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The Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) provided official testimony to the U.S. House of Representatives Committee on Oversight and Accountability, Subcommittee on Health Care and Financial Services, asking that Congress demand the U.S. Food and Drug Administration (FDA) complete the work Congress directed the agency to do under the 2018 Farm Bill by permitting CBD and other hemp-derived cannabinoids to be lawfully marketed as dietary supplements using the appropriate safeguards found in the existing law.
Lawmakers are currently examining the FDA’s lack of regulatory oversight on hemp-derived CBD products. On Thursday, July 27, the subcommittee conducted a hearing titled “Hemp in the Modern World: The Yearslong Wait for FDA Action.” The trade associations’ submissions come in response to FDA’s declarations earlier this year: first asserting in January that the existing legal framework was not appropriate to regulate CBD products; and subsequently stating, during a stakeholder call the agency hosted in June, that it would request an entirely new regulatory framework for all cannabis products, ignoring the distinction Congress previously made between hemp and marijuana in the 2018 Farm Bill.
“… [NPA has] spearheaded the charge to create a lawful pathway to market for foods and dietary supplements that contain cannabidiol (CBD),” said Daniel Fabricant, PhD, president and CEO of NPA. “NPA worked with the House Appropriations Committee in 2019 on language to force FDA to set a daily consumption level, as that is the primary question on Main Street: ‘How much should I use daily?’
“Instead of collaborating with Congress and industry to use its existing legislative authority wisely, FDA has embarked on the pursuit of a new regulatory empire via a ‘center’ for cannabis/hemp. Based on what happened with the Center for Tobacco Products (CTP) at FDA, another new center will be yet another huge expense, likely costing the taxpayer hundreds of millions of dollars, more delays — and, as we’ve seen with CTP, no demonstrable functionality as a regulator.
“FDA will claim that they need more time; however, this assertion is deliberate and not without severe public health consequence and further confusion in the marketplace,” said Fabricant.
CRN asserted that the current regulatory framework for dietary supplements provides ample tools by which FDA can mitigate risks and protect consumers, while allowing access to safe botanicals, like CBD. Other possible safeguards that FDA imagines for a new category of cannabis products could be achieved under the existing framework.
“The FDA is downplaying, underestimating and misrepresenting its enforcement capabilities and consumer protection tools it already has for dietary supplements as a justification for establishing new staff and resources within the FDA, and a regulatory category that undermines and ignores the existing structure,” said CRN President and CEO Steve Mister. “Creation of this new framework would require substantial funding requests from Congress to set up and staff it; or, if the FDA instead decided to seek user fees on these products, doing so could ultimately raise costs for consumers. In the meantime, consumers are left to navigate the CBD marketplace without any guardrails imposed on these products, when a viable framework for dietary supplements already exists.”
While FDA first claimed in 2019 that CBD was precluded from use in dietary supplements due to a high-dose, highly purified form of CBD being approved in 2018 in the prescription drug Epidiolex, CRN contended that the agency currently has several options that would allow for the inclusion of CBD in dietary supplements, and that Congress should inquire why none of these options have been pursued. CRN also refuted FDA’s claim that the agency lacks the safety data for CBD to appropriately provide safeguards for its supplement use. FDA has been presented with a vast amount of safety evidence over the past five years, including information from the trade associations, as well as from other organizations and companies. Additionally, other government bodies have established recommended maximum intake levels of CBD. Despite the plethora of safety data available to FDA, the agency continues to claim that adequate safety evidence is lacking, according to the associations.
For more information, visit www.npanational.org and www.crnusa.org.
The Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) provided official testimony to the U.S. House of Representatives Committee on Oversight and Accountability, Subcommittee on Health Care and Financial Services, asking that Congress demand the U.S. Food and Drug Administration (FDA) complete the work Congress directed the agency to do under the 2018 Farm Bill by permitting CBD and other hemp-derived cannabinoids to be lawfully marketed as dietary supplements using the appropriate safeguards found in the existing law.
Lawmakers are currently examining the FDA’s lack of regulatory oversight on hemp-derived CBD products. On Thursday, July 27, the subcommittee conducted a hearing titled “Hemp in the Modern World: The Yearslong Wait for FDA Action.” The trade associations’ submissions come in response to FDA’s declarations earlier this year: first asserting in January that the existing legal framework was not appropriate to regulate CBD products; and subsequently stating, during a stakeholder call the agency hosted in June, that it would request an entirely new regulatory framework for all cannabis products, ignoring the distinction Congress previously made between hemp and marijuana in the 2018 Farm Bill.
“… [NPA has] spearheaded the charge to create a lawful pathway to market for foods and dietary supplements that contain cannabidiol (CBD),” said Daniel Fabricant, PhD, president and CEO of NPA. “NPA worked with the House Appropriations Committee in 2019 on language to force FDA to set a daily consumption level, as that is the primary question on Main Street: ‘How much should I use daily?’
“Instead of collaborating with Congress and industry to use its existing legislative authority wisely, FDA has embarked on the pursuit of a new regulatory empire via a ‘center’ for cannabis/hemp. Based on what happened with the Center for Tobacco Products (CTP) at FDA, another new center will be yet another huge expense, likely costing the taxpayer hundreds of millions of dollars, more delays — and, as we’ve seen with CTP, no demonstrable functionality as a regulator.
“FDA will claim that they need more time; however, this assertion is deliberate and not without severe public health consequence and further confusion in the marketplace,” said Fabricant.
CRN asserted that the current regulatory framework for dietary supplements provides ample tools by which FDA can mitigate risks and protect consumers, while allowing access to safe botanicals, like CBD. Other possible safeguards that FDA imagines for a new category of cannabis products could be achieved under the existing framework.
“The FDA is downplaying, underestimating and misrepresenting its enforcement capabilities and consumer protection tools it already has for dietary supplements as a justification for establishing new staff and resources within the FDA, and a regulatory category that undermines and ignores the existing structure,” said CRN President and CEO Steve Mister. “Creation of this new framework would require substantial funding requests from Congress to set up and staff it; or, if the FDA instead decided to seek user fees on these products, doing so could ultimately raise costs for consumers. In the meantime, consumers are left to navigate the CBD marketplace without any guardrails imposed on these products, when a viable framework for dietary supplements already exists.”
While FDA first claimed in 2019 that CBD was precluded from use in dietary supplements due to a high-dose, highly purified form of CBD being approved in 2018 in the prescription drug Epidiolex, CRN contended that the agency currently has several options that would allow for the inclusion of CBD in dietary supplements, and that Congress should inquire why none of these options have been pursued. CRN also refuted FDA’s claim that the agency lacks the safety data for CBD to appropriately provide safeguards for its supplement use. FDA has been presented with a vast amount of safety evidence over the past five years, including information from the trade associations, as well as from other organizations and companies. Additionally, other government bodies have established recommended maximum intake levels of CBD. Despite the plethora of safety data available to FDA, the agency continues to claim that adequate safety evidence is lacking, according to the associations.
