Hemp in the Modern World: The Yearslong Wait for FDA Action (U.S. House Committee on Oversight and Accountability, Subcommittee on Health Care and Financial Services)

Hearing	Hemp in the Modern World: The Yearslong Wait for FDA Action
Committee	U.S. House Committee on Oversight and Accountability, Subcommittee on Health Care and Financial Services
Date	July 27, 2023

 

Hearing Takeaways:

• Current U.S. Hemp Landscape: The hearing focused on the current state of the U.S. hemp landscape following the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill). This law had legalized the growth and sale of hemp and hemp-derived products, including cannabidiol (CBD). Subcommittee Members and the hearing’s witnesses expressed support for the legalization of hemp and hemp-derived products and highlighted how these products can have many beneficial uses (including medicinal uses). They noted however that the U.S. Food and Drug Administration (FDA) has not adopted regulations for these products in the years following the 2018 Farm Bill’s passage. They expressed concerns that this current lack of regulation poses health and safety risks to consumers and undermines the efforts of scrupulous hemp producers and companies to fairly compete within the market.
  • Scientific Evidence for the Safety of Hemp and Hemp-Derived Products: Subcommittee Republicans, Mr. Miller, and Dr. Henderson asserted that the FDA is refusing to recognize scientific evidence regarding the safety of hemp and hemp-derived products. They stated that there exists ample evidence regarding the safety of these products and accused the FDA of failing to recognize this evidence to justify their continued inaction on hemp regulation. Rep. Summer Lee (D-PA) and Dr. Schauer argued however that that there remains uncertainty regarding the safety of consuming hemp and hemp-derived products. They stated that there are safety questions related to consumption amounts, the form in which these products are consumed, interactions between these products and other substances, the effects of these products on special populations (such as children and the elderly), and the long-term impact of these products.
  • Prevalence of Intoxicating Hemp-Derived Products: Subcommittee Members, Mr. Miller, Mr. Badaracco, and Dr. Schauer expressed concerns over the prevalence of intoxicating hemp-derived products (particularly Delta-8 THC). They noted how these intoxicating products are legal because of the 2018 Farm Bill and raised specific concerns regarding the ability of children to obtain these products. They highlighted how the consumption of these products is leading users to experience hospitalizations and unexcited impairments. Mr. Miller stated however that these intoxicating products have been a “lifesaver” for many farmers who have struggled financially due to the lack of federal CBD regulation.
  • Hemp and Hemp-Related Product Labelling Problems: Subcommittee Members and Dr. Schauer raised concerns that U.S. consumers are currently unable to verify the purity or potency of retail hemp and hemp-related products due to the FDA’s lack of hemp regulations. They stated that this lack of regulation is resulting in hemp products being marketed and sold with inaccurate dosage labels. They lamented that this lack of accurate labeling is harming both consumers and the hemp industry. Subcommittee Members, Mr. Miller, Mr. Badaracco, and Dr. Schauer also noted how the current lack of regulation for hemp products has led commercially available hemp and hemp-derived products to contain contaminants, such as heavy metals, mold, THC, and pesticides.
  • FDA Enforcement Actions: Subcommittee Chairman Lisa McClain (R-MI) and Mr. Miller asserted that the FDA has not engaged in meaningful enforcement actions within the hemp and hemp-derived products space. Mr. Miller expressed frustration that the FDA has only issued warning letters for CBD products making illegal medical treatment claims and contended that the FDA should do more to police this space.
  • Impact of Policy Uncertainty on Hemp Producers: Mr. Miller stated that federal regulatory uncertainty “severely” impacts the U.S. hemp and CBD markets and indicated that reduced manufacturing demand has resulted in a greater than 90 percent commodity price decline (which has significantly damaged U.S. hemp farming opportunities). He asserted that this regulatory uncertainty has caused many large retailers to not carry hemp and hemp-derived products. He also stated that this lack of action has caused many food and beverage companies to not add CBD into their mixes.
  • Industry Self-Regulation through the U.S. Hemp Authority: Mr. Miller and Mr. Badaracco discussed how the U.S. hemp industry had established the U.S. Hemp Authority, which is a self-regulatory organization (SRO) to promote high standards and best practices for hemp and hemp-derived products. They noted that the U.S. Hemp Authority’s standards are largely based on the FDA’s regulatory regime concerning dietary supplements and food and beverage additives and that third-party auditors enforce these standards. Mr. Badaracco asserted however that self-regulation is not sufficient for the U.S. hemp industry. He contended that federal regulation of hemp and hemp-derived products is necessary to ensure that all available products maintain high safety standards.
  • State Regulation of the U.S. Hemp Industry: Mr. Miller, Mr. Badaracco, and Dr. Schauer lamented how the lack of federal regulation for hemp and hemp-derived products has led states to adopt their own regulatory frameworks for hemp and hemp-derived products. They warned that this state-based regulatory approach is creating an inconsistent “patchwork” of regulations, which poses consumer safety and market challenges and regulatory gaps that states alone cannot address. Dr. Schauer indicated these regulatory gaps include those in online markets and interstate commerce. 
  • Foreign Regulation of Hemp: Rep. Glenn Grothman (R-WI) and Mr. Miller discussed how other countries currently maintain robust regulatory frameworks for hemp and hemp-derived products (such as CBD). Mr. Miller remarked that the U.S. CBD market is not different from the CBD markets in other countries. He stated that the U.S. should study how the UK, Australia, and Canada regulate CBD and apply lessons learned from these countries as it develops its own regulatory framework for CBD.
• Policy Proposals for Regulating Hemp and Hemp-Derived Products: Subcommittee Members and the hearing’s witnesses expressed interest in developing a federal regulatory framework for hemp and hemp-derived products. Mr. Miller mentioned how the Brightfield Group had estimated that such regulation would be worth $5 billion annually. However, Subcommittee Members and the hearing’s witnesses differed as to whether federal hemp regulation could be pursued using the FDA’s existing authorities or whether new legislation would be necessary to enable this regulation.
  • FDA Regulation of Hemp and Hemp-Derived Products Under Existing Authority: Subcommittee Republicans, Mr. Miller, and Dr. Henderson contended that the FDA should use its existing authorities under the 2018 Farm Bill to regulate hemp and hemp-derived products as dietary supplements and food additives. They criticized the FDA for its failure to pursue such regulations in the five years following the 2018 Farm Bill’s passage and asserted that this lack of regulation is harming consumers and the U.S. hemp industry. Mr. Miller expressed support for several pieces of legislation that would explicitly direct the FDA to pursue regulation of hemp and hemp-related products through dietary supplement and food and beverage additive pathways. He suggested that these bills could be attached to the upcoming 2023 Farm Bill. Subcommittee Chairman Lisa McClain (R-MI) stated that Congress should consider cutting the FDA’s funding if it continues to not take action to regulate hemp and hemp-derived products.
  • Adoption of New Legislation to Establish a Regulatory Framework for Hemp and Hemp-Derived Products: Subcommittee Democrats, Mr. Badracco, and Dr. Schauer argued that Congress should pass new legislation to develop a regulatory framework for hemp and hemp-derived products. Subcommittee Democrats and Dr. Schauer argued that it would be inappropriate to regulate hemp and hemp-derived products under existing pathways for dietary supplements and food and beverage additives and that new legislation could provide a better tailored regularly framework for these products. Dr. Schauer specifically stated that this new regulatory pathway should account for inhalable and combustible products, contaminants present in the products, and labeling based on route of administration. Mr. Miller expressed receptiveness to policy proposals that would impose additional regulatory requirements for CBD so long as Congress directs the FDA to regulate the substance. Subcommittee Republicans accused the FDA of attempting to take advantage of this situation to call for more authority, staff, and money to carry out its existing duties under the law.
• Other Policy Topics: Subcommittee Members and Mr. Miller further used the hearing to discuss additional cannabis and hemp-related policy topics and concerns regarding the FDA.
  • Permitting People with Prior Cannabis Use Histories to Access Federal Employment Opportunities: Full Committee Ranking Member Jamie Raskin (D-MD) discussed his bipartisan legislation, the Cannabis Users Restoration of Eligibility (CURE) Act, which would eliminate prior marijuana use as an obstacle for obtaining federal government jobs and passing the federal security clearance process. He lamented how many Americans are prevented from applying for federal employment opportunities due to prior marijuana use.
  • Promoting Diversity within the U.S. Hemp Industry: Rep. Summer Lee (D-PA) and Mr. Miller remarked that the U.S. must encourage diversity and inclusion in the U.S. hemp industry. Mr. Miller remarked that cannabis policy has a “sad history” regarding the disparate treatment of people of color and noted how the U.S. Hemp Roundtable (and the broader industry) has worked to promote diversity and equity to address and help remedy this previous discrimination.
  • FDA Telework Policies: Subcommittee Chairman Lisa McClain (R-MI) criticized the FDA for not returning to its pre-COVID-19 pandemic telework policy. She suggested that having FDA staff work in-person might improve the Agency’s ability develop a regulatory framework for hemp and hemp-derived products.

