US House Oversight - Health Care and Financial Services - Subcommittee Hearing
(July 27, 2023) - Summary

2023-07-27 - US House Oversight - Health Care and Financial Services - Subcommittee Hearing - Summary - Takeaways
[ Event Details ]

A congressional committee heard how lack of federal rulemaking on CBD and hemp products contributed to endangering consumers through sale of unsafe hemp-derived cannabinoid products. 

Here are some observations from the Thursday July 27th United States House Oversight and Accountability Committee Health Care and Financial Services Subcommittee (US House Oversight - Health Care and Financial Services) Subcommittee Hearing.

My top 4 takeaways:

  • Members of both the subcommittee and the wider Committee on Oversight and Accountability provided remarks displaying a partisan contrast in who they believed was at fault for the lack of rulemaking around cannabidiol in food: FDA leadership or Congress itself.
    • Subcommittee Chair Representative Lisa McClain (R-Michigan-R, audio - 4m, video)
      • In a press statement about the hearing, McClain argued that FDA leadership had “failed for too long to do its job to ensure the safety of legalized hemp-derived products. Without these regulations, dangerous products could make their way to the shelves while safe and credible CBD products could be prevented from entering the market. We are going to investigate why exactly the FDA has decided to ignore their regulation responsibilities related to CBD and other areas of jurisdiction. We need to ensure that the FDA is not setting what would be a dangerous precedent and using this as an opportunity to seek more authority and resources from Congress.”
      • Leading the hearing, McClain stated the committee had convened “yet again to discuss the failures of the Food and Drug Administration,” referencing prior hearings she’d chaired on a different topic, and said agency staff had failed to regulate hemp products which “hurt families and children.” Going over some of the background of hemp legalization, McClain felt it made “sense to remove CBD from Schedule I status. We know that CBD can have a medical use because the FDA approved a prescription CBD drug [Epidiolex] that…is used to treat children with severe forms of epilepsy.” She added that CBD lacked a “high potential for abuse, and cannot cause a high because it is not intoxicating.” However, she alleged a lack of FDA rules led to compromised hemp consumables as “there [was] no way for the average consumer to verify its purity, or even the amount of CBD in it, or rely on the FDA's enforcement of regulations.”
      • McLain cited a 2022 study of approximately 3,000 CBD products, where testing showed “only one quarter of the brands tested their CBD products for purity, and that only 16% of those products tested contained exclusively what was stated on their label.” There were also cases of “contaminants like heavy metals, mold, and THC” which she argued was also a result of FDA leaders’ lack of action, and “led to children accidentally ingesting and overdosing on THC.” McLain called for regulations treating CBD as a dietary supplement, which would enable FDA staff to “enforce labeling requirements and keep Americans safe and healthy,” something she argued was allowed with the existing authority for dietary supplements and their labeling.
      • Interpreting the call from agency leaders for a new “regulatory framework” as equating to “Give us more authority, give us more money, give us more staff, and only then will we actually do our duties under the law,” McClain said this had “led to confusion and uncertainty in the market which has suppressed the ability for good faith manufacturers to sell CBD products,” and “only benefits bad actors who capitalize on the confusion and the flood of the market with potentially unsafe products.” She wanted the agency to do more with their existing resources “to regulate hemp-derived products.”
    • Subcommittee Ranking Member Representative Katie Porter (D-California, audio - 4m, video)
      • Porter agreed with the concept of "doing the job they're supposed to do," but argued it was Congress—not FDA leaders—which needed to take action to regulate hemp products. The items “may provide numerous health benefits,” she commented, believing there was bipartisan interest in “determining how we should regulate these products right now.” She echoed concerns over purity and labeling given that there was already a “great deal of accessibility” to hemp consumables. Lacking federal oversight meant products “may include not just CBD, but THC, an intoxicant [and] these products can be sold in packaging that makes them look like traditional snack foods that can be confusing to adults and children alike.” Porter saw a bipartisan interest in regulating hemp items “in a way that protects our constituents, while also making safe products available to them.”
