CRN president and CEO Steve Mister elucidated his organization’s position in reaction to a recent editorial written by former FDA Commissioner Scott Gottlieb that appeared in the Washington Post.
Mister said that getting hung up on the drug exclusionary clause has created a logjam in the process which in CRN’s view is not necessary. That clause in DSHEA says that if an ingredient has been first researched for use as a drug, it cannot be subsequently be developed as a dietary ingredient for use in dietary supplements.
Disagreement over time frame
“We agree with a lot of what Dr Gottlieb had to say in the Washington Post piece. We agree with him that there is a need for urgency. Where we disagree is this notion that it takes three to five years to start the process,” Mister said.
Epidiolex, a CBD drug developed by English company GW Pharma, was approved last year by FDA. It treats two seizure disorders of childhood. The precise dates of when GW’s IND (Investigational New Drug) application was filed and made public have become important data points in the CBD discussion. In CRN’s view, those dates have assumed an importance out of proportion to their true significance.
And complicating the case is where CBD comes from—cannabis—which until recently was on the Schedule One list of controlled substances maintained by the Drug Enforcement Administration (THC, the plant’s psychoactive component, is still on the list).
Unnecessary race to market
“The first step and the basis for FDA’s objection for having CBD be sold as a supplement is this provision that creates a race to market between the supplement or the drug. But FDA’s position is that no CBD product could have been on the market as a legal dietary ingredient prior [to GW’s IND filing] because CBD would have been a controlled substance,” Mister said.
Mister said the CBD drug/supplement interplay has been framed in terms of consumer safety, which in his organization’s view is turning the argument on its head. The purpose of the clause is to protect the incentives for drug development, he said.
“This is not a safety question. It’s an economic question that is asking FDA to look at benefits and market forces and the effects of restrictive monopolies and where there is a case for granting such a monopoly,” he said.
“If they wanted to say that you cannot sell a drug and a supplement with the same ingredient, they could have said that. But that is not what DSHEA says,” Mister said.
There are other examples in which supplement and drug forms of the same ingredient have peacefully coexisted, most notably in the realm of omega-3s. Mister said DSHEA grants the FDA commissioner the authority to grant an exception, and doing so wouldn’t taint the well for future drug discovery.
“It might turn out that a high dose of CBD could have dramatic effects on arthritis pain. I don’t think having a low dose CBD supplement on the market for sleep or relaxation would remove the incentive for a drug company to study CBD for an arthritis application,” he said.
Once logjam clears, safety info will flow
Once that issue is resolved, the safety question can be dealt with via the filing of NDI Notifications or GRAS affirmations, Mister said. Gottlieb said as much in his editorial, without touching on the current Catch-22 that an NDIN would be rejected out of hand because CBD at the moment does not meet the definition of a dietary ingredient.
FDA’s practice has been to get to that first step in a filing and cease work on the document at that point if that box is not checked. The agency says something similar in the case of poorly constructed filings on other substances, in which the ingredient is not characterized well enough. FDA says in effect, we can’t evaluate the safety of this ingredient because we’re not sure what it is.
“FDA has the authority to do this. We see this as a six month rule making process. Once that is done, the safety information will come,” he said.
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FDA is actively exploring potential pathways to permit certain cannabis-derived compounds in food or dietary supplements, but what are the key boxes that need to be ticked to move forward with CBD products that meet the quality standards required of mainstream products? What safety questions remain unanswered? Where do we stand on a potential NDI notification or GRAS no objection? What claims can be supported by the science? And what does the CBD space look like in five years?
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