By Mike Montemarano, Associate Editor08.08.23
The U.S. House of Representatives Subcommittee on Health Care and Financial Services held a first-of-its-kind hearing in which over 120 witnesses called upon the U.S. Food and Drug Administration (FDA) to establish a legal pathway to market for cannabidiol (CBD) products.
While there was some disagreement about whether Congress should provide FDA with the new regulatory framework outside of food and supplement laws it requested, there was widespread agreement to expedite a legal path to market for CBD and other hemp derivatives.
For years FDA has asserted its position that CBD can’t be approved for use in supplements due to first being investigated as a drug since the passage of the 2018 Farm Bill. The agency this year said it is willing to work with Congress to establish a regulatory scheme for the thousands of CBD-containing products already in commerce.
Those who don’t want to establish CBD-specific regulations fear that the marketplace will continue to languish, and illegal, adulterated CBD products will continue to proliferate with the continued lack of enforcement. They argue that food and supplement regulation is sufficient, and it’s far too late to begin discussions on new regulations.
Citing one study, Representative Lisa McClain (R-MI) noted that of 3,000 market-available products, only one quarter of brands tested their products for purity and quality, and only 16% of products contained what was claimed on their labels.
“Common adulterants found in CBD products today include mold, heavy metals, and THC, the intoxicating chemical found in the cannabis plant,” she said at the hearing. FDA could eliminate these issues by regulating these products as dietary supplements […] instead, FDA asks for more authority, more money, and more staff, and only then will they actually do their duties under the law.”
However, some in the committee are holding out that FDA will play ball with “common sense” legislation.
“The FDA knows that Congress will appropriately hold it accountable if it exceeds its regulatory authority. That’s our job. So they’re not going to take that risk of going too far on matters like CBD,” said Representative Katie Porter (D-CA). “Let’s not ask them to take their risk, and instead work across the aisle on common-sense legislation. Given the strong bipartisan support, members of Congress should have no problem rolling up their sleeves and establishing the regulatory pathway that FDA says it needs.”
Based on the many forms that CBD and other hemp derivatives can take, such as oils, tinctures, vape pens, and cosmetics, Rep. Jamie Raskin (D-MD) concurred with FDA’s assessment that food and supplement regulatory schemes are insufficient to regulate all manufacturers of products containing hemp derivatives.
There’s a great deal to learn from state regulations despite their inconsistencies, noted Gillian L. Schauer, PhD, MPH, executive director of the Cannabis Regulators Association (CANNRA).
“As an association of state regulators, we want comprehensive regulation that covers the full range of available products. We have the opportunity to learn from approaches that states have taken to set thoughtful and comprehensive federal regulatory policy,” she said. “There needs to be a specific timeframe with which to implement a regulatory framework for these products and it can’t just focus on CBD, but the breadth of cannabinoids we see on the market, and it must account for products we don’t yet know about. It must account for products including foods, beverages, vapes, and smoked products, and it must require contaminant testing, compliance, and enforcement.”
“When Congress passed the 2018 Farm Bill, it explicitly legalized the sale of hemp and its derivatives such as CBD,” said Jonathan Miller, general counsel at the U.S. Hemp Roundtable, an association representing the hemp/CBD industry. “Without a federal regulatory pathway for requiring such standards, economic opportunities for U.S. hemp farmers will be diminished and consumers will not have access to safe, quality products.”
“There are abundant consumer safeguards encompassed in the Federal Food, Drug, and Cosmetic Act (FDCA) that would be applied to CBD products sold as dietary supplements,” Miller said, which cover mislabeling, adulteration, serious adverse events reporting, and warnings against use by children.
The Council for Responsible Nutrition (CRN) said in its statement that there was clear intention to create a path to market for CBD-containing products in the 2018 Farm Bill’s definitions, which separated hemp from marijuana. FDA’s proposal for a new set of rules “was not a way forward,” CRN stated, but rather “a series of excuses to step backwards from what Congress intended.”
