The cannabidiol industry hit a hurdle on Wednesday with the Food and Drug Administration rejection of two “new dietary ingredient” (NDI) applications for full-spectrum hemp extract that contained cannabidiol.
In two separate rejections to Irwin Naturals and Charlotte’s Web, the FDA wrote that the products “cannot be used in dietary supplements” because, essentially, of Epidiolex, a cannabidiol-based product that is the first cannabis plant extract-based medicine approved by the FDA. This approval, which came in June 2018, has loomed large in the months following the passage of the 2018 Farm Bill that legalized hemp, as the national cannabis and hemp industries eagerly await FDA rules to guide the hemp-derived cannabidiol (CBD) landscape.
Parts of the rejection letters contained the same language and reasoning for the denials. “The term ‘dietary supplement,’” the FDA wrote to Charlotte’s Web and Irwin Naturals, does not include “an article that is approved as a new drug,” or has been “authorized for investigation as a new drug,” or “for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.”
Further, the FDA wrote, the Administration “has concluded that CBD products are excluded from the dietary supplement definition under [federal regulations]. CBD is the active ingredient in the approved drug product, Epidiolex.” The FDA added that Irwin Naturals’ application was for a product that was “produced from hemp plants that contain robust amounts of CBD; that the manufacturing process results in a product that delivers a relatively high amount of CBD per day, comparable to a drug product.” So, finally, “your product may not be marketed as or in a dietary supplement.”
Both of the FDA rejection letters also expressed some level of concern over the suggested use of CBD as a dietary supplement.
“The agency has concerns about the adequacy of safety evidence included in your submission as a basis for concluding that a dietary supplement containing [your product] will reasonably be expected to be safe under the conditions of use described in your notification,” the FDA wrote to Charlotte’s Web. While their application did include “some evidence intended to show adequate history of safe use,” as well as some literature related to safety studies, the FDA concluded that it fell short.
“These categories of evidence had deficiencies on their own and, even when all of the evidence was considered as a whole, the notification failed to show that the [new drug indication] will reasonably be expected to be safe,” the FDA wrote, adding an example that the Charlotte’s Web applicant included two years of marketing of the product as “evidence of history of use, which is insufficient to establish the safety of your ingredient when used under the proposed conditions of use.”
Charlotte’s Web, in response to the FDA letter to them on Wednesday, noted that “this response from the FDA indicates to Charlotte’s Web that without legislation by Congress, this market will remain unregulated.”
The company highlighted that, in Congress, both chambers have introduced bills that would regulate hemp-derived CBD as a dietary supplement.
“Both the House of Representatives and the Senate introduced bills that would legislate hemp CBD as a dietary supplement. Charlotte’s Web strongly supports HR 841, introduced by Rep Schrader of Oregon and Rep Griffith of VA,” Kelly Shea, senior vice president of government affairs and communications for Charlotte’s Web, told Cannabis Wire. The legislation currently has 29 co-sponsors. “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 efforts to move the legislation forward toward law,” Shea added.
The FDA noted that Irwin Naturals’ application also failed to meet their bar on safety, leading to the agency’s “significant concerns about the adequacy of safety evidence included in your notification as a basis for concluding that a dietary supplement containing” the product.
“For example, your notification asserted a general history of use of various cannabis preparations (including extracts) and preclinical and clinical studies of certain cannabis preparations,” the FDA wrote. “These categories of evidence had deficiencies on their own and, even when all of the evidence was considered as a whole, the notification failed to show that the NDI will reasonably be expected to be safe. For example, your evidence for history of use was vague and did not provide an adequate description of the cannabis preparations (e.g., composition), serving levels, or frequency and durations of use which makes it difficult to compare this history of use to the proposed conditions of use for your ingredient and establish the safety of your product.”
Some deeper context: the 2018 Farm Bill removed cannabis plants containing .3% THC or less, also known as hemp, from the Controlled Substances Act, and the FDA was tasked with sorting out regulations for everything from supplements to foods containing CBD, which, by that point, was already at the center of a national wellness craze. But, also in 2018, the FDA approved its first medicine extracted directly from cannabis plants, Epidiolex, which is a CBD-based oral solution for patients with seizures associated with Dravet and Lennox-Gastaut syndromes and tuberous sclerosis.
The approval of Epidiolex has complicated the FDA’s task when it comes to non-drug products derived from hemp because, under the Federal Food, Drug, and Cosmetic Act, “if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved … or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement.” The same, generally, applies to adding CBD to foods.
This has posed a significant problem for companies like GNC, Romano Romani, president of the lobbying firm Parry, Romani, DeConcini & Symms, which represents the national supplements chain, told Cannabis Wire in 2020, calling the exclusionary clause “unnecessary.” He said he felt that it is “designed, in this case, to protect GW Pharmaceuticals, to protect their product Epidiolex from competition from supplement makers.”
He added that while the FDA has “made CBD as a supplement, and as a food, illegal, they have not tried to enforce that illegality because, you know, there are hundreds, if not thousands of CBD products on the market.”
Nonetheless, the FDA spent considerable time during 2019 and 2020 seeking public input on CBD and other cannabinoids, including hosting an unprecedented public meeting in mid-2019.
But, following a vocal couple of years, on which Cannabis Wire has closely reported, the FDA has been relatively quiet on CBD during 2021. In January, Stephen Hahn and Amy Abernethy, then FDA Commissioner and Principal Deputy Commissioner, respectively, published a progress update that essentially called for more data on CBD.
This drew criticism from industry stakeholders, including the Council for Responsible Nutrition, a Washington, D.C.-based trade and lobbying group, which called out the FDA for dropping the notice as a news dump, “late in the day, late in a week that has seen a national crisis,” adding that it was “nothing more than an end-of-Administration desk-clearing exercise from an FDA that has failed to lead in this crucial policy area.”
