In the final days of the 115th Congress, legislators and President Donald Trump passed the 2018 Farm Bill, which, while the Farm Bill is always an important piece of legislation, could have a significant effect on the dietary supplement industry by creating a pathway for the legal cultivation and sale of hemp in the United States. Prior to the passage of the 2018 Farm Bill, hemp, with limited exemptions for some hemp-derived ingredients and research-based programs developed for industrial hemp, was regulated by the Drug Enforcement Agency (DEA) as a Schedule I controlled substance under the Controlled Substances Act (CSA) because hemp is a form of the Cannabis sativa L. plant.
But, the question of how much of an effect this bill will have largely rests with FDA’s interpretation of which hemp-derived substances can be used in supplements. The dietary supplement industry has significant interest in how the 2018 Farm Bill and subsequent FDA actions will affect the popular cannabis constituent—cannabidiol (CBD).
The 2018 Farm Bill’s effect on CBD
The 2018 Farm Bill removed hemp from the CSA. Hemp, as defined by the bill, includes the Cannabis sativa L. plant and any parts of this plant, including cannabinoids found in the plant, provided that the concentration of tetrahydrocannabinol (THC) in the plant is not more than 0.3 percent. Removing hemp from the CSA eliminated a significant hurdle to the use of CBD in dietary supplements, but does not clear the path. The 2018 Farm Bill does not change FDA’s jurisdiction over CBD’s use as a food or supplement ingredient, or its position on CBD use in food and dietary supplements. Similarly, the bill does not affect the ability of states to regulate hemp use, including the use of CBD, except that states may not block interstate transportation of the product.
FDA’s position on CBD
Citing language in the Food, Drug and Cosmetic Act (FD&C) that is intended to protect pharmaceutical industry investments in research, FDA takes the position that CBD cannot be a legal ingredient in food and dietary supplements because the substance was the subject of significant clinical trials as a drug, before it was used in foods or dietary supplements. The FD&C precludes the use of a substance in a dietary supplement if the substance was “an article authorized for investigation as a new drug . . . for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.” FD&C § 201(ff)(3)(B)(ii). This provision is often referred to as “IND preclusion.” A similar provision exists under section 301(ll) of the FD&C for food. In this instance, FDA has cited the existence of clinical investigations for the CBD-derived drug Epidiolex manufactured by GW Pharmaceuticals as precluding CBD’s use in supplements and food.
Finally, it should be noted that FDA has acknowledged that some hemp-derived ingredients, such as hemp oil, hemp protein and hemp flour are generally recognized as safe (GRAS), but these substances differ from CBD in thier cannabinoid content and other factors. Thus, while the 2018 Farm Bill did not clear all the obstacles for CBD use in food and supplements, the bill did create a pathway for U.S. sources of other hemp-derived ingredients.
Given FDA’s stance, some would believe that FDA will never consider CBD to be a legal ingredient in food and supplements. However, pathways may appear.
FDA’s position that CBD cannot be used in food and dietary supplements because of IND preclusion has not been challenged. In guidance, FDA has noted that the agency “is not aware of any evidence that would call into question its current conclusions [on CBD]” but that “[i]interested parties may present the agency with any evidence bearing on this issue.” For example, companies could challenge FDA not only on the timing of GW Pharmaceuticals CBD drug trials in relationship to when CBD may have been used in food and dietary supplements, but also on FDA’s determinations as to what are considered “substantial clinical investigations” and whether hemp-derived CBD is the same “article” as the CBD used by GW Pharmaceuticals.
Another pathway would rely on FDA creating an exemption through regulation for CBD. The FD&C allows FDA to create a regulation allowing the use of a substance in dietary supplements and food, despite a determination that the IND preclusion clause applies. FDA has never exercised this authority, but statements made by FDA Commissioner, Dr. Scott Gottlieb—issued immediately after passage of the 2018 Farm Bill—indicated the agency is open to exploring this pathway for hemp-derived CBD.
In his statements, Dr. Gottlieb reiterated FDA’s current position on CBD as an illegal food or dietary supplement ingredient, but highlighted that “FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement” and that the agency is “taking new steps to evaluate whether we should pursue such a process.” Dr. Gottlieb also announced that the agency intends to hold a public meeting soon to discuss this issue with stakeholders.
Members of Congress also have already weighed in on this issue, urging FDA to create a pathway for CBD in supplements and food.
Industry’s next steps
Significant momentum has started to create a legal pathway for the sale of CBD in dietary supplements and food. Dietary supplement companies interested in these types of products should begin preparing salient arguments on why CBD should be included in supplements to take advantage of the current spotlight.
Companies also should not lose track of the many other requirements that will need to be met for the legal sale of hemp-derived CBD products. For example, companies will still be required to substantiate the safety and efficacy of their CBD products. Substantiating product claims could present unique challenges, as different CBD preparations effect the relevance of scientific evidence for a particular product. Further, given FDA’s stance that CBD drug trials (which commenced after 1994) preceded CBD’s use in food and supplements, companies will need to consider whether a new dietary ingredient (NDI) application must be submitted for a CBD supplement. Finally, companies should consider what unique GMP (good manufacturing practices) might apply to the use of CBD-type supplements, such as what analytical test methods might need to be developed to ensure THC content remains below 0.3 percent and how to ensure consistent CBD levels across product batches.
Learn more about hemp-derived CBD products, how CBD works and the evidence supporting its safety and benefits in the Council for Responsible Nutrition (CRN) and Natural Products INSIDER webinar “CBD is Out of the Block—Can Science Catch Up?”
Megan Olsen is the assistant general counsel, Council for Responsible Nutrition (CRN), a trade association for the dietary supplement and functional food industry.