The proliferation in the last few years of cannabidiol (CBD)-containing products in the U.S. markets has been greatly accelerated by changes in the regulatory environment, and by perceptions of their health benefits and presumed safety. The result has been aggressive marketing of many types of products, some of dubious quality, making or implying drug-type claims. The recent approval by the U.S. Food and Drug Administration (FDA) of CBD in the form of Epidiolex®, further complicates the regulatory picture. In addition, a number of studies suggest that, at least at high doses, there may be serious adverse effects or drug interactions associated with CBD. At present, CBD-containing products do not meet the strict definition of dietary supplements, but the FDA is continuing to consider some framework under which they might be allowed. Meanwhile, FDA has adopted a “risk-based” enforcement policy. Possible approaches to a new framework for regulation of CBD products as dietary supplements are discussed here, including expanded research emphasis, a robust corporate stewardship program, and a rigorous adverse event reporting program.

The Current Regulatory State of Play In December of 2018, the 2018 Farm Bill was signed into law. It removed hemp, defined as cannabis (Cannabis sativa L.) and derivatives of cannabis with extremely low concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC) (no more than 0.3 percent THC on a dry weight basis), from the definition of marijuana in the Controlled Substances Act (CSA). The 2018 Farm Bill explicitly preserved FDA’s authorities over hemp products.

Therefore, hemp products must meet any applicable FDA requirements and standards, just like any other 2 FDA-regulated product. For example, FDA’s existing authorities over foods, dietary supplements, human and veterinary drugs, and cosmetics apply to hemp products to the extent such hemp products fall within those categories. These safeguards help ensure that Americans have access to safe and accurately labeled hemp products, and, in the case of drugs, that patients can depend on the effectiveness of these products. In late 2018, FDA advanced three hemp seed derived food products through the Agency’s Generally Recognized as Safe (GRAS) process.1 Hemp seeds do not naturally contain cannabidiol (CBD) or THC, which are cannabinoid compounds that are found in other parts of the cannabis plant. The hemp seed products – hulled hemp seed, hemp seed protein powder, and hemp seed oil – can be legally used in the U.S. food supply. Any food products made with these hemp seed ingredients are subject to the same FDA requirements as any other food, such as those related to ingredient and nutrition labeling, as well as the risk-based, prevention focused Food Safety Modernization Act (PL 111-353) safeguards. 2 The current regulatory state of play is more complex when it comes to hemp products that contain CBD.

It is unlawful under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to introduce into interstate commerce a food (including any animal food or feed) to which has been added a substance that is an active ingredient in an approved drug product or a substance for which substantial clinical investigations have been instituted, and the existence of such investigations has been made public. 3 Similarly, these types of substances are outside of the statutory definition of a dietary supplement. These provisions in our statute exist to protect patients and to preserve American patients’ access to the most safe and advanced pharmaceutical system in the world. I think everyone on this Committee can understand why, in general, adding drugs like blood pressure medicines or chemotherapeutics to foods, or to products marketed as dietary supplements, may not be in the best interests of American consumers and patients. In June 2018, FDA approved the drug Epidiolex4 for treatment of seizures associated with two very rare and severe pediatric diseases. The approval of this medicine was a significant milestone for these patients and their families. The active ingredient in this drug is CBD.

Based on both the approval of this drug, as well as previous substantial clinical investigations of CBD, CBD cannot be marketed as a dietary supplement, and foods to which CBD has been added cannot be introduced into interstate commerce under the FD&C Act. The FD&C Act provisions that prohibit adding an active drug ingredient to foods or marketing an active drug ingredient as a dietary supplement contain an exception if the drug was marketed in foods or dietary supplements before the drug was approved and before it was subject to substantial clinical investigations. The Agency is not aware of any evidence that CBD was marketed in foods or dietary supplements prior to it being subject to substantial clinical investigation.

Therefore, FDA has concluded this exception does not apply to CBD. The FD&C Act further allows for the Agency to make an exception through notice and comment rulemaking to one or both of the provisions that prohibit adding active drug ingredients to foods or marketing them as dietary supplements. It is important to note that it can take three to five years to complete even an expedited notice and comment rulemaking process that complies with the Administrative Procedure Act and other requirements. Completing a rulemaking requires the Agency to develop a robust record to support the rulemaking, including economic analyses, and to consider public comments, which can be voluminous when rulemakings concern substantive topics for which there is extensive public interest, as in the case of CBD. Creating an exception for an active drug ingredient to be used in either foods or dietary supplements would make sense only if we could determine that products would be able to meet the other relevant safety standards in the FD&C Act, such as the food additive safety standards for human or animal foods, or the New Dietary Ingredient standards for dietary supplements.

If we were to create an exception under one provision of the FD&C Act, but other provisions of the statute still barred products from coming to market, our action could end up generating additional confusion in the marketplace – a result the Agency believes all stakeholders would prefer to avoid. FDA recognizes that three to five years is a long time to wait for regulatory clarity, particularly given the significant public interest in hemp products, and CBD in particular. That is why, as I discuss in greater detail later in my testimony, the Agency is exploring options to reach a resolution more quickly and efficiently. Cannabidiol (CBD) It has only been seven months since the 2018 Farm Bill removed hemp, which includes lowTHC derivatives of cannabis, such as CBD products, from the definition of marijuana in the CSA. I cannot overstate how significant of a policy sea change this has been.

