The Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) have denounced the U.S. Food and 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.
“CRN is extremely 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, it seems that the agency engaged these supplement companies in a months-long process unnecessarily,” said CRN President & CEO Steve Mister in a statement.
“FDA has wrongly mischaracterized these products as the same article as a prescription drug and has ignored, dismissed, and downplayed ample evidence that these 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.
“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,” he continued.
“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. 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.
“Despite very clear direction from Congress when it removed hemp from the Controlled Substances Act in 2018, 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.”
Daniel Fabricant, PhD, NPA president and CEO, also commented on the issue, stating “Future NDI guidance without real clarity on cannabinoids including CBD, doesn’t help the millions of Americans who already believe FDA regulates the space. The response to this NDI indicates that there is confusion and misunderstanding on all sides of the issue and it must be addressed by the forthcoming guidance. There have to be clear safety rules and thinking on these matters.”
Mister noted that CRN publicly endorsed HR 841, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021 and that the association is actively lobbying Congress to 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,” Mister concluded. “Congress must take action now.”