Four leading U.S. consumer groups are calling on federal lawmakers to reject efforts that would speed up the process of legalizing CBD for use in supplements and food products, warning that “forcing the FDA (U.S. Food & Drug Administration) into rushed decisions and to prematurely implement major regulatory changes would result in an unsafe CBD market.”
“More well-funded profiteers would inevitably barrage Congress with requests for their chosen products to be given carte blanche, bypassing oversight that assures safety and quality,” the groups warned in a June 17, 2020 letter sent to lawmakers. Noting the Congress is not a guarantor of safety in consumer products, the groups said “a political decision to legislatively override a careful and scientific evaluation of CBD safety would create terrible precedent.”
Submitted to members of the U.S. House of Representatives and Senate, the letter was signed by officials from non-profit organizations the Center for Science in the Public Interest, a food and health watchdog; Consumer Reports, which carries out independent product testing; the Public Health Institute, which advances health related research and policy; and the Consumer Federation of America, an association of consumer organizations.
More time to study risks
The 8-page letter, which tacked on two and a half pages of footnotes, said FDA needs more time and resources to properly assess the risks in CBD. The authors cited a number of instances in which specific CBD products on the market have been sanctioned by the FDA for reasons ranging from excessive THC content to mislabeling and contamination with heavy metals, noting in particular producers who turn out CBD-laden supplements in shapes appealing to children, and websites that promote CBD as a palliative for discomfort common in pregnancies. More recently, FDA has sent warning letters to vendors who make claims about the compound’s efficacy in treating COVID-19 symptoms.
Even the one approved CBD product, Epidiolex, cleared as a pharmaceutical in 2018 and taken off the list of federally controlled substances by the U.S. Drug Enforcement Administration (DEA) in April 2020, was cited for its potential to cause liver damage based on clinical trials. Epidiolex has been been found to be therapeutic in patients suffering Lennox-Gastaut Syndrome and Dravet syndrome, two debilitating forms of epilepsy.
Incentivizing ‘serious study’
The consumer groups said FDA should request scientific evidence regarding the safety of CBD in food, take steps to monitor adverse effects in users, and establish quality controls.
“This would incentivize serious study by the food industry of the risks and safe use of CBD products, and would require better quality controls in the supply chain,” the groups wrote. “Such a process might identify doses and/or particular conditions of sale for CBD that would be legal to market.”