First up was the FDA's announcement last week that a "new regulatory pathway for CBD is needed that balances an individual's desire for access to CBD products with the regulatory oversight needed to manage risks."
"It’s more delay,” said Dr Fabricant. "Four years of anticipation since we had that public meeting with Commissioner Hahn. At the time he was like, ‘We’re going to do something’… A whole lot of nothing happened. It’s different language but it’s status quo."
“It’s nice that they [FDA] want new authorities, but they didn’t really try at all to use the existing authorities. The existing authorities specific to drug preclusion, since 1994, the Secretary has the authority, by regulation, to suspend the drug exclusion and go to notice and comment where things about safety and identity can come up."
“There are going to be chemicals that walk in two worlds – the pharmaceutical world and the food world. This is completely anti-innovation by the Agency.”
The question then becomes if Congress can step in and provide a solution, although given the nature of the divisions in Congress, particularly with the composition and priorities of the House, it remains debatable if any meaningful resolution would be forthcoming during the next two years.
“I think everyone is going to scramble in different directions,” said Dr Fabricant. “We really are dependent on Congress and dependent on the correct vehicle. I think one thing from FDA’s letters is that any legislative efforts that just try to exempt it without specifically directing FDA, that’s not a good plan.”
State-led initiatives
Dr Fabricant also discussed the ongoing state-led efforts to restrict access to some dietary supplement products in States like California, New Jersey, and Massachusetts.
“Here’s the funny thing about the States, it only punishes brick-and-mortar. You can’t regulate the internet [at the State level] so how is it that you’re solving the problem?” he said.
NMN
We also talked about the current situation with Nicotinamide mononucleotide (NMN), a cellular aging ingredient that has been getting an outsized amount of attention given the very small market for the supplement at the moment, which is linked to the FDA’s stance on the ingredient’s status, how the Agency has approached this, and the potential wide-reaching precedent this sets.
“It’s kind of back to the anti-innovation stance, but moreover you had an ingredient manufacturer that submitted an NDI, got an AKL – a Good Day letter [from the Agency] – and then FDA pulled that AKL, which unless it’s adulterated, they can’t do. So that left us scratching our head,” he said.
“With NAC, they showed some flexibility. Same flexibility could be shown here: Enforcement discretion [etc]… but whatever questions we ask, the answer seems to be no.”
