08.18.23
After five years of inaction from the U.S. Food and Drug Administration (FDA) on establishing a legal pathway to market for CBD and other cannabinoids, Congress is taking long-awaited initiative to intervene.
On the heels of a first-of-its-kind hearing held by the U.S. House of Representatives Subcommittee on Health Care and Financial Services, many stakeholders submitted comments to a bicameral Request for Information (RFI) from the U.S. Congress Energy and Commerce Committee in order to create a legislative approach to the regulation of CBD products. The RFI sought information from a range of subject matter experts intimately involved with FDA.
The 2018 farm bill de-scheduled hemp and hemp-derived CBD products from the Controlled Substances Act, but FDA was quick to announce its stance that CBD products cannot be sold for human consumption in foods, dietary supplements, and other products. FDA has held the same stance since, while widespread advocates have argued that Congress’ intent behind the 2018 farm bill was to introduce these products to market via the regulatory schemes of foods and/or supplements. However, FDA recently called for a new set of regulations for CBD, arguing that the New Dietary Ingredient Notification (NDIN) pathway isn’t sufficient to keep consumers safe.
Supplement industry trade organizations Council for Responsible Nutrition (CRN) and Natural Products Association (NPA) were among the stakeholders who submitted commentary to the latest RFI.
CRN argued that FDA has the authority already to regulate CBD-containing hemp products, based on authority granted to it in the Dietary Supplements Health and Education Act (DSHEA), which defines dietary supplements to include “an herb or other botanical, concentrate, metabolite, constituent extract, or combination.” Dozens of such botanicals are already used in supplements, such as cranberry, aloe vera, garlic, ginseng, turmeric, echinacea, and green tea extract. Just as importantly, data on the safety of CBD as a dietary ingredient is well-established at this point, according to the association, and consumers are more at risk with FDA’s refusal to regulate these products.
“Congress is asking the right questions, because they created in DSHEA a framework that could accommodate CBD, and their reasonable expectations for the FDA around this ingredient were not met,” said Steve Mister, President and CEO of CRN, in a statement. “Meanwhile, despite an overwhelming amount of safety data the industry has already presented to FDA, the agency continues to place an entire industry in innovation-stifling limbo, and consumers at continued risk in a needlessly unsupervised environment.”
CRN’s full response to the RFI can be found here.
NPA also submitted commentary in response to 28 questions which were posed by Congress on a number of topics, such as the current state of the CBD marketplace and its products, how CBD-specific product framework should compare to other approved substances with safety concerns, non-ingestible routes of administration, the patchwork of state laws on CBD, how FDA should distinguish between CBD supplements and the CBD drug Epidiolex, and more.
“For more than five years, Americans have been asking the FDA to make a safety determination for CBD. In that time, NPA has worked with Congress and the states to establish appropriate measures and even petitioned the FDA to exercise enforcement discretion in a specific and selective manner consistent with the premarket safety review of a new dietary ingredient notification,” said Daniel Fabricant, Ph.D., president and CEO of the NPA.
“Instead of using existing regulatory authority, FDA has resisted fulfilling their mandate for years and is now chasing the fantasy of a ‘center’ for hemp and cannabis products that would mimic the Center for Tobacco Products. Through DSHEA, Congress has provided the FDA with broad authority to review safety data for new dietary ingredients like CBD to enter commerce. Our proposal demonstrates that putting a clock on FDA to use existing authority is the most efficient and straightforward pathway for public health and to stabilize a robust marketplace for dietary supplements and foods containing CBD. We look forward to working with Congress and the FDA to finalize a reasonable regulatory approach that protects Americans and provides certainty to industry.”
On the heels of a first-of-its-kind hearing held by the U.S. House of Representatives Subcommittee on Health Care and Financial Services, many stakeholders submitted comments to a bicameral Request for Information (RFI) from the U.S. Congress Energy and Commerce Committee in order to create a legislative approach to the regulation of CBD products. The RFI sought information from a range of subject matter experts intimately involved with FDA.
The 2018 farm bill de-scheduled hemp and hemp-derived CBD products from the Controlled Substances Act, but FDA was quick to announce its stance that CBD products cannot be sold for human consumption in foods, dietary supplements, and other products. FDA has held the same stance since, while widespread advocates have argued that Congress’ intent behind the 2018 farm bill was to introduce these products to market via the regulatory schemes of foods and/or supplements. However, FDA recently called for a new set of regulations for CBD, arguing that the New Dietary Ingredient Notification (NDIN) pathway isn’t sufficient to keep consumers safe.
Supplement industry trade organizations Council for Responsible Nutrition (CRN) and Natural Products Association (NPA) were among the stakeholders who submitted commentary to the latest RFI.
CRN argued that FDA has the authority already to regulate CBD-containing hemp products, based on authority granted to it in the Dietary Supplements Health and Education Act (DSHEA), which defines dietary supplements to include “an herb or other botanical, concentrate, metabolite, constituent extract, or combination.” Dozens of such botanicals are already used in supplements, such as cranberry, aloe vera, garlic, ginseng, turmeric, echinacea, and green tea extract. Just as importantly, data on the safety of CBD as a dietary ingredient is well-established at this point, according to the association, and consumers are more at risk with FDA’s refusal to regulate these products.
“Congress is asking the right questions, because they created in DSHEA a framework that could accommodate CBD, and their reasonable expectations for the FDA around this ingredient were not met,” said Steve Mister, President and CEO of CRN, in a statement. “Meanwhile, despite an overwhelming amount of safety data the industry has already presented to FDA, the agency continues to place an entire industry in innovation-stifling limbo, and consumers at continued risk in a needlessly unsupervised environment.”
CRN’s full response to the RFI can be found here.
NPA also submitted commentary in response to 28 questions which were posed by Congress on a number of topics, such as the current state of the CBD marketplace and its products, how CBD-specific product framework should compare to other approved substances with safety concerns, non-ingestible routes of administration, the patchwork of state laws on CBD, how FDA should distinguish between CBD supplements and the CBD drug Epidiolex, and more.
“For more than five years, Americans have been asking the FDA to make a safety determination for CBD. In that time, NPA has worked with Congress and the states to establish appropriate measures and even petitioned the FDA to exercise enforcement discretion in a specific and selective manner consistent with the premarket safety review of a new dietary ingredient notification,” said Daniel Fabricant, Ph.D., president and CEO of the NPA.
“Instead of using existing regulatory authority, FDA has resisted fulfilling their mandate for years and is now chasing the fantasy of a ‘center’ for hemp and cannabis products that would mimic the Center for Tobacco Products. Through DSHEA, Congress has provided the FDA with broad authority to review safety data for new dietary ingredients like CBD to enter commerce. Our proposal demonstrates that putting a clock on FDA to use existing authority is the most efficient and straightforward pathway for public health and to stabilize a robust marketplace for dietary supplements and foods containing CBD. We look forward to working with Congress and the FDA to finalize a reasonable regulatory approach that protects Americans and provides certainty to industry.”
