CBD May Be Legal, But Is It Safe?
Few rules require CBD products to be tested for contaminants or how much CBD they contain. Here’s how to stay safe.
Barbara Crouch first realized something was wrong when, on Dec. 7, 2017, she heard from a colleague that several patients had been brought into a Salt Lake City emergency room unconscious, having seizures, or agitated and confused after ingesting a product labeled Yolo CBD. “This looks weird,” Crouch remembers an emergency room doctor saying.
Crouch, who is a registered pharmacist and the director of Utah’s Poison Control Center, also thought it odd. She knew that CBD, or cannabidiol, was a compound extracted from hemp or marijuana plants that was increasingly being used to treat a range of health problems. And she knew that, unlike THC (tetrahydrocannabinol), another compound in cannabis plants, CBD doesn’t get users high or have serious side effects.
“It just didn’t add up,” Crouch says.
So, Crouch says she drove to one of the stores where patients had purchased the product, bought a bottle of Yolo CBD herself, and took it to local law enforcement. The police then had those pills tested, along with other samples collected from patients in the emergency room. To her surprise, the tested products contained a dangerous compound—a synthetic cannabinoid called 4-CCB (4-cyano CUMYL-BUTINACA)—and no CBD at all.
Eventually, with the help of the Centers for Disease Control and Prevention, Crouch and her colleagues determined that 52 patients had been sickened by counterfeit CBD, including 33 by Yolo CBD and the rest by other, unidentified products. Thirty-one people wound up in emergency rooms in the Salt Lake City area
ing a CBD vape pen. Alarmed, the researcher—Michelle Peace, Ph.D., associate professor in the department of forensic science—and her team decided to test the product to see what was going on.
“There was nothing unusual looking about the products,” she says. But her testing showed that, as in Utah, the vaping liquid contained a dangerous form of synthetic cannabinoid. In this case, it was 5-fluoro MDMB-PINACA or 5F-ADB, a compound that can trigger paranoia and panic attacks, increase heart rate and blood pressure, and cause convulsions, organ damage, and even death, according to the Drug Enforcement Agency.
And the test found something else, too: One product contained over-the-counter cough medicine dextromethorphan, which has a reputation, especially in teens, for being able to get users high.
“We were not that surprised by the synthetic cannabinoid, 5F-ADB, since the effects the person had were in line with what other patients have said [with that drug],” Peace says. “But the dextromethorphan was a surprise.” She and colleagues are testing additional samples of the same products now and hope to have results by this summer.
Those may be extreme examples, but adulterated, contaminated, or mislabeled CBD products aren’t isolated occurrences. A 2017 study published in JAMA by researchers at Johns Hopkins School of Medicine and University of Pennsylvania Perelman School of Medicine found that more than two-thirds of the products they purchased online were mislabeled, containing more CBD than listed on the label, less of it, or none at all. The tests also found some CBD products with more THC than listed on the label, sometimes much more.
And, in the last three years, tests conducted by the Food and Drug Administration of CBD products found that many did not contain the levels of CBD they claimed to contain, says Michael Felberbaum, a spokesperson with the agency. The FDA sent warning letters to each. And just last month, the agency and the Federal Trade Commission cited three additional companies—Advanced Spine and Pain (dba Relievus), Nutra Pure, and PotNetwork Holdings—for making unapproved health claims that include, among other things, promoting CBD as a treatment for cancer, Alzheimer’s disease, or diabetes.
As CBD has become federally legal and finds it way into the mainstream—a 2019 Consumer Reports survey found that 26 percent of Americans have tried CBD in the past two years, and two national retailers, CVS and Walgreens, say they plan to sell CBD in a handful of states—having products free of contaminants and containing what is claimed are critical.
“CBD is gaining popularity among consumers, particularly those looking for alternative care products,” says CVS spokesperson Michael J. DeAngelis. The drugstore chain will sell only CBD products tested by a third party to verify they don’t exceed the federal legal limit of 0.3 percent THC, or certain contaminants, DeAngelis says.