With the approval of Epidiolex for investigation as a new drug prior to the legal marketing of CBD-containing supplements, FDA has generally applied drug standards to safety considerations for broad-spectrum hemp extracts which contain naturally-occurring CBD in addition to other cannabinoids.
But it doesn’t have to, according to CRN, and the agency has opposed several options it already has to regulate CBD products in a way that keeps consumers safe. “FDA could determine that the pharmaceutical and dietary supplements are not using the same ‘article,’ and thus, these low dosage products are not precluded by the drug preclusion provision […] alternatively, FDA could invoke the rulemaking authority expressly granted to it by the statute and initiate a notice and comment rulemaking that would allow the legal marketing of CBD as a supplement […] a third option available to FDA to bypass the drug preclusion issue is to ask Congress to amend the law to grant a special case for CBD.”
“When FDA feigns that its hands are tied by the drug preclusion language in the FDCA, Congress should inquire why none of these options have been pursued,” CRN said in its statement.
“The current hemp/cannabis leads at FDA are unfamiliar with the science and policy regarding foods and dietary supplements and have ignored basic toxicology,” The Natural Products Association (NPA) said in its statement. “FDA can today, under current authorities, set a daily consumption level which would address the major public health concerns in foods and dietary supplements. Establishment of such a level would trigger other authorities dealing with labeling and product quality through good manufacturing practices (cGMP), which the agency can use to effectively regulate the marketplace and inspect facilities and analyze products.”
“There’s a growing body of evidence, including data published by the industry, demonstrating that hemp-derived CBD, especially at the levels found in many dietary supplements and food, is safe,” Miller said. “A published 2021 observational study, updated with more compelling evidence in 2022, demonstrated that CBD does not pose significant safety concerns at the levels typically found in many dietary supplements and food and that also addresses specific safety concerns raised by FDA […] Data already exists to determine that hemp extracts containing CBD can be Generally Recognized As Safe (GRAS).”
While FDA defers to a study conducted by the Center for Food Safety and Applied Nutrition (CFSAN) on CBD, which highlighted a number of concerns including liver and reproductive toxicity, critics were quick to pan this study since the dosages studied were about three-times the dose of that found in the FDA-approved drug, Epidiolex.
“FDA simply isn’t being transparent with industry stakeholders or Congress about which scientific studies it relies on, and often moves goal posts for researchers who are trying to satisfy the agency’s requirements through rigorous studies,” said Representative James Comer (R-KY).
Preclinical data on the safety of CBD is sufficient enough that future safety studies which inform regulatory approaches should be designed in ways similar to food and supplement studies, rather than drug studies, said Rayetta G. Henderson, PhD, senior managing scientist at ToxStrategies LLC who provided a roundup of existing literature to the hearing in her statement.
“Recommendations for safe use, including levels of consumption, can be derived based on the available data—what these levels are will depend on a number of factors, including the safety data available to those conducting the assessment and the population intended to use the product.”
“Despite the plethora of safety data available to FDA [which was submitted over the past five years by several trade associations], the agency continues to claim that adequate safety evidence is lacking, while not appreciating that the safety profile of CBD-containing dietary supplements would be different than much higher-dosed approved drug products, as well as the body of evidence on the safety of CBD-containing hemp extracts,” CRN stated. The trade group also pointed out that, internationally, tolerable upper limits are being established, such as 70 mg per day for healthy adults by the UK Food Standards Agency, and 60 mg daily by the Australian Therapeutic Goods Administration.
NPA and CRN both noted that several compounds present in food, like sodium or corn syrup, have toxicology concerns when consumed at extremely high levels, yet the agency has not considered the potential for abuse of these ingredients when present in foods.
Across the country, a patchwork of states have imposed unique quality requirements for CBD-containing products, with a wide variety of specifications, NPA noted in its statement. Approximately 3,000 CBD products are in commerce now, yet only 37 laboratories can legally test products for THC since certification with the Drug Enforcement Agency is required to do so.
