The United States Food and Drug Administration (FDA) has reaffirmed that CBD cannot be marketed as a dietary supplement.
The FDA opposed two claim forms from CBD companies Charlotte’s Web and Irwin Naturals in August. Both companies filed New Dietary Ingredient (NDI) notifications for full-spectrum CBD extracts with the FDA in early 2021.
The FDA rejected both notifications because CBD is the active ingredient in the approved drug Epidiolex and it cannot be marketed as a dietary supplement.
The FDA’s concerns have also focused on the scientific evidence submitted by the companies to show their NDI notifications. According to the agency, they did not provide an adequate basis for concluding that a dietary supplement containing CBD would be reasonably safe.
For these reasons, the FDA has concluded that CBD products are excluded from the definition of dietary supplements.
For the agency, isolated, full-spectrum CBD cannot be marketed as a diet product. While isolated CBD contains only the purest form of this cannabinoid, full spectrum CBD contains small amounts of other cannabinoids, including THC, flavonoids, and terpenoids. Several studies have found that full spectrum CBD has more effective benefits than isolated CBD when it interacts with other cannabinoids through the so-called entourage effect.
In letters to both companies, the FDA also noted that clinical and preclinical studies did not provide enough information regarding liver (hepatotoxicity) and reproductive toxicity.
While the FDA’s objection does not affect the existing business operations of the two companies, it highlights the lack of regulation on CBD.
Charlotte’s Web does not agree with the reasoning of the FDA. The company believes in its extensive and credible scientific evidence on its CBD products. However, he interprets the FDA’s decision as confirmation that Congress needs to regulate CBD.
In its response letter, Charlotte’s Web joins the FDA’s call for appropriate legislation. Congress must act by passing legislation to allow the FDA to monitor full spectrum hemp extract (FSHE) as a dietary supplement, in order to properly regulate the hemp wellness category.
The Council for Responsible Nutrition (CRN) also denounced the FDA’s objection to two new NDI notifications for full-spectrum CBD. He urged Congress to act on pending legislative proposals that require the agency to address the lack of regulation of hemp-derived products.
Regarding the FDA’s objection, CRN argued that the agency cannot compare full spectrum CBD products eligible to be dietary supplements with the only CBD drug approved by the FDA. Epidolex is a highly concentrated CBD isolate drug that contains ten times more CBD than full spectrum CBD products, according to CRN.
“The FDA’s refusal to regulate the CBD market opens the door to CBD products that can be poorly manufactured or illegally traded. The FDA has demonstrated today that it will rely on bureaucracy to launch the box, and Congress should take that into account, ”CRN noted in a press release.
Since hemp became legal at the federal level through the 2018 Farm Bill, no political intervention has regulated the CBD market, which has become legal under the bill.
Although the FDA has said it wants to ensure the safety of consumer products containing CBD, it has yet to act. Meanwhile, the CBD market lives in a gray area, where CBD products are produced and used legally across the country, but they are currently only regulated by one state and not at the federal level.
As a result, the absence of federal regulations can affect the transportation of CBD products from one state to another. In addition, regulations on overproduction, marketing and labeling may differ from state to state.
Companies that sell CBD could benefit from a federal regulatory framework. Regulations on CBD will make the market and consumers more aware of the products. Additionally, it could boost the market, which could reach $ 19.5 billion by 2025, with FDA approval, according to cannabis market research firm BDSA.