By Mike Montemarano, Associate Editor, Nutraceuticals World03.09.20
One month overdue, the latest report by FDA on tentative CBD regulation provides little detail on future action, or which regulatory pathways CBD makers should take.
The passage of the 2018 Farm Bill catalyzed the hemp and cannabidiol industries, which have seen explosive growth by being able to sell any hemp-derived product with less than 0.3% THC, and the whirlwind of innovations in products and delivery methods has been nonstop.
How CBD will be regulated by the U.S. Food and Drug Administration (FDA) in the future remains in a state of limbo.
Last year, the federal government gave FDA a 60-day time frame to provide updates on its regulatory approach to CBD, which was due in a report last month. The agency released the report on March 5.
FDA provided a rundown of safety concerns regarding the use of CBD, sourced from a variety of scientific journals. Additionally, the agency voiced concern over providing consumers information on the degree to which it has the authority to regulate or oversee the marketing and quality of CBD products under its auspices.
FDA has approved only one CBD drug, Epidiolex, which is used to treat two life-threatening seizure disorders in children. The agency currently takes the position that CBD should not be marketed as a food ingredient or dietary supplement. Aside from companies making egregious health claims about CBD, or committing serious violations of good manufacturing practices, the agency has not taken any administrative action against less-than-reputable companies selling or producing CBD in a problematic way.
Since the 2018 Farm Bill passed, the onus has been on companies to monitor the quality, safety, and efficacy of their own products. Meanwhile, CBD manufacturers and companies are coming online at a rate which can be followed on a day-to-day basis.
Latest Updates
Among other things we’ve learned from the latest FDA report, the agency may be taking steps toward providing the public with a risk-based enforcement policy ahead of any tentative enforcement decisions. The risk-based enforcement policy would highlight the agency’s key goals that it hopes to accomplish in a regulatory structure it has not made yet.
FDA also provided a rundown of the health risks it has identified thus far based on the body of research the agency is utilizing.
“CBD is not a risk-free substance,” FDA said in its report. “As evidenced in the public clinical development data for Epidiolex and in the publicly available published scientific literature, CBD is associated with risks including liver injury, drug-drug interactions, drowsiness that may affect driving, and the possibility of male reproductive toxicity.
The agency tallied off a number of potential risks that it hopes to address by assessing more research. Those risks include the health effects of daily CBD use for sustained periods of time, what intake levels trigger known CBD risks, how different methods of exposure affect intake, the effect of CBD on the developing brains of children, CBD’s impact on pregnancy and breastfeeding, CBD’s interaction with other herbs and botanicals, whether male reproductive toxicity occurs in humans as it did in a study on animals, and whether CBD forms residues within the edible tissues of food-producing mammals.
FDA believes there are shortcomings in regulating CBD the same as any other dietary supplement, and perceives these shortcomings as a roadblock to swift action. Companies might not be required to provide “sufficient” information on what products they are making and selling to consumers. FDA is also concerned that expanding its own responsibilities to provide unique rules for CBD would adversely impact the agency’s overall workload.
FDA pointed out particular concerns over CBD vape products.
“FDA is concerned that CBD vapes pose public health risks in that vaping CBD raises toxicity concerns—both inherent to the substance and due to potential contaminants—and could attract children and adolescents, which are vulnerable populations,” the agency wrote.
On labeling concerns, FDA reported that it wants to establish labeling guidelines for CBD products claiming to be “full spectrum” or “broad spectrum.”
“We are actively seeking information from individual manufacturers, trade groups, and others regarding the processes by which ‘full spectrum’ and ‘broad spectrum’ hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products,” the agency said.
Lastly, CBD researchers should know that FDA will reopen a docket from its May 2019 public meeting on CBD in order to establish a centralized, publicly-accessible place for researchers to provide new data related to safety information.
In the meantime, FDA’s focus is to ensure the public understands that CBD production is essentially unregulated by any government agency at this point, and there are many unknowns in regard to its benefits and risks.
“We are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt,’” The agency said in a statement.
Too Little, Too Late
Industry trade groups believe that FDA should have developed a comprehensive regulatory plan at least a year ago, lambasted the latest update as all talk, with no regulatory oversight of CBD coming any time soon. They believe that regulations on par with other dietary supplements are more worthwhile than further debate with no foreseeable end.
“The time for ‘active consideration and evaluation’ has long since passed,” the Council for Responsible Nutrition (CRN) said in a statement in response to the report. “As we’ve said before, the time for action was more than a year ago, but we will settle for now. Today’s report amounts to more bureaucratic can-kicking, and Congress should recognize it as such and take action now to declare CBD a lawful dietary ingredient. That will direct FDA to allow CBD in dietary supplements and impose that significant regulatory framework on these products.”
CRN said that CBD’s safety as a standalone ingredient should no longer be on the table when the FDA could enable itself to reduce the tangential public risks.
“Every day, more CBD products come to market, some from responsible manufacturers, and some from less reputable companies,” CRN continued. “By not enforcing the full range of dietary supplement regulations on this category, FDA is essentially an absentee regulator and the public is at risk. As several recent risk assessments have demonstrated, the safety of CBD as an ingredient itself is no longer an issue. However, as long as FDA ‘actively’ continues to drag its feet, the public is at risk from CBD products that may be poorly manufactured or illegally marketed. The best way to protect public health and promote market clarity is to give industry a clear pathway to market.”
Daniel Fabricant, the president and CEO of the Natural Products Association (NPA) echoed the sentiment that passing CBD through as a dietary ingredient is the only way to ensure safe products.
“This is more of the same from the FDA: all words and no action,” Fabricant said. “The longer FDA waits to regulate the CBD industry the greater chance we have of risking another public health crisis. Setting a safe level of consumption for CBD products is the best way to move forward with this promising new product while protecting consumers.”
