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The Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) have submitted responses to a Congressional Request for Information (RFI) seeking insight from industry stakeholders on CBD in order to develop “a regulatory pathway for non-intoxicating hemp-derived cannabinoid products that prioritizes consumer safety and provides certainty to the U.S. markets.”
According to CRN, FDA has spent the past five years ignoring not only Congress’ directive to regulate CBD, but also the credible, well-conducted research that demonstrates the safety of well-made CBD products. FDA’s failure to establish a regulatory pathway for CBD has forced states to enact their own disparate policies to protect consumers. This has resulted in a patchwork of laws that is detrimental to the industry and should be unified by federal intervention, the Association stated.
“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 CRN President and CEO Steve Mister. “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.”
In 1994, Congress enacted DSHEA, giving FDA the authority to oversee the manufacturing and marketing of dietary supplements, defined to include “an herb or other botanical, concentrate, metabolite, constituent extract or combination.” CRN pointed out that dozens of commonly used botanicals such as cranberry, aloe vera, garlic, ginseng, turmeric/curcumin, echinacea and green tea extract are all regulated under the provision.
“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, PhD, president and CEO of the NPA.
“Instead of using existing regulatory authority, FDA has resisted fulfilling their mandate for years and 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.”
For more information, visit www.crnusa.org or www.npanational.org.
The Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) have submitted responses to a Congressional Request for Information (RFI) seeking insight from industry stakeholders on CBD in order to develop “a regulatory pathway for non-intoxicating hemp-derived cannabinoid products that prioritizes consumer safety and provides certainty to the U.S. markets.”
According to CRN, FDA has spent the past five years ignoring not only Congress’ directive to regulate CBD, but also the credible, well-conducted research that demonstrates the safety of well-made CBD products. FDA’s failure to establish a regulatory pathway for CBD has forced states to enact their own disparate policies to protect consumers. This has resulted in a patchwork of laws that is detrimental to the industry and should be unified by federal intervention, the Association stated.
“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 CRN President and CEO Steve Mister. “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.”
“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, PhD, president and CEO of the NPA.
“Instead of using existing regulatory authority, FDA has resisted fulfilling their mandate for years and 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.”
