On May 31st, 2019 a panel of ten FDA officials, including the acting Commissioner, Dr. Ned Sharpless, sat for hours listening to over 100 presentations from a variety of viewpoints on the topic of cannabis and CBD. This public hearing was assembled quickly1 in response to growing pressure from stakeholders, the public, and lawmakers for some direction from FDA. Throughout the hearing, the FDA asked numerous pointed questions which, provided some insight into the shape of potential regulatory framework being considered for CBD, but also highlighted some areas of uncertainty that were likely being debated behind closed doors at FDA. Now, in the aftermath of the May 31st public hearing, it remains to be seen if the FDA can make timely and meaningful progress on establishing a regulatory pathway for CBD or if stakeholder input only contributed to FDA’s indecision.
With each day that passes, a chasm grows between the authority the FDA has been given and that which they are able to wield. Moreover, in the absence of effective leadership at the FDA on the issue of CBD and related substances, states are increasingly carving out their own legislative framework. Will FDA’s lack of a firm and dispositive response on CBD lead to a vision of FDA as an ineffectual agency? Does this mean a rise in Federalism where the each of the states will take drug approval in their own hands, much like now exists for animal feed ingredients? Will the lack of a firm hand by FDA result in a potential existential threat to FDA’s power to approve and issue standards on a national level?
CBD was catapulted into mainstream consciousness with the passage of the 2018 Farm Bill which legalized the commercial production of hemp, and importantly, removed hemp from the Controlled Substances Act and thence, Drug Enforcement Agency oversight. Products claiming to be infused with CBD quickly became ubiquitous across the US shortly thereafter. Within the first months of 2019, it became commonplace to find gas stations selling candy that claimed to be spiked with CBD, pharmacies and health food stores selling CBD oils, and pet treats readily available with supposed infusions of CBD. As the popularity of CBD skyrocketed, the FDA responded with a logical, but seemingly unsympathetic declaration that CBD is not allowed in foods or dietary supplements as the result of its prior approval for use as a drug (Epidiolex®). The response by FDA, although textbook in nature, was not presented in a manner appropriate for the intended audience and ironically telegraphed an ambivalence toward CBD regulation. Overall, the FDA’s response failed to abate the unlawful sale of CBD to any appreciable degree. Although FDA clearly stated its position on the legality of CBD in foods and dietary supplements, the pervasiveness of these products persists in the market. One might reasonably hypothesize that the FDA lacks significant authority or the will to enforce its position. In fact, though, federal agencies, including the FDA, have broad authority to interpret and enforce US law, and the strength of this authority has been reinforced repeatedly in court decisions. Therefore, the FDA’s inability or unwillingness to enforce its position on CBD is in fact a self-inflicted wound to its credibility.
After a few months of continuing to repeat the same mantra but failing to enforce their position, the FDA began to entertain the concept of flexibility and scheduled a public hearing to relieve the building pressure. The FDA no doubt recognized that the blatant disregard for their position on CBD poses a serious challenge to its authority and without legislative relief from Congress or undertaking a convulsive change in regulations, the FDA would eventually forfeit its authority by either loss of public recognition or by the courts unwillingness to uphold interpretations of a law that are applied discriminately. Without course correction, many past regulatory actions would come into question (e.g. health claims, structure function claims, nutrient claims, and the definition of natural). Therefore, the FDA acquiesced to having a conversation about movement on their position; hence the May 31st public hearing.
The public hearing was officially titled “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds.” In keeping with that title, the FDA telegraphed during the May 31st hearing that regulatory pathways being considered will require rigorous scientific data to support the safety of consuming CBD. For example, in the opening remarks of the meeting, Dr. Sharpless noted important questions that need to be answered to determine the safety of CBD in food and dietary supplements including, “How much CBD is safe to consume in a day? What if someone applies a topical CBD lotion, consumes a CBD beverage or candy and also consumes some CBD oil? How much is too much? How will it interact with other drugs the person may be taking? What if she’s pregnant? What if children access CBD products like gummy edibles? What happens when someone chronically uses CBD for prolonged periods?”
