The petition is based on information presented to the US Food and Drug Administration in a meeting that the firm cbdMD had with the Agency. The petition states that FDA has hamstrung itself in its evaluation of CBD by declining to review existing safety data on the substance.
Review of existing safety information has languished
This results from a chicken and egg question that has plagued the regulatory resolution of the CBD issue from the opening of the market, which can be traced to the passage of the 2018 Farm Bill, though state initiatives had opened some doors even before then.
In that time, FDA has taken the position that CBD is not a legal dietary ingredient because of its prior investigation as a drug. The Agency states that it has received no credible information that CBD containing products were on the market prior the 1994 grandfather date in DSHEA, which would make CBD an Old Dietary Ingredient, and thus not subject to the prior drug development provision.
That being the case, safety information submitted via NDI Notifications has not been reviewed in good faith by the Agency, in NPA’s and cbdMD’s view, because CBD would be disqualified in any event from being a legal dietary ingredient.
CbdMD claims that is has a significant amount of safety information developed at its own expense. The citizen’s petition claims the company has spend $1 million developing that safety substantiation. The company said it has an NDI Notification dossier ready to go, but doesn’t plan to submit it if the process is doomed from the start. Not only would it be futile, but it could expose the company to having some of its confidential data revealed to no good end.
“We had one pre NDI meeting with them,” said Sibyl Swift, PhD, cbdMD’s vice president of scientific and regulatory affairs. In that meeting, at which Dan Fabricant, PhD, president and CEO of NPA was also present, it became clear that an NDIN on CBD submitted at that time would have no chance of success.
“That’s our stance on the issue. We’re not going to submit safety information and data if its just going to go onto a federal docket and sit there,” Swift said.
The Citizen’s Petition outllines much of the information that cbdMD says its has ready to submit in detail. That would include safety data that could put to rest FDA’s fears about hepatotoxicity and reproductive problems, the company claims.
“I think that we are doing our due diligence and submitting information where the Agency says it has gaps,” Swift said.
Evidence of ODI status
To start with, the petition makes that case that CBD ought to be consider an ODI. CbdMD has found a USP document from 1850 that refers to an alcohol-based “extract of the dried tops of Cannabis sativa — variety Indica.”
Federal law states that to qualify as an ODI a substance must have been in the food supply as an article of food prior to Oct. 15, 1994. Does a tincture fit that bill?
Swift said it’s important to remember that the distinction of this thing is a supplement, that thing is a food is an anachronism when applied to the market of 1850. The important thing to remember is that the reference indicates people were consuming hemp extracts in the United States more than 170 years ago.
“We believe it’s an ODI,” Swift said. “The reason that reference is important is it cites an agency (USP) that FDA frequently interacts with and considers an authority.”
Misapplication of drug approval rigor
If FDA disagrees on the ODI issue, then the Agency ought to be willing to review safety data in good faith via an NDIN, the petition states. And in so doing, the Agency should refrain from inappropriately applying a pharmaceutical standard to these assessments.
“While cbdMd’s CBD safety data exceeds the criteria that should be applied to NDINs, it is not at all clear it will satisfy the Agency’s moving-target requirements for demonstrating safety of hemp-derived products. The Agency has been improperly applying drug approval rigor to its safety reviews of CBD as a dietary ingredient, demonstrating its arbitrary and capricious application of the Act,” the petition states.
Rewarding bad behavior
Swift said she expects that FDA will at best respond with a ‘we need more time’ type of communication. Fabricant said the strategy is to use every tool to dial up pressure on the Agency in an attempt to get a resolution. That’s urgently needed, he said, in a market filled with thousands of products for which there is at the moment no real regulatory oversight.
“It’s unfortunate that we have to exhaust every avenue to box them in, but that’s where we are,” he said.
“In the meantime, the Agency has rewarded bad behavior. They say they need more science, but then they won’t look at the science. That $1 million that cbdMD spent could have gone straight to marketing,” Fabricant said.
To see the full text of the petition, click here.