The FDA Is About to Crack Down on Shady CBD Products
This ‘Wild West’ industry could be facing some law and order
Federal officials are coming for America’s latest health trend. The Food and Drug Administration (FDA) is gearing up to tighten its oversight of cannabidiol, better known as CBD — the non-intoxicating chemical cousin of THC that is marketed as a natural remedy for a wide variety of ailments.
Since late last year, products containing CBD — from pills, oils, and cosmetics to drinks, gummies, and even dog treats — have proliferated across the country. The boom is largely thanks to a change in federal law in December 2018 that legalized hemp, a low-THC variety of marijuana that had previously been categorized with pot and harder drugs like cocaine and heroin. That change opened the door for legal hemp-derived CBD and a market that could explode to $22 billion by 2022, according to the market research firm Brightfield Group.
Now a broad cross section of medical researchers, policy analysts, marijuana industry insiders, and federal regulators are worried that door was opened a little too wide. On June 20, the House of Representatives approved an amendment to a package of upcoming spending bills that directs the FDA to come up with new regulations for CBD products.
The agency was already on it: In May, it hosted an all-day hearing on CBD, where officials grilled dozens of experts about which — if any — of the multitude of claims made about CBD were actually backed by science, and how consumers can be sure about the quality of what they’re getting when they pay for a CBD product. The FDA also fired off a series of menacing letters to CBD-selling companies that the agency claims violated marketing laws. It’s accepting public comments on potential CBD regulation until July 16, and has already received more than 2,700 (many of which sing CBD’s praises). After that, new rules could follow quickly.
“We must sort this out in service of public health,” Amy Abernethy, the FDA’s principal deputy commissioner, said on Twitter after the hearing. “We will work as quickly as possible to define a way forward.”
So is it time to start stockpiling your favorite CBD products before they disappear? Here’s all you need to know about CBD and its future.
Is CBD legal?
This is a very tough question to answer, and can differ based on where you live. “It’s just crazy. It’s the Wild West,” says Daniele Piomelli, director of the University of California-Irvine’s Institute for the Study of Cannabis, describing the legal landscape for CBD.
At the federal level, CBD is now legal to produce when it is derived from legally-grown hemp — not, of course, from marijuana, which remains a Schedule 1 narcotic (meaning the government believes it has a high potential for abuse). The sticking point is how you market it after that. The FDA has made clear that it is not legal to market CBD as a dietary supplement or as a food additive, and that only one CBD-containing product — Epidiolex, which can be used to treat certain rare forms of childhood epilepsy — has been approved as a prescription drug.
“Lettuce is more regulated than CBD. Right now there’s no way to determine what’s good and what’s not.”
But enforcement of those rules has been scarce. Instead, a grab bag of local laws have filled the gap: New York City, for example, is about to implement a ban on CBD in food and drinks. Oklahoma state health officials recently promised to start patrolling facilities that produce CBD. In April, Tampa Bay police arrested a great-grandmother in line at Disney World for carrying a bottle of CBD oil (the charges were later dropped). And at the Dallas-Fort Worth International Airport, confiscations of CBD products by security officers have “skyrocketed.”
Meanwhile, without specific criteria from the FDA for how CBD can and can’t be used, consumers have no way to ensure whether a product they’re buying even contains CBD at all, says Rosemary Mazanet, chief scientific officer of the medical marijuana company Columbia Care.
“Lettuce is more regulated than CBD,” she says. “Right now there’s no way to determine what’s good and what’s not.”
What does CBD actually do?
Because it was federally illegal until recently, CBD has not been easily available to medical researchers, so its physiological effects are still not well understood. It appears to boost the neurotransmitter serotonin, a mood stabilizer, and may stimulate chemical receptors in the nervous system that produce a calming effect.