      • However, an internal FDA work group “explore[d] how the agency might go about regulating hemp derived products…and they said we need a new regulatory pathway,” Porter asserted. She said some stakeholders expressed a wish to “work with Congress to get that pathway set up through legislation.” In Porter’s estimation, skepticism over the request of FDA officials for greater statutory authority around hemp was problematic since “some of the same lawmakers who want to do oversight of the FDA for being cautious about its existing powers would turn around and blast the agency if…they ever felt like it went too far beyond its legal authority.” With FDA leaders knowing they’d be held accountable if they exceeded their powers, she thought agency leaders were only asking lawmakers to “work together across the aisle on some common sense legislation…Let's not jump to blaming the FDA until Congress has done everything it can to set it up for success.”
      • Later in the hearing, Porter entered “a letter from the American Trade Association for Cannabis and Hemp, and a report titled Toward Normalized Cannabinoid Regulation” into the committee record (audio - <1m, video).
      • At time of publication, Porter was running for the US Senate.
    • US House Oversight Chair Representative James Comer (R-Kentucky, audio - 5m, video)
      • Comer had been a leading advocate for hemp reform since serving as the Kentucky Agriculture Commissioner. In 2012, he pushed for successful legislation on industrial hemp and had spearheaded several projects and programs for the crop by 2015. Following a so-called Great Kentucky Hemp Experiment, Comer became a leading voice in Congress for hemp and a key proponent of the 2018 Farm Bill hemp provision. As a Ranking Member of a different US House Oversight subcommittee in April 2022, Comer requested a hearing on the lack of FDA action on hemp product regulation, and raised the issue again with agency representatives during a hearing that November.
        • See a 2012 interview with Comer on reviving the Kentucky hemp sector.
        • A July 16th article suggesting the Kentucky hemp sector had experienced less growth than predicted began with a quote from then-Commissioner Comer promising the commonwealth would become “the epicenter of industrial hemp production in America.”
      • As US House Oversight Chair, Comer had the prerogative to participate in any subcommittee hearing. He highlighted some of the history of the Farm Bill and the burgeoning hemp sector which he claimed had “looked for various ways to grow the industry and provide hemp and CBD products to the American people.” Comer specified a February 2022 USDA National Hemp Report focusing on industry statistics (audio announcement) which found there were 54,000 acres being used for hemp farming.
        • A subsequent national hemp report that was released on April 19th indicated production “for all utilizations totaled 28,314 acres, down 48 percent from 2021. The value of hemp production in the open for the United States totaled $212 million, down 70 percent from last year. Area harvested for all purposes in the open totaled 18,251 acres, down 45 percent from 2021.”
      • “Clearly, hemp has so much potential for our American economy, from growers and manufacturers, to businesses of all sizes, and consumers of many backgrounds,” Comer commented, and he felt “since 2018 scientific research and careful study has continued to shed light on both the efficiency and safety of these products, especially CBD.” He pushed back on claims from FDA staff that “adequate scientific data is not available to inform their decision making around CBD and hemp derived products.” Comer insisted there was “ample available data studying CBD and hemp derived compounds; FDA [was] simply not being transparent with the industry stakeholders, or Congress, in what scientific studies it relies on and often moves the goal post for researchers attempting to satisfy the FDA’s requirements through rigorous studies.”
      • Comer said he’d seen “no meaningful action to provide clear guidance and certainty in the market” by FDA officials, and that businesses and consumers looking for safe, accurately labeled hemp items were left “in the dark; it's well past time for FDA to do its job and act.” He stressed that the “American people need to know what is in their products, and the FDA has the power to enforce reasonable regulations by regulating CBD as a dietary supplement or food additive.” Comer added that labeling could also safeguard children from accidental ingestion of hemp consumables, and such labels needed “an accurate accounting of their contents.” He further favored limiting availability of the products to “responsible adults who are aware of any side effects and risks.”