There is no “consistent approach to regulation or any plan on how consumer access will be balanced with consumer safety by public health officials at the Food and Drug Administration,” NPA stated.
Richard Badaracco, president-elect of the Kentucky Narcotic Officers, noted that the few regionalized regulations in place are clearly failing to keep consumers safe.
“Self-regulation is not sufficient. Federal regulation is necessary to ensure that all products in the marketplace maintain the highest safety standards,” Badaracco said. He specifically noted anecdotes of children having to go to the emergency room with agitation, increased heart rate, nausea, unconsciousness, and other issues due to taking adulterated, intoxicating products purporting to be CBD.
Beyond quality concerns, reputable actors in the CBD industry have suffered financially as a direct result of inaction on the regulatory front, industry representatives argued.
“The lack of action has cast a shadow over the industry. It’s kept a lot of big box stores from carrying products that they otherwise would. It’s kept a lot of big food and beverage companies from adding CBD to their mixes. As a result, there was a decrease in demand when the supply went way up […] the price has collapsed, and farmers are bearing the burden,” Miller said.
“Given that it has been over five years since enactment of the 2018 Farm Bill, and the agency has refused to act, punting the ball now to Congress, we agree that this is the time to act,” he continued, noting U.S. Hemp Roundtable’s support for House Resolutions 1628 and 1629 which would provide a regulatory pathway to market for CBD as a food/supplement ingredient.
Miller pointed to data from Hemp Benchmarks, which showed that CBD biomass, crude oil, full spectrum distillate, and CBD isolate have all declined more than 90% in value between April 2019 and October 2022, and suppliers have little left to do with oversupply. Concurrently, hemp and CBD companies are being rejected by major banks and payment processing services, and this ban extends even to hemp fiber and grain companies as well as nonprofit organizations.
While there was some disagreement about whether Congress should provide FDA with the new regulatory framework outside of food and supplement laws it requested, there was widespread agreement to expedite a legal path to market for CBD and other hemp derivatives.
For years FDA has asserted its position that CBD can’t be approved for use in supplements due to first being investigated as a drug since the passage of the 2018 Farm Bill. The agency this year said it is willing to work with Congress to establish a regulatory scheme for the thousands of CBD-containing products already in commerce.
Those who don’t want to establish CBD-specific regulations fear that the marketplace will continue to languish, and illegal, adulterated CBD products will continue to proliferate with the continued lack of enforcement. They argue that food and supplement regulation is sufficient, and it’s far too late to begin discussions on new regulations.
Citing one study, Representative Lisa McClain (R-MI) noted that of 3,000 market-available products, only one quarter of brands tested their products for purity and quality, and only 16% of products contained what was claimed on their labels.
“Common adulterants found in CBD products today include mold, heavy metals, and THC, the intoxicating chemical found in the cannabis plant,” she said at the hearing. FDA could eliminate these issues by regulating these products as dietary supplements […] instead, FDA asks for more authority, more money, and more staff, and only then will they actually do their duties under the law.”
However, some in the committee are holding out that FDA will play ball with “common sense” legislation.
“The FDA knows that Congress will appropriately hold it accountable if it exceeds its regulatory authority. That’s our job. So they’re not going to take that risk of going too far on matters like CBD,” said Representative Katie Porter (D-CA). “Let’s not ask them to take their risk, and instead work across the aisle on common-sense legislation. Given the strong bipartisan support, members of Congress should have no problem rolling up their sleeves and establishing the regulatory pathway that FDA says it needs.”
Based on the many forms that CBD and other hemp derivatives can take, such as oils, tinctures, vape pens, and cosmetics, Rep. Jamie Raskin (D-MD) concurred with FDA’s assessment that food and supplement regulatory schemes are insufficient to regulate all manufacturers of products containing hemp derivatives.