The strongest evidence for CBD’s effectiveness is in treating certain forms of epilepsy. In a May 2018 study published in the peer-reviewed New England Journal of Medicine, people with epilepsy treated with CBD reported a 40% reduction in seizures, compared to 17% reported by those given a placebo. That study was funded by GW Pharmaceuticals, a British company with offices in California that produces Epidiolex. Steve Schultz, the company’s VP of investor relations, says several other trials have produced similar outcomes, which paved the way for the drug — which is swallowed as a liquid — to be approved by the FDA.
Some other applications are also promising. A growing body of research has found evidence that CBD can be useful in mitigating anxiety and certain psychological disorders, including schizophrenia. Applied to the skin, it may be anti-inflammatory.
“We’re talking about a drug that could really help in certain situations and should definitely be considered seriously,” Piomelli says.
As for the panoply of more ambitious claims sometimes found in CBD marketing — that it can address Alzheimer’s and Parkinson’s, slow the growth of cancerous tumors, help kick addictions, and cure rheumatoid arthritis, among others — the jury is still out.
“That’s not to say that CBD might not have some role in some of these conditions, but the evidence is just lacking at the moment,” says Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California-San Diego. Grant says research is especially vague on what dosages and delivery mechanisms — pill, oil, etc. — are most effective, and what the potential side effects might be: Some studies have shown signs that high doses of CBD could affect liver function.
What’s the FDA’s issue with CBD?
Lyndsay Meyer, an FDA spokesperson, declined an interview request, citing the ongoing public comment period, but said in a statement that “the currently available data leave open crucial questions about whether these products are safe or effective. Our biggest concern is the marketing of products that put the health and safety of consumers at greatest risk, such as those claiming to prevent, diagnose, treat, or cure serious diseases, such as cancer.”
The FDA gave a preview of its position in three warning letters it sent in March, two to CBD product manufacturers and one to a chain of New Jersey pain clinics. All three letters list extensive examples of medical benefit claims made on the companies’ websites and social media that “may not be substantiated by competent and reliable scientific evidence.” The letters also cite products that are marketed as drugs or dietary supplements without FDA approval and threaten that without changes, the FDA will seek a federal court injunction, and may also be able to compel the companies to reimburse customers.
All three websites that received letters appear to have removed the dubious medical claims, although two of the three, Florida-based Diamond CBD and Washington-based CBD Pure, still offer CBD products that are labelled as dietary supplements (neither company responded to requests for comment).
Semantics isn’t the FDA’s only concern. Recent studies have found that many CBD products on the market either misrepresent the concentration of CBD they actually contain — which could be none at all — or contain alarming additives, including synthetic cannabinoids and the cough syrup ingredient dextromethorphan.
“We’re trying to do self-regulation, but without [federal] regulation what’s happening is that smaller shops can mislabel and put whatever they want in there,” says Justin Blehar, a managing partner of California-based CBD producer Genco Pura.
A 2017 study in the journal JAMA sampled 84 CBD products and found that 42% contained more CBD than advertised and 26% contained less. The study also found that one-fifth of the samples contained THC, raising not only a legal problem but also the risk that users could get high unintentionally.
“The name CBD can be used as a marketing ploy,” Daniele Piomelli says, adding that the concentrations of CBD in many commercially available products may be far below the levels that might produce a medical benefit. “The FDA should be much more aggressive.”
What’s next for CBD?
“There’s no doubt that the FDA is going to be fairly strict in the way it regulates these products,” says John Hudak, who researches the cannabis industry at the nonpartisan Brookings Institution.
That process will likely start with manufacturers of CBD products, including more scrutiny of where the CBD is coming from (remember, it’s still illegal to produce from marijuana) and setting an official standard for its purity. The FDA is also expected to introduce maximum concentrations, especially as a food additive. It may facilitate greater access to CBD for medical researchers, in the interest of answering some of the unresolved health questions. And it may choose to pursue more aggressive legal action against companies that step out of line.
The effect of all this, Hudak says, will be to smooth the waters for up-and-coming hemp entrepreneurs who want to invest in high-quality CBD products. So some sketchier CBD products will soon disappear from shelves, he says, and hopefully, be replaced by better legal alternatives.