Hearing Witnesses:

1. Mr. Jonathan S. Miller, General Counsel, U.S. Hemp Roundtable
2. Dr. Rayetta G. Henderson, Ph.D. Senior Managing Scientist, ToxStrategies, LLC
3. Mr. Richard A. Badaracco, President-Elect, Kentucky Narcotic Officers Association, (Retired) Assistant Special Agent in Charge, U.S. Drug Enforcement Administration
4. Dr. Gillian L. Schauer, PhD, MPH, Executive Director, Cannabis Regulators Association (CANNRA)

Member Opening Statements:

Subcommittee Chairman Lisa McClain (R-MI):

• She discussed how the 2018 Farm Bill had legalized the growth and sale of hemp and hemp-derived products, including CBD.
  • She also noted that this law had removed CBD’s Schedule I status under the Controlled Substances Act and expressed support for this change.
• She indicated that CBD has medicinal uses and mentioned how the FDA has approved a prescription CBD drug that is used to treat children with severe forms of epilepsy.
  • She also commented that pure CBD does not have a high potential for abuse and is not intoxicating.
• She stated however that U.S. consumers are currently unable to verify the purity or potency of retail CBD products and cannot rely on the FDA to enforce CBD regulations.
  • She mentioned how one study that tested almost 3,000 CBD products had found that only one quarter of the brands had tested their CBD products for purity and that only 16 percent of those products tested contained exclusively what was stated on their labels.
• She attributed these problems to the FDA’s failure to regulate CBD as a dietary supplement or a food additive in the five years since the 2018 Farm Bill’s passage.
• She also discussed how it is common for CBD products to contain contaminants, such as heavy metals, mold, and THC.
  • She explained that THC is the intoxicating chemical in the cannabis plant.
• She highlighted how the widespread usage of CBD products that contain unknown contaminants has led children to accidentally ingest and overdose on THC.
• She asserted that these problems could be avoided if the FDA were to regulate CBD as a dietary supplement.
  • She commented that such regulation would provide the FDA with the authority to enforce labeling requirements and keep Americans safe and healthy.
• She noted however that the FDA had recently argued that it requires a new regulatory framework for hemp and CBD and that it could not rely upon its existing authorities.
  • She characterized the FDA’s position as calling for more authority, staff, and money to carry out its existing duties under the law.
• She stated that the FDA’s recent announcement has led to market confusion and uncertainty, which has suppressed the ability of good faith manufacturers to sell CBD products.
  • She commented that this announcement only benefits bad actors that take advantage of the confusion and floods the market with potentially unsafe products.
• She remarked that the FDA must use their existing authorities to regulate hemp-derived products.

Subcommittee Ranking Member Katie Porter (D-CA):

• She discussed how hemp-derived products may provide numerous health benefits (including the easing of anxiety, insomnia, chronic pain, and addiction) and noted how there is bipartisan interest in regulating these products.
  • She highlighted how hemp-derived products (such as CBD) can currently be purchased at grocery stores or be ordered online to be shipped anywhere in the U.S.
• She noted however that hemp-derived products are currently not regulated at the federal level and that this lack of regulation could lead many of these products to include THC (which is an intoxicant).
• She highlighted how these products can be sold in packaging that can resemble traditional snack foods.
  • She commented that this situation can be confusing to both adults and children who may not want or intend to consume products with intoxicating levels of THC.
• She called this situation problematic and mentioned how the FDA and the U.S. Federal Trade Commission (FTC) had recently issued warning letters to six companies for illegally selling products containing THC.
  • She asserted that the federal government must regulate hemp-derived products in a manner that both protects Americans and makes safe products available.
• She discussed how the FDA had recently convened an internal working group to explore how the Agency might pursue regulation of hemp-derived products and indicated that this FDA working group had called for a new regulatory pathway for these products.
  • She added that this FDA working group had expressed interest in working with Congress to establish this new regulatory pathway for hemp-derived products through legislation.
• She accused Subcommittee Republicans of taking an inconsistent approach in their criticisms of the FDA.
  • She characterized the position of Subcommittee Republicans as calling for the FDA to use their existing authorities to regulate novel hemp-derived products while being critical when the FDA uses their existing authorities to regulate other novel products.
• She stated that the FDA knows that Congress will hold it accountable if it exceeds its authorities, which discourages the Agency from pursuing an ambitious regulatory agenda.
• She called it unnecessary for the FDA to pursue regulations of hemp-derived products that may exceed their existing authorities and asserted that Congress should instead work with the FDA to develop a new regulatory pathway for these products.
  • She noted how there is bipartisan interest in ensuring the safety of hemp-derived products and commented that Congress should be able to develop a regulatory pathway in a bipartisan manner.

