On Tuesday, November 26th, the United States Food and Drug Administration (“FDA”) issued a set of 15 warning letters to manufacturers of cannabidiol (“CBD”) products for violations of the Food, Drug, and Cosmetic Act (“FDCA”). While the FDA has previously issued warning letters to CBD manufacturers for violations of FDCA provisions, the most recent set of warning letters is more significant than previous warning letters that targeted companies accused of marketing and advertising CBD products as drugs and dietary supplements. The most recent enforcement actions are notable in that they target rather discrete provisions of the FDCA related to the addition of CBD in food and beverage products, animal drug products, and animal feed, thus demonstrating the FDA’s increasing interest in the proliferation of non-FDA approved products containing CBD to consumers. In other words, the FDA was providing the industry with another obvious, glaring, and overwhelmingly direct message: The FDA Has Zero Tolerance for Ipse-Dixit Claims Regarding CBD Products.
In September, I spoke about these more discrete provisions of the FDCA that had yet to be enforced by the FDA for a Continuing Legal Education (“CLE”) conference hosted by the Oregon State Bar Association Northwest Cannabis Law Institute. At the time, I advised attorneys in the room that this recent FDA enforcement action demonstrates the importance of anticipating, rather than reacting to, FDA enforcement actions in order to properly advise clients operating in the hemp and cannabis industry. While some attorneys complain about the unfairness of FDA enforcement actions against the largest cannabis and CBD companies, this is hardly a surprise to us here at Green Light Law Group. In fact, these enforcement actions are seemingly long overdue for an industry that has evaded the purview of FDA officials for several years, notwithstanding the previous warning letters sent to CBD manufacturers over the past few years.
The warning letters specifically cited companies for violating Section 201(v) of the FDCA, which prohibits the sale of new animal drugs into interstate commerce, Section 301(II) of the FDCA, which prohibits the sale of adulterated animal and human food products into interstate commerce, and Section 409 of the FDCA, which prohibits the use of food additives in human and animal food products in the absence of FDA approval for such use. Many of the warning letters also emphasized (yet again!) that the FDA does not currently, has never previously, and likely never will allow CBD products to be sold as “dietary supplements” pursuant to Section 505 of the FDCA. As in many other warning letters, the FDA noted that the use of non-FDA-approved health claims for marketing and advertising purposes violates the FDCA prohibition against the sale of non-FDA-approved drug products in interstate commerce.
Several of the warning letters cite violations of Section 501(f)(1) of the FDCA related to the sale of misbranded products in interstate commerce, which requires adequate directions for use if the product is offered for conditions amenable to self-diagnosis and treatment by individuals who are not medical practitioners. The warning letter explained that CBD products are not exempt from the FDCA requirement that all products sold over-the-counter include adequate instructions for use by a layperson and for conditions amenable to self-diagnosis. Thus, the usage and dosage information included on the CBD product label constituted a separate and distinct FDCA violation because the products, while containing “directions for use and dosage,” were marketed and advertised for treatment of medical conditions that are not amenable to self-diagnosis and treatment in the eyes of the FDA (the only eyes that matter!).
Ironically, a management consulting firm client was confused when I explained the various legal provisions of the FDCA that inhibit the sale of CBD products, as they did not understand how companies were actively engaging in the CBD product market in light of the obvious legal risks related to potential FDA enforcement actions (i.e. all the above). The confusion was further exacerbated by the fact that so many of the largest retailers and companies have announced plans to market and sell CBD-containing products over-the-counter in the form of dietary supplements, animal food products, animal drug products, and a number of other forms. Apparently, several lawyers had advised the client that the FDA only prohibited the sale of products that contain non-FDA-approved health claims for marketing and advertising. The frustration of the client was obvious as the legal advice provided to them by other counsel was inaccurate and ultimately presented a significant risk and liability to the firm’s own client.
The moral of the story? Please reach out to us at Green Light Law Group sooner rather than later in order to proactively manage and mitigate the risk of FDA enforcement actions. Not only have we advised clients on these issues long before other law firms even began representing cannabis clients, we’ve also accurately anticipated these legal issues from the beginning.