But because there are few rules about how hemp-derived CBD products should be tested, online sellers and less responsible retailers could be selling contaminated or even adulterated CBD products. And it can be almost impossible for a consumer to tell the good ones from the bad.
While federal agencies are still working out how to regulate CBD, a few states and the hemp industry itself have taken measures to better assure the safety of legal CBD products. But even then, you may need to remain vigilant, experts say. Here’s what you can do to stay safe.
A Regulatory Grey Zone
There are now hundreds of CBD products on the market, everything from vape pens and tinctures to creams and bath bombs to brownies and cafe lattes.
And there is reason to believe legal, hemp-derived CBD may have some health benefits—the Food and Drug Administration has approved one prescription drug with it, called Epidiolex, to treat epilepsy, and there’s a growing body of preliminary research suggesting CBD may help with other problems, too, from sleep to pain to opioid addiction.
But experts worry that in many cases hemp growers and CBD manufacturers are ahead not just of the scientific evidence but also of the state and regulators tasked with overseeing the safety of foods and dietary supplements.
One reason is the confused and rapidly evolving legal status of cannabis, including hemp, says Sunny Summers, cannabis policy coordinator for the Department of Agriculture in Oregon, which has one of the nation’s longest histories with legalized cannabis.
For most of the past century, the federal government had made little distinction between marijuana and hemp, even though hemp contains very little THC, considering both to be illegal. That started to change in 2014 when Congress passed that year’s Farm Bill, making it easier for states to let farmers grow hemp in test programs. But the language in that law “was so vague that [CBD marketers] said, ‘We can run with this,’” Summers says.
And over the past 12 months, several developments have prompted CBD marketers to run even faster. That included not just the FDA approving the first prescription drug with CBD, in Epidiolex, but also Congress passing another version of the Farm Bill making it legal to grow hemp and to sell derivatives from it, including CBD. The bill also allows each state to regulate hemp and CBD.
Partly as a result of those developments, the CBD market exploded over the past few years, with even more rapid growth expected soon. The Brightfield Group, which tracks the cannabis market, expects hemp-derived CBD sales to multiply from $327 million in 2017 to almost $22 billion by 2022.
Faced with that coming onslaught, state and federal regulators seem to be playing catch-up. The FDA recently clarified that, despite the recently passed Farm Bill and approval of Epidiolex, the agency has still not taken the steps necessary to allow CBD to be used as a food additive or even sold as a dietary supplement. Several states and cities, including New York City, reacted by cracking down, at least temporarily, on shops that sell CBD.
Recognizing the growing confusion and the need to ensure the safety of the growing number of products, the FDA recently announced that it will hold at least one public hearing before the end of the year to inform its regulatory strategy for the compound. But in March, outgoing FDA commissioner Scott Gottlieb, M.D., told Congress that without a new federal law, it could take years for the FDA to determine how to regulate CBD.
In the meantime, there are still no federal testing requirements for legal hemp-derived CBD, says Julianne Nassif, Ph.D., director of environmental health at the Association of Public Health Laboratories, which helps develop guidance for chemical testing for government and industry laboratories. So it could be difficult to know whether legal CBD products contain what’s claimed or aren’t contaminated with potentially harmful substances.
What States Are Doing
As states have legalized the medical and recreational use of marijuana, they have also established guidelines for the testing and sale of those products, Nassif says. That can include checking THC, CBD, and contaminant levels, requiring standardized labels, and restricting sales to state-licensed stores, called dispensaries.
But the CBD marketplace, which mainly uses CBD extracted from hemp, is not as well-developed or regulated, says Jonathan Miller, legal counsel of the U.S. Hemp Roundtable, a group of more than 60 CBD companies in the U.S.
The state-required testing for CBD often focuses simply on hemp while it’s still growing in the field or just after it’s harvested, says Miller, and is meant to simply make sure that the plants have low levels of THC—which means 0.3 percent or less.
