The FDA and CBD have had a rocky relationship since day one. The source of their issues has largely been medical claims —some of which are unfounded and/or far-fetched — that CBD products can “prevent, diagnose, mitigate, treat or cure various diseases,” which violates the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Herein lies the problem, or one of the problems – saying that something can potentially happen and saying that something will surely or most likely happen are two vastly different things, which the FDA treats as identical. We’ll get to that in a second. CBD companies that make these problematic claims often fall into one of two categories: over-zealous, wide-eyed dreamers who mistake therapeutic potential and their own, personal CBD experience with solid medical facts; and blatant charlatans.
Considering that COVID-19 has unleashed a flood of misinformation on one hand, and a flood of conflicting, nuanced, and ever-developing information on the other, CBD companies were bound to chime in on the free-for-all conversation and offer their solutions.
Naturally, the FDA wasn’t happy about that and issued warning letters to several companies on March 28. This comes on the heels of the Federal Trade Commission’s (FTC) Operation CBDeceit, which is the regulatory body’s most sweeping crackdown on CBD yet. It’s worth noting that the FDA is concerned with unfounded claims, whereas the FTC is after false advertising. The FDA’s latest batch of warning letters went to:
- Heaven’s Organics LLC
- Functional Remedies
- Greenway Herbal Products
- CBD Social
- UPSY LLC
- Nature’s Highway
The warning letters cite the various studies, referenced by the CBD companies in support of their medicinal COVID-related claims, concluding that “it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the products identified above.”
FDA Mistaking Theories for Claims
To play Devil’s advocate, some of the cited studies speak in theoretical terms, using words like “can” and “could.” Moreover, while these studies do bridge CBD and COVID-19, at least they do so via CBD properties that do have some scientific backing, like CBD alleviating cytokine storms and thus inflammation, which is a well-known fuel of the virus.
In other words, some of these problematic claims aren’t really claims but theories – other researchers’ referenced theories at that – and moreover, they are not beyond the realm of possibility.
Above everything else, this case underscores the need for the clearer and uniform CBD regulations, which have now been long overdue – something that is not the fault of CBD companies, but of the bodies governing them.
Image Credits: Felton Davis / flickr