November 28, 2021

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There's nothing like our health

FDA Rejects Full-Spectrum CBD As A Dietary Supplement

3 min read

The U.S. Food and Drug Administration (FDA) reaffirmed that CBD can’t be marketed as a dietary supplement. 

FDA objected to two application forms from CBD companies Charlotte’s Web and Irwin Naturals in August. The two companies filed New Dietary Ingredient (NDI) notifications for full-spectrum CBD extracts to FDA in early 2021. 

FDA has rejected the two notifications as CBD is the active ingredient in the approved drug product Epidiolex, and it can’t be marketed as a dietary supplement.

FDA’s concerns also focused on the scientific evidence submitted by the companies to show their NDI notifications. They didn’t provide an adequate basis to conclude that a dietary supplement containing CBD would reasonably be expected to be safe, according to the agency. 

For these reasons, FDA has concluded that CBD products are excluded from the dietary supplement definition.

For the agency, both isolated and full-spectrum CBD can’t be marketed as a dietary 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 out that full-spectrum CBD has more effective benefits than isolated CBD when interacting with other cannabinoids through the so-called entourage effect.

In the letters addressed to the two companies, FDA has also noted that the clinical and pre-clinical studies didn’t provide enough information regarding liver (hepatotoxicity) and reproductive toxicity.

Although FDA’s objection doesn’t affect the existing business operations of the two companies, it highlights the lack of regulation over CBD.

Charlotte’s Web disagrees with FDA’s reasoning. The company believes in its extensive and credible scientific evidence over its CBD products. However, it interprets FDA’s decision as a confirmation that Congress must regulate CBD.

In its response letter, Charlotte’s Web joins FDA’s calling for appropriate legislation. Congress must act by passing legislation to enable FDA oversight of full-spectrum hemp extract (FSHE) as a dietary supplement, to properly regulate the hemp wellness category.

The Council for Responsible Nutrition (CRN) has also denounced the FDA’s objection to two new NDI notifications for full-spectrum CBD. It has urged Congress to act on pending legislative proposals that require the agency to address the lack of regulation of hemp-derived products. 

Regarding FDA’s objection, CRN has argued that the agency can’t compare full-spectrum CBD products eligible to be dietary supplements with the only CBD drug approved by FDA. Epidolex is a highly concentrated CBD-isolate drug that contains ten times more CBD than full-spectrum CBD products, according to CRN.

“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,” has noticed CRN 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 became legal under the bill.

Although FDA has claimed it wants to ensure consumer products containing CBD are safe, it has yet to act. Meanwhile, the CBD market lives in a grey area, where CBD products are legally produced and used across the nation, but they are currently regulated only by a single state and not at the federal level. 

As a result, the lack of federal regulation may affect the transportation of CBD products from one state to another one. Furthermore, regulation on overproduction, marketing, and labeling may differ from state to state.

Companies that sell CBD could benefit from a federal regulatory framework. A regulation over CBD will make the market and consumers more about products. Furthermore, it could boost the market, which may reach $19.5 Billion By 2025, with FDA Approval, according to the cannabis market research firm BDSA.

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