The FDA is quietly targeting CBD in 2022

The Food and Drug Administration (FDA) has consistently held the position that hemp (CBD)-derived cannabidiol cannot be marketed or sold as a dietary supplement or food. The FDA’s position is based on the fact that CBD has been approved for use in a pharmaceutical drug and therefore cannot legally be sold in any ingestible form.

When a CBD company makes health or health claims (e.g. CBD can help you relax, CBD cures back pain), then the FDA considers the product to be an unapproved drug.

The FDA has enforced this position on companies that sell CBD by issuing warning letters that, as the name suggests, warn companies against improperly selling adulterated and mislabeled edibles. Despite the FDA’s consistency, there has been a recent surge in the agency sending out warning letters to CBD companies.

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*Note: A letter was sent to a company selling Delta-8 in 2022 and is not included in this chart.

As you can see, Warning Letters increased in 2019, coinciding with the passage of the Farm Bill 2018 in December 2018. With the rise of Covid, the FDA was preoccupied with the pandemic and the number of Warning Letters dropped significantly. However, it appears that the FDA is targeting CBD again, with 13 warning letters being sent out in 2022. I would expect that number to increase as the year is not over.

Warnings are a fairly minor enforcement measure. However, the FDA also has the power to levy fines and even refer cases to the Department of Justice. A warning letter can also lead to stricter action by the FDA, damage a company’s reputation, and scare investors away.

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With this surge in warnings, it’s a good time to re-evaluate how to mitigate the risks of CBD sales. This requires avoiding any direct or indirect claim that CBD has any health or wellness benefits. Direct claims are along the lines of “CBD cures insomnia” or “CBD can treat anxiety”. Indirect claims may relate to a study on CBD, post customer reviews indicating that CBD has medicinal benefits, or imply in some way that CBD actually has positive health or wellness effects.

If you are unsure how to mitigate the risks associated with CBD products, contact our regulatory attorneys for more information.

Daniel Shortt is a Seattle, Washington-based corporate and regulatory attorney who works extensively with entrepreneurs in the cannabis industry. You can reach him at info@gl-lg.com or (206) 430-1336. This article originally appeared on the Green Light Law Group and has been republished with permission.