There’s a great deal to learn from state regulations despite their inconsistencies, noted Gillian L. Schauer, PhD, MPH, executive director of the Cannabis Regulators Association (CANNRA).
“As an association of state regulators, we want comprehensive regulation that covers the full range of available products. We have the opportunity to learn from approaches that states have taken to set thoughtful and comprehensive federal regulatory policy,” she said. “There needs to be a specific timeframe with which to implement a regulatory framework for these products and it can’t just focus on CBD, but the breadth of cannabinoids we see on the market, and it must account for products we don’t yet know about. It must account for products including foods, beverages, vapes, and smoked products, and it must require contaminant testing, compliance, and enforcement.”
Was the 2018 Farm Bill Sufficient?
Proponents of CBD argue there’s no validity to FDA’s interpretation that the 2018 Farm Bill was insufficient in granting them authority to regulate CBD products.“When Congress passed the 2018 Farm Bill, it explicitly legalized the sale of hemp and its derivatives such as CBD,” said Jonathan Miller, general counsel at the U.S. Hemp Roundtable, an association representing the hemp/CBD industry. “Without a federal regulatory pathway for requiring such standards, economic opportunities for U.S. hemp farmers will be diminished and consumers will not have access to safe, quality products.”
“There are abundant consumer safeguards encompassed in the Federal Food, Drug, and Cosmetic Act (FDCA) that would be applied to CBD products sold as dietary supplements,” Miller said, which cover mislabeling, adulteration, serious adverse events reporting, and warnings against use by children.
The Council for Responsible Nutrition (CRN) said in its statement that there was clear intention to create a path to market for CBD-containing products in the 2018 Farm Bill’s definitions, which separated hemp from marijuana. FDA’s proposal for a new set of rules “was not a way forward,” CRN stated, but rather “a series of excuses to step backwards from what Congress intended.”
Application of Drug Standards
The debate over whether drug standards should be applied to low-dose consumer products, when it comes to safety reviews and novel regulations, persists.With the approval of Epidiolex for investigation as a new drug prior to the legal marketing of CBD-containing supplements, FDA has generally applied drug standards to safety considerations for broad-spectrum hemp extracts which contain naturally-occurring CBD in addition to other cannabinoids.
But it doesn’t have to, according to CRN, and the agency has opposed several options it already has to regulate CBD products in a way that keeps consumers safe. “FDA could determine that the pharmaceutical and dietary supplements are not using the same ‘article,’ and thus, these low dosage products are not precluded by the drug preclusion provision […] alternatively, FDA could invoke the rulemaking authority expressly granted to it by the statute and initiate a notice and comment rulemaking that would allow the legal marketing of CBD as a supplement […] a third option available to FDA to bypass the drug preclusion issue is to ask Congress to amend the law to grant a special case for CBD.”
“When FDA feigns that its hands are tied by the drug preclusion language in the FDCA, Congress should inquire why none of these options have been pursued,” CRN said in its statement.
“The current hemp/cannabis leads at FDA are unfamiliar with the science and policy regarding foods and dietary supplements and have ignored basic toxicology,” The Natural Products Association (NPA) said in its statement. “FDA can today, under current authorities, set a daily consumption level which would address the major public health concerns in foods and dietary supplements. Establishment of such a level would trigger other authorities dealing with labeling and product quality through good manufacturing practices (cGMP), which the agency can use to effectively regulate the marketplace and inspect facilities and analyze products.”
“There’s a growing body of evidence, including data published by the industry, demonstrating that hemp-derived CBD, especially at the levels found in many dietary supplements and food, is safe,” Miller said. “A published 2021 observational study, updated with more compelling evidence in 2022, demonstrated that CBD does not pose significant safety concerns at the levels typically found in many dietary supplements and food and that also addresses specific safety concerns raised by FDA […] Data already exists to determine that hemp extracts containing CBD can be Generally Recognized As Safe (GRAS).”
