The U.S. Food and Drug Administration “has signaled concern as CBD products started flooding the consumer market in the past year and warned a handful of companies for illegally selling those products in ways that violate federal law,” LNP’s Heather Stauffer reported Wednesday. “Last week the agency got more specific, updating a consumer advisory to say that the compound derived from hemp or marijuana that does not cause a high still ‘has the potential to harm you’ — and issuing warning letters to 15 more companies.” CBD stands for cannabidiol, a compound found in the cannabis plant that does not cause a high. In Pennsylvania, CBD sold to general consumers must be from hemp; only medical marijuana dispensaries may offer CBD from marijuana.
The “potential to harm you.”
Let that sink in for a minute.
Sure, you might think, everything has the potential to cause harm — a car ride, a hard pretzel eaten too quickly, some artery-clogging french fries.
That’s why we need to drive carefully, chew slowly and limit fried foods in our diet.
We need to think carefully about our use of CBD, too.
We shouldn’t use any random CBD product — gummies, teas, tinctures, oils, or in whatever form we find it at our local gas station or convenience store.
This is what FDA Principal Deputy Commissioner Dr. Amy Abernethy said: “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ ”
“Aside from one prescription drug approved to treat two pediatric epilepsy disorders,” she continued, “these products have not been approved by the FDA, and we want to be clear that a number of questions remain regarding CBD’s safety — including reports of products containing contaminants, such as pesticides and heavy metals — and there are real risks that need to be considered.”
One more thing: According to the FDA, it is currently “illegal to market CBD by adding it to a food or labeling it as a dietary supplement.”
Here’s some of what is known about CBD, according to the FDA: It can cause liver injury. It can affect the metabolism of other drugs, causing serious side effects. It can cause gastrointestinal distress, most commonly diarrhea. And it can cause mood changes, most commonly irritability and agitation.
The unknowns are far greater, and, as Stauffer reported, they include: “the effects of taking it daily for long periods of time, how it affects developing brains, how it interacts with herbs and botanicals, and whether it could negatively affect a man’s fertility.”
As a Harvard Medical School publication pointed out last month, “There are a lot of extravagant product claims out there about the benefits of CBD … but little high-quality research supports them.”
Indeed, CBD products are marketed as remedies for everything from anxiety to chronic pain. But as physicians Rose McKeon Olson and Eve Rittenberg wrote on the Harvard Health Blog, there are no “rigorous studies and long-term data to prove whether or not a wide range of CBD products are safe for everyone.”
And because “CBD products aren’t regulated by the FDA in the way that drugs are, there is huge variation in quality and, quite possibly, safety.”
Some manufacturers of CBD products say they welcome more regulation.
Among them is Floyd’s of Leadville, a Colorado-based CBD company founded by Lancaster County native Floyd Landis. As Stauffer reported, Floyd’s products, “ranging from creams to gummies to drinks, are sold in stores including Rutter’s and Sheetz.”
Jake Sitler, director of business for Floyd’s, said the company — seeking to get into major retailers — has embraced the need to do everything by the book and self-regulate as the industry develops.
Self-regulation is inadequate.
As reader Drew William Anderson commented beneath Stauffer’s article on LancasterOnline, the article should have been headlined: “Lack of FDA regulation increases chances of unsafe CBD products.”
He’s right, of course. CBD ought to be regulated — and more thoroughly researched.
Olson and Rittenberg noted that the reason that medical research on CBD is so thin is “partly because laws on marijuana made it difficult to study.”
We hope to see this change in the future.
In the meantime, buyer beware — and be proactive: Check with your physician before you use any CBD product. Your physician can help you decide whether it’s worth the risk.
If you think trying CBD can’t hurt, you may be wrong.
And if a manufacturer or seller tells you with certainty it won’t hurt you, be skeptical. CBD is certainly not a sure bet.