The U.S. Federal Trade Commission will step up its enforcement of advertising claims made by CBD-containing products, an official from the agency warned Thursday.
“This is a space that we are very focused on at this point,” said the FTC official, Keith Fentonmiller, senior attorney, advertising practices. “We’ve already joined with the FDA on warning letters and are now moving into the enforcement space. Expect to see this year some significant enforcement activity for these serious claims.”
Although technically illegal, CBD oil-infused food, drinks and dietary supplements are seeing brisk sales. Many cannabis companies are positioning themselves as mainstream wellness brands. But quite often, the claims made by these firms also veer into treating disease. The U.S. Food and Drug Administration has yet to issue marketing regulations, creating a Wild West-style environment where advertising is concerned.
“The problem is the FDA is slow to act and takes a lot of public comment,” observed Joseph Bondy, a New York-based criminal defense attorney whose clients include CBD companies. “The rules lag behind our needs, and so there’s a lot of hemp-oil hustlers out there.”
Both attorneys were panelists at an event hosted by Good Housekeeping and Prevention, designed to clear up questions and misinformation surrounding CBD – aka cannabidiol, the compound found in hemp and marijuana. As it stands, the emerging field lacks clear answers to many questions, making it hard for brand managers to create content and marketing and, in turn, confusing for the consumer and clinician alike.
By way of example, Stacia Woodcock, PharmD, director of education at the International Research Center on Cannabis and Heath (IRCCH), said at the CBD event that “there isn’t any regulation of what’s in, or what should be in, [a hemp-based CBD product], or that what’s claimed is really in it.”
An important distinction is the amount of THC present. CBD extracted from a plant with more than .3% THC is classified as cannabis; less than that is hemp. Even though they typically contain less than .3% THC, hemp-based products can still affect the brain, Woodcock explained, although probably in a non-intoxicating way.
Some outfits use third-party labs to verify this, she added. “But lab tests are easy for hemp manufacturers to falsify.”
Labeling standards differ from those of the pharmaceutical industry. The dosage amount appearing on CBD bottles refers to the amount contained in the entire bottle, not in each dose. The patient is left to figure out that the capsules in a “300 mg” bottle of 30 pills are 10 mg apiece.
In some ways the hype has outpaced the science, noted Julia Arnsten, MD, MPH, chief, division of general internal medicine and professor of medicine, psychiatry, epidemiology, Albert Einstein College.
Cannabis remains among Schedule 1 controlled substances considered to have high potential for abuse and no medical value. “The reality is that there is inadequate research for the FDA to say that this has medical uses and an acceptable safety profile,” said Arnsten, speaking on the second of two panels at the event.
Why don’t we have great data? “Research in the U.S. on cannabis or marijuana is largely funded by the National Institute of Drug Abuse,” Arnsten explained. “This is largely interested in elucidating harm from illicit substances…not potential benefit.”
She added that although millions of people are now using CBD and getting benefit, “we don’t consider that to be sufficient evidence… The way in which we’re ultimately going to learn about these molecules and how they act is when large pharmaceutical companies get involved and start to isolate the different molecules and do very large-scale studies into which they put billions of dollars to determine these impacts.”
In the meantime, Arnsten said, “Every patient is an ‘n of one’ experiment.”
An FDA official recently told Congress that the agency supports the development of more CBD-derived drugs. The official, Douglas Throckmorton, MD, deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research, said these substances can be evaluated in clinical trials as long as sponsors submit an IND and register with the Drug Enforcement Administration.
The 2018 Farm Bill gave the FDA oversight over CBD. The agency in 2018 approved one CBD-derived drug, GW Pharmaceuticals’ Epidiolex, for two rare seizure disorders. Sales reached $296 million last year, its full year on the market, and are forecast to hit a half-billion dollars this year as the drug picks up additional insurance coverage in Europe.
However, the FDA is still on the fence about issuing regulation for safe marketing of CBD-containing dietary supplements and/or foods. Last July it sent a warning letter to the firm Curaleaf for making unproven health claims related to treating pain, depression and anxiety, among others, prompting Walgreens and CVS to pull it off shelves. In March the FDA and FTC sent joint warning letters to three makers of over-the-counter, CBD-based dietary supplements over claims related to anxiety and fibromyalgia.
September saw the FTC send out three more warning letters, regarding claims for cancer, Alzheimer’s disease and multiple sclerosis. While FTC tends to be more aggressive than FDA in issuing fines and prosecution for advertising violations, it has yet to exercise the full extent of its authority.
“There have been cease-and-desist letters, but not a single case of a product yet being enjoined [by FTC],” Bondy said. “That will become a critically important vehicle for [this] year.”
When asked how the FTC might get involved in enforcement against dietary supplement makers and others, Fentonmiller, the FTC official who specializes in investigating deceptive health-related claims, clarified that it won’t pull product. “That’s more [the province of] FDA,” he said. “But we have the power to get injunctions as far as advertising claims are concerned and to seek monetary redress. Unfortunately, we don’t pre-approve claims or preclear claims. We come in after they are already on the market and try to stop them.”
Addressing the editors and writers in the room, Fentonmiller quipped that the press tends to obsess over FDA’s “machinations and inability at this point to create regulatory clarity in this space.” At the same time, he characterized the FTC as “sort of the little agency that could. Our budget is basically a rounding error in the whole scheme of our trillion-dollar budget.”
FTC, he added, is agnostic to whether the product is a food, drug, dietary supplement, vape, cream, suppository or tampon, or a combination thereof. “However you want to consume it, it doesn’t really matter from our regulatory perspective,” he said. “We are looking at the claims – and if a marketer is making a serious disease claim, that this product will cure a particular disease, that’s a problem, because the science isn’t there.”
Introduction of FTC enforcement action would be a new development in the space, and one welcomed by many. In its absence, the many reputable CBD firms are self-regulating, and the landscape is changing.
“Those companies [engaging in proper manufacturing processes] will be ahead of the game in the long run,” said Bondy. In the meantime, he warned against purchasing from websites that make spurious health claims, buying from places like gas stations or choosing products that lack a certificate of authenticity.
“There’s a little bit of de-selection going on there with choosing your [CBD] branding,” said Bondy. “That will change over the next 12 months.”