The U.S. Food and Drug Administration just issued a report to Congress outlining the results of sampling tests conducted on CBD products. (link) Required by Congress as part of a 2019 appropriations bill, the FDA studied CBD products currently available on the internet “to determine the extent to which products are mislabeled or adulterated”. After detailing the results of prior, similar studies, the FDA outlines the recent testing of over 200 CBD and hemp products available online (it is not apparent whether any CBD knishes were tested).
Although the FDA doesn’t provide any conclusions in the report (rather, the report only presents the methodology and results of the tests), our (my FDA regulatory partner, Cori Annapolen Goldberg, and my) general takeaway is that there is still a disconnect between what’s advertised versus what’s in the package. For example, the FDA found that, of 102 products that indicated a specific amount of CBD, 18 of them contained less than 80% of the amount indicated and 38 of them contained more than 120% - in other words, more than half of the products had CBD amounts outside of a 20% range. Two products were found to not even contain any CBD. On the other hand, the testing found heavy metals in only one of 133 samples, one of the concerns raised during public hearings.
As the industry waits for the FDA to decide how to treat CBD in food, beverages, and dietary supplements, and is working to gain mainstream consumer acceptance of a wellness product made with a regulated ingredient, quality control and label compliance will be critical to long-term success.
It’s also worth noting that the FDA tested for a number of different cannabinoids, including CBG, CBN, THCV, and ∆8-THC, due to “concerns about the characteristics of currently marketed CBD products, including … whether these products contained other cannabinoids” (namely those beyond simply CBD and ∆9-THC). Although it’s a bit of a fool’s errand to speculate why the FDA is looking for the presence of other cannabinoids in CBD products, this could be a signal that the FDA may eventually try to distinguish between full spectrum products (namely, products with a broad range of cannabinoids) and products that only contain CBD. Or not.
Digging even deeper, although it seems relatively obvious why the FDA would test for levels of ∆9-THC (namely, to determine whether the product even qualifies for the “hemp” exemption under the Controlled Substances Act), it’s interesting that they also tested for THCV and ∆8-THC. There’s a debate over whether THC compounds that are not ∆9-THC (such as THCV, THCA, and ∆8-THC, which have psychoactive properties), but which are nonetheless extracted from hemp, are federally legal based a read of how the 2018 Farm Bill amended the Controlled Substances Act. It’s arguable that the reason for the FDA’s specific testing for these other tetrahydrocannabinols does not bode well for that debate (that’s not legal advice).
As to the timing of any decision by the FDA on CBD rulemaking? Well, the FDA notes that it will be starting up a longer-term study in 2020 to capture a broader range of products and retail sources. Will the FDA wait for the results of that study to start rulemaking? Nobody knows for sure, but it’s very likely. Chances are, we won’t see any FDA regulations any time soon.