FDA bans products containing CBD.
After rejecting two new dietary ingredient (NDI) notifications for full-spectrum hemp extract including CBD, the FDA’s chances of approving cannabidiol (CBD) in meals, drinks, and dietary supplements were dashed.
In letters dated July 23, the FDA informed Charlotte’s Web, Boulder, Colorado, and Irwin Naturals, Los Angeles, that because CBD is the active ingredient in Epidiolex, a medication that has received approval, their products did not fall under the category of dietary supplements.
On August 11, the Council for Responsible Nutrition, a trade group representing the dietary supplement and functional food industries based in Washington, provided a response.
According to Steve Mister, president and chief executive officer of the Council for Responsible Nutrition, “the 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.” “In the meantime, after more than two years of inaction, the agency has done little to protect consumers from the unregulated marketplace it has created.”
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Hemp is used to extract CBD. In December 2018, the Agricultural Improvement Act of 2018, popularly referred to as the farm bill, was ratified. It made the cultivation of hemp legal in the US; however, if a product is being sold and controlled as a medicine, the FDA must approve its sale as a food, drink, or dietary supplement.