At first glance, it may seem like there is a simple, straightforward way to answer these questions – testing. Testing a novel substance requires a significant investment of money and time, but this is not new territory for novel ingredients. These questions related to intended use and consumption levels are commonly addressed in Food Additive Petitions (FAP), new dietary ingredient notifications (NDIN), and documentation affirming the Generally Recognized as Safe (GRAS) status of an ingredient. However, CBD presents a unique challenge for use as an ingredient in food or dietary supplements because of its prior approval as a drug. As a compromise position, it is highly unlikely that the FDA will allow pure CBD (i.e. CBD isolate) in food or dietary supplements. Instead, it is much more likely that any regulatory pathway for CBD in foods and dietary supplements will be under the condition that the CBD is a component of a hemp extract. Hemp strains are notoriously heterogeneous in composition, and the method by which hemp is processed can significantly alter the composition of the extract. Safety testing will be required for each compositionally different extract. This is in contrast to the scenario of conducting tests on CBD isolate, which could have results used as reference for any CBD isolate.
Indeed, the intention of Dr. Sharpless asking questions about the safety of CBD in the opening remarks was more nuanced than a simple solicitation of data to determine if pure CBD is safe to allow in food and dietary supplements. The true contemplations of the FDA became clear shortly after these opening remarks. Following comments from the 17th scheduled speaker, Dr. Philip Blair, a physician representing a manufacturer of full-spectrum hemp-derived CBD, one FDA panel member said, “you used the term full spectrum CBD derived from hemp. And I’m wondering if you could elaborate on the term full spectrum and what you meant by that [statement].” This impromptu request for clarification on the definition of full spectrum and broad spectrum was repeated throughout the remainder of the meeting. The desire from the FDA to define terms used to describe various extractions of hemp that contain CBD is consistent with a compromise from the FDA that they are considering a regulatory pathway for hemp extract that contains CBD but are not going to allow isolated CBD in food or dietary supplements.
Following the May 31st public hearing, it appears the most likely federal regulatory scenario at this point is that the use of hemp extracts containing limited amounts of CBD will be allowable as dietary ingredients if they undergo approval as new dietary ingredients (NDI). Emphasis on the specifics of each CBD hemp extract will be such that all different formulations will require individual NDI evaluations. To make this regulatory path work, though, the FDA will need to step up to its enforcement obligations. It will be critical that if companies make investments in the proper analysis of their products and safety studies, that the FDA cracks down on those marketing CBD and CBD containing products illegally.
However, it has been over six months since the passage of the 2018 Farm Bill and over a month since the FDA public hearing. Although the FDA has regulation and authority in place that could address the issue of CBD immediately, if history is any indicator, it may take years for the FDA to clarify a regulatory pathway for these products. In the meantime, state level governments are responding to the passage of the 2018 Farm Bill with their own legislation. Some states are focusing on the issue of contamination and misbranding that is pervasive in products claiming to contain CBD. Other states are focused on restricting the sale of products containing hemp and hemp extracts that farmed outside of their state. Once the FDA delineates the federal regulatory dimensions for CBD, the state laws will mostly stay in place and manufacturers will have to navigate the complex system of state regulations in addition to federal regulations. Companies that want long-term success in the CBD arena will need to carefully strategize how to approach approval as prohibition in one state can jeopardize the potential for interstate commerce of a product.
Here at Burdock Group, we specialize in providing the highest quality consulting for companies that want long-term success in the food and dietary supplement industry. Our regulatory expertise includes federal and state level regulations. If you are considering selling CBD or hemp-extract CBD, we can provide you with the advice and expertise necessary to navigate these waters. It is imperative that companies with CBD products included in their portfolio are getting sound advice for how to best design the specifications of their product and how to conduct robust safety testing that will meet the FDA’s and states’ demands. Companies often realize they should have sought expert regulatory consulting only after they have spent hundreds of thousands of dollars getting an inappropriate manufacturing process in place and doing inadequate safety testing and/or performing unnecessary tests that raise more questions than they answer. Before your company moves forward with manufacturing and testing of your substance, it is highly advised you avail yourself to consultation services and do things the right way, the smart way, and the way best for long-term business success.
- FDA (2019) Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products