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If you have been to any kind of spa, beauty supply store or
health food store in the past four years, chances are you have
seen, if not purchased, a product with cannabidiol (CBD). The 2018
passage of the Farm Bill removed hemp-deprived products, like CBD,
from the Controlled Substances Act, leading to a flood of CBD
products to the consumer marketplace that boast a wide variety of
health and beauty claims, from relieved pain to lessened anxiety,
among many others.
However, these products are being produced and marketed in a
largely unregulated fashion, falling through the cracks of Food
& Drug Administration (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 have
found the majority of products were labeled with dramatically
incorrect CBD levels and many products even contained undisclosed
levels of delta-9-tetrahydrocannabinol (THC), the psychoactive
ingredient in cannabis that produces a “high.”
The UW-Madison study analyzed beverages, oils and
other miscellaneous CBD products (such as chocolate bars, honey and
transdermal patches). Researchers determined that among the
beverages analyzed (such as coffee, seltzer, kombucha, water, tea
and beer), 78 percent were over-labeled (containing less than 90
percent of the CBD they claimed to) and 7 percent were
under-labeled (containing 110 percent or more of the CBD they
claimed). Of the oils, researchers found roughly one-third were
appropriately labeled and another third were under-labeled, with
one product shockingly containing nearly 130 percent of what was
indicated on the label. Of the miscellaneous products, 67 percent
were found to be over-labeled. THC was detected in 24 percent of
the beverages, 55 percent of the oils and 71 percent of
miscellaneous products.
A recent Johns Hopkins Medicine study found, of 105
products tested, only 85 percent actually had the correct amount of
CBD claimed on the label. Of those products, 18 percent were
under-labeled and 58 percent were over-labeled. THC was found
(within the legal limits) in 35 percent of the products; however,
11 percent of those were labeled “THC Free” while 51
percent did not reference THC at all on the label. CBD products
that are mislabeled as THC-free can create problems for individuals
subject to workplace drug testing. Despite not being approved by
the FDA 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 is a drug claim that requires certain
approvals from the FDA. Pain relief products can contain CBD, but
the claim itself should be based on something approved for that
purpose. Similarly, 15 percent of products tested made a beauty
claim (e.g., reduce wrinkles), which typically isn’t 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 nearly half of the products analyzed were
incorrectly labeled, the majority of which contained 90 percent or
less CBD than claimed.
The vast inaccuracies of CBD product labeling and
unsubstantiated claims pose a serious health risk to consumers and
violate the fundamentals of marketing, perpetuating consumer
distrust and harming the industry. At least one company has taken
matters into its own hands and successfully brought 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 for people using products with unknown
active ingredient levels or unknown psychoactive ingredients.
Over-dosing can cause unexpected side effects and adverse
interactions with other drugs. Under-dosing can diminish or fail to
generate potential therapeutic benefits consumers may seek.
Overall, the CBD industry will suffer from this as will anyone who
could actually reap the benefits from CBD.
Notably, the FDA isn’t unaware of these issues. It advised
consumers to be cautious of unproven claims after its own testing
revealed many products did not contain the advertised level of CBD.
Because CBD is the active ingredient in the prescription
anti-seizure drug Epidiolex, however, there are significant
regulatory hurdles to its use in food or dietary supplements. Thus
far, as a matter of enforcement discretion, the agency has only
brought action against anyone making aggressive drug claims, such
as the treatment of cancer and Alzheimer’s. This leaves a
massive hole in CBD regulation, particularly in light of the
growing evidence that many products misstate their ingredients.
Some states have attempted to fill the gap 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 did not have a warning about THC, which is required by
law in Oregon. While the massive CBD market presents opportunity,
the relative lack of a regulatory structure continues to create
risk. Until Congress takes action and develops a pathway for
approval and regulation, businesses will continue to struggle with
the lack of clarity in this area.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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