2018 Farm Bill Provides A Path Forward for Industrial Hemp
The inclusion of hemp in the 2018 farm bill has many people — both inside and outside the agriculture sector – racing to figure out the potential market for this relatively new (well, new to the U.S., at least) agricultural product. Hemp’s proponents are growing more optimistic and vocal each year about hemp as a potential game changer for U.S. agriculture. Whether you think hemp is the next big thing, see it with more moderate potential as a new crop for farmers, or if you believe it will be a big dud, everyone can agree that farmers, policymakers and the general public are showing an increasing interest in the product.
What is Hemp?
While many people are expressing excitement, or at the very least interest, in hemp’s potential, it is helpful to take a step back and talk about what it is, and what it is not. For centuries, hemp has been a fiber and oilseed used around the world for production of a variety of industrial and consumer products. Industrial hemp is not marijuana, although it is a different variety of the same species, a fact that has at times resulted in a negative association and stymied hemp’s growth. That species is Cannabis sativa L., a substance that has historically been classified in the U.S. as a Schedule I controlled substance and regulated under the Controlled Substance Act. Since the 1990s, varieties of this plant containing low levels of delta-9-tetrahydrocannabinol, or THC, which is the ingredient that lends marijuana is psychoactive properties, have been legalized in many European countries, as well as Canada and Australia. The common threshold level of allowable THC for industrial hemp is 0.3 percent on a dry weight basis.
Industrial hemp can be grown as a seed, a fiber or a dual-purpose crop. When hemp is grown as a fiber, it is planted in a high density to maximize stalk production. The hemp plant produces an outer ring of more valuable bast fibers, and an inner ring of less valuable hurd fibers. When hemp is grown for seed, the plants tend to be spaced further apart to encourage seed production. The seeds typically contain 29 to 34 percent oil, which is similar to other oils, such as linseed.
What is in the 2014 Farm Bill and 2018 Farm Bill?
The hemp industry in the U.S. received a boost with the passage of the 2014 farm bill, which allowed “institutions of higher education” and state agriculture departments to grow hemp under a pilot program as long as state law permitted it. Additionally, the 2014 bill established a definition of industrial hemp, officially setting the THC threshold in the U.S. at 0.3 percent on a dry weight basis. At the time, all cannabis varieties were considered Schedule I controlled substances, and though the 2014 bill allowed hemp to be grown, certain aspects of production were still subject to Drug Enforcement Administration oversight, including the importation of seeds for cultivation.
The 2018 farm bill went several steps further and legalized the production of hemp as an agricultural commodity while removing it from the list of controlled substances. The 2018 bill also listed hemp as a covered commodity under crop insurance and directed the Federal Crop Insurance Corporation board to streamline the process for developing hemp policies. Given the excitement and uncertainty around the market potential for hemp, the 2018 bill also requires the secretary of agriculture to conduct a study of the hemp-related agricultural pilot programs implemented under the 2014 farm bill, along with any other agricultural and academic research on the subject, to determine the economic viability of a domestic hemp market. Additionally, while the law expands the potential for hemp production, it does not create a system in which producers can grow it as freely as other crops. The bill outlined actions that would be considered violations of the law, such as producing a plant with higher than 0.3 percent THC content or cultivating hemp without a license; it even goes into potential punishments and what happens to repeat offenders. The bill also sets up a shared state and federal regulatory authority over the issue, outlining the steps a state must take to develop a plan to regulate hemp and submit it to the secretary of agriculture for approval.
Production, Imports and Markets for Hemp
With the 2014 farm bill allowing the production of hemp under specific conditions, hemp production in the United States has begun a sharp upward march. No official estimates of hemp production are available at this time, but private estimates show that although the overall acreage is modest, the growth rate is very strong. Vote Hemp, an organization that promotes hemp in the marketplace, estimates that in the last three years hemp acreage has increased from 9,800 in 2016, to 26,000 in 2017, to 78,000 acres in 2018.
Over the past few decades, hemp imports have been growing, reaching a high of nearly $80 million worth in 2015, before declining to just under $70 million worth in 2017. Nearly two-thirds of the value of hemp imports was derived from hemp seeds. As is the casewith many U.S. imports, Canada is the largest supplier of hemp to the U.S., accounting for as much as 90 percent.
