The U.S. Food and Drug Administration (FDA) rejected an application from Charlotte’s Web Holdings, Inc. for their full spectrum hemp extract. In a press release on August 11, 2021, Charlotte’s Web, a hemp health supplement company, announced that the FDA published an objection to their New Dietary Ingredient (NDI) application the company submitted on March 31, 2021.
In its rejection letter to Charlotte’s Web, the FDA stated that the rejection was based on “concerns about the adequacy of safety evidence” the company provided in their application. As numerous advocates for regulation of cannabidiol (CBD) and marijuana-derived products face FDA-imposed obstacles, many look towards congressional action. Read below to learn more about the FDA’s most recent rejection to recognize hemp as a dietary supplement and how this rejection fares for the future of hemp and cannabis-derived products in commerce.
FDA’s History with Marijuana
The FDA has a long history of rejecting marijuana-derived products. Marijuana regulation dates back to the Controlled Substances Act of 1970, when marijuana was first classified as a dangerous Schedule I substance.
In 2017, the FDA sent several CBD businesses, including Charlotte’s Web, a warning letter against CBD supplements. In the letter, the FDA warned businesses against certain health risks CBD products may cause to some consumers, such as liver damage, drowsiness, and mood swings. Similar to the warning letter sent in 2017, the FDA provides information on its website about negative side effects related to the usage of cannabis and cannabis-derived compounds.
While the FDA has a long history of turning down marijuana-related treatments and dietary supplements, there is an FDA-approved drug on the market that contains pharmaceutical-grade cannabidiol oil. In June of 2018, the FDA approved Epidiolex as a prescription drug for the treatment of seizures related to two rare forms of childhood epilepsy. Epidiolex remains the only drug approved by the FDA that contains a substance derived from marijuana.
The Future of Regulating the Use of Hemp and Cannabis-Derived Products
The FDA’s recent rejection of Charlotte Web’s application for its full spectrum hemp extract as a New Dietary Ingredient poses significant delays and challenges when it comes to the future of marijuana-derived product regulation in the United States. Charlotte’s Web stated in its press release that it looks towards the future and assures that “[t]he FDA objection… does not impact the existing business operations of Charlotte’s Web but does provide useful guidance about what’s required to secure a regulatory framework for FSHE (full spectrum hemp extract) as a dietary supplement.”
Currently, selling products containing marijuana-derived compounds as a dietary supplement is illegal. Although the FDA has a long history of CBD prohibition, the FDA cautiously acknowledges the potential for future approvals. On its website, the FDA states that it “recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the significant interest in these possibilities. However, FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk.”
With more states legalizing marijuana, many look towards federal political or legislative action for the regulation of cannabis-derived supplements. On July 14, 2021, Senate Majority Leader Chuck Schumer announced historic draft legislation that would make marijuana legal in all fifty states. Even Charlotte’s Web declared hope in such potential cannabis legislative reform:
“[b]oth the House of Representatives and the Senate introduced bills that would legislate hemp CBD as a dietary supplement. We believe this legislation is a critical step to protect consumers and to establish guidance for manufacturers, and Charlotte’s Web intends to stay at the forefront of these efforts. Our vertically integrated supply chain and category leadership uniquely position us to work effectively with Congress, and the FDA, to ensure this critical path forward for the hemp industry.”
Chelsie Spencer is a cannabis lawyer in Dallas, Texas, who is deeply involved in the CBD, cannabis, and hemp legal communities. With years of experience in the marijuana industry, Chelsie is a trusted advisor to a wide range of CBD and cannabis businesses. Her additional expertise in commercial litigation and intellectual property law makes her even more prepared to guide her clients through unique legal issues. Contact Ritter Spencer or give us a call at 214.295.5074 for more information.