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Last August, Erin Gilbert’s organs began to shut down. First her lungs, then her kidneys and liver. Medical staff at the hospital in Miami, where she had been airlifted, struggled to keep her alive. Just days earlier, Gilbert—a 35-year-old mother of three—had used her first CBD (cannabidiol) vaping product, a mango-flavored oil she says she purchased where she lives in St. Croix, U.S. Virgin Islands, according to a lawsuit filed in September.
CBD is a nonpsychoactive compound found in cannabis plants, which include hemp and marijuana, that is often used to ease anxiety, insomnia, and pain.
It’s now legal in the U.S.—thanks to legislation passed in 2018 that allows farmers to grow hemp and extract derivatives such as CBD from it—as long as the product contains no more than 0.3 percent THC (tetrahydrocannabinol). That’s the compound in cannabis that can get a person high when taken in larger amounts.
Gilbert had been vaping CBD for just four days when she developed a fever, shortness of breath, cough, vomiting, and diarrhea, and went to a St. Croix emergency room. There she went into acute respiratory failure and had to be moved to Miami, according to legal documents in her ongoing lawsuit against multiple defendants, including the alleged maker of the CBD product, JustCBD. But Gilbert’s condition worsened, and as her organs shut down, her blood became toxic. Serious clots restricting blood flow formed in her legs, both of which had to be amputated, the suit alleges.
Gilbert’s lawyers said that neither they nor their client would comment on the case at this time. Terry Fahn, a spokesperson for JustCBD, told CR that the company does not sell products in the U.S. Virgin Islands and that it “has received numerous reports of counterfeits” and it believes that Gilbert’s injuries may have stemmed from “using a counterfeit product illegally sold through the black market.”
The risks of vaping have garnered a lot of attention since last August, after the Centers for Disease Control and Prevention linked the products to a mysterious outbreak of more than 2,600 lung illnesses so serious that people had to be admitted to the hospital. Sixty people have died. The CDC says several thousand more people have probably been admitted to emergency rooms with complaints related to vaping.
The CDC traced many of the hospitalizations back to vitamin E acetate, used to dilute oils used in vaping. The vast majority of the illnesses involved products that contained nicotine or THC, especially those purchased illicitly, says Brian King, Ph.D., chief science officer with the CDC. After initially warning consumers to avoid all vaping products, on Jan. 17 the agency limited that advice to THC vape pens, especially those obtained from family, friends, online, and illicit dealers─because growing research found “a strong link between these products and the lung injuries,” King says.
But in at least 26 of the cases, people—like Gilbert—were hospitalized after they reported vaping only CBD, and more people probably went to the ER. In addition, many doctors, scientists, government officials, and even industry representatives remain concerned about vaping, especially CBD, for several reasons.
For one thing, beyond the dangers of vitamin E acetate, little is known about the long-term effect of inhaling several other chemicals often found in vaping oils, says Michelle Peace, Ph.D., a toxicologist and associate professor in the department of forensic science at Virginia Commonwealth University in Richmond who has studied and tested vaping oils.
For another, the devices themselves, when heated, can cause a chemical reaction in the vapor, posing further risk to the lungs—one reason the American Lung Association cautions people away from all vaping devices, says Erika Sward, national assistant vice president for advocacy at the association, which has long urged people to not vape at all.
Finally, there is little regulatory oversight of CBD in general and vaping it in particular. The FDA—which oversees tobacco products, including vaping ones—has not yet determined how it should regulate CBD vaping products.
The CBD industry has called for more FDA oversight, says Jonathan Miller, general counsel for the U.S. Hemp Roundtable, which represents CBD manufacturers and funds the industry’s certifying group, called the U.S. Hemp Authority. While the FDA provides some guidance on dietary supplements, foods, and cosmetics, it does not offer similar oversight of vaping products, he says. That lack of regulation on vaping prevents the U.S. Hemp Authority from certifying CBD vape oils, as it does for CBD topicals, tinctures, and edibles.
All those concerns take on added urgency now as the popularity of CBD continues to grow, and vaping remains one of the most popular ways of using it. Sales of CBD overall are expected to nearly triple in the next five years to $1.6 billion, according to the Brightfield Group, which tracks the CBD industry. And nearly a third of Americans who tried CBD in the past 24 months—an estimated 20 million people—said they vaped the substance, according to a January 2019 CR nationally representative survey of more than 1,000 U.S. adults. Even after the lung-injury crisis made headlines, fewer than a quarter of people who vape CBD said they changed their habits, according to the Brightfield Group.
Here’s what concerns experts the most.
While vitamin E in bootleg vaping products appears to be the main culprit in most of the reported injuries and deaths, there are other substances, even in legitimate vaping oils, that also raise concern.