While some claim there could be as many as 50,000 various uses for hemp products, there may be only a few products with the potential to generate a significant market, with the major categories being fiber, oilseed and pharmaceuticals. Not much official data exists on the value of retail sales of hemp-based products in the U.S. Hemp Business Journal estimated 2017 U.S. hemp sales at $820 million, an increase of 19 percent over 2016’s estimated $688 million in sales. There have been many feasibility and market studies conducted by universities and USDA, and most researchers acknowledge industrial hemp as a potentially very profitable prospect. At the same time, these researchers note the uncertainty surrounding that potential market, much of it stemming from the general lack of information and research.
The markets for bast fibers, such as industrial hemp, include specialty textiles, paper and composites. Hemp fibers are used in textiles, fabrics, yarns, paper, carpeting, insulation, construction materials and even auto parts. Hemp seed and oilcake are used in various foods and beverages, including salad and cooking oil. Hemp seeds are crushed for their oil, producing hempseed oil, which is used in soap, shampoo and cosmetics. Other various uses of industrial hemp include hempcrete (a mixture of hurds and other products), which is used as a building material, and composites for use as a fiberglass alternative for the auto and aviation industry.
One of the biggest potential markets for hemp products is cannabidiol, or CBD. CBD is a non-psychoactive compound in cannabis that is low in THC. CBD is generally marketed as relief for various illnesses and symptoms such as epilepsy, post-traumatic stress disorder, nausea and other disorders. There is some concern that some products derived from industrial hemp, such as hemp oil, are being marketed as having comparable therapeutic uses to CBD extracts, but this issue is unresolved. However, research into potential uses for industrial hemp-derived CBD products is an important area being investigated. Unfortunately, there is still uncertainty surrounding the 2018 farm bill’s impact on the regulation of CBD.
What are Some of the Challenges?
Regulation: Uncertainty still exists about how and when regulations in general will be implemented and what those regulations will look like. There are also still many unknowns about the regulation of CBD as a Schedule I substance. On Feb. 27, Secretary Perdue testified before the House Agriculture Committee that USDA is proceeding slowly and carefully in working on the multiple rules required for hemp production. Secretary Perdue indicated that it will likely not be until the 2020 planting season that the department has definitive rules in place. Until the 2018 bill is implemented and clear rules are in place, there are still nine states that have not legalized the cultivation of hemp under the previous farm bill law: Connecticut, Georgia, Iowa, Idaho, Louisiana, Mississippi, Ohio, Texas and South Dakota. Once the new federal process is in place, each state will likely need to submit a plan for approval before farmers in those states can produce hemp. Concerning CBD, the question about the classification of CBD as Schedule I appears to be somewhat in limbo. The 2018 farm bill removed hemp and hemp-derived products from Schedule I status, but there is still much CBD produced from plants that are above the 0.3 percent threshold and it is unclear how CBD in general is going to be treated. FDA made it clear that the 2018 bill did not impact the agency’s regulatory authority over CBD and other hemp-derived products used in food and drugs. FDA will be hosting a public meeting to gather input from stakeholders on the development of policy regarding the regulation of these products.
Crop Insurance: Uncertainty also exists over how hemp will be treated under crop insurance in the near future. Fortunately, USDA’s Risk Management Agency issued a bulletin on Feb. 25 addressing some of the questions about how hemp will be treated now that it is covered in the 2018 farm bill. The bulletin established that a producer who derived part of his revenue from hemp (as defined in the 2018 farm bill), would not be found ineligible to participate in the Whole Farm Revenue Protection Plan. In the past, since hemp was classified under Schedule I, if any revenue of the operation came from a Schedule I substance, the producer would be ineligible for all insurance under that policy. Unfortunately, since hemp was classified as a Schedule I substance when the 2019 WFRP was published in August 2018, hemp as a commodity is not insurable in 2019. This means that a producer can grow hemp in 2019 without becoming ineligible to insure their other commodities but cannot have that hemp insured under WFRP. In 2019, there is no safety net for this crop. So, producers who get into the game must understand that they could lose their investment in the crop if it fails. Most observers think that in 2020 hemp will be a covered commodity for crop insurance, but questions still remain. For example, let’s say a farmer enrolls his hemp crop in crop insurance, but then the crop goes over the 0.3 percent limit required by law and the farmer has to destroy the crop. Would that be a covered loss?
