On July 8, 2020, the U.S. Food and Drug Administration (“FDA”) delivered the results of its most comprehensive sampling study on the current cannabidiol (“CBD”) marketplace to the U.S. House Committee on Appropriations and the U.S. Senate Committee on Appropriations.1 Congress mandated FDA to conduct this study last year in appropriations legislation. The study aimed to determine the extent that CBD products are mislabeled or adulterated, as FDA has previously researched annually since 2014.2 FDA has continued to allow CBD products to live in a regulatory gray area, asserting time and time again that it will not regulate the CBD industry until it receives sufficient data regarding CBD’s safety for consumers.3 These studies are the preliminary workings of producing said data.
The report delivered on July 8 established major and widespread inconsistencies between what CBD products’ labels claimed they contained and what was actually in the products. Nearly a quarter of food products tested by the agency did not meet label claims in one way or another. Out of the 200 randomly tested tinctures, capsules, edibles, oils, drinks, and pet products containing CBD, nearly half were found to contain THC. Of the products tested that listed the amount of CBD contained in the product, over half were shown to contain either less than 80% or more than 120% of the CBD indicated on the label. The good news is that out of all the products that were tested for the hazardous elements lead, mercury, arsenic, and cadmium, only one product was found to be a potential health concern. The results of this study are consistent with previous studies conducted by FDA itself as well as additional organizations and agencies.4
Though the results are from a limited sample size and FDA calls for a longer-term study that will include products sold in brick-and-mortar stores, the results further affirm the need for federal regulation of the CBD industry. FDA’s “head in the sand” approach is once again allowing bad actors to continue to infiltrate the market, leaving those with legitimate products and labels to continue to be frustrated.
This report was presented to Congress as FDA’s 2020-2021 fiscal year spending bill is currently in markup.5 As The Rodman Law Group previously wrote, FDA allocated a mere $5 million to the regulation of CBD and CBD products, equating to approximately .0807% of the total budget. With the confirmation of mislabeling and adulterated products provided in the July 8 study, industry members are hopeful that Congress realizes that the CBD regulation budget must be increased in order to conduct more meaningful studies, theoretically providing more informative results.
While FDA claims this study to be its most comprehensive of the CBD market to date, it was largely underwhelming and provided virtually no new insight as it is hardly a secret that many products on the market do not contain the amount of CBD listed on their labels. Moreover, given the variance in testing facilities, the nature of cannabinoid extraction, not to mention unscrupulous actors who cut corners when making consumer goods, the fact that half the CBD products that were tested contained THC is surprising. FDA’s main takeaway from the study was that additional testing is needed because “the preliminary data are from a limited sample size and cannot be used to draw conclusions about the marketplace…”.6 It is frustrating, yet sadly par for the course, that FDA would conduct a study like this only to come to the conclusion that its sample size was too small. That particular factor seems like something that could have been easily addressed prior to the study’s commencement. Given the size of the market, it is high time for FDA to provide sensible guidance to CBD manufacturers and distributors instead of simply deeming CBD products to be illegal and treating them as though they do not exist.
This delay in regulation and guidance is unfair to consumers and the CBD industry in a number of ways. Particularly, this lack of concrete information from FDA has now seeped into the federal litigation landscape. At least three federal judges have held that the courts cannot hear cases involving CBD products until FDA completes its rulemaking process on the regulation of CBD products.7 The plaintiffs in these cases all brought similar claims under the Food, Drug, and Cosmetic Act (“FD&C Act”), alleging that the products purchased were misleading to the amount of CBD concentrated in the actual product versus the amount listed on the label. Based on the stay orders issued, federal judges are unlikely to consider FDA enforcement actions or public statements as guiding principles for future case law.8 This factor makes it even more important for FDA to set a time period for rulemaking and engage in meaningful, informative studies. It is time for FDA to stop taking its traditional “head in the sand” approach, and make decisions for the good of the industry, consumers, judges, and litigants alike.
- https://www.foodandwine.com/news/cbd-products-fda-tests-cbd; https://hempindustrydaily.com/wp-content/uploads/2020/07/CBD-Marketplace-Sampling_RTC_FY20_Final.pdf