While FDA defers to a study conducted by the Center for Food Safety and Applied Nutrition (CFSAN) on CBD, which highlighted a number of concerns including liver and reproductive toxicity, critics were quick to pan this study since the dosages studied were about three-times the dose of that found in the FDA-approved drug, Epidiolex.
“FDA simply isn’t being transparent with industry stakeholders or Congress about which scientific studies it relies on, and often moves goal posts for researchers who are trying to satisfy the agency’s requirements through rigorous studies,” said Representative James Comer (R-KY).
Preclinical data on the safety of CBD is sufficient enough that future safety studies which inform regulatory approaches should be designed in ways similar to food and supplement studies, rather than drug studies, said Rayetta G. Henderson, PhD, senior managing scientist at ToxStrategies LLC who provided a roundup of existing literature to the hearing in her statement.
“Recommendations for safe use, including levels of consumption, can be derived based on the available data—what these levels are will depend on a number of factors, including the safety data available to those conducting the assessment and the population intended to use the product.”
“Despite the plethora of safety data available to FDA [which was submitted over the past five years by several trade associations], the agency continues to claim that adequate safety evidence is lacking, while not appreciating that the safety profile of CBD-containing dietary supplements would be different than much higher-dosed approved drug products, as well as the body of evidence on the safety of CBD-containing hemp extracts,” CRN stated. The trade group also pointed out that, internationally, tolerable upper limits are being established, such as 70 mg per day for healthy adults by the UK Food Standards Agency, and 60 mg daily by the Australian Therapeutic Goods Administration.
NPA and CRN both noted that several compounds present in food, like sodium or corn syrup, have toxicology concerns when consumed at extremely high levels, yet the agency has not considered the potential for abuse of these ingredients when present in foods.
Enforcement Vacuum and Consequences
Consumers can’t differentiate safe products from those that contain intoxicants and contaminants, and CBD proponents blame FDA for its refusal to enforce cGMPs.Across the country, a patchwork of states have imposed unique quality requirements for CBD-containing products, with a wide variety of specifications, NPA noted in its statement. Approximately 3,000 CBD products are in commerce now, yet only 37 laboratories can legally test products for THC since certification with the Drug Enforcement Agency is required to do so.
There is no “consistent approach to regulation or any plan on how consumer access will be balanced with consumer safety by public health officials at the Food and Drug Administration,” NPA stated.
Richard Badaracco, president-elect of the Kentucky Narcotic Officers, noted that the few regionalized regulations in place are clearly failing to keep consumers safe.
“Self-regulation is not sufficient. Federal regulation is necessary to ensure that all products in the marketplace maintain the highest safety standards,” Badaracco said. He specifically noted anecdotes of children having to go to the emergency room with agitation, increased heart rate, nausea, unconsciousness, and other issues due to taking adulterated, intoxicating products purporting to be CBD.
Beyond quality concerns, reputable actors in the CBD industry have suffered financially as a direct result of inaction on the regulatory front, industry representatives argued.
“The lack of action has cast a shadow over the industry. It’s kept a lot of big box stores from carrying products that they otherwise would. It’s kept a lot of big food and beverage companies from adding CBD to their mixes. As a result, there was a decrease in demand when the supply went way up […] the price has collapsed, and farmers are bearing the burden,” Miller said.
“Given that it has been over five years since enactment of the 2018 Farm Bill, and the agency has refused to act, punting the ball now to Congress, we agree that this is the time to act,” he continued, noting U.S. Hemp Roundtable’s support for House Resolutions 1628 and 1629 which would provide a regulatory pathway to market for CBD as a food/supplement ingredient.
Miller pointed to data from Hemp Benchmarks, which showed that CBD biomass, crude oil, full spectrum distillate, and CBD isolate have all declined more than 90% in value between April 2019 and October 2022, and suppliers have little left to do with oversupply. Concurrently, hemp and CBD companies are being rejected by major banks and payment processing services, and this ban extends even to hemp fiber and grain companies as well as nonprofit organizations.