A few states require some additional testing. Colorado, for example, requires manufacturers that add CBD to food to check the THC in those products and to keep levels below the 0.3 percent cutoff.
Oregon says growers must test the initial CBD extract of hemp plants—which is later added to consumer products such as tinctures, oil, or edibles—not just for CBD and THC levels but also for contaminants such as pesticides and residue of the chemical solvents sometimes used to extract CBD from hemp.
Vermont plans to go further, planning to develop a program that will test all finished products for CBD, THC, and contaminant levels, says Stephanie Smith, chief policy enforcement officer at Vermont’s Agency of Agriculture, Food and Markets. In addition, the state has plans to establish an official Vermont designation, where hemp products, including CBD, are verified grown and processed in Vermont under conditions that reduce risks from contaminants, among other possible standards.
Two other states—Indiana and Utah—have taken yet a different approach. They require that hemp-derived CBD products sold at retail stores include a QR code or in some cases a website. Snap a picture of the code or follow the link, and you will be taken to information about the product—typically its “certificate of analysis,” or COA, which has the results of testing that the company did on its own, typically showing CBD and THC levels as well as whether it contains any contaminants.
The hemp industry itself is trying to build on companies’ voluntary testing, and other self-regulatory measures, to provide some reassurance about the quality of hemp products and legal CBD.
Two industry groups—the Hemp Roundtable and the Hemp Industries Association—recently initiated a program to offer certified seals to companies that meet specific quality standards. That includes documenting how they are grown, processed into finished products, and tested, says Miller, at the Hemp Roundtable.
As of April 2019, 13 CBD companies have received the Hemp Authority designation. “They’ll be able to put a logo on their products that will indicate to consumers that the products are safe and indicate to law enforcement that the products are hemp, and are legal,” Miller says.
At least one national retailer, CVS, says it will also take steps to reassure consumers about the safety of the CBD products it sells, by partnering with a third-party testing lab, Eurofin. “Only products passing these independent tests [will be] offered for sale in our stores,” says CVS spokesperson DeAngelis.
What You Should Do
Despite those developments, there are still limitations to how CBD products are tested.
For one thing, industry and retail testing of hemp-derived CBD remains largely voluntary. Even then, that testing may reflect only the industry’s minimum standard, and test results are only as accurate as the lab itself, says Nassif at APHL. “A good laboratory will utilize validated methods, have a defined quality management system, and ideally have third-party accreditation or certification,” she says.
Given that, here’s how to have as much confidence in possible in the CBD products you buy:
Consider shopping in a dispensary if possible. If you live in a state that has legalized the recreational or medical use of marijuana, your best bet may be to buy legal CBD products in one of the state’s licensed marijuana dispensaries. That’s because the marijuana marketplace, for now, is more strictly regulated, with clearer standards for testing, than is the market for hemp-based products. While those dispensaries sell mostly products with relatively high levels of THC, typically from marijuana, they may also carry some with very low levels of it, too. And in some states, dispensaries may also carry legal CBD products made from hemp, as in Oregon, according to Summers. Tell the salesperson there, or the “bud-tender,” that you want a product with no or very low THC levels.
Look for the Hemp Authority Symbol. When shopping online or in a retail store, look for a product with this seal. That indicates the company has passed an audit of its manufacturing processes and testing. Although just 13 companies now offer the seal, Miller says more companies have applied and more approvals are expected.
Ask for a Certificate of Analysis. Even without such a seal of approval, all companies that sell CBD should follow a best practice of providing a consumer a COA. Most major sellers will readily offer their COA for each product on their website. But even smaller producers, like Elmore Mountain Therapeutics in Morrisville, Vt., offer it as well.
Choose CBD products from Oregon, Colorado, and soon Vermont. For now, these states require some level of testing of CBD products, providing some assurance about their purity and potency.