      • Comer acknowledged he had used hemp-derived CBD products tested by “labs in my congressional district in Kentucky that I've seen and have confidence in,” and his goal was ensuring “our shelves are stocked with products that contain what they say they contain while limiting the ability of irresponsible and bad faith actors to mislead consumers.” Comer concluded that this could be achieved if only the FDA regulated hemp consumables as dietary supplements: “it would be a win for our economy, a win for industry, and a win for the American consumer.” He reiterated claims officials were dragging their feet on hemp rulemaking, accusing them of wanting to “use this as an opportunity for a power grab, asking Congress for even more authorities, and more money.” Comer remained opposed to "further bloating the federal bureaucracy” and wanted to see bipartisan support “to bring about positive changes for the hemp industry” and serve the public interest.
    • US House Oversight Ranking Member Representative Jamie Raskin (D-Maryland, audio - 5m, video, written comments).
      • Raskin supported the hemp sector as “part of a sweeping rethinking of cannabis policymaking" in the country. He first highlighted the re-introduction of the Cannabis Users Restoration of Eligibility (CURE) Act along with GOP Representative Nancy Mace, which would “remove prior marijuana use as an obstacle to people getting hired in the federal government or passing the federal security clearance process.” He’d become interested in the issue after a constituent was denied the opportunity for “a sub cabinet-level post in the Biden Administration” based on state-legal medical cannabis use. Raskin encouraged support for the CURE Act, indicating that Comer had “asked some good questions about it,” and he hoped others would work to pass a “a good common sense bill that all Americans would be able to get behind.”
      • Calling for a “common sense approach” to FDA regulations, Raskin was more sympathetic to concerns expressed by agency leaders that the established regulatory structures were “not appropriate” for managing hemp products. He wanted to support “good actors” in the industry as well as consumers, yet he saw a “vast world of hemp derivatives [was] flourishing, beyond just CBD. Among them are newly developed synthetic cannabinoids including delta-8-THC which can have intoxicating effects.” Raskin didn’t want a commercial market “without proper testing, labeling, or other safety precautions,” and felt the variety of hemp consumables meant products “cannot be easily or always categorized simply as food or supplements.” He wanted Congress to allow FDA leaders to do additional research and grant the agency statutory powers to “regulate the entire world of hemp and its derivatives.”
      • Learn more from Raskin’s press release on his remarks from the hearing.
    • Representative Summer Lee (D-Pennsylvania, audio - 1m, video)
      • Later in the hearingJoining the hearing later, Lee expressed appreciation for FDA representatives using “science and data as a basis for making policy decisions to protect public health and safety,” finding agency staff “publicly and repeatedly stated that [they] had a roster of important questions about hemp derived products that needed answers before it could regulate” them. To her knowledge this included “how much hemp derived product an individual could safely consume in a day, whether this amount varies depending on the form taken, potential negative interactions with other drugs or substances, effects on special populations like children or the elderly, and the risks of long-term exposure.” Lee was “glad we've extended hemp and CBD into our marketplace,” yet “anecdotal evidence and marketing claims are not the same as rigorous scientific research.”
  • Four panelists representing hemp industry, testing, law enforcement, and regulatory bodies gave introductory remarks about the gaps and problems they perceived in federal hemp regulation.
    • Jonathan Miller, U.S. Hemp Roundtable General Counsel (audio - <1m, video, biography)
      • Expressing his gratitude to McLain and the subcommittee for taking up the issue, Miller directly thanked Comer for his “decade-long leadership on behalf of Kentucky and US hemp farmers. You and I started on this journey in 2012 and worked across the aisle to secure hemp’s legalization in the Bluegrass State” (audio - 5m, video, written testimony).
      • Miller claimed “the US hemp industry has been struggling considerably in the last few years, and this turmoil is due in large part to decisions” made by leaders at the FDA. He said many had seen the 2018 Farm Bill as having “explicitly legalized the sale of hemp and its derivatives such as CBD.” Miller explained that farmers had “invested considerable resources to grow and market commercial hemp crops, particularly for the product for which there was immediate processing, infrastructure, and consumer demand: CBD and cannabinoids.” However, he noted that “hours after the Farm Bill was signed into law, FDA asserted its opinion that it was illegal to market CBD as a dietary supplement or to use as a food additive,” yet hadn’t engaged in “meaningful enforcement” besides sending warning letters to manufacturers.