Supply Chain: Because industrial hemp production had been illegal in the U.S. prior to the 2014 farm bill, procuring the seed used to grow hemp has been a challenge. Since other countries have had legal production for a few decades now, most of the seeds come from Canada and Europe. Additionally, downstream processing for hemp and hemp-derived products has a long way to go in terms of developing the supply chain in the U.S. Even if the consumer demand for a product is there and farmers are growing the crop, the supply chain link between the farmer and the consumer needs to have capacity to process and develop the product. This will likely take some time.
THC Threshold and Genetics: Since most of the seeds used to produce hemp have been imported from other countries, the U.S. still doesn’t have a very long history of research into how some of these seeds acclimate to this climate. If a farmer brings in seed from Europe, and the hemp crop tests at above the 0.3 percent THC at harvest, then that crop becomes illegal and must be destroyed. This is likely more of a short-term issue as producers and researchers develop a better understanding for how different genetics express themselves.
Hemp as an agricultural commodity could be an exciting game changer, but there are no guarantees. Some pro-hemp activists have cultivated the idea that the hemp market already is poised to take off and become massive, while ignoring the many challenges still facing the industry. In the U.S. hemp still is very new, and with the potential it offers comes issues such as developing the supply chain, branding the product, educating consumers and policymakers, developing end markets and a host of other challenges. Additionally, there is a great amount of uncertainty surrounding the hemp market in general, as well as in the policy and regulatory arenas. There certainly are great possibilities for hemp in the U.S., but the industry is still at square one, and has a lot of hard work ahead of it.
U.S. Food and Drug Administration
Testimony of Amy Abernethy, Md, Phd., Principal Deputy Commissioner, Office of the Commissioner, Food and Drug Administration, Department of Health And Human Services
before the Senate Committee on Agriculture, Nutrition, and Forestry
Good morning, Chairman Roberts, Ranking Member Stabenow, and Members of the Committee. I am Dr. Amy Abernethy, Principal Deputy Commissioner of the Food and Drug Administration (FDA or the Agency), which is part of the U.S. Department of Health and Human Services (HHS). Thank you for the opportunity to appear before you today to discuss FDA’s role in the regulation of hemp products. I am also pleased to appear with Greg Ibach from the U.S. Department of Agriculture (USDA) and Alexandra Dunn from the Environmental Protection Agency (EPA). FDA works collaboratively with USDA and EPA on a day in and day out basis across the Agency’s programs to ensure coordination across the Federal government.
First, I would like to thank this Committee for explicitly preserving FDA’s authority over hemp products in the Agriculture Improvement Act of 2018 (2018 Farm Bill, PL 115-334). We recognize the substantial potential that hemp has for our nation’s farmers and agriculture sector. FDA’s approach to cannabis and cannabis derived products, including hemp products, is to treat these products just like we do any other. FDA is committed to advancing hemp products through the Agency’s existing regulatory pathways, and we are further exploring whether it would be appropriate to make additional regulatory pathways available to hemp products such as those containing cannabidiol (CBD). FDA believes taking this approach protects patients and the public health, fosters innovation for safe and appropriate products, and promotes consumer confidence.
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 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 Epidiolex 4 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.
It has only been seven months since the 2018 Farm Bill removed hemp, which includes low- THC 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 Bill 5 . 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 injury 6 . 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.
Listening to and Learning from Stakeholders
As part of the Agency’s commitment to engage the public on cannabis products and their derivatives, we held a public hearing on May 31, 2019. The goal of the public hearing was to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. The hearing was attended in person by more than 600 people, with over 2,000 more viewing it on line, and included presentations from more than 100 speakers, representing a broad and diverse array of stakeholders, including patients, consumers, and their advocacy groups; health care providers; academia; manufacturers, retailers and distributors; agricultural coalitions; and state, tribal, and local government representatives.
The public hearing raised many issues, including the need for more and better data regarding the benefits and risks of CBD, concerns related to manufacturing, adulteration, and unlawfully marketed products, and even as simple as the need for consistent terminology related to cannabis products. We opened a public docket to collect comments as part of the public hearing, and it just closed on July 16, 2019. We received 4,492 comments submitted to the docket, which we have been reviewing. As this issue progresses, we are committed to being transparent with the public about our path forward and providing information that is based on sound science and data.
We recognize that hemp producers, the food and supplements industry, the pharmaceutical industry, retailers, academic institutions, patients, and consumers all want and need regulatory certainty in this area. The Agency has also put out several statements since the passage of the 2018 Farm Bill to keep the public informed about the current regulatory landscape and our efforts to consider the appropriateness of potential new pathways for cannabis products 7 . We also maintain a Questions and Answers page on cannabis products to help address questions from the public and our stakeholders 8 . We are committed to keep the public updated on this evolving area.
