The Natural Products Association (NPA) on Monday requested FDA Commissioner Robert Califf determine CBD is not excluded from the definition of a dietary supplement or "exercise enforcement discretion" after reviewing the safety of an individual dietary supplement product.
Alternatively, NPA requested FDA issue a regulation for CBD through the secretary of the U.S. Department of Health and Human Services (HHS).
NPA made the requests in a lengthy citizen petition filed with FDA that included a redacted version of a new dietary ingredient notification (NDIN) on behalf of cbdMD Inc.
An FDA spokesperson, Lindsay Haake, said the agency is reviewing the petition and will respond directly to NPA.
If FDA will not reverse its position that CBD is excluded from the definition of a supplement, NPA requested its "commissioner exercise enforcement discretion in a specific and selective manner over CBD products following a safety review of a notification on an individual dietary supplement product submitted consistent with 21 C.F.R. Part 190.6."
NPA’s filing is the third citizen petition seeking relief from FDA over the last four years, in response to the agency’s long-held view that CBD cannot be marketed in dietary supplements because it was first studied as a drug by GW Pharmaceuticals.
FDA has yet to provide substantive responses to citizen petitions filed by the Consumer Healthcare Products Association (CHPA) in 2019 and Council for Responsible Nutrition (CRN) in 2020. Instead, it’s advised both trade associations in separate “interim” responses that it needs more time to review the petitions due to the “complexity of issues” raised in them.
NPA requested FDA conclude CBD is an “old dietary ingredient” under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and therefore not excluded from the definition of a dietary supplement. The U.S. Pharmacopeia (USP), which sets standards for medicines, food ingredients and supplements, first documented the use of hemp-derived products in 1850, according to NPA’s citizen petition.
If FDA will not grant the requested relief above, NPA President and CEO Dan Fabricant made an alternative request: That FDA agree to scientifically review cbdMD’s safety data and provide a substantive response.
cbdMD has invested about $1 million to prepare identity and safety data to answer FDA’s questions, according to Fabricant. The citizen petition incorporates 119 pages of an NDIN to demonstrate cbdMD’s ingredient meets the relevant safety standard under DSHEA. But much of the filing is redacted.
cbdMD does not want to share all its safety data with FDA if the agency is not willing to put aside the CBD drug exclusion issue and complete a full scientific review of the data.
“After all, submitting cbdMD’s confidential data to the agency without the guarantee that it will be reviewed and appropriately replied to does nothing other than expose cbdMD to the risk of disclosure of the data along with potential misrepresentations of the data without any benefit to cbdMD,” Fabricant, who oversaw FDA’s Division of Dietary Supplement Programs from 2011 to 2014, wrote in the citizen petition.
FDA has reviewed NDINs for CBD-containing products identified as “full-spectrum hemp extracts.” But it reiterated last year in responses to two notifications from Charlotte’s Web and Irwin Naturals that CBD is excluded from the definition of a dietary supplement, and FDA also raised concerns about the adequacy of the safety data presented.
Representatives of NPA and cbdMD met with FDA in a pre-NDI meeting, at which time FDA raised the CBD drug exclusion issue.
“We’ve given FDA in a pre-NDI meeting as much science as you could give on an NDI for FDA to evaluate it,” Fabricant said in an interview Tuesday. “So why not make use of the statute, which is product-specific and ingredient-specific, and do it on a one-to-one basis? Nobody’s asked for that before, so we’re asking for that now.”
Sibyl Swift, a former FDA official who now serves as vice president of scientific and regulatory affairs with cbdMD, expressed confidence in a news release that her company would receive an acknowledgment letter from FDA if given the opportunity to submit an NDIN. Just last week, cbdMD announced receiving “validation of its novel food application” for a plant-based CBD formulation from the Food Standards Agency in the United Kingdom.
The company is seeking "a scientific path to market" that's consistent with DSHEA and "does not bureaucratically reward companies that aren’t putting consumers first with safety and science," Swift said in the news release.
There’s no guarantee FDA will respond to NPA’s citizen petition by the end of 2022, much less sooner. While FDA has 180 days to respond to a citizen petition, the CBD citizen petitions filed by CRN and CHPA demonstrate the agency frequently doesn’t meet the deadline. The agency’s own regulations permit FDA to delay a decision on a citizen petition due to such reasons as “the existence of other agency priorities, or a need for additional information.”
In a Feb. 14 email, CRN's senior vice president and general counsel, Megan Olsen, said her association last heard from FDA on its CBD citizen petition in November 2020. That's when FDA said it needed additional time to substantively respond to the petition.
"The agency will require additional time to issue its final response because of the complexity of issues raised in your petition," an FDA official at the time, Amy Abernethy, wrote to Olsen and CRN's president and CEO, Steve Mister, in a Nov. 17, 2020 letter. "FDA will issue a final response to your citizen petition after completing the analyses of all of the legal and policy issues related to this petition."
FDA last responded to CHPA in June 2020 when it issued a similar interim response to the association, the regulatory docket shows.
"We have no reason to believe that any other citizen petition on CBD would receive a different type of response at this point," Olsen told Natural Products Insider.
But NPA must “exhaust the possibilities here,” Fabricant said in the interview. “We have to find a way to get relief, and if that means we’ve got to go either tell Congress or tell the courts that … we’ve exhausted every administrative possibility, we’re doing that.”
Asked for this article about priorities and activities this year relating to CBD, an FDA spokesperson said she had nothing additional to share and referred to the agency's webpage regarding the regulation of cannabis-derived products.