      • “FDA has swung back and forth with contradictory positions,” Miller argued, insisting agency representatives initially “affirmed [FDA] ability to regulate CBD under current law…but then in the intervening four years FDA stalled, even ignoring congressional appropriations report directives to take expedited action.” He shared hemp sales data he interpreted as showing how “federal regulatory uncertainty severely impacted the hemp and CBD market, with reduced manufacturing demand resulting in a more than 90% commodity price decline, crushing opportunities for US farmers.” And Miller said the final decision in January by FDA leaders that they couldn’t regulate hemp items without further congressional approval was based on “a concern over the substance safety,” but “FDA relied on a narrow set of research focused on super high dosage CBD isolate formulations while refusing to acknowledge a range of studies that demonstrate the safety of various CBD formulations at much, much lower dosage levels.”
      • Miller remarked that in the absence of federal regulation there’d been a “proliferation of unregulated products some of which raise significant quality and safety concerns.” Yet sale of hemp biomass for extraction and conversion of CBD continued, he observed, and some resulting products featured “impairing products such as delta-8-THC.” U.S. Hemp Roundtable members were against banning these products, but Miller clarified “they need to be strictly regulated for safety and kept out of the hands of children; Kentucky’s General Assembly recently passed unanimously legislation to this effect, HB 544, it should be a model for the nation.”
      • Miller highlighted several bills he hoped Congress would advance to help the hemp industry, stating all “would require compliance with the entire existing comprehensive regulatory frameworks for dietary supplements and food.”
        • H.R. 1628 - CBD Product Safety and Standardization Act of 2023
        • H.R. 1629 - Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023
        • S. 2451/H.R. 4898 - A bill to allow for hemp-derived cannabidiol and hemp-derived cannabidiol containing substances in dietary supplements and food
      • Although he disagreed with the assertion of FDA staff that they required another “pathway” for hemp consumable products, “we are certainly open to stricter regulation of CBD and other cannabinoid products on top of the existing frameworks,” Miller told members. He praised the US Hemp Authority as a “self-regulatory organization to promote high standards and best practices” along with the work of state regulators, even as that led to a “patchwork” of standards for hemp items. Miller summed up his remarks by observing the “hemp industry may be unique in that. We are coming to Congress to ask ‘please, regulate us.’”
        • Miller was one of the founding members of the US Hemp Authority, which his professional biography called a “sister organization” to the U.S. Hemp Roundtable.
    • Rayetta Henderson, ToxStrategies Senior Managing Scientist (audio - <1m, video, biography)
      • There to “talk about our research, and its utility in an overall evaluation of cannabidiol (CBD) to support its safe use as a dietary ingredient,” Henderson described ToxStrategies as a “a scientific consulting firm that provides support for clients in the public and private sectors.” She’d been engaged “in the safety assessment of CBD and other hemp-derived products” since 2018 and would present on “our recently published preclinical safety studies that provide key information needed to conduct robust science-based assessments to evaluate the safety of CBD as a dietary ingredient.” Henderson testified that “these studies in combination with other available data provide a sufficient basis from which to determine safe levels of CBD for oral consumer use” (audio - 5m, video, written testimony).
      • Henderson described ToxStrategies researchers creating a “safety testing program to specifically address gaps identified for a CBD product that would be expected to be filled as part of regulatory compliance.” She highlighted some considerations of the study designs: “a fundamental concept in any safety assessment is that the finding of a potential adverse effect does not automatically mean there is a risk of that effect occurring. Preclinical toxicology studies are intentionally designed to be conducted at high enough exposure levels to identify potential adverse effects,” which she said was “an important distinction because exposure levels associated with human consumption may be very different from exposure levels tested in toxicology studies. Substances considered to be beneficial, and even necessary for health, can be toxic if consumed in large enough amounts.” As a result, Henderson reported that knowing “levels at which these effects might occur provides the information necessary to determine levels of consumption that are unlikely to be associated with such effects.” With sufficient data, a risk assessment for CBD could be conducted for researchers to determine “whether a sufficiently protective margin of safety exist and determine a safe level of intake for consumers.”