Working with our Federal, State, Tribal, and Local Partners
FDA recognizes that our approach to regulating hemp products must occur in close collaboration with our Federal, state, tribal, and local regulatory partners.
First, I would like to thank my counterparts from USDA and EPA who are also testifying today. FDA has strong relationships with these agencies, and we are working closely with them as USDA and states implement the hemp provisions in the 2018 Farm Bill.
FDA and USDA staff and leaders have participated in numerous meetings and conversations regarding cannabis issues. These include a recent conference with senior leaders from the USDA Agricultural Marketing Service Specialty Crops Program to discuss the agencies’ respective roles and responsibilities. FDA and USDA remain in close communication on this issue.
FDA and EPA are engaged in sustained information sharing. For example, earlier this spring, FDA provided EPA’s Office of Pesticide Programs with information regarding FDA’s regulation of cannabis and cannabis-derived products, including information regarding the recent public hearing. FDA and EPA remain in communication on this issue and plan to further discuss together moving forward.
FDA has been working closely with our state, tribal, and local partners to assist them in navigating the regulation of hemp products, including those that contain CBD. A number of states, tribes, and local jurisdiction have enacted various laws that decriminalize or allow different types of cannabis compounds or products under state law. FDA is also aware that products that contain CBD have become available in these jurisdictions, as well as in jurisdictions that have not enacted any cannabis legalization-related legislation.
We remain committed to moving forward on the regulation of hemp products in close coordination with our Federal, state, and local partners.
Preserving Incentives for Research and Drug Development
While FDA is considering the possibility of new legal pathways for CBD products, we know that it is important to maintain adequate incentives for drug research and development. Drugs have important therapeutic value and are approved after rigorous scientific studies that provide important new information about therapeutic uses. It is critical that we continue to do what we can to support the science needed to develop new drugs from cannabis. To date, FDA has approved four drugs that contain active ingredients that are cannabinoids found in or related to the cannabis plant. In addition to Epidiolex, which contains plant-derived purified CBD, and was approved for treating two rare forms of pediatric epilepsy, FDA has approved three drugs containing other cannabinoids for treating the side effects of chemotherapy, such as nausea 9 . Among these three products, two contain synthetically-derived dronabinol, which is chemically identical to THC, and the third contains nabilone, a synthetic chemical analogue of THC, not naturally occurring in cannabis.
FDA has also received feedback from stakeholders interested in conducting research with cannabis and CBD. FDA is committed to doing what we can to facilitate and preserve incentives for clinical research. We are concerned that widespread availability of CBD in products like foods or dietary supplements could reduce commercial incentives to study CBD for potential drug uses, which would be a loss for patients.
To conduct clinical research that could potentially lead to an approved new drug, researchers need to submit an Investigational New Drug application to the FDA’s Center for Drug Evaluation and Research. For use as an animal drug product, researchers would establish an Investigational New Animal Drug file with the FDA’s Center for Veterinary Medicine.
Because the 2018 Farm Bill removed hemp from the definition of marijuana in the CSA, this change may streamline the process for researchers to study certain cannabis derivatives that have no more than 0.3% THC by dry weight, including cannabinoids such as CBD, which could advance the development of new drugs from those substances.
The 2018 Farm Bill made tremendous changes to the regulation of hemp products, and FDA is fully committed to the work that lies ahead in this space. We are working, and will continue to work, quickly and efficiently. We recognize the significant interest and potential this crop has for farmers across the United States. FDA looks forward to keeping Congress and stakeholders updated on our work to bring appropriate hemp products to market through existing regulatory pathways, as well as our efforts to determine whether additional regulatory frameworks are appropriate for products containing CBD. Our work on hemp products will continue to be founded in our public health mission and our commitment to making sound, science-based policy.
Thank you for the opportunity to discuss FDA’s regulation of hemp products. I would be happy to answer any questions.
The Farm Bill, hemp legalization and the status of CBD: An explainer
This week, Congress agreed to the final version of the 2018 Farm Bill, and President Trump is expected to sign the legislation within days. But this is not your typical farm bill. While it provides important agricultural and nutritional policy extensions for five years, the most interesting changes involve the cannabis plant. Typically, cannabis is not part of the conversation around farm subsidies, nutritional assistance, and crop insurance. Yet, this year, Senate Majority Leader Mitch McConnell’s strong support of and leadership on the issue of hemp has thrust the cannabis plant into the limelight.
