The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, this week denounced the U.S. Food & Drug Administration’s (FDA) rejection of two new dietary ingredient (NDI) notifications for full-spectrum hemp extract containing cannabidiol (CBD) – and urged Congress to act on pending legislative proposals that require the agency to address the lack of regulation of hemp-derived products.
In an Aug. 11, statement, CRN President Steve Mister said the organization is disappointed to learn that FDA rejected NDI notifications for full-spectrum hemp extract containing CBD, submitted earlier this year by supplement manufacturers Charlotte’s Web and Irwin Naturals.
“Ultimately,” Mister noted, “it seems that the agency engaged these supplement companies in a months-long process unnecessarily.”
Mister explained that he feels the FDA has wrongly mischaracterized the products as the same article as a prescription drug and has ignored, dismissed and downplayed ample evidence that the full-spectrum hemp products can be marketed in a manner that is reasonably expected to be safe.
“Meanwhile, the agency has done little to protect consumers from the unregulated marketplace it has created from more than two years of inaction,” said Mister.
According to Mister, the FDA continually asked the companies for meetings and safety data about their products containing full-spectrum hemp extract. After complying with FDA’s requests, these companies saw FDA reject their NDI notifications — disregarding published peer-reviewed toxicology studies and years’ worth of real-world safety evidence.
“FDA also claimed the full-spectrum ingredients containing CBD and Epidiolex should be considered the same ‘article,’ a term used for purposes of determining what substances are eligible to be dietary supplements under the Federal Food, Drug and Cosmetic Act,” Mister said in the statement. “However, Epidiolex, manufactured by GW Pharma, is a highly concentrated CBD isolate that contains 10 times more CBD than either of the full-spectrum hemp ingredients and plainly is not the same article supplement companies are producing, as CRN has argued for several years.”
Epidiolex is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome or tuberous sclerosis complex.
Congressional Action Needed
Despite very clear direction from Congress when it removed hemp from the Controlled Substances Act in 2018, he said, “FDA seems to have made up its mind not to support CBD in supplements and is now trying to justify it. That’s the only logical conclusion to draw from FDA’s actions — and its continued inaction. These mixed messages from FDA are unacceptable, and Congress must exercise leadership by stepping in to end it.”
CRN has publicly called for FDA to act on CBD for more than two years to provide consumers with a safe, regulated market for CBD products. In June 2019, CRN submitted comments to FDA with scientific data and information on CBD. In December 2019, CRN and FDA met to discuss those issues. With still no action from FDA, CRN filed a citizen petition with the agency in June 2020, calling on FDA to clarify when a substance is considered an ‘article’ and to regulate CBD as a legal dietary supplement. More than a year later, said Mister, the FDA has failed to provide a meaningful response. In fact, FDA leaders refused to discuss CBD during a May 2021 meeting with CRN leadership, according to Mister.
“Since we first urged the agency to act two years ago, consumer interest in CBD has grown, sales have multiplied, and product innovation has expanded,” explained Mister. “Individual states have grown impatient and begun devising their own inconsistent patchwork of regulations. Meanwhile, FDA has turned its back on the safety of millions of Americans by refusing to take action on a legal pathway to marketing CBD.
Lack of Industry Standards Poses Danger
“While most supplement companies follow good manufacturing practices (GMPs), bad actors do exist; FDA’s refusal to regulate the CBD marketplace opens the door to CBD products that may be poorly manufactured or illegally marketed. FDA demonstrated today it will lean on bureaucracy to kick the can down the road, and Congress should take notice.”
CRN has publicly endorsed HR 841, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021, and is actively lobbying Congress to do what Mister said the FDA has refused to do — create a legal pathway to market CBD as a dietary supplement.
“FDA is failing America’s hemp farmers, supplement manufacturers, retailers, and most importantly—170 million supplement consumers,” said Mister. “Congress must take action now.”