The passage of the 2018 Farm Bill catalyzed the hemp and cannabidiol industries, which have seen explosive growth by being able to sell any hemp-derived product with less than 0.3% THC, and the whirlwind of innovations in products and delivery methods has been nonstop.
How CBD will be regulated by the U.S. Food and Drug Administration (FDA) in the future remains in a state of limbo.
Last year, the federal government gave FDA a 60-day time frame to provide updates on its regulatory approach to CBD, which was due in a report last month. The agency released the report on March 5.
FDA provided a rundown of safety concerns regarding the use of CBD, sourced from a variety of scientific journals. Additionally, the agency voiced concern over providing consumers information on the degree to which it has the authority to regulate or oversee the marketing and quality of CBD products under its auspices.
FDA has approved only one CBD drug, Epidiolex, which is used to treat two life-threatening seizure disorders in children. The agency currently takes the position that CBD should not be marketed as a food ingredient or dietary supplement. Aside from companies making egregious health claims about CBD, or committing serious violations of good manufacturing practices, the agency has not taken any administrative action against less-than-reputable companies selling or producing CBD in a problematic way.
Since the 2018 Farm Bill passed, the onus has been on companies to monitor the quality, safety, and efficacy of their own products. Meanwhile, CBD manufacturers and companies are coming online at a rate which can be followed on a day-to-day basis.
Latest Updates
Among other things we’ve learned from the latest FDA report, the agency may be taking steps toward providing the public with a risk-based enforcement policy ahead of any tentative enforcement decisions. The risk-based enforcement policy would highlight the agency’s key goals that it hopes to accomplish in a regulatory structure it has not made yet.
FDA also provided a rundown of the health risks it has identified thus far based on the body of research the agency is utilizing.
“CBD is not a risk-free substance,” FDA said in its report. “As evidenced in the public clinical development data for Epidiolex and in the publicly available published scientific literature, CBD is associated with risks including liver injury, drug-drug interactions, drowsiness that may affect driving, and the possibility of male reproductive toxicity.
The agency tallied off a number of potential risks that it hopes to address by assessing more research. Those risks include the health effects of daily CBD use for sustained periods of time, what intake levels trigger known CBD risks, how different methods of exposure affect intake, the effect of CBD on the developing brains of children, CBD’s impact on pregnancy and breastfeeding, CBD’s interaction with other herbs and botanicals, whether male reproductive toxicity occurs in humans as it did in a study on animals, and whether CBD forms residues within the edible tissues of food-producing mammals.
FDA believes there are shortcomings in regulating CBD the same as any other dietary supplement, and perceives these shortcomings as a roadblock to swift action. Companies might not be required to provide “sufficient” information on what products they are making and selling to consumers. FDA is also concerned that expanding its own responsibilities to provide unique rules for CBD would adversely impact the agency’s overall workload.
FDA pointed out particular concerns over CBD vape products.
“FDA is concerned that CBD vapes pose public health risks in that vaping CBD raises toxicity concerns—both inherent to the substance and due to potential contaminants—and could attract children and adolescents, which are vulnerable populations,” the agency wrote.
On labeling concerns, FDA reported that it wants to establish labeling guidelines for CBD products claiming to be “full spectrum” or “broad spectrum.”
“We are actively seeking information from individual manufacturers, trade groups, and others regarding the processes by which ‘full spectrum’ and ‘broad spectrum’ hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products,” the agency said.
Lastly, CBD researchers should know that FDA will reopen a docket from its May 2019 public meeting on CBD in order to establish a centralized, publicly-accessible place for researchers to provide new data related to safety information.
In the meantime, FDA’s focus is to ensure the public understands that CBD production is essentially unregulated by any government agency at this point, and there are many unknowns in regard to its benefits and risks.
“We are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt,’” The agency said in a statement.
Too Little, Too Late
Industry trade groups believe that FDA should have developed a comprehensive regulatory plan at least a year ago, lambasted the latest update as all talk, with no regulatory oversight of CBD coming any time soon. They believe that regulations on par with other dietary supplements are more worthwhile than further debate with no foreseeable end.
“The time for ‘active consideration and evaluation’ has long since passed,” the Council for Responsible Nutrition (CRN) said in a statement in response to the report. “As we’ve said before, the time for action was more than a year ago, but we will settle for now. Today’s report amounts to more bureaucratic can-kicking, and Congress should recognize it as such and take action now to declare CBD a lawful dietary ingredient. That will direct FDA to allow CBD in dietary supplements and impose that significant regulatory framework on these products.”
CRN said that CBD’s safety as a standalone ingredient should no longer be on the table when the FDA could enable itself to reduce the tangential public risks.
“Every day, more CBD products come to market, some from responsible manufacturers, and some from less reputable companies,” CRN continued. “By not enforcing the full range of dietary supplement regulations on this category, FDA is essentially an absentee regulator and the public is at risk. As several recent risk assessments have demonstrated, the safety of CBD as an ingredient itself is no longer an issue. However, as long as FDA ‘actively’ continues to drag its feet, the public is at risk from CBD products that may be poorly manufactured or illegally marketed. The best way to protect public health and promote market clarity is to give industry a clear pathway to market.”
Daniel Fabricant, the president and CEO of the Natural Products Association (NPA) echoed the sentiment that passing CBD through as a dietary ingredient is the only way to ensure safe products.
“This is more of the same from the FDA: all words and no action,” Fabricant said. “The longer FDA waits to regulate the CBD industry the greater chance we have of risking another public health crisis. Setting a safe level of consumption for CBD products is the best way to move forward with this promising new product while protecting consumers.”
