First up was the recent proposal from the FDA to relocate the current Office of Dietary Supplement Programs (ODSP) to a new Office of Food Chemical Safety, Dietary Supplements, and Innovation, which would also include food additives.
Speaking with NutraIngredients-USA via video from Washington, D.C., Dr Fabricant said: “My concern, coming at it operationally from my time at the Agency, is that there’s a budgetary issue where the buck stops at the Office level. When you look at a proposed budget to Congress for FDA it only bleeds down to the Office level and nothing below that, so if you co-mingled those offices we wouldn’t know how much of that funding goes to supplement activities versus food additives activities.
“Concerning our past history with food additives and how FDA tried to use them to eliminate the industry once upon a time, that’s concerning to say the least,” he added.
Dr Fabricant noted that the person at FDA in charge of the reorganization is Dr Janet Woodcock. NPA has requested a meeting and raised their points with the Agency about this reorganization.
“Any reorg has to go through Congress,” he said.
Another recent FDA announcement focused on an update of priority of guidance topics to include Draft Guidance on Dietary Supplement Master Files, which would be part of the wider issue of New Dietary Ingredients.
“We had some inside baseball here,” said Dr Fabricant. “Bob Durkin, now at AGG, and Dr Sybil Swift, now at cbdMd, actually worked on a redraft of the guidance before they left [FDA]. We had some meetings with them and there was some talk of breaking the guidance up into parts… what seems to have bubbled up first is the concept of Master Files.
“We’ve been on record before, and a lot of people have, we like the idea of Master Files, but what’s the value if there’s not enforcement?
“Until we see a clear-cut direction on enforcement it’s a bit of red herring. More importantly, we’d like to see FDA lead with a conversation on definitions.”
Dr Fabricant also discussed what is happening with NMN (nicotinamide mononucleotide), one of the forms of vitamin B3, or niacin, that has been shown to enhance the levels of nicotinamide adenine dinucleotide (NAD+) in the cells of the body.
Earlier this year, NPA, along with the Alliance for Natural Health (ANH), filed a Citizen’s Petition with FDA requesting the Agency reevaluate the status of NMN or exercise Enforcement Discretion on Drug Exclusion Clause for the ingredient.
“Things are playing out in a few different directions,” said Dr Fabricant. “Legislatively, we’ve had some members of Congress send letters. They still haven’t been responded to. FDA has blown their deadline, which is concerning.
“We’ve been watching FDA very carefully on this for ripeness, if you will, to pursue a legal action on this we need to wait to that 180-day point [from submission of the Citizen’s Petition]. We’re about 60 days out, at which point our organization will have to figure out if we’re going to move forward with some sort of litigation.
“FDA tripped some wires with NAC. We followed the NAC playbook very carefully [for NMN]. FDA rejected some certificates of free sale [for NAC] that could be considered final agency action and allowed us to move forward quicker. That hasn’t happened for NMN. I don’t want to say we’re in a holding pattern – there’s certainly discussions going on behind the scenes.”
Dr Fabricant also discussed pending legislation to expand eligibility of dietary supplements for HSAs and FSAs and provided an update on where things stand at the State level regarding bills to restrict access to weight loss and body building supplements for minors.
Watch the video for the full conversation.