For a little bit of background, hemp is defined in the legislation as the cannabis plant (yes, the same one that produces marijuana) with one key difference: hemp cannot contain more than 0.3 percent of THC (the compound in the plant most commonly associated with getting a person high). In short, hemp can’t get you high. For decades, federal law did not differentiate hemp from other cannabis plants, all of which were effectively made illegal in 1937 under the Marihuana Tax Act and formally made illegal in 1970 under the Controlled Substances Act—the latter banned cannabis of any kind.
It’s true that hemp policy in the United States has been drastically transformed by this new legislation. However, there remain some misconceptions about what, exactly, this policy change does.
Hemp is legal in the United States—with serious restrictions
The allowed pilot programs to study hemp (often labeled “industrial hemp”) that were approved by both the U.S. Department of Agriculture (USDA) and state departments of agriculture. This allowed small-scale expansion of hemp cultivation for limited purposes. The 2018 Farm Bill is more expansive. It allows hemp cultivation broadly, not simply pilot programs for studying market interest in hemp-derived products. It explicitly allows the transfer of hemp-derived products across state lines for commercial or other purposes. It also puts no restrictions on the sale, transport, or possession of hemp-derived products, so long as those items are produced in a manner consistent with the law.
However, the new Farm Bill does not create a completely free system in which individuals or businesses can grow hemp whenever and wherever they want. There are numerous restrictions.
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First, as noted above, hemp cannot contain more than 0.3 percent THC, per section 10113 of the Farm Bill. Any cannabis plant that contains more than 0.3 percent THC would be considered non-hemp cannabis—or marijuana—under federal law and would thus face no legal protection under this new legislation.
Second, there will be significant, shared state-federal regulatory power over hemp cultivation and production. Under section 10113 of the Farm Bill, state departments of agriculture must consult with the state’s governor and chief law enforcement officer to devise a plan that must be submitted to the Secretary of USDA. A state’s plan to license and regulate hemp can only commence once the Secretary of USDA approves that state’s plan. In states opting not to devise a hemp regulatory program, USDA will construct a regulatory program under which hemp cultivators in those states must apply for licenses and comply with a federally-run program. This system of shared regulatory programming is similar to options states had in other policy areas such as health insurance marketplaces under ACA, or workplace safety plans under OSHA—both of which had federally-run systems for states opting not to set up their own systems.
Third, the law outlines actions that are considered violations of federal hemp law (including such activities as cultivating without a license or producing cannabis with more than 0.3 percent THC). The law details possible punishments for such violations, pathways for violators to become compliant, and even which activities qualify as felonies under the law, such as repeated offenses.
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Ultimately, the Farm Bill legalizes hemp, but it doesn’t create a system in which people can grow it as freely as they can grow tomatoes or basil. This will be a highly regulated crop in the United States for both personal and industrial production.
Hemp research remains important
One of the goals of the 2014 Farm Bill was to generate and protect research into hemp. The 2018 Farm Bill continues this effort. Section 7605 re-extends the protections for hemp research and the conditions under which such research can and should be conducted. Further, section 7501 of the Farm Bill extends hemp research by including hemp under the Critical Agricultural Materials Act. This provision recognizes the importance, diversity, and opportunity of the plant and the products that can be derived from it, but also recognizes an important point: there is a still a lot to learn about hemp and its products from commercial and market perspectives. Yes, farmers—legal and illegal—already know a lot about this plant, but more can and should be done to make sure that hemp as an agricultural commodity remains stable.
Deputy Director – Center for Effective Public Management
Senior Fellow – Governance Studies
Hemp farmers are treated like other farmers
Under the 2018 Farm Bill hemp is treated like other agricultural commodities in many ways. This is an important point. While there are provisions that heavily regulate hemp, and concerns exist among law enforcement—rightly or wrongly—that cannabis plants used to derive marijuana will be comingled with hemp plants, this legislation makes hemp a mainstream crop. Several provisions of the Farm Bill include changes to existing provisions of agricultural law to include hemp. One of the most important provisions from the perspective of hemp farmers lies in section 11101. This section includes hemp farmers’ protections under the Federal Crop Insurance Act. This will assist farmers who, in the normal course of agricultural production, face crop termination (crop losses). As the climate changes and as farmers get used to growing this “new” product, these protections will be important.
