The subject line of the PR email in my inbox promoted “CBD products to help prevent Covid infection. Launched in mid-January by Houston-based CBD company Hometown Hero, the 30 milliliter tinctures contain 600 milligrams of cannabigerolic acid (CBD-A) and cannabidiolic acid (CBD-A), acid precursors found in live cannabis plants that turn into CBD when heated or burned.
“Hometown Hero is honored to provide a product that can help the world get through these difficult times,” said Lukas Gilkey, the company’s CEO in a Jan. 19 press release.
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The product launch came just one week after a scientific revelation out of two Oregon universities that the very cannabis acids in Hometown Hero’s products have the ability to glom onto the SARS-CoV-2 spike protein and prevent its entry into human cells. The findings were published in the peer-reviewed Journal of Natural Products, the brainchild of a devoted team of researchers who faced an uphill battle for federal funding, Motherboard has previously reported. But Hometown Hero’s advertising is emblematic of what scientists feared would happen when their research hit the mainstream, despite their insistence that more research is needed and that cannabis-derived products are no substitute for vaccines.
“When we heard about their promising effects and rarity, we immediately stepped up to make sure that CBDA and CBGA would be accessible to the general public,” Gilkey continues in the release. “We believe this product can have a massive positive impact.”
The Oregon research does point to the possibility that cannabis acids could one day be developed into an oral dose administered to prevent COVID-19 infection. Another study out of the University of Chicago identified a negative correlation between prescribed CBD intake and COVID-19 positivity on a sample of 1,212 real patients. But these findings have yet to be tested via human clinical trials, without which they are only promising data points to justify the need for further research on dosage, side effects, and proper administration. Without further investigation, any advertising that a cannabis product can, with certainty, prevent COVID-19 infection, is premature and misleading.
“Many of these advertisements that say that it may have this effect, they may quote a study that is indeed an attractive hypothesis, it could be attractive hypothesis,” said Theodore Witek, professor at the University of Toronto Institute of Health Policy, Management and Evaluation, author of a December study on false advertising in the wake of COVID-19. “I don’t disregard good science, but it does not mean that the drug is proven to be safe, effective.”
The eventuality that their research be used to justify incorrect—and potentially unsafe—advertising, is one that Dr. Richard van Breemen, first author on the paper, and researchers of similar studies that have come out in its wake, have feared.
“What we don’t want, as it’s happened with some other drugs, is a run on the FDA-approved drug, or as I said, people just running out and thinking I can take CBD, and then I don’t have to get vaccinated or I don’t have to be masked,” Dr. Marsha Rosner, professor in the Ben May Department for Cancer Research at the University of Chicago and first author on the paper that looked at real patients taking CBD, previously told Motherboard.
Regulators at the U.S. Food and Drug Administration and Federal Trade Commission have had to crack down on false advertising related to a range of products over the course of the pandemic, even before the current slate of research was released. Some actions concerned ivermectin and hydroxychloroquine, but cannabis, too, has become the subject of enough false COVID prevention advertising that regulators have had to issue a slew of warning letters and orders to fraudulent advertisers.
“The FDA has issued numerous warning letters to companies illegally selling cannabis-related products that claim to prevent, diagnose, treat or cure serious diseases, including COVID-19,” a spokesperson for the agency told Motherboard by email. “We are actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. The FDA is exercising its authority to protect consumers from firms selling unapproved products and making false or misleading claims, including, by pursuing warning letters, seizures, injunctions or criminal prosecutions against products and firms or individuals that violate the law.”
“This has been a long-running issue with CBD,” reporters Nicholas Florko and Andrew Joseph wrote in health news outlet STAT News on Tuesday. All CBD products, including those marketed for COVID-19, must go through the FDA’s regulatory process to be able to position themselves as safe, effective treatments. But “few companies have been willing to invest the time and effort needed to actually get a CBD drug through the regulatory odyssey,” the authors write. “Instead, most market their products as dietary supplements in hopes that the FDA will not crack down on their individual products.”