      • Henderson identified “six preclinical toxicity studies on a hemp-derived CBD isolate” done in “collaboration and oversight of scientists from multiple disciplines and research organizations.” She pointed out that  “three manuscripts summarizing these studies have undergone an independent peer review process and are now publicly available in scientific journals,” sharing the articles in Attachment A, along with high level summaries in her testimony:
        • Genotoxicity evaluation of cannabidiol - Three studies were conducted to evaluate the ability of CBD isolate to interact with DNA or cause chromosomal damage..The results of all three studies confirmed that CBD was not associated with genotoxic effects under the study conditions. This is critical, because a genotoxic finding would have precluded its use as a dietary ingredient.
        • Oral toxicity evaluation of cannabidiol - Studies were conducted to investigate the potential for toxicity following repeated exposure to oral CBD in male and female rodents. First, a 14-day study was performed to look for signals of potential adverse effects, in order to ascertain what dose levels should be used in the follow-up 90-day (subchronic) oral toxicity study…CBD was well tolerated at all dose levels following up to 90 days of treatment. Microscopic liver and adrenal gland changes observed in the 90-day study resolved after a 28-day recovery period and were determined by the experts in the testing laboratory, as well as our team, to be non-adverse. Therefore, CBD dose levels up to 150 and 140 mg/kg-bw/d were determined to be without adverse effects in the 14- and 90-day toxicity studies, respectively. The results of these studies are comparable to findings reported in unpublished studies conducted with other CBD isolates.
        • Reproductive and developmental toxicity evaluation of cannabidiol - This study was designed to investigate the effects of oral CBD exposure on male and female reproductive performance and offspring development in rodents…In this study, parental males and females were dosed with CBD starting prior to mating and through weaning of offspring for females; offspring were then dosed directly through PND 42…The main reproductive finding in this study was lower body weights in male and female offspring, primarily after birth and only at the highest dose of CBD tested (300 mg/kg bw/day). Based on this study, a dose of 100 mg/kg bw/day was determined not to cause reproductive toxicity in females or neonatal toxicity in offspring. When converted to mg/day based on body weight, this value would equate to a safety margin of 100-fold for dietary supplement products containing 70 mg of CBD. Finally, while the highest dose tested in this study (300 mg/kg bw/day of CBD) did not cause male reproductive toxicity under the study conditions, it is important to note that effects on sperm could not be fully assessed in this protocol.
      • “Together this suite of studies provides the baseline data that are typically required to evaluate use of a dietary ingredient,” Henderson said. She felt a safety and risk assessment of CBD as a dietary supplement could be completed since there were already “core safety studies that add to an already extensive body of science for CBD which includes human clinical trials and studies in animal models.” Henerdon expressed confidence that there was enough data to “follow the same principles that we as risk assessors apply when evaluating any ingredient for dietary use” such as “factors including the data available for review by the assessors, and the population of interest for the product.” She added that “recommendations for safe use could be refined as necessary as new data continue[d] to become available.”
    • Richard Badaracco, Kentucky Narcotic Officers Association President-Elect (audio - <1m, video, biography)
      • Badaracco indicated his remarks ”focuse[d] on the absence of a federal regulatory structure to govern the marketing of CBD and other hemp-derived products,” picking up from Miller’s remarks that a “collapse of hemp and CBD led many farmers and businesses to chemically convert CBD biomass…into intoxicating compounds.” Badaracco felt that although the Farm Bill hadn’t contemplated such compounds, it had “effectively legalized the sale of hemp-derived delta-8-THC products with no oversight.” He mentioned that even without rules, hemp consumables had grown increasingly popular with consumers, and therefore, with hemp producers as well. Hemp and cannabis were “primarily the same plant and often [were] not visually distinguishable” besides their cannabinoid profiles, he said, claiming that “mostly the distinction between hemp and marijuana is the concentration of delta-9-THC.” Badaracco described another difference being the concentration of CBD, which was more abundant in hemp (audio - 5m, video, written testimony).
      • ”In many states, including Kentucky, most delta-8-THC products [were] sold throughout unregulated market sources, like convenience stores, grocery stores, smoke vape shops, gas stations, and can even be ordered online,” he said, alleging that such items were “not reliably tested and have been found to contain many impurities.” Badaracco suggested regulators could work with the US Hemp Authority, “the hemp industry’s self-regulating organization in the absence of FDA regulations.” He stated authority standards had been “based largely on FDA's regulatory regime concerning dietary supplements and food and beverage additives and is enforced by third party auditors,” yet federal regulators were still needed to ensure product safety since people ignoring industry standards had grown to be a “concern for law enforcement in many instances.”
