ODSP’s director on NDIs, MPL, and NMN

By Danielle Masterson

- Last updated on GMT

Related tags ODSP Cara Welch mandatory product listing Fda NMN Ndi IND NDIs

NutraIngredients-USA caught up with Cara Welch, PhD, Director of FDA's Office of Dietary Supplement Programs. Welch talked inspections, made the case for MPL and hinted NDI guidance is on the way.

SupplySide East is an opportunity for attendees to see the latest innovations, hottest ingredients and make connections. It’s also a chance to hear firsthand what the industry is really​ thinking. One of the most divisive issues among trades is the idea of a mandatory product listing (MPL). Advocates say an MPL would provide transparency to regulators, retailers and consumers. Opponents argue bad actors would simply choose not to list their products.

“We are the first ones to say it won't fix all the problems,” said Cara Welch, PhD, Director of FDA's Office of Dietary Supplement Programs. “I think it will make those firms that choose not to list that much more obvious, which is another big step.”

“FDA continues to be a big supporter of dietary supplement listing, we think it would be a huge step to modernize our program and bring it into the 21st century. It's been 30 years and it's been a huge 30 years for the supplement industry since DSHEA was initially enacted. It's a very different marketplace now than what it used to be–I mean, look at the floor out there, lots of innovation happening. And so we continue to believe that dietary supplement listing would be a great progress to modernize our program.”

Another hot topic is nicotinamide mononucleotide (NMN), something the FDA previously accepted as a New Dietary Ingredient (NDI), allowing firms to market it. However, in late 2022, the FDA determined that NMN isn’t a dietary ingredient, citing it’s under investigation as a drug, and ultimately revoking NMN NDIs.

Earlier this year, the Natural Products Association (NPA) and the Alliance for Natural Health (ANH) filed a Citizen’s Petition with FDA. The petition asks the FDA to reevaluate its position concerning the nicotinamide adenine dinucleotide (NAD+), a precursor to NMN.

Welch said she can’t speak to any pending NMN Citizen’s Petitions, but did discuss the situation more broadly, noting that NDIs are notifications, not approvals.

“There was an NDI notice, actually there were several NDI notifications submitted for NMN and unfortunately it took the FDA longer than we wanted to to find out that NMN was also being studied under clinical investigation. Once we figured that out, we did our best to determine whether or not we felt it was excluded, and then very quickly communicate that to the firms that had submitted NDI notifications. An NDI notification, of course, is a notification. It's not an approval. So I don't know that I would say ‘revoked,’ but it is an unfortunate situation. It really is important that we can communicate this determination to the firms as quickly as possible so they can make a good decision after that.”

When asked about any progress on NDI final guidance, Welch said it’s at the top of her list.

“So finalizing the guidance on NDI notifications is a priority. I've been saying it for a number of years, I recognize that, but it's something that we're really working on this year. We can't really talk about timelines, but we have indicated that we are hoping for this calendar year, 2023. We will finalize at least sort of the administrative section of the guidance, and then we can move on to the next sections about preparing the NDI notification,” said Welch. “So stay tuned.”

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