Manufacturers sometimes add a solvent to an oil to make it inhalable by vape pens, the battery-powered devices that heat and vaporize the oil, says Neal Benowitz, M.D., a cardiologist and toxicologist at the University of California, San Francisco, who has studied cigarette smoking, cannabis, and vaping.
Two common ones are propylene glycol and vegetable glycerin, though manufacturers sometimes also use polyethylene glycol and what’s known as medium chain triglycerides (MCTs), such as coconut oil.
The long-term effect on human health of repeated use of these solvents is virtually unknown. There have been few animal or human studies on the safety of propylene glycol or vegetable glycerine when inhaled, especially long-term, according to a 2018 National Academies of Sciences, Engineering, and Medicine (NASEM) report.
Still, manufacturers use some solvents that the FDA had given a GRAS (“Generally Recognized As Safe,”) designation, Peace says. “But the chemicals were only considered safe by the FDA to ingest into your digestive tract, and have not been deemed safe to inhale into your lungs,” Peace says.
In fact, the FDA does not maintain a list of chemicals that are safe to inhale. “GRAS is a standard that applies to food,” says Stephanie Caccomo, an FDA spokesperson. “The FDA does not have a GRAS standard for tobacco products and/or ingredients.”
That’s a problem for CBD manufacturers, says Miller from the U.S. Hemp Roundtable. Without an FDA-approved list of substances that can be used in vaping, they’re on their own to figure out what chemical combinations work best. “Bad actors seize this gray area of regulation and can put out products solely to make a profit and without concern about public health or safety,” Miller says.
In addition to the solvents in vape oils being potentially dangerous by themselves, the byproducts that can be created when the solvents are heated to high temperatures are also dangerous. For example, heating propylene glycol can create formaldehyde, a known carcinogen, and acetaldehyde, a possible carcinogen, both of which are also present in cigarette smoke, Benowitz says.
Heating polyethylene glycol may create more of those two harmful chemicals than propylene glycol, vegetable glycerin, or MCTs, according to a 2017 study in the Journal of Alternative and Complementary Medicine. The study authors note that with just a single inhalation from a vape oil containing polyethylene glycol, a person’s intake of formaldehyde would be nearly the same as smoking an entire cigarette.
That’s not all. The device’s coil, when heated, can leak trace amounts of other dangerous compounds into the oil—primarily nickel and chromium but also arsenic, lead, and manganese, according to a 2018 Johns Hopkins Bloomberg School of Public Health study.
How much gets released depends on several factors, says Sward, at the American Lung Association. “Ultimately, what is inhaled into the user’s lungs can depend, based on the device used, its voltage, and even its temperature.”
The FDA has acknowledged the risks posed by chemicals leaking from vaping coils. When asked by CR what it was doing to address the problem, agency spokesperson Caccomo said that starting in 2020, manufacturers of new tobacco products, including vape pens, will have to submit applications and that the FDA will review the products’ components and toxicological profiles, and how they are manufactured.
But those new rules would apply only to tobacco vape products, not those that contain CBD.
Unstudied Flavor Additives
While there are more than 7,000 flavorings that can be added to CBD and other vaping oils, little is known about their safety, according to the NASEM report. In some cases the flavoring agents aren’t even listed in a product’s ingredients list. And like the solvents, the flavorings have not been cleared by the FDA for inhalation.
To address the possible danger—and because flavors such as fruit and mint might attract children and teens—the FDA recently banned flavorings except menthol and tobacco in most nicotine vaping products. The agency will now require manufacturers to provide evidence that their flavor additives are safe to be inhaled before they can be marketed and sold.
But again, because the FDA does not yet regulate CBD vaping, the ban does not apply to CBD products.
Easy Access for Teens
Among the more than 2,000 lung injuries reported with vaping overall, roughly 12 percent were in people under the age of 18. It’s unclear how many of those injuries were related to CBD-only products. But it is known that 214 of the reported lung injuries were in people who used CBD combined with either THC or nicotine, and that 16 of those were in children under 18.
Partly to reduce that risk posed by vaping, in December President Donald Trump signed legislation to raise the federal minimum age to purchase any tobacco product, including nicotine vapes, to 21, up from age 18. But, again, the new age rule does not apply to CBD vape products, which the CDC’s King says varies by state.
That’s troubling because many believe that any kind of vaping—whether THC, nicotine, or CBD—may be harmful for the development of teens or young adults.
“Youth lungs are especially susceptible to the damaging chemicals that can permanently alter their bodies,” says the ALA’s Sward. And nicotine products fundamentally alter brain development, according to the Surgeon General. The damage is not just for lung health but for brain development up until about age 25.
Read more about the other forms of CBD, such as creams and tinctures, that might not pose the same risks.
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