On December 30, 2019, Congress passed the Further Consolidated Appropriations Act of 2020, which was later accompanied by a Joint Explanatory Statement, directing the FDA to conduct a sampling study of the current CBD marketplace to determine the extent to which products are mislabeled or adulterated. Last week, the FDA met its obligation by submitted the requested report.
Alas, the report fails to adequately respond to Congress’ request to solve the proliferation of improperly labeled and unsafe CBD products in the United States. The report offers virtually no new insight and merely reiterates the well-known information that prompted Congress’ original request. Though the FDA shared the results of a short-term sampling study it conducted in the past six months, the agency ultimately admitted this data could not be used to draw definitive conclusions on the state of the market.
For the past 18 months, the hemp-derived CBD industry has consistently stressed the need to regulate these products to ensure quality control. Yet, the FDA has limited its involvement to issuing warning letters to CBD companies making egregious, unsubstantiated medical claims about their products.
Despite the fact that the agency “recognizes the significant public interest in CBD products,” the report concludes that the FDA is not yet in a position to regulate these products and ensure public safety given the limited amount of data available for these products.
This conclusion is frustrating because the FDA is pointing to a problem only it can solve. While the rulemaking process can be tedious and lengthy, it does not absolve the FDA for months of inaction on CBD-related issues.
For instance, the agency could have issued informal guidance — agency advice that influences regulated entities but does not carry the force and effect of law — to CBD manufacturers and distributors as opposed to offering broadly drafted FAQs that leave readers with more questions than answers. Over the years, the FDA has come to adopt informal guidance as its primary method of policy making. This nonbinding, informal process allows the FDA to efficiently deploy resources while maintaining administrative flexibility.
Moreover, by delaying its rulemaking process and limiting its enforcement actions to issuing warning letters, the FDA seems to have created the problem it is now addressing in the report.
Back in 2018, Pediatric Neurology Briefs published an article entitled Inadequate Regulation Contributes to Mislabeled Online Cannabidiol Products, which concluded:
Overall, the results of this study are an important contribution to the growing evidence that online CBD products have a high rate of mislabeling. A need exists for consistency and regulation of these products. There is potential for adverse events by having higher CBD concentrations than expected, resulting in changing serum antiepileptic levels.
As this peer-reviewed article suggests, until the FDA starts regulating CBD products, the proliferation of improperly labeled and unsafe products will continue.
In concluding the report, the agency explained it is planning a long-term sampling study that will be conducted by a third party, using the same methodology adopted in the short-term sampling study. The FDA expects the long-term sampling study to be initiated this year but provides no information as to the date of completion. This lack of specificity regarding the study’s timeline suggests that the agency is not close to implementing meaningful reforms surrounding CBD products.
As was shown again in this report, the FDA’s slow approach to carving a legitimate legal pathway for CBD products is not tenable. By failing to expeditiously serve its administrative functions, the FDA is further denying U.S. hemp farmers access to profitable markets for their crops, is preventing the CBD industry from following its course and succeeding, and is jeopardizing the very task with which the agency is responsible: to protect public health and safety.
Nathalie Bougenies practices in the Portland office of Harris Bricken and was named a “2019 Rising Star” by Super Lawyers Magazine, an honor bestowed on only 2.5% of eligible Oregon attorneys. Nathalie’s practice focuses on the regulatory framework of hemp-derived CBD (“hemp CBD”) products. She is an authority on FDA enforcement, Food, Drug & Cosmetic Act and other laws and regulations surrounding hemp and hemp CBD products. She also advises domestic and international clients on the sale, distribution, marketing, labeling, importation and exportation of these products. Nathalie frequently speaks on these issues and has made national media appearances, including on NPR’s Marketplace. Nathalie is also a regular contributor to her firm’s Canna Law Blog.
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