If you’ve been to any type of spa, beauty store, or health food store in the past four years, chances are you’ve seen, if not purchased, a product containing cannabidiol (CBD). The passage of the 2018 Farm Bill removed private hemp products, such as CBD, from the Controlled Substances Act, leading to a flood of CBD products into the consumer market that has a wide variety of ‘health and beauty claims, from pain relief to anxiety reduction. , among many others.
However, these products are being produced and marketed in a largely unregulated manner, slipping through the cracks of the Food & Drug Administration’s (FDA) regulatory oversight. Recent studies by the University of Wisconsin-Madison School of Pharmacy, Johns Hopkins Medicine and the University of Kentucky College of Medicine have found dangerous levels of inaccuracy in the labeling and marketing of these products. Specifically, these studies found that most products were labeled with dramatically incorrect levels of CBD, and that many products even contained undisclosed levels of delta-9-tetrahydrocannabinol (THC), the psychoactive ingredient in cannabis that produces a ” high”.
The UW-Madison study they analyzed various CBD drinks, oils, and other products (such as chocolate bars, honey, and transdermal patches). The researchers determined that among the beverages analyzed (such as coffee, seltzer, kombucha, water, tea, and beer), 78 percent were overlabeled (containing less than 90 percent of the CBD they claimed) and 7 percent were sublabeled (containing 110 percent or more of the CBD they claimed). Of the oils, the researchers found that about a third were properly labeled and another third were unlabeled, with one product surprisingly containing nearly 130 percent of what was stated on the label. Of the miscellaneous products, 67% were found to be overlabeled. THC was detected in 24% of drinks, 55% of oils and 71% of miscellaneous products.
A recent Johns Hopkins Medicine Study It found that of the 105 products tested, only 85 percent had the correct amount of CBD claimed on the label. Of these products, 18 percent were underlabeled and 58 percent were overlabeled. THC was found (within legal limits) in 35 percent of the products; however, 11 percent of these were labeled “THC Free,” while 51 percent made no mention of THC on the label. CBD products that are incorrectly labeled as THC-free can create problems for people undergoing drug testing in the workplace. Despite not being FDA-approved to treat any of these conditions, 28 percent of the products analyzed made therapeutic claims (mostly about pain and inflammation). While “pain relief” may seem like a standard description, it’s a drug claim that requires certain FDA approvals. Pain relief products can contain CBD, but the claim itself must be based on something approved for that purpose. Similarly, 15 percent of the products tested made a beauty claim (eg, reducing wrinkles), which is typically not subject to the same regulatory process as a drug claim, but still requires adequate testing.
Researchers at the University of Kentucky College of Medicine found that nearly half of the products analyzed were mislabeled, with most containing 90 percent or less CBD than claimed.
Gross inaccuracies in CBD product labeling and unsubstantiated claims pose a serious risk to consumer health and violate the fundamentals of marketing, perpetuating consumer mistrust and harming the industry. At least one company has taken matters into its own hands and successfully filed a National Advertising Division challenge to a competitor’s CBD content claim, which it alleged significantly overstated the actual amount of CBD in the product .
There are obvious dangers to people using products with unknown active ingredient levels or unknown psychoactive ingredients. Overdose can cause unexpected side effects and adverse interactions with other drugs. Insufficient dosage may diminish or fail to produce potential therapeutic benefits that consumers may seek. The CBD industry in general will suffer from this, as well as anyone who can actually reap the benefits of CBD.
In particular, the FDA is not unaware of these problems. It advised consumers to be wary of unproven claims after its own tests revealed many products did not contain the advertised level of CBD. However, because CBD is the active ingredient in the prescription anticonvulsant drug Epidiolex, there are significant regulatory hurdles to its use in food or dietary supplements. So far, as a matter of enforcement discretion, the agency has only brought actions against anyone making aggressive drug claims, such as treating cancer and Alzheimer’s. This leaves a huge hole in the regulation of CBD, especially in light of the growing evidence that many products are missing their ingredients. Some states have tried to fill the void with new licensing requirements for CBD products, but class-action lawsuits may be more consequential for CBD sellers in the short term. For example, Curaleaf was sued in May for selling CBD drops that contained THC. The label had no warning about THC, which is required by law in Oregon. While the massive CBD market presents opportunities, the relative lack of a regulatory framework continues to create risk. Until Congress takes action and develops a path for approval and regulation, businesses will continue to struggle with the lack of clarity in this area.