Cannabidiol or CBD is made legal—under specific circumstances
One big myth that exists about the Farm Bill is that cannabidiol (CBD)—a non-intoxicating compound found in cannabis—is legalized. It is true that section 12619 of the Farm Bill removes hemp-derived products from its Schedule I status under the Controlled Substances Act, but the legislation does not legalize CBD generally. As I have noted elsewhere on this blog CBD generally remains a Schedule I substance under federal law. The Farm Bill—and an unrelated, recent action by the Department of Justice—creates exceptions to this Schedule I status in certain situations. The Farm Bill ensures that any cannabinoid—a set of chemical compounds found in the cannabis plant—that is derived from hemp will be legal, if and only if that hemp is produced in a manner consistent with the Farm Bill, associated federal regulations, association state regulations, and by a licensed grower. All other cannabinoids, produced in any other setting, remain a Schedule I substance under federal law and are thus illegal. (The one exception is pharmaceutical-grade CBD products that have been approved by FDA, which currently includes one drug: GW Pharmaceutical’s Epidiolex.)
There is one additional gray area of research moving forward. Under current law, any cannabis-based research conducted in the United States must use research-grade cannabis from the nation’s sole provider of the product: the Marijuana Program at the University of Mississippi School of Pharmacy’s National Center for Natural Products Research. That setup exists because of cannabis’s Schedule I status. However, if hemp-derived CBD is no longer listed on the federal schedules, it will raise questions among medical and scientific researchers studying CBD products and their effects, as to whether they are required to get their products from Mississippi. This will likely require additional guidance from FDA (the Food and Drug Administration who oversees drug trials), DEA (the Drug Enforcement Administration who mandates that research-grade cannabis be sourced from Mississippi), and NIDA (National Institute on Drug Abuse who administers the contract to cultivate research-grade cannabis) to help ensure researchers do not inadvertently operate out of compliance.
State-legal cannabis programs are still illegal under federal law
The Farm Bill has no effect on state-legal cannabis programs. Over the past 22 years, 33 states have legalized cannabis for medical purposes, and over the past six years, 10 states have legalized cannabis for adult use. Every one of those programs is illegal under federal law, with no exceptions, and the Farm Bill does nothing to change that. That said, many in the advocacy community hope that the reforms to hemp policy under the Farm Bill serve as a first step toward broader cannabis reform. (Although I would argue that a soon-to-be-sworn-in Democratic House majority alongside a president with a record of pro-cannabis reform rhetoric is the more likely foundation for broader cannabis reform.)
Even CBD products produced by state-legal, medical, or adult-use cannabis programs are illegal products under federal law, both within states and across state lines. This legal reality is an important distinction for consumer protection. There are numerous myths about the legality of CBD products and their availability. Under the 2018 Farm Bill, there will be more broadly available, legal, CBD products; however, this does not mean that all CBD products are legal moving forward. Knowing your producer and whether they are legal and legitimate will be an important part of consumer research in a post-2018 Farm Bill world.
Mitch McConnell, cannabis champion?
Many advocates applaud Leader McConnell for his stewardship of these hemp provisions into the Farm Bill and his leadership on the legislation overall. That assessment is accurate. Without Mr. McConnell’s efforts, the hemp provisions would never had found their way into the legislation initially. And although his position as Senate leader gave him tremendous institutional influence over the legislation, he went a step further by appointing himself to the conference committee that would bring the House and Senate together to agree on a final version.
McConnell understood much about this issue. First, he knows hemp doesn’t get you high and that the drug war debate that swept up hemp was politically motivated, rather than policy-oriented. Second, Kentucky—the leader’s home state—is one of the best places to cultivate hemp in the world, and pre-prohibition the state had a robust hemp sector. Third, the grassroots interest in this issue was growing in Kentucky, and McConnell knows that his role as Senate Majority Leader hangs in the balance in 2020, as does his Senate seat as he faces re-election that same year. McConnell emerges from the Farm Bill as a hemp hero, but advocates should be hesitant to label him a cannabis champion; Leader McConnell remains a staunch opponent of marijuana reform and his role in the Senate could be the roadblock of Democratic-passed legislation in the 116 th Congress.
 Under the Controlled Substances Act, all controlled drugs fall under five schedules. Schedule I has the highest level of control, designated a substance as having no safe medical use and has a high risk of abuse or misuse. Schedule I substances are illegal under the law.