Full Committee Chairman James Comer (R-KY):

• He discussed how the 2018 Farm Bill had removed hemp and hemp-derived products (including CBD) from Schedule I status under the Controlled Substances Act.
• He noted how farmers, manufacturers, researchers, and distributors have worked in the ensuing years to grow the hemp industry and to provide hemp and CBD products to Americans.
  • He mentioned how the U.S. Department of Agriculture’s (USDA) February 2022 National Hemp Report shows that over 54,000 acres of U.S. land is used for hemp farming.
• He remarked that hemp has significant potential for the U.S. economy that can benefit producers, businesses, and consumers.
  • He discussed how scientific research and studies have highlighted the efficiency and safety of hemp and hemp-derived products (especially CBD).
• He noted that while the FDA has continued to imply that adequate scientific data is not available to inform their decision making around CBD and hemp-derived products, he asserted that there exists ample available data studying CBD and hemp-derived compounds.
  • He accused the FDA of not being transparent with industry stakeholders or Congress as to which scientific studies it relies upon.
  • He also accused the FDA of shifting its standards for researchers attempting to satisfy the FDA’s requirements through rigorous studies.
• He stated that the FDA has taken no meaningful action to provide clear guidance and certainty to the market and has refused to regulate CBD products under existing lawful pathways.
  • He commented that the absence of FDA CBD regulations hinders good faith CBD producers and harms consumers.
• He called on the FDA to take action to regulate hemp and hemp-derived products using their existing authorities.
• He then discussed how the FDA’s inaction on hemp regulation poses concerns for consumers and noted how many commercially available hemp and hemp-derived products include claims about content and dosage that may not be accurate.
  • He added that many of these products may be mislabeled and contain intoxicating variants of the cannabis plant, including Delta-8 THC and Delta-9 THC.
• He remarked that Americans need to know what is in the products that they are consuming and asserted that the FDA has the power to regulate CBD as a dietary supplement or as a food additive.
  • He also raised concerns over the ability of children to access potentially dangerous hemp-derived products and asserted that these products should be clearly labeled with an accurate accounting of their contents.
• He mentioned how he personally uses CBD products that are developed in laboratories based in his Congressional District and expressed his confidence in these laboratories.
• He stated that it would be beneficial to both industry and consumers to have hemp-derived products with accurate labeling and that the FDA’s regulation of CBD products as dietary supplements would support this outcome.
  • He expressed frustration with the FDA’s inaction in this space and the FDA’s requests for more authorities and money from Congress.

Full Committee Ranking Member Jamie Raskin (D-MD):

• He noted that while the hearing is focused on hemp, he stated that the hearing’s topic is part of a larger conversation regarding federal cannabis policy.
• He discussed how he had just introduced the bipartisan CURE Act with Rep. Nancy Mace (R-SC).
  • He explained that this legislation would remove prior marijuana use as an obstacle for obtaining federal government jobs and passing the federal security clearance process.
• He indicated that he had become interested in this issue when one of his constituents had been denied a federal job in the Biden administration for honestly reporting their medicinal cannabis use for a chronic back condition.
  • He added that this story is not an isolated incident and noted that many Americans are prevented from applying for federal employment opportunities due to prior marijuana use.
• He then remarked that the U.S. should take a “commonsense” approach toward the regulation of hemp and hemp-derived products.
• He mentioned how the FDA had recently stated that its current regulatory frameworks for foods and supplements are inappropriate for CBD products. 
  • He noted how the FDA had claimed that these regulatory frameworks may be insufficient for managing risk and conducting appropriate oversight for CBD products.
• He stated that the U.S. needs “reasonable” regulations for the hemp and hemp-derived product marketplaces to protect consumers and ensure that legitimate hemp businesses can operate and grow.
• He discussed how there exist many hemp-derived products beyond CBD and highlighted the development of synthetic cannabinoids.
  • He indicated that these synthetic cannabinoids include Delta-8 THC, which can have intoxicating effects when consumed.
• He warned that an absence of regulation for hemp and hemp-derived products can enable companies to synthesize intoxicants from legal hemp and evade regulatory scrutiny and federal marijuana laws.
  • He commented that this situation enables products to reach the market without proper testing, labeling, and other safety precautions.
• He then noted how hemp-derived products can come in a variety of forms and stated that these products cannot always be categorized as food or dietary supplements.
  • He indicated that these products include oils, tinctures, vaporizer pens, cigarettes, cosmetics, and skin care products.
• He remarked that the FDA cannot realistically regulate hemp and its derivatives without additional research authority and resources.
  • He expressed hope that the Subcommittee could develop a new pathway for regulating hemp and hemp-derived products.

Witness Opening Statements:

Mr. Jonathan S. Miller (U.S. Hemp Roundtable):

• He discussed how the U.S. hemp industry has always achieved its policy successes through bipartisanship and lamented how the U.S. hemp industry has faced significant challenges in recent years.
  • He largely attributed these challenges to the FDA’s decisions.
• He noted how the 2018 Farm Bill had explicitly legalized the sale of hemp and its derivatives (such as CBD) and highlighted how U.S. farmers have since invested considerable resources into growing and marketing commercial hemp crops.
  • He mentioned how U.S. farmers had focused on growing and marketing CBD and cannabinoids because of the immediate processing infrastructure and consumer demand for these products.
• He noted that the FDA had quickly asserted that it is illegal to market CBD as a dietary supplement or use CBD as a food additive following the 2018 Farm Bill’s enactment.
  •  He indicated however that the FDA has only issued warning letters for CBD products making illegal medical treatment claims and commented that the FDA has not engaged in meaningful enforcement within the CBD space.
• He remarked that the FDA’s regulatory inaction regarding CBD products has created regulatory uncertainty for the hemp industry.
• He stated that the FDA has been capricious in its positions toward the CBD space since the 2018 Farm Bill’s enactment.
  • He noted that while the FDA had initially affirmed its ability to regulate CBD under current law, he indicated that the FDA has subsequently failed to take action to regulate the CBD space.
  • He also highlighted how the FDA had ignored Congressional Appropriations report directives to take expedited action on CBD.
• He noted how the FDA had concluded in January 2023 that it cannot regulate CBD under existing regulatory pathways due to a concern over the substance’s safety.
  • He asserted that this conclusion had relied upon a narrow set of research focused on high-dosage CBD isolate formulations.
  • He also commented that the FDA had refused to acknowledge a range of studies that demonstrate the safety of various CBD formulations at much lower dosage levels, such as those typically found in retail products.
• He remarked that the U.S.’s lack of a federal regulatory framework for hemp and hemp-derived products has resulted in a proliferation of unregulated products and commented that some of these products raise significant quality and safety concerns.
• He noted how surplus hemp CBD biomass is being chemically converted into impairing products, such as Delta-8 THC.
  • He indicated that these products are being sold in an unregulated fashion and sometimes to minors.
• He remarked that hemp and hemp-derived products serve as a “lifeline” to U.S. farmers and can provide considerable value to adult consumers when manufactured properly.
  • He contended that these products need to be permitted, strictly regulated for safety, and inaccessible to children.
• He also stated that federal regulatory uncertainty “severely” impacts the U.S. hemp and CBD markets and highlighted how reduced manufacturing demand has resulted in a greater than 90 percent commodity price decline (which has significantly damaged U.S. hemp farming opportunities).
  • He indicated however that the price of hemp flower had rebounded when it had started to be used widely for Delta-8 THC.
• He called on Congress to pass legislation to regulate hemp and CBD products.
  • He expressed support for the CBD Product Safety and Standardization Act of 2023, which would provide a regulatory pathway for CBD as a food and beverage additive.
  • He also expressed support for the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023, which would ensure that hemp ingredients could be lawfully marketed as dietary supplements.
  • He further expressed support for the Hemp Access and Consumer Safety Act, which would provide both aforementioned regulatory pathways.
• He noted that the aforementioned bills would require hemp and hemp-derived products to comply with existing regulatory frameworks for dietary supplements and foods.
  • He commented that these frameworks help to ensure that products are safe, properly labeled, and produced using good manufacturing practices.
• He indicated that while he disagreed with the FDA’s assertion that a new regulatory regime is needed for hemp and hemp-derived products, he expressed receptiveness to stricter regulation of CBD and other cannabinoid products on top of existing regulatory frameworks.
  • He cautioned however that a new regulatory regime for hemp and hemp-derived products would be very lengthy to adopt and implement.
• He then discussed how the U.S. hemp industry had established the U.S. Hemp Authority, which is a SRO to promote high standards and best practices for hemp and hemp-derived products.
• He also noted how states have developed their own regulatory frameworks for hemp and hemp-derived products, which has resulted in the emergence of an inconsistent “patchwork” of regulations. 
  • He warned that the absence of a federal regulatory pathway for hemp and hemp-derived products would result in a diminishment of economic opportunities for U.S. hemp farmers and the inability for U.S. consumers to access safe and quality products.
• He contended that federal hemp legislation is necessary to help protect consumers, stabilize hemp markets, enable a promising opportunity for the U.S. agriculture sector, and honor the 2018 Farm Bill’s promise.