        • At time of publication, Badaracco served as secretary for the US Hemp Authority, which wasn’t specified in his professional biography or testimony.
      • Badaracco hoped Congress would pass standards for manufacturing, testing, and distribution of hemp products, “along with restriction[s] to advertising which may appeal to minors.” Moreover, he felt there should be “mandatory reporting to a government entity when ingestion of the substances led to an adverse reaction [as] law enforcement believes these events are under reported,” and that police officers needed more training around hemp consumables.
    • Gillian Schauer, Cannabis Regulators Association (CANNRA) Executive Director (audio - <1m, video, biography)
      • Calling regulation of hemp cannabinoid products the “number one issue facing my members,” Schauer commented that there had been an “explosion” in hemp derived items since passage of the 2018 Farm Bill which were failing standards of consumer safety as well as being appealing to children. She argued “Farm Bill compliant cannabinoid hemp products can also contain far more delta-9-THC than is legal in state regulated marijuana markets, and yet still be under the [0].3% delta-9-THC threshold.” Schauer believed that “full spectrum” hemp consumables “contain all of the compounds found in the hemp plant, [and] can also have enough delta-9-THC to be intoxicating.” These compounds had similar effects on the body, yet “federal…legality of it differs based on the source” (audio - 5m, video, written testimony).
      • Hemp cannabinoid products were able to be “sold to anyone, anywhere, without any standards or federal regulations,” Schauer warned, finding a lack of testing and labeling put consumers and children at risk. “This is in stark contrast to state regulated marijuana markets,” she added, where consumer safety rules were in place, whereas “states have seen a range of public health and safety issues directly linked to intoxicating [hemp] cannabinoid products, including accidental ingestion by young kids resulting in hospitalization, over consumption by teenagers resulting in hospitalization, and unexpected impairment by adults.”
      • As a result, she said state authorities were “bringing intoxicating hemp products under the purview of the marijuana regulator, where the same cannabinoids but derived from marijuana are being regulated without federal minimum standards.” A network of differing regulations contributed to “consumer safety and market challenges, and leaves regulatory gaps that cannot be covered by states alone, including an online markets and through interstate commerce,” Schauer told the committee.
      • CANNRA members wanted to see a “comprehensive federal regulatory policy” for hemp items, she noted: a “federal regulatory agency with a focus on public health and safety like FDA needs to be authorized and funded with a specific time frame” for implementing rules and regulations that didn’t “just focus on CBD, it must contend with the breadth of hemp derived cannabinoids.” Beyond food and beverages, Schauer mentioned hemp products could be smoked or vaped, necessitating a different “regulatory framework for cannabinoid hemp…beyond traditional food and dietary supplement pathways.”
      • Schauer concluded her remarks with a call for members to connect with their states’ cannabis or hemp regulators “to hear firsthand from them what this issue looks like on the ground in your state in your jurisdiction.”
      • Schauer, also a University of Washington (UW) Researcher, spoke to Washington state lawmakers about the status of cannabinoid regulations in other states in December 2022. She has previously participated in the WSLCB Cannabinoid Science Work Group which was scheduled to meet on Thursday, August 3rd.
  • Committee members posed a series of questions to panelists on the cannabidiol (CBD) market, research, risks around youth access, and other topics.
    • Comer wondered about the size of the CBD market. Miller referred to an article in his written testimony predicting the market could reach $20 billion by 2024. He mentioned that the “lack of action has cast a shadow over the industry,” keeping “big box stores” from carrying CBD items. He also suggested hemp prices decreased “when the supply went way up,” but then “prices collapsed and farmers [were] bearing the burden” (audio - 1m, video).