The Food and Drug Administration did not offer comment to Motherboard about the possibility of a new wave of premature advertising for cannabis compounds as prevention or treatment for COVID-19. Instead, a spokesperson highlighted a series of warning letters around fraudulent marketing for products containing cannabis and products that wrongfully claim to treat coronavirus. Some hit on both.
Cannabis scientists, for their part, are left with the fear that their legitimate and hard-earned scientific discovery could fuel misinformation or mean little more than a cash cow for an industry prone to dubious advertising claims.
For his paper published in the Journal of Cannabis Research, Witek and his research team identified 130 warning letters the FDA’s Center for Drug Evaluation and Research issued for promotional violations between March 6, 2020 and August 30, 2021. These letters were delivered to companies that promoted unapproved products, made claims without scientific substantiation, and misbranded their offerings, the paper notes. The most frequent subject of violation, present in 11 per cent of FDA warning letters, was cannabis.
To date, there is only one FDA-approved cannabis derivative on the market, the paper reads, approved for medical use in the treatment of epilepsy. This approval process is vital for safe use, Witek says, to stamp out side effects and identify possible harms.
“When you sell cannabis, you’ve got to do release testing and issues of the presence of pesticides and all this is all very important,” Witek said of the regulatory gauntlet inherent in receiving FDA approval. “You’re rolling dice that your benefit is going to help weigh the risks and in fact, many of these advertisements don’t even speak of any risks.”
It makes sense that amid a period of global uncertainty, individuals would cling to what they know for comfort, or the illusion of a cure, Witek says. This has pervaded most public health crises throughout history, his paper notes: “Red treatment,” or surrounding oneself with red, was said to treat smallpox, and smoking tobacco was said to cure the bubonic plague.
“Given the devastation of illness from COVID-19 and the uncertainties surrounding its pathogenesis and presentations, it is understandable that the public, clinicians, and other stakeholders may be more open to atypical modalities for prevention and treatment, even forgoing usual scientific rigor,” the paper reads. “Nevertheless, proper public health practices must overtake misguided enthusiasm.”
The immediate aftermath of a short period of profound scientific discovery has paved way for more than just Hometown Hero to latch onto a glimpse of good news. On Jan. 19, for example, a website called 101 Hemp, the self-described “largest global maker of raw CBGa and CBDa products,” issued a press release celebrating van Breemen’s research, new insight that CEO Justin Benton said was evidence of the broader health merits of hemp.
“Those of us in the industry have long known the beneficial properties of raw hemp–my own child has been treated with hemp products to help overcome an autism diagnosis,” Benton said in the press release. (There is peer-reviewed evidence that CBD can calm symptoms of autism, but, to date, there is no evidence that cannabis “cures” autism.)
In an email to Motherboard, a spokesperson for 101 Hemp underscored their excitement to see more research come out of van Breemen’s work.
“Everyone should know that these research studies are in their preliminary laboratory stages that show the potential benefits of these hemp cannabinoids for use with COVID, but are not fully researched with successful human clinical trials focused on effectiveness and clinically documented dosages,” the email read.
“We’re extremely gratified and relieved to see that the scientific community is really digging into the potential for hemp products to help fight other diseases like COVID-19,” Benton continued in the release. “Based on a poll that we recently ran, 100% of our participants agree, voting ‘Yes,’ that they would be willing to take CBDa and CBGa on a daily basis after reading this latest research out of Oregon State.”
The latter is not something even van Breemen would advise yet: In a previous interview with Motherboard, he called his findings a “basic science discovery,” one that could “eventually” lead to a product that is safe to use. But he cautioned that a follow-up study to identify dosage was vital. Until then, the vision of hemp as a treatment for COVID-19 is just that: a vision, albeit a promising and exciting one that deserves more careful investigation.
Hometown Hero did not respond to Motherboard’s request for comment.