WASHINGTON — The Council for Responsible Nutrition (CRN) on Wednesday denounced the Food and Drug Administration’s 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.

The following is a statement from CRN president & CEO Steve Mister:

“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.

Steve Mister, CRN

“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.

“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.

“CRN has publicly called for FDA to act on CBD for more than two years to provide consumers with a safe, regulated market for these 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 these 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, FDA has failed to provide a meaningful response. In fact, FDA leaders refused to discuss CBD during a May 2021 meeting with CRN leadership.

“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. 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. 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 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. Congress must take action now.”