The Food and Drug Administration (FDA) made two major announcements yesterday, both of which took very aggressive action against CBD products.
First, FDA simultaneously issued 15 Warning Letters to companies selling CBD products. Not only is this the largest number of Warning Letters FDA has ever issued regarding CBD products, but it is also more Warning Letters than it issued in the last three years combined. For reference, in 2018, FDA issued one Warning Letter to a CBD company, four Warning Letters in 2017, and eight Warning Letters in 2016. You can find more information regarding the launch of this enforcement action in FDA’s press release.
Of note, in its press announcement regarding the issued Warning Letters, FDA cited the following specific concerns regarding the sale of CBD products:
- Marketing products that are intended to prevent, diagnose, mitigate, treat, or cure a serious disease.
- Marketing products to infants and children.
- Marketing food products with CBD added.
- Marketing CBD products as dietary supplements.
- Marketing products containing CBD to food-producing animals.
Significantly, FDA also issued a statement in this press announcement that it could not conclude that CBD is Generally Recognized As Safe, suggesting that the Agency has grown more concerned about the safety issues associated with consumption of CBD. Given that FDA’s warnings today appear to encompass all foods and dietary supplements that contain CBD, this is a major development with serious implications for the industry.
Second, FDA issued a revised Consumer Update that set forth the Agency’s opinion on specific safety issues associated with CBD, further showing the Agency’s increasing concerns regarding consumers’ ability to safely use CBD. In particular, FDA has concerns regarding CBD’s potential to cause issues with liver toxicity, drug interactions and male reproductive toxicity. FDA also continues to have concerns regarding the use of CBD in vulnerable populations including children and pregnant women.
Taken together, these actions suggest that FDA has decided to change its enforcement position regarding the marketing of products containing CBD, especially those marketed towards vulnerable populations like children and pregnant women. Whether or not this new position will continue despite consumer and political pushback remains to be seen. Regardless, it is clear that FDA has stepped up its enforcement in the CBD space and companies need to adjust their risk assessment of this area accordingly.