Dr. Rayetta G. Henderson, Ph.D. (ToxStrategies, LLC):

• She testified that she has been assessing the safety of CBD and other hemp-derived products as a toxicologist since the enactment of the 2018 Farm Bill.
  • She indicated that safety studies from her company (ToxStrategies, LLC) and other available data provide a sufficient basis from which to determine safe levels of CBD for oral consumer use.
• She discussed how dietary ingredients must meet prescribed safety standards for their intended use, such as those established for new dietary ingredients.
• She mentioned how her company had conducted a safety testing program to address gaps identified for a CBD product that would need to be filled as part of regulatory compliance.
  • She commented that the need for these studies is based on standard for evaluating the safety of dietary ingredients.
• She noted how a dietary ingredient safety study’s finding of a potential adverse safety effect does not necessarily mean that there is a risk of that adverse safety effect occurring.
• She explained that preclinical toxicology studies are designed to be conducted at high enough exposure levels to identify potential adverse effects.
  • She commented that this design is important because exposure levels associated with human consumption may be very different from exposure levels tested in toxicology studies.
  • She further commented that substances considered to be beneficial and necessary for health can be toxic if consumed in large enough quantities.
• She stated that understanding the exposure levels at which adverse effects may occur provides the information necessary to determine a substance’s consumption levels that are unlikely to be associated with such effects.
• She noted how a risk assessment can be performed based on information from safety studies and exposure levels in consumers in order to evaluate whether a sufficiently protective margin of safety exists and to determine a safe level of intake for consumers.
  • She indicated that this ability to perform the risk assessment is predicated on having sufficient data available for an ingredient.
• She mentioned how her company had conducted six preclinical toxicity studies on a hemp-derived CBD isolate.
  • She indicated that all studies had been performed according to the highest standards available and involved the collaboration and oversight of scientists from multiple disciplines and research organizations.
  • She further indicated that three manuscripts summarizing these studies have undergone an independent peer review process and are now publicly available in scientific journals.
• She testified how her company’s testing program had found that CBD did not cause DNA or chromosomal damage.
  • She explained that this finding is significant because a genotoxic finding would have precluded CBD’s use as a dietary ingredient.
• She then mentioned how her company’s studies had demonstrated that CBD was well-tolerated following repeated consumption in animal models up to the highest dose tested.
  • She indicated that the highest dose tested was 140 milligrams per kilogram body weight for 90 days.
• She also noted how her company’s reproductive study had found that exposure of up to 100 milligrams per kilogram body weight per day did not cause adverse effects on fertility or reproduction in female animals or developmental effects for their offspring.
  • She commented that this value would be 100-fold higher than a dietary supplement product containing 70 milligrams of CBD.
• She further testified that her company had not observed any adverse effects on male reproductive parameters up to the highest dose tested of 300 milligrams per kilogram body weight per day.
• She remarked that the aforementioned studies provide sufficient data for evaluating the use of a dietary ingredient.
  • She commented that these studies add to an already “extensive” body of science for CBD, which includes human clinical trials and studies in animal models.
• She asserted that the available data are sufficient for conducting a safety assessment of hemp-derived CBD isolates.
• She further discussed how recommendations for the safe use of CBD (such as exposure levels) will depend on several factors, including the data available for review by the assessors and the population of interest for the product.
  • She commented that recommendations for safe use can be later refined as new data continues to become available.

Mr. Richard A. Badaracco (Kentucky Narcotic Officers Association):