    • Then, Comer asked Henderson about what studies were available to FDA researchers. She responded that they had data associated with the approval of Epidiolex and were conducting their own studies, only some of which were published. Henderson then identified “other human clinical trials outside of Epidiolex with other CBD formulations across a wide range of populations,” along with her company’s studies, plus “other studies that have been conducted by stakeholders that aren't published yet. And then there are other preclinical safety related studies that are published. So, there [was] a lot of data that we typically don't have access to when reviewing an ingredient as a dietary supplement” (audio - 1m, video).
    • Comer reiterated his position that the situation was the fault of FDA leadership, which Miller concurred with. Comer next asked if agency staff had “at least been transparent with stakeholders as to what it needs to move forward with regulating CBD?” Miller replied that “we don't think a new regulatory pathway is needed, but we would be happy to entertain or even support additional regulatory safeguards above what's currently under law. But the FDA has not specified those in a way that's allowed members of Congress to draft legislation to, to accommodate that” (audio - 1m, video).
    • Comer’s next question was put to Badaracco as he was curious “what you [were] hearing in the law enforcement community about the dangers consumers may face.” Badaracco explained that he’d sent out a request to “400 members within the state of Kentucky” for anecdotal reports of adverse incidents involving youth and was “continuing to get reports.” Representatives of a police department in “far eastern Kentucky” mentioned hemp products were their “number one priority,” as well as “two physicians from two hospital ERs [emergency rooms]. I haven't talked to them yet, but they want to talk to me.” Comer surmised hemp items were “a huge problem; we see that everywhere,” and that “very seldom do I as a conservative Republican advocate for regulations,” but in this instance regulations were needed to thwart “bad actors” in the market. He described purity and labeling oversight as being absent from, and needed in, the hemp sector (audio - 3m, video).
    • Lee pressed Schauer on why federal officials couldn’t rely on self-regulating efforts by the hemp industry alone. Schauer replied that "we really do need science to create thoughtful regulation" on hemp cannabinoids, but the existing regulatory pathways weren’t sufficient. “We're not just seeing dietary supplements in the field,” she warned, “we're seeing inhalables…and combustible products as well,” and data was needed for “products [which] don't fit neatly into a regulatory pathway that FDA currently has.” Schauer expanded on the fact that it wasn’t only CBD which needed evaluation, but “novel cannabinoids” like delta-8-THC: “we need to understand how those cannabinoids interact, what their effects are on on humans, and we need not to be using humans as the test case for that” (audio - 2m, video).
    • Lee then asked Miller about efforts at diversity, equity, and inclusion (DEI) in the hemp industry. Describing how “I've worked hard this Congress to promote diversity, both in and out of committee hearings, and…I'll be sending a letter to the chair addressing the need for more diverse witnesses,” Lee wanted to hear about the “purpose of the US Hemp Roundtable’s Minority Empowerment committee.” Miller answered that “cannabis has a very sad history when it comes to disparate treatment of people of color and, and there's been structural racism that's pervaded federal farm programs. And so that's why our organization and I think the industry is…really engaged in an effort to promote diversity and equity in our ranks” (audio - 1m, video).
    • Representative Glenn Grothman (R-Wisconsin) wanted to know more about the economic implications and legislative solutions to the lack of federal oversight on CBD. Miller referred to research by the Brightfield Group suggesting it was costing the sector five billion dollars not having clear federal regulations. Grothman noted that the United Kingdom and Australia regulated CBD, asking how the US market differed. Miller didn’t believe the market was different, and agreed American officials could learn from regulatory structures in other countries (audio - 2m, video).
      • Miller repeated his call for passage of H.R. 1628 and H.R. 1629, language directing FDA action on regulating CBD as a dietary supplement, when asked by Grothman what representatives should do regarding hemp in the 2023 Farm Bill. Miller further acknowledged that any language would need to be negotiated with members of the US House Agriculture Committee.
    • Grothman asked about the legality of shipping CBD items between states, with Badaracco emphasizing that access was a “mixed bag” based on the laws of the states involved. Gorthman then inquired “why do you think some companies feel that they can do this?” Badaracco suggested it was an “unintended consequence” of the 2018 Farm Bill, confirming that he could only speak “anecdotally” based on what narcotics officers in Kentucky were telling him (audio - 2m, video). Grothman also asked about the market share for intoxicating cannabinoid products but neither Badaracco nor Miller acknowledged specific data on that point (audio - <1m, video).
