FDA reaffirms that CBD products can’t be marketed as dietary supplements

Regulatory NewsRegulatory News | 13 August 2021 |  By 

The US Food and Drug Administration (FDA) has objected to New Dietary Ingredient (NDI) notifications submitted by two developers of full-spectrum hemp extract products, telling the companies an earlier decision by the agency to consider cannabidiol (CBD) as a drug means it won’t consider their applications to sell the products as dietary supplements.
Writing to Irwin Naturals, FDA said the company’s product, NDI 1199, contains CBD, which is an active ingredient in Epidiolex, a drug approved by FDA for the treatment of seizures in patients with Lennox-Gastaut syndrome and Dravet syndrome. Because CBD was not marketed as a dietary supplement before it became an active ingredient in an approved drug product, it is not excluded from the definition of a dietary supplement under the Federal Food, Drug, and Cosmetic Act (FD&C Act). (RELATED: FDA approves first marijuana-derived drug, Regulatory Focus 25 June 2018)
FDA sent a similar letter to Charlotte’s Web, Inc., a company with a similar full-spectrum hemp extract product, NDI 1202, that was intended to be marketed as a dietary supplement. Both NDI 1199 and NDI 1202 are “subject to the exclusion from the definition of dietary supplement,” the agency said, and “may not be marketed as or in a dietary supplement.”
While FDA has shown an interest in developing a product approval pathway for cannabis and cannabis-derived products, the agency doesn’t appear to have changed its stance on approving CBD products as food or dietary supplements.
In 2019, then-FDA Commissioner Scott Gottlieb stated it is illegal for companies to put CBD in food or market it as a dietary supplement because it is an active ingredient in an FDA-approved drug product. “[T]he only path that the FD&C Act allows for such substances to be added to foods or marketed as dietary supplements is if the FDA first issues a regulation, through notice-and-comment rulemaking, allowing such use,” Gottlieb said. (RELATED: FDA Begins Plotting Pathway for Cannabis Product Approvals, Regulatory Focus 02 April 2019)
However, FDA’s Q&A document on how it regulates cannabis and cannabis-derived products like CBD indicates it might reverse its position if presented with evidence of benefit. “FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act,” FDA wrote in the Q&A. “Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.” (RELATED: Update on the Regulatory Status of Cannabidiol in Food and Dietary Supplements and Future Prospects, Regulatory Focus 12 June 2019)
‘Significant concerns’ about safety
Apart from the issue of CBD products being marketed as dietary supplements, FDA also raised concerns about safety of NDI 1199 and NDI 1202. In its letter to Irwin Naturals, FDA said the company “failed to show that the NDI will reasonably be expected to be safe,” citing vague evidence and inadequate descriptions of how it prepares cannabis, serving levels, frequency and duration of use. The letter noted some evidence provided by Irwin Naturals was for phytocannabinoid mixtures that couldn’t be compared to the product. FDA also said reports of hepatotoxicity and reproductive toxicity for CBD were not adequately addressed in the company’s notification.
“For these reasons, the information in your submission indicates that, even if NDI 1199 were not excluded from the definition of a dietary supplement, your notification does not provide an adequate basis to conclude that a dietary supplement containing the ingredient, when used under the conditions recommended or suggested in the labeling of your product, would reasonably be expected to be safe,” FDA wrote.
In its letter to Charlotte’s Web, FDA said the submission of 2 years of marketing for NDI 1202 was “insufficient to establish the safety of your ingredient when used under the proposed conditions of use.” The company also failed to provide underlying data for a study cited as evidence for proposing NDI 1202 as having no-observed adverse effect level. “In addition, none of the clinical and pre-clinical studies that you provided adequately address certain reported toxicity endpoints of CBD such as hepatotoxicity and reproductive toxicity,” the agency wrote.
Charlotte’s Web posted a response to FDA’s letter on their website, noting that the agency’s letter is inaccurate and “the conclusions drawn by the FDA do not appear to be based on the data provided in our NDI application.” The company also called on Congress to pass legislation that would regulate CBD as a dietary supplement.
“Both 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,” they wrote.
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Tags: cannabidiol, CBD, NDI

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