• He discussed how the collapse of the hemp and CBD markets had led many farmers and businesses to chemically convert CBD biomass into intoxicating compounds.
  • He indicated that the most common of these intoxicating compounds is Delta-8 THC.
• He noted that while the passage of the 2018 Farm Bill and its deregulation of hemp did not specifically address Delta-8 THC, he stated that this law had effectively legalized the sale of Delta-8 THC products.
  • He highlighted how Delta-8 THC products have grown “dramatically” in popularity since 2020 because of this de facto legalization.
• He noted how hemp and marijuana are primarily the same plant, are often not visually distinguishable, and contain many cannabinoids.
  • He indicated that the two well-known compounds that are naturally produced in the cannabis plant are THC (both THC-8 and THC-9) and CBD.
• He stated that the primary distinction between hemp and marijuana involves the concentration of Delta-9 THC in the two plants.
  • He explained that hemp must contain no more than 0.3 percent Delta-9 THC while marijuana plants usually contain between 5 percent Delta-9 THC and 30 percent Delta-9 THC.
  • He noted that Delta-9 THC produces the intoxicating effects of the marijuana plant.
• He discussed how CBD is the more prevalent compound in the hemp plant and explained that the standard method for creating Delta-8 THC involves chemically extracting CBD from hemp and converting it into Delta-8 THC.
  • He highlighted how Delta-8 THC has psychoactive and intoxicating effects.
• He noted how Delta-8 THC products are sold throughout many states (including his commonwealth of Kentucky) throughout unregulated market sources, such as convenience stores, grocery stores, smoke shops, gas stations, and online stores.
  • He emphasized that Delta-8 THC products are not reliably tested and have been found to contain many impurities.
• He remarked that Congress and regulators may work with the U.S. Hemp Authority to address the aforementioned issues, which is the hemp industry’s SRO.
  • He noted how the U.S. Hemp Authority encourages hemp and hemp-derived product manufacturers to use best practices and higher standards in preparing their products.
• He indicated that the U.S. Hemp Authority’s standards are largely based on the FDA’s regulatory regime concerning dietary supplements and food and beverage additives.
  • He also indicated that third-party auditors enforce these standards.
• He asserted however that self-regulation is not sufficient for the U.S. hemp industry and contended that federal regulation of hemp and hemp-derived products is necessary to ensure the safety of these products.
  • He also highlighted how hemp and hemp-derived products and their abuse have become a common concern for law enforcement agencies.
• He remarked that Congress, law enforcement agencies, and states can address many issues within the hemp sector and called for legislation to address these issues.
  • He first called for legislation that would regulate the manufacturing, sale, and distribution of products containing hemp-derived cannabinoids and stated that this legislation should include a system for licensing retailers of these products.
  • He then called for legislation that would establish testing requirements for all products containing hemp-derived cannabinoids and create rules for pass-fail action levels for safety and toxicity.
  • He thirdly called for legislation to create child safety labeling requirements and restrictions on advertising for hemp and hemp-derived products.
  • He fourthly called for legislation to ensure that hemp and hemp-derived products contain only the legal limit of 0.3 percent or less of a concentration of THC.
  • He fifthly called for legislation to require mandatory reporting to a government entity when the ingestion of hemp and hemp-derived products has resulted in an adverse reaction.
  • He sixthly called for legislation to provide state or federal funding for forensic laboratory infrastructure that could help with the development of hemp and marijuana differentiation methods.
  • He lastly called for legislation to support training for law enforcement officers concerning hemp and hemp-derived products and navigating the possible implications of arresting and prosecuting individuals under the influence.

Dr. Gillian L. Schauer, PhD, MPH (Cannabis Regulators Association):

• She discussed how her organization, the Cannabis Regulators Association (CANNRA), is a non-partisan association of government agencies implementing cannabis and hemp regulations across 45 states and U.S. territories.
• She remarked that the 2018 Farm Bill’s broad definition of hemp has resulted in an “explosion” of hemp-derived products that are intoxicating, that are not regulated to be safe for consumers, and that can appeal to and be accessed by youth.
  • She commented that all states are grappling with these challenges, regardless of their political landscape.
• She noted how intoxicating hemp-derived cannabinoids are being made chemically using CBD as a source material.
  • She indicated that these intoxicating cannabinoids include Delta-8 THC, HHC, THC-O-acetate, and H4-CBD.
• She highlighted how many of these compounds have not been studied for safety and are widely available in gas stations, grocery stores, and online shops.
• She also stated that 2018 Farm Bill-compliant cannabinoid hemp products can contain “far more” Delta-9 THC than is legal in state-regulated marijuana markets and remain under the 0.3 percent Delta-9 THC threshold.
  • She explained that these products can contain high levels of THCA, which readily converts to Delta-9 THC when heated.
  • She further noted how products marketed as full spectrum or whole plant CBD can have enough Delta-9 THC to be intoxicating.
• She emphasized that hemp and marijuana come from the same plant and possess the same compounds.
  • She indicated that Delta-9 THC works the same in the human body, regardless of whether it comes from hemp or marijuana.
  • She noted however that the federal legality of Delta-9 THC differs based on its sources.
• She remarked that the 2018 Farm Bill had not created a federal regulatory structure for cannabinoid hemp products to adequately protect consumers.
  • She first indicated that these products (regardless of whether they are intoxicating) have no required testing for contaminants, pesticides, or heavy metals.
  • She then indicated that these products are not regulated at the federal level for ingredients or additives (particularly those that can be harmful when smoked or vaped).
  • She thirdly indicated that these products are not subject to packaging and labeling requirements, which prevents consumers from knowing what is in the products and whether the products are intoxicating.
  • She fourthly indicated that there do not exist federal restrictions on products that mimic commercial food and candy.
  • She lastly indicated that children can access intoxicating hemp products because there do not exist any federal age restrictions.
• She remarked however that state-regulated marijuana markets are highly regulated for consumer safety and youth prevention.
• She discussed how states have observed a variety of public health and safety issues directly linked to intoxicating cannabinoid products.
  • She indicated that these issues include accidental ingestion of these products by young children (resulting in hospitalization), overconsumption of these products by teenagers (also resulting in hospitalization), and unexpected impairment by adults who thought that they were purchasing a non-intoxicating product.
• She stated that the absence of federal regulation for hemp and hemp-derived products is leading state legislatures to enact their own policies.
  • She commented that these state policies can vary and that states are increasingly bringing intoxicating hemp products under the purview of their marijuana regulators.
• She remarked that the absence of federal minimum standards for hemp and hemp-derived products is resulting in a “patchwork” of regulations that creates consumer safety and market challenges and regulatory gaps that states alone cannot address.
  • She elaborated that these regulatory gaps include those in online markets and interstate commerce.
• She emphasized that CANNRA is not calling for the recriminalization of cannabinoid hemp products and is instead calling for the establishment of comprehensive regulation that protects consumers and public health.
  • She asserted that the U.S. could have state approaches inform the development of thoughtful and comprehensive federal regulatory policy.
• She remarked that a federal regulatory agency with a focus on public health and safety (like the FDA) needs to be authorized and funded with a specific timeframe to implement a regulatory framework for cannabinoid hemp products.
  • She first asserted that this framework cannot solely focus on CBD and must instead address a broad range of hemp-derived cannabinoid products (including both intoxicating and non-intoxicating products).
  • She then asserted that this framework must account for future and currently unknown hemp-derived cannabinoid products.
  • She further asserted that this framework must consider the many ways in which cannabinoid hemp products are consumed (such as foods, beverages, vaped products, and smoke products).
  • She lastly asserted that this framework must require contaminant testing and contain compliance and enforcement measures.
• She stated that the aforementioned elements of a regulatory framework for cannabinoid hemp extend beyond the FDA’s traditional regulatory pathways foods and dietary supplements.

