The U.S. Food & Drug Administration has objected to two New Dietary Ingredient (“NDI”) notifications submitted by hemp businesses intending to market CBD as a dietary ingredient in their dietary supplement products.
In letters made public in August 2021, the FDA continued to make clear that the agency questions whether CBD is a proper “dietary ingredient” in dietary supplement products. While the FDA’s general stance objecting to CBD as an ingredient in various orally ingested consumer goods is nothing new, these letters mark the first time the FDA has commented directly in response to any NDI notifications submitted for CBD.
As many in the supplement industry may know, federal regulations governing dietary supplements provide that the manufacturer or distributor of a dietary supplement containing a “new dietary ingredient” that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered must submit to the FDA, at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce, information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such new dietary ingredient will reasonably be expected to be safe. The NDI process then requires the FDA to review this information to determine whether the information provides an “adequate basis” for a conclusion that a dietary supplement containing CBD is expected to be safe.
Accordingly, pursuant to these regulations, Charlotte’s Web and Irwin Naturals both submitted information these companies believe supports the safe use of CBD as an ingredient in their dietary supplements to the FDA earlier this year.
Unfortunately for these companies, the FDA has indicated via its response letters that the agency has concerns about the adequacy of safety evidence included in these submissions.
For example, in the letter to Charlotte’s Web, the FDA stated that while the notification included some evidence intended to show an adequate history of safe use of CBD, including reports of certain safety studies, the FDA concluded these categories of evidence have deficiencies. Accordingly, the FDA said that upon a collective review of the evidence provided, the notification failed to show that CBD will reasonably be expected to be safe. More specifically, the FDA reasoned that while Charlotte’s Web’s submission provided two years of marketing as evidence of history of use, this amount of time is insufficient to establish the safety of CBD.
Additionally, in both letters, the FDA reiterated its lingering concerns regarding the use of CBD in dietary supplements due to the status of CBD as an “active ingredient” in the FDA-approved drug product, Epidiolex. In short, the FDA has long argued that CBD products are excluded from the dietary supplement definition under federal law due to CBD’s status as the active ingredient in a drug called Epidiolex. Not surprisingly, the FDA highlights this argument in both letters by contending that CBD is precluded from use in dietary supplements under this rule, notwithstanding any lack of evidence supporting CBD’s safety.
Luckily, a new bill introduced (H.R. 841) would make hemp-based CBD lawful for use under the Federal Food, Drug and Cosmetic Act as a dietary ingredient in a supplement. Other bills also have been introduced in the 117th Congress to provide a legal pathway for CBD ingestible products.
Of course, until this legislation passes or other clarification results from an alternative solution to this issue, uncertainty concerning the use of CBD as an ingredient in consumer products remains, at least from an FDA perspective.
If you have questions concerning CBD as an ingredient in dietary supplements or any other consumer goods, please contact Smart Counsel today for a free consultation.
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