@GMA) November 26, 2019

The FDA is absolutely right to say that CBD products’ efficacy require more research, testing, and verification. CBD might do a bunch of things, research indicates; the threshold for guaranteeing that it does these things has not yet been met. The FDA is also very right on when it says that various products might not have the amount of CBD advertised and might also be contaminated with pesticides, heavy metals, or other adulterants. If it had stopped at “buyer beware; this stuff might be bunk” all would be well, but the FDA appears to have overstated its case and overstepped its bounds when claiming that CBD products have the ability to cause harm.

Probably the worst misleading claim is the FDA’s supposition that CBD can cause liver injury. The basis for this claim was the FDA’s review of Epidiolex, the CBD-based pharmaceutical drug used to treat a rare and heretofore incurable form of childhood epilepsy. Too much Epidiolex, or Epidiolex taken at the same time as other drugs, caused harm to the liver detected through blood tests, the FDA found. The thing is that Epidiolex is a concentrated CBD solution. It bears as much resemblance to CBD products on the market as a bumper car does to a Ferrari.

To ingest as much CBD as one could do on an Epidiolex binge with over-the-counter products might require drinking several bottles of oil or eating an entire package of gummies. “Don’t eat so much CBD that it will sicken you” is a much different message than “CBD could f*ck you up!” but that’s what we got from the FDA.

“The FDA is desperately, and disingenuously, seeking harm,” said Martin A. Lee, a researcher and founder of Project CBD, which has been spreading awareness of the cannabinoid for more than a decade.

“There is not a single published peer reviewed study that shows that CBD — at any dose — is harmful to humans who are not taking another drug,” he told Cannabis Now. “Harm appears only in cases when a person is taking high amounts of a potent anti-epileptic drug that has a toxic profile of its own.”

“That doesn’t mean that CBD is perfectly safe, it just means that the FDA’s latest anti-CBD PR binge is not based on science,” he added. “The greatest harm that CBD can cause is anorexia of the wallet, as one would needlessly spend a lot of money purchasing and consuming the large amounts of CBD that the FDA falsely claims is harmful.”

The FDA ought to have known that any such warnings on cannabis-related products needed significant detail and qualification in order to be properly understood. The FDA is also stuck in the same circular-logic vortex with regards to doing its job and regulating: there isn’t enough science, and so there isn’t enough information to say what’s safe. Yet somehow there’s enough to say what might be unsafe? But there is a hidden bonus in this steaming pile, as many observed: at the least, the FDA admitted that CBD does something.

TELL US, have you tried CBD?