Congressional Question Period:

Full Committee Chairman James Comer (R-KY):

• Chairman Comer noted how the 2018 Farm Bill had removed hemp products (including CBD) from Schedule I status under the Controlled Substances Act. He asked Mr. Miller to indicate whether private companies have attempted to introduce hemp and CBD products into the U.S. market.
  • Mr. Miller answered affirmatively.
• Chairman Comer asked Mr. Miller to indicate whether there exists any data regarding the size of the U.S. CBD market.
  • Mr. Miller indicated that his written testimony contains data regarding the size of the U.S. CBD market.
• Chairman Comer noted how the FDA has not regulated hemp-derived products (including CBD) in the five years following the passage of the 2018 Farm Bill. He asked Mr. Miller to indicate whether the FDA’s lack of regulations has impacted the U.S. hemp industry.
  • Mr. Miller answered affirmatively. He asserted that the FDA’s lack of hemp regulations has caused many large retailers to not carry hemp and hemp-derived products. He also asserted that this lack of regulation has caused many food and beverage companies to not add CBD into their mixes. He stated that this regulatory uncertainty has resulted in a decrease in demand for hemp and hemp-derived products, which has caused hemp prices to fall. He commented that these hemp price declines have primarily harmed hemp farmers.
• Chairman Comer then asked Dr. Henderson to indicate whether she is aware of any scientific studies on CBD (beyond her company’s research) that are available to regulators at the FDA.
  • Dr. Henderson answered affirmatively. She stated that there exists “plentiful” data on CBD. She mentioned how the FDA has evaluated the use of CBD in the drug Epidiolex, which means that the FDA has access to the clinical and nonclinical data packages submitted during Epidiolex’s review process. She also noted how the FDA has commissioned and conducted its own targeted safety studies on CBD. She indicated that there are additional human clinical trials outside of Epidiolex involving other CBD formulations across a wide range of populations. She further mentioned how other stakeholders have conducted CBD studies and indicated that these include both published and unpublished studies. She concluded that there exists a large amount of data regarding CBD that is typically not available for ingredients being reviewed as dietary supplements.
• Chairman Comer stated that there exists a large amount of available scientific data regarding CBD. He asserted that the FDA is falsely claiming that it lacks sufficient data to proceed on rulemaking for the hemp industry. He asked Mr. Miller to indicate whether he agrees with this assertion.
  • Mr. Miller expressed agreement with Chairman Comer’s assertion. He remarked that there exists sufficient data for the FDA to pursue regulation for hemp and hemp-derived products as dietary supplements and food and beverage additives.
• Chairman Comer asked Mr. Miller to indicate whether the FDA has been transparent with stakeholders regarding what it needs to proceed on developing a regulatory pathway for CBD products.
  • Mr. Miller asserted that while a new regulatory pathway for CBD products is unnecessary, he expressed the U.S. Hemp Roundtable’s willingness to support additional regulatory safeguards for CBD products. He stated however that the FDA has not specified its needs in a manner that would enable Congress to accommodate these needs.
• Chairman Comer then expressed concerns that the absence of FDA regulations will enable mislabeled CBD products that are adulterated with other substances to remain available and endanger the public (including children). He asked Mr. Badaracco to discuss the dangers that these types of products can pose to consumers.
  • Mr. Badaracco mentioned how he had solicited reports from Kentucky Narcotic Officers Association members regarding the adverse health impacts resulting from ingestion of intoxicating CBD products by middle school and high school students. He testified that one police department in eastern Kentucky had indicated that their top priority was addressing the ingestion of intoxicating CBD products. He also mentioned how emergency room (ER) physicians have expressed concerns over these ingestions.
• Chairman Comer stated that the problem of mislabeled CBD products is widespread and emphasized that there does not currently exist a regulatory body that is overseeing this space. He remarked that there are both credible actors and bad actors in the CBD space. He asserted that the U.S. must develop a way to ensure that CBD products are being accurately labeled and commented that this lack of accurate labeling is harming both consumers and the hemp industry. He reiterated his call for the FDA to regulate this space.

Rep. Summer Lee (D-PA):

• Rep. Lee discussed how the FDA has publicly and repeatedly stated that it must answer numerous important questions about hemp-derived products before it can regulate these products. She noted how the FDA had questioned the number of hemp-derived products that an individual can safely consume in a day, whether this amount varies depending on the form of the products taken, potential negative interactions between these products and other drugs or substances, the effects of these products on special populations (such as children and the elderly), and the risk of long-term exposure to these products. She indicated that while she supports the legalization of hemp and CBD, she asserted that anecdotal evidence and marketing claims are inadequate substitutes for rigorous scientific research. She asked Dr. Schauer to address why it is problematic to use online calculators and to trust product manufacturers when determining appropriate CBD dosages.
  • Dr. Schauer remarked that there must exist academic and non-partisan hemp data sources and regulatory pathways that account for market realities. She stated that the current hemp market does not exclusively involve dietary supplements and indicated that this market also includes inhalable and combustible products. She contended that the U.S. requires data on these inhalable and combustible products and commented that these products are not perfectly suited for the FDA’s existing regulatory pathways. She also stated that the U.S. needs data on novel cannabinoids being converted from CBD. She remarked that very few products exclusively involve CBD and indicated that these products often contain additional cannabinoids. She stated that the U.S. must understand how these cannabinoids interact with each other and their effects on humans. She concluded that science is necessary to inform the development of thoughtful regulations.
• Rep. Lee asked Dr. Schauer to indicate whether regulating hemp through the FDA’s existing food and dietary supplement pathway would address CBD product safety concerns.
  • Dr. Schauer answered no. She highlighted how there exist inhalable and combustible CBD products and stated that these products are ill-suited for a food and dietary supplement regulatory pathway. She also called it important for regulators to ascertain the contaminants present in CBD products. She commented that the FDA’s dietary supplemental pathway traditionally does not ascertain contaminants present in CBD products. She lastly remarked that CBD products need specific warnings and labeling based on the route of administration. She emphasized that there exist administration routes for these products beyond food and dietary supplements.
• Rep. Lee noted how the FDA believes it needs additional scientific studies and new authorities to balance consumer access with appropriate safeguards and oversight. She stated that the Subcommittee should work with the FDA to achieve a level of “careful oversight.” She then remarked that the U.S. must encourage diversity and inclusion in the U.S. hemp industry. She asked Mr. Miller to discuss the purpose of the U.S. Hemp Roundtable’s Minority Empowerment Committee.
  • Mr. Miller remarked that cannabis policy has a “sad history” regarding the disparate treatment of people of color. He also asserted that structural racism has pervaded federal farm programs. He remarked that the U.S. Hemp Roundtable (and the broader industry) has worked to promote diversity and equity to address and help remedy this previous discrimination.
• Rep. Lee then remarked that the U.S. must be deliberate in its approach to CBD regulation and should be cautious against pursuing the overcriminalization of the substance. She expressed encouragement with the potential benefits of CBD products.

Note: The Subcommittee took nearly a 20-minute recess at this point for votes.

