11.27.19
In response to the FDA’s recent warning letters and consumer advisory about safety concerns related to CBD, Steve Mister, president & CEO, Council for Responsible Nutrition (CRN), said the announcements were unnecessarily alarmist, noting the agency hasn’t offered a plan to address any perceived health risks.
Mister went on to say that FDA has abdicated its regulatory oversight “for the subset of these products that do pose risks to consumers because they are poorly made, improperly labeled, or illegally deliver THC.”
He further stated that FDA’s inaction for the past year has facilitated an unregulated marketplace, “which is bad for consumers and bad for business. It’s time for FDA to announce a legal pathway to market for these CBD-containing supplements and to commence meaningful enforcement against products that flout category-wide requirements for dietary supplements.”
FDA’s announcement raises serious and legitimate questions about the safety of CBD, but the agency’s actions to date have not advanced that cause, Mister added.
For example, “FDA invokes potential adverse effects from CBD, but does not distinguish between the high doses delivered in the approved prescription drug, and supplement levels,” he said. “It is worth noting the CBD prescription drug Epidiolex uses daily doses that could be as high as 1,500 mg; many supplement products in the market provide suggested daily doses of 50 mg/day or less. As with most substances, the dose makes the poison, and publicly-available data, including a report from the World Health Organization indicates CBD is generally well tolerated and has a good safety profile.”
FDA has acknowledged the presence of CBD-containing products that are in violation of general dietary supplement regulations—products that include appreciable levels of THC; ones whose CBD content does not come close to matching the labeled amounts; and others that contain unsafe levels of pesticides, heavy metals or other contaminants.
“Third-party analyses by watchdog groups confirm these concerns,” said Mister. “FDA has the authority to mandate recalls, to begin seizures of potentially harmful products, and to issue injunctions, but instead, the agency is choosing to issue tepid warning letters about CBD while the market of poorly made products continues to explode.”
FDA has the opportunity to receive meaningful safety data through new dietary ingredient notifications (NDIN) and generally recognized as safe (GRAS) submissions. “Yet while FDA broadly declares CBD to be an illegal ingredient—despite the express statutory discretion to change that status—the agency declines the opportunity to create incentives for that research or to give this data assurances of confidentiality that drug submissions are accorded,” Mister said. “FDA continues to call on industry to produce safety research for the public docket but to dismiss NDI notifications and GRAS declarations for CBD.”
Mister suggested FDA “explicitly open the dietary supplement lane to CBD and be the ‘cop on the beat’ enforcing the whole range of dietary supplement laws and regulations against those products.”
Otherwise, Congress should get involved to direct the agency toward these goals while offering ample enforcement tools.
“Responsible companies marketing CBD in dietary supplements already comply with the law—which means that they hold data justifying their own evaluations that their products are safe, that they follow good manufacturing practices, that they register their facilities, and that they have a serious adverse event reporting system in place,” Mister said. “These responsible companies have been unfairly maligned by FDA’s overbroad warnings on safety, and ironically, are actually deterred from sharing the safety data they have with the agency.”
Mister went on to say that FDA has abdicated its regulatory oversight “for the subset of these products that do pose risks to consumers because they are poorly made, improperly labeled, or illegally deliver THC.”
He further stated that FDA’s inaction for the past year has facilitated an unregulated marketplace, “which is bad for consumers and bad for business. It’s time for FDA to announce a legal pathway to market for these CBD-containing supplements and to commence meaningful enforcement against products that flout category-wide requirements for dietary supplements.”
FDA’s announcement raises serious and legitimate questions about the safety of CBD, but the agency’s actions to date have not advanced that cause, Mister added.
For example, “FDA invokes potential adverse effects from CBD, but does not distinguish between the high doses delivered in the approved prescription drug, and supplement levels,” he said. “It is worth noting the CBD prescription drug Epidiolex uses daily doses that could be as high as 1,500 mg; many supplement products in the market provide suggested daily doses of 50 mg/day or less. As with most substances, the dose makes the poison, and publicly-available data, including a report from the World Health Organization indicates CBD is generally well tolerated and has a good safety profile.”
FDA has acknowledged the presence of CBD-containing products that are in violation of general dietary supplement regulations—products that include appreciable levels of THC; ones whose CBD content does not come close to matching the labeled amounts; and others that contain unsafe levels of pesticides, heavy metals or other contaminants.
“Third-party analyses by watchdog groups confirm these concerns,” said Mister. “FDA has the authority to mandate recalls, to begin seizures of potentially harmful products, and to issue injunctions, but instead, the agency is choosing to issue tepid warning letters about CBD while the market of poorly made products continues to explode.”
FDA has the opportunity to receive meaningful safety data through new dietary ingredient notifications (NDIN) and generally recognized as safe (GRAS) submissions. “Yet while FDA broadly declares CBD to be an illegal ingredient—despite the express statutory discretion to change that status—the agency declines the opportunity to create incentives for that research or to give this data assurances of confidentiality that drug submissions are accorded,” Mister said. “FDA continues to call on industry to produce safety research for the public docket but to dismiss NDI notifications and GRAS declarations for CBD.”
Mister suggested FDA “explicitly open the dietary supplement lane to CBD and be the ‘cop on the beat’ enforcing the whole range of dietary supplement laws and regulations against those products.”
Otherwise, Congress should get involved to direct the agency toward these goals while offering ample enforcement tools.
“Responsible companies marketing CBD in dietary supplements already comply with the law—which means that they hold data justifying their own evaluations that their products are safe, that they follow good manufacturing practices, that they register their facilities, and that they have a serious adverse event reporting system in place,” Mister said. “These responsible companies have been unfairly maligned by FDA’s overbroad warnings on safety, and ironically, are actually deterred from sharing the safety data they have with the agency.”