    • Representative Virginia Foxx (R-North Carolina) inquired about the health risks associated with hemp cannabinoid ingestion. Badaracco said he’d heard of “children having to go to the emergency room” with symptoms such as “agitation, increased heart rate, nauseous, unconsciousness, things of that nature.” He then referred to a “report just yesterday from Covington, Kentucky of” a child who “bought a gummy bear which turned out to be a…delta-8 gummy bear treated and it had 10 doses in it, and the child consumed it, and of course went to the ER…and I'm finding this across the state.” Foxx next asked why federal drug enforcement wasn’t cracking down on hemp consumables. Badaracco believed this was due to a “mixed bag from the court system…the ninth circuit said that delta-8 [was] a derivative of hemp, So therefore it's [legal]; a Kentucky court has also expressed that opinion as well,” but product safety and control was lagging due to federal inaction (audio - 3m, video).
    • When Foxx asked for clarification about FDA enforcement actions, Miller noted this was limited to warning letters sent to companies making “outrageous” claims about their CBD product. She then wondered whether it had been the intent of lawmakers passing the 2018 Farm Bill to legalize intoxicating cannabinoids. Miller replied that “when we were lobbying up on the hill…we said ‘hemp is not marijuana, hemp is not intoxicating’ and so I don't believe that that was the intent of Congress but the language got written as it was.” He wanted federal authorities to “get a hold of it, we need to regulate it, we need to get it out of the hands of kids” through a “stricter regulatory regime” either at FDA or the US Alcohol and Tobacco Tax and Trade Bureau (US TTB, audio - 2m, video).
    • McClain reiterated the dangers to consumers of not having federal regulation of hemp items, wondering how consumers could verify anything about the products. Miller stated that US Hemp Authority certification was the best option, though “some states have also stepped into the breach, and have come up with good regulatory structure” (audio - 5m, video).
      • McClain was curious if this included consequences for false labeling. Miller answered this depended on the state.
      • She then asked about the impact to the existing hemp industry, to which Miller said it was “devastating…it imposed tremendous burdens because of this lack of regulatory authority.”
      • McClain inquired whether FDA leaders had been “receptive” to industry calls for further regulation. Miller told the committee that FDA staff “meets with… the industry about once a year. They’re always listening sessions,” but stakeholders didn’t get feedback from the FDA.
      • “If we didn't regulate [CBD], would it help [the] industry,” McClain asked. Miller replied regulations would both stabilize and help the hemp sector grow. McClain speculated that regulations had been “instituted in the 2018 Farm Bill, yet the FDA has slow walked, maybe not even at all done any sort of regulation on this,” complaining this was akin to her coming to Congress “and say ‘you know, what if you just paid me a little bit more, I'll go to a few more hearings, I'll take a few more votes.’ It just doesn't work like that.” She suggested reducing funding to the FDA as a consequence for the lack of guidelines on hemp, and attempted to draw a connection to her understanding that “the FDA has not returned to its pre-pandemic telework policy.”
    • Bringing the hearing to a close, McClain commented, “unfortunately, the government bureaucracy appears to have gotten in the way of the American hemp industry, and consumer safety, the actual opposite of what they were supposed to do.” She saw hemp stakeholders as wanting to “inject certainty into the market” for “growers and everyone else up and down the supply chain all the way to the end” with “consumers who consume the hemp product.” McClain believed that Miller’s testimony showed FDA officials had “not engaged really in any meaningful enforcement actions,” nor been “transparent or consistent in their…decision-making with the hemp industry.” She argued there was sufficient “rigorous” study of CBD to create regulations, and by not passing them, the FDA “left a market where dangerous dangers lurk for consumers…the FDA just needs to do the job that the American taxpayer is paying them for, and if they can't do their job, maybe we should stop funding them or funding them at reduced levels” (audio - 3m, video).
      • McClain gave committee members “five legislative days within which to…submit additional written questions for the witnesses, which will be forwarded to the witnesses for the responses.”
      • The following day a hearing wrap up press release was sent out with takeaways and member highlights.

Information Set