 Rep. Glenn Grothman (R-WI):

• Rep. Grothman asked the witnesses to address the economic consequences of having the FDA regulate CBD as a food supplement or additive.
  • Mr. Miller remarked that there would be “enormous” economic consequences if the FDA were to regulate CBD as a food supplement or additive. He mentioned how the Brightfield Group had estimated that such regulation would be worth $5 billion annually.
• Rep. Grothman then discussed how other countries (including the UK and Australia) have regulated CBD and commented that these countries appear to have found CBD to be safe. He asked the witnesses to address how the U.S. CBD market differs from the CBD markets in these countries.
  • Mr. Miller remarked that the U.S. CBD market is not different from the CBD markets in other countries. He stated that the U.S. should study how the UK, Australia, and Canada regulate CBD and apply lessons learned from these countries as it develops its own regulatory framework for CBD.
• Rep. Grothman asked Mr. Miller to provide recommendations for how Congress should address CBD in the Farm Bill currently under development.
  • Mr. Miller expressed support for attaching current legislative proposals (such as the CBD Product Safety and Standardization Act of 2023 and the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023) to the upcoming Farm Bill. He acknowledged that the U.S. House Committee on Agriculture may face jurisdictional challenges in seeking to attach these legislative proposals to the upcoming Farm Bill. He expressed hope that these jurisdictional challenges can be resolved. He also stated that these legislative proposals may need to be added at the conference committee stage.
• Rep. Grothman then asked Mr. Miller to indicate the percentage of hemp farming that is dedicated to CBD and other extracts.
  • Mr. Miller noted how the percentage of hemp farming dedicated to CBD and other extracts had previously been around 90 percent. He indicated however that this figure is several years old. He stated that the percentage of hemp farming dedicated to CBD and other extracts has likely declined in the ensuing years. He noted how there has occurred a growth in hemp fiber production. He remarked however that CBD and other extracts remain an “overwhelming” part of the hemp industry.
• Rep. Grothman asked Mr. Miller to address how Congress can take action on CBD regulation.
  • Mr. Miller reiterated his call for Congress to pass the CBD Product Safety and Standardization Act of 2023 and the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023. He expressed appreciation for Rep. Grothman’s support for these bills. He also expressed receptiveness to proposals that would impose additional regulatory requirements for CBD so long as Congress directs the FDA to regulate the substance.
• Rep. Grothman then asked Mr. Badaracco to indicate whether it is legal to ship Delta-8 THC products derived from CBD across state lines.
  • Mr. Badaracco remarked that the legality of shipping Delta-8 THC products derived from CBD across state lines depends on the state. He highlighted how state cannabis policies vary significantly.
• Rep. Grothman asked Mr. Badaracco to indicate whether Delta-8 THC products derived from CBD can be ordered online.
  • Mr. Badaracco answered affirmatively.
• Rep. Grothman asked Mr. Badaracco to explain why some companies believe they can sell Delta-8 THC products derived from CBD online.
  • Mr. Badaracco stated that companies are relying upon the 2018 Farm Bill to justify their online sales of Delta-8 THC products derived from CBD. He commented that the online sale of these products is an unintended consequence of this law. He discussed how CBD constitutes a very small portion of the hemp plant. He stated however that there exists “plentiful” CBD contained in the hemp plant. He noted how some companies will extract CBD from hemp plants and chemically convert the CBD into Delta-8 THC. He indicated that these companies will then use this Delta-8 THC in a variety of retail products, including hemp flowers for smoking, capsules, and ingestibles (including candies and brownies).
• Rep. Grothman interjected to ask the witnesses to address the extent to which the availability of Delta-8 THC products derived from CBD is a problem.
  • Mr. Badaracco testified that the Kentucky Narcotic Officers Association’s members are increasingly reporting that middle school and high school students are having adverse reactions to Delta-8 THC products derived from CBD.
• Rep. Grothman interjected to asked Mr. Badaracco to indicate whether middle school and high school students are ordering Delta-8 THC products derived from CBD online.
  • Mr. Badaracco stated that it is unknown whether middle school and high school students are ordering Delta-8 THC products derived from CBD online. He indicated that there are ongoing investigations regarding this matter.
• Rep. Grothman asked Mr. Miller to indicate whether there exist any concrete statistics regarding the availability of Delta-8 THC products derived from cannabis.
  • Mr. Miller commented that most of the data regarding availability of Delta-8 THC products derived from cannabis has been gathered on a state-by-state basis. He remarked that children are currently accessing these products and highlighted how these products are available for sale at vaporizer stores and convenience stores.

Rep. Virginia Foxx (R-NC):

• Rep. Foxx asked Mr. Badaracco to discuss the dangers associated with consuming CBD products that may contain “wildly” varying levels of intoxicants.
  • Mr. Badaracco highlighted how many children are requiring ER treatment following the consumption of intoxicating CBD products. He also noted how the consumption of these products can result in agitation, increased heart rates, nauseousness, and unconsciousness.
• Rep. Foxx asked Mr. Badaracco to explain why the U.S. Drug Enforcement Administration (DEA) does not pursue intoxicating CBD products that are synthesized from legally grown hemp.
  • Mr. Badaracco mentioned how there have been several court decisions (including from the U.S. Court of Appeals for the Ninth Circuit) ruling that Delta-8 THC is legal under current law. He remarked that there is currently no legislative or regulatory framework governing Delta-8 THC.
• Rep. Foxx asked Mr. Badaracco to indicate whether an average person can currently determine whether a CBD product contains intoxicants.
  • Mr. Badaracco answered no. He noted how manufacturers will employ solvents and acids to chemically convert CBD into Delta-8 THC.
• Rep. Foxx highlighted how the FDA is not regulating hemp-derived products. She asked Mr. Miller to indicate whether the FDA has engaged in any meaningful enforcement regarding these products.
  • Mr. Miller answered no. He discussed how the FDA’s current enforcement actions for hemp-derived products consist of sending warning letters and indicated that most of these warning letters have been to companies making “outrageous” medical claims. He noted however that the FDA has not seized any hemp-derived products for sale to date.
• Rep. Foxx asked Mr. Miller to indicate whether Delta-8 THC and other intoxicating CBD-derived products are currently legal to produce and sell under federal law.
  • Mr. Miller remarked that the federal legality of Delta-8 THC and other intoxicating CBD-derived products remains an open question. He noted that while several federal and state courts have deemed these products to be legal, he indicated that these products have been declared illegal in certain states (such as New York). He asserted that a federal approach to hemp and CBD regulation could help to address this legal uncertainty. He remarked that the U.S. should strictly regulate these products and ensure that children cannot access the products.
• Rep. Foxx asked Mr. Miller to indicate whether Congress had intended to allow for the sale of intoxicating CBD products when it had passed the 2018 Farm Bill.
  • Mr. Miller stated that Congress had likely not intended to permit the sale of intoxicating CBD products when it had passed the 2018 Farm Bill. He described the subsequent emergence of intoxicating CBD products as a “loophole.” He stated however that these intoxicating CBD products have been a “lifesaver” for many farmers who have struggled financially due to the lack of federal CBD regulation. He reiterated his call for the U.S. to regulate these products and ensure that children cannot access them.
• Rep. Foxx asked Mr. Miller to indicate whether intoxicating CBD products should be permitted for sale under federal law.
  • Mr. Miller called for new federal legislation that would subject intoxicating cannabinoids to a stricter regulatory regime. He commented that this regulatory regime could be at the FDA or the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB). He also stated that Congress should ensure that children cannot access these intoxicating cannabinoids.