Prior to the enactment of the 2018 Farm Bill, the CSA did not differentiate between marijuana and hemp, and all cannabis (with certain exceptions, e.g. sterilized seeds and mature stalks of the plant) was a Schedule I substance and therefore controlled by the Drug Enforcement Administration (DEA). Early interest in clinical research was focused on the development of drugs using THC rather than CBD. More recently, interest in CBD as a drug is increasing, and, as discussed above, FDA approved Epidiolex in 2018, a drug for the treatment of two severe forms of childhood seizures. The passage of the 2018 Farm Bill has led to the misperception that all products made from or containing hemp, including those made with CBD, are now legal to sell in interstate commerce. The result has been that storefronts and online retailers have flooded the market with these products, many with unsubstantiated therapeutic claims. FDA has seen CBD appear in a wide variety of products including foods, dietary supplements, veterinary products, and cosmetics. As this new market emerges, we have seen substantial interest from industry, consumers, and Congress. However, in the midst of the excitement and innovation, FDA’s role remains the same: to protect and promote the public health.

At present, any CBD food or purported dietary supplement products in interstate commerce is in violation of the FD&C Act due to the statutory provisions discussed above. However, FDA’s biggest concern is the marketing of CBD products that make unsubstantiated therapeutic claims to prevent, diagnose, mitigate, treat, or cure serious diseases, but have not obtained new drug approvals. For example, FDA has seen various CBD products with claims of curing cancer or treating Alzheimer’s disease. The proliferation of such products may deter consumers from seeking proven, safe medical therapies for serious illnesses – potentially endangering their health or life. FDA’s commitment to protect consumers from these unsubstantiated therapeutic claims does not just apply to CBD products – it is a longstanding commitment of the Agency across all the products we regulate.

FDA has issued numerous warning letters to firms selling unapproved CBD drug products with claims to treat or prevent serious diseases, and in fact, the Agency began doing this in 2015, prior to the passage of the 2018 Farm Bill5 . It is also worth noting that, while investigating these unapproved CBD drug products, FDA identified other concerns. For example, laboratory analysis of some of these products revealed they did not contain the amount of CBD that was claimed on a product’s label, and/or the products contained other substances that were not on the product’s label, such as other cannabinoids like THC. Through the approval of the CBD-containing drug Epidiolex, which was based on adequate and well-controlled clinical studies, FDA has learned that CBD is not a risk-free substance. During our review of the marketing application for Epidiolex, we identified certain safety risks, including the potential for liver injury6 . In that context, the risks are outweighed by the benefits of the approved drug to the particular population for which it was intended. The drug approval process offers significant benefits to prescribers and patients, including those who seek to prescribe or use hemp products for therapeutic purposes. Drug approvals generally are based on adequate and well-controlled clinical studies, which gives prescribers and patients confidence in the drug’s safety and effectiveness for its indicated use. In addition, approved drugs have uniform strength and consistent delivery that support appropriate dosing needed to treat patients, particularly patients with complex and serious conditions such as the epilepsy syndromes that Epidiolex was approved to treat. Moreover, patients using an approved prescription drug are under medical supervision to monitor any potential adverse effects of the drug. But for consumers purchasing the types of CBD products that are proliferating throughout the marketplace, these protective factors are generally not present.

FDA’s Commitment to Sound, Science Based Policy on CBD Given the substantial public, industry, and congressional interest in CBD, FDA has formed a high-level CBD Policy Working Group, which I co-chair along with Lowell Schiller, who is the Agency’s Principal Associate Commissioner for Policy. The goal of the CBD Policy Working Group is to coordinate the Agency’s approach to CBD policy making, including considering the appropriateness of potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed. The first priority of the CBD Policy Working Group has been to obtain and assess safety data for CBD, given the Agency’s public health mission. Although FDA has approved one drug, Epidiolex, that contains CBD, Epidiolex is approved for use in a limited population at a specific dose, was studied for safety and efficacy in rigorous randomized clinical trials, and is available only by a prescription from a licensed medical professional.

When considering the use of CBD in non-drug products, such as conventional foods and dietary supplements, FDA must evaluate different factors than for a prescription drug product. CBD food and dietary supplement products would be directly available to a wide range of consumers, which could potentially include pregnant or nursing mothers, children, the elderly, those with chronic illnesses, and those taking medications that might interact with CBD. CBD products could also be given to a wide variety of animal species, some of which are used for food. These would also be available without discussions with a doctor or other medical professional. Given this, FDA must consider the potential safety implications of long-term use of CBD by different human and animal populations. FDA is wrestling with questions not only about the intrinsic safety of CBD, but also about potentially unsafe manufacturing processes for products containing CBD. FDA knows from CBD products it has tested that they may not contain the amount of CBD indicated on a label, or they may contain other potentially dangerous compounds that are not listed on the label. Therefore, FDA must consider questions related to good manufacturing practices for CBD products and potential labeling that might be appropriate for these products to address any potential risks to consumers. FDA has made it a priority to address these questions, and we are working diligently to make progress.

However, FDA will only consider creating legal pathways for CBD to be marketed as a dietary supplement or in a food if the Agency is confident that it can develop a framework that addresses safety concerns. Another issue that FDA plans to consider is whether allowing CBD to be marketed as a dietary supplement or in a food will deter clinical research to substantiate additional therapeutic uses for cannabis-derived compounds. Less research into the promise of cannabis-derived compounds and fewer drug approvals in this area would be a significant loss for American patients.