Subcommittee Chairman Lisa McClain (R-MI):

• Chairman McClain asked Mr. Miller to indicate whether the average consumer can verify the ingredients in hemp and hemp-derived products without FDA regulation.
  • Mr. Miller discussed how the U.S. Hemp Authority is an SRO that can provide certificates for manufacturers of hemp and hemp-derived products. He stated that this SRO ensures that these products have sufficient manufacturing processes and accurate labeling.
• Chairman McClain interjected to asked Mr. Miller to indicate whether consumers should look for U.S. Hemp Authority certificates on hemp and hemp-derived products for assurances that products have accurate labeling of ingredients.
  • Mr. Miller answered affirmatively. He also mentioned how some states have developed regulatory structures for hemp and hemp-derived products.
• Chairman McClain asked Mr. Miller to indicate whether hemp and hemp-derived product manufacturers that convey inaccurate ingredient information are subject to any liability.
  • Mr. Miller noted that while some states maintain regulations regarding inaccurate ingredient labeling for hemp and hemp-derived products. He stated however that there are no robust enforcement mechanisms for the vast majority of these products.
• Chairman McClain expressed interest in how the lack of federal regulation for hemp and hemp-derived products has impacted the private sector’s ability to market products that are legal under the 2018 Farm Bill.
  • Mr. Miller remarked that the lack of federal regulation for hemp and hemp-derived products has “devastated” the U.S. hemp industry.
• Chairman McClain asked Mr. Miller to confirm that the only hemp product that is currently profitable is the hemp flower that can be chemically converted into Delta-8 THC.
  • Mr. Miller confirmed that the only hemp product that is currently profitable is the hemp flower that can be chemically converted into Delta-8 THC.
• Chairman McClain asked Mr. Miller to indicate whether the hemp flower that can be chemically converted into Delta-8 THC is dangerous.
  • Mr. Miller stated that this hemp flower that can be chemically converted into Delta-8 THC can be dangerous if improperly manufactured and sold to children.
• Chairman McClain asked Mr. Miller to confirm that these hemp flowers that can be chemically converted into Delta-8 THC are unregulated.
  • Mr. Miller confirmed that these hemp flowers that can be chemically converted into Delta-8 THC are unregulated.
• Chairman McClain asked Mr. Miller to indicate whether the FDA has been receptive to efforts from the private sector to have their products regulated.
  • Mr. Miller answered no. He mentioned how the FDA holds listening sessions with the U.S. hemp industry about once a year. He stated however that the FDA does not meaningfully engage with the industry during these listening sessions.
• Chairman McClain commented that it is unusual for private industries to petition the federal government for regulation. She asked Mr. Miller to explain how regulations for the U.S. hemp industry would help the industry.
  • Mr. Miller remarked that federal regulation would help the U.S. hemp industry because it would stabilize the U.S. hemp market. He stated that this regulation would lead retailers and food companies to carry hemp and hemp-derived products, which would cause hemp prices to increase. He also remarked that this regulation would signal to consumers that hemp and hemp-derived products are safe. He concluded that federal regulation of hemp and hemp-derived products would benefit U.S. hemp businesses.
• Chairman McClain interjected to comment that federal regulation of hemp and hemp-derived products would benefit businesses and protect children. She highlighted how the 2018 Farm Bill had legalized hemp and lamented the FDA’s lack of action to oversee the hemp sector.
  • Mr. Miller confirmed Chairman McClain’s statements.
• Chairman McClain expressed frustration with the FDA’s failure to develop a regulatory framework for hemp and hemp-derived products, despite Congress’s allocations of funding and authority to the FDA. She asserted that the FDA is failing to fulfill its obligations under current law. She then asked Mr. Miller to confirm that the FDA has not returned to its pre-COVID-19 pandemic telework policy.
  • Mr. Miller stated that he is unaware of the FDA’s telework policies.
• Chairman McClain asked Mr. Miller to indicate whether the FDA’s failure to require in-person work may be contributing to its failure to develop a regulatory framework for hemp and hemp-derived products.
  • Mr. Miller refused to comment on the impact of the FDA’s in-person work requirements on its development of a regulatory framework for hemp and hemp-derived products. He stated however that the FDA’s failure to develop a regulatory framework for hemp and hemp-derived products had also been a problem prior to the COVID-19 pandemic.
• Chairman McClain suggested that having FDA staff work in-person might improve the Agency’s ability to develop a regulatory framework for hemp and hemp-derived products. She then asked Mr. Miller to recommend concrete actions that the FDA could take to provide better oversight of hemp and hemp-derived products.
  •  Mr. Miller remarked that the FDA could immediately start to regulate hemp and hemp-derived products as dietary supplements and food and beverage additives.
• Chairman McClain interjected to ask Mr. Miller to indicate whether the FDA currently possesses the authority to regulate hemp and hemp-derived products as dietary supplements and food and beverage additives.
  • Mr. Miller answered affirmatively. He also noted how the FDA desires additional regulatory authorities to oversee hemp and hemp-derived products. He expressed the U.S. Hemp Roundtable’s receptiveness to providing the FDA with these additional regulatory authorities. He stated that the FDA should define their desired regulatory structure for hemp and hemp-derived products in order to assist Congress in developing a regulatory regime for this space.
• Chairman McClain lamented that the federal government’s bureaucracy is undermining the U.S. hemp industry and consumer safety. She emphasized that the U.S. hemp industry desires federal regulation so that good-faith businesses can deliver high demand products to consumers with certainty. She asserted that federal hemp regulation would benefit U.S. growers (and their associated supply chains), as well as consumers. She also lamented that the FDA has not engaged in any meaningful enforcement actions within the hemp and hemp-derived products space. She further accused the FDA of not being transparent or consistent in their decision making with the U.S. hemp industry. She disputed the FDA’s claims that it lacks sufficient safety data regarding these products. She remarked that the FDA possesses sufficient decisions to make informed decisions regarding labeling requirements, appropriate dosage levels, and other measures needed to ensure public safety. She stated that there exists a rigorous scientific process for toxicology testing and research for hemp and hemp-derived products and highlighted how this research is peer-reviewed prior to publication. She asserted that the FDA possesses sufficient research data for making appropriate decisions under their existing authorities. She also mentioned how law enforcement professionals have highlighted how the U.S.’s current lack of hemp regulations creates challenges for consumers. She noted how consumers are currently at risk of receiving hemp and hemp-derived products that contain unlabeled substances and inconsistent dosages. She further discussed how CBD is one of many cannabis plant derivatives and asserted that the FDA must be engaged in this emerging market for the benefit of both industry and consumers. She remarked that the FDA already has a viable pathway for regulating hemp and hemp-derived products and called on the FDA to act on this topic. She suggested that Congress should cut the FDA’s funding if it continues to not take action to regulate hemp and hemp-derived products.