From FDA to Industry Consultant: Dr. Sibyl Swift on Priorities and Mandatory Product Listing

At the Future Nutra Innovation Summit in Lake Conroe, Texas, Nutritional Outlook met up with Sibyl Swift, PhD, founder and principal of Swift Strategy Group.

Drawing on her tenure at the agency, Swift reflects on the need for prioritization in the office. She points to real examples, including a hangover warning letter effort she worked on in 2019 that wasn't published until 2020, and new dietary ingredient draft guidance she helped develop in 2019 that didn't see daylight until 2024.

The conversation then turns to mandatory product listing, a consequential and divisive regulatory shift since Swift's departure in 2019. She unpacks why the industry is split and acknowledges the FDA's need for better information. Swift makes the case for a more transparent, shared repository of information that could help separate credible companies from bad actors rather than adding new submission burdens.

Transcript

Nico Saraceno: Ladies and gentlemen, welcome to another edition of the Nutritional Outlook video series. Reporting live from FNIS in Margaritaville, Lake Conroe, Texas, I'm Nico Saraceno, senior editor of Nutritional Outlook magazine, and today, I am joined by none other than Dr. Sibyl Swift. You are the founder and principal of Swift Strategy, amongst your many titles here in the industry. So, first of all, thank you for taking the time to meet with me here at the show. I really do appreciate it.

Sybil Swift: I appreciate the opportunity to speak with you today.

Saraceno: So, there's a lot to get into. Obviously, you've spent quite a bit of time inside the FDA's Office of Dietary Supplement Programs. I'm curious, looking back on that time during your tenure there, was there any sort of specific policy debate or disagreement that kind of shaped how the agency kind of formulated and like drafted that supplements oversight kind of thing, or like what was the dynamic there that maybe like outsiders in the industry might not have if you could maybe break that down a little bit for us?

Swift: Absolutely. And I think I'm going to more focus on the amount of time most people don't understand that it takes. So, the office was a division when I came in in 2014. It was buried in this massive office with nutrition and food labeling. It became an office in 2015, and I'll talk about that later today. There were 14 people in that office when I joined. Fourteen people to regulate the industry, which is amazing.

They're still not prioritized. So, for example, hangover warning letter series: I worked on that in 2019, and I don't believe those warning letters were published until 2020. So, it took a year for that action to actually get through agency prioritization and be issued. The administrative section for the new dietary ingredient draft guidance, it's timelines and procedures or something like that is what they're calling it. I worked on that in 2019. I believe it was published in 2024. So, it's, I think, frustrating to see this still happening, that that office is still not prioritized in terms of agency actions. It's a bit disappointing.

Saraceno: Yeah, that's a that's a fair point. I appreciate you bringing that to light, too. Obviously, the FDA's got a lot going on, but considering all the announcements and changes the FDA has made since you left, which one do you personally think the industry is most misinterpreting or misreading, either by overestimating or underestimating the impact? I know that's a loaded question, but if you had to maybe break it down, what would kind of like hone in on in that regard?

Swift: Mandatory product listing. It's something that, while at the agency, not having any industry experience, coming straight out of the Department of Defense, I understood, and you know, it made sense. Let's help the agency have more information. I left at the end of 2019, and this announcement came out of a mandatory product listing, and it's quite frightening from a practical application standpoint. I think the industry is pretty divided on this. Some people are all for it. Yes, the agency needs tools, they need information. I don't disagree. I absolutely I agree that they need more information, but the premise is labels. So with a certificate of free sale, labels and label information are presented. Structure, function, claim notifications, labels are presented. External, there's an NIH label database. I think a lot of people are also not aware that every change in a formulation would require a new submission. So the burden on industry is almost prohibitive, and the agency has this information available.

So I think it would be wonderful if we're talking about sharing information. Let's have a repository of their claims for structure, function, and claim notifications. I don't want to have to dig through regulations.gov to find the courtesy letters. That's where they disagree with something that you've presented, and they're letting you know out of courtesy that they disagree. No teeth. So I'd like to see a little bit more sharing of information. I think it would help guide, and then you'd start to see almost like a science experiment: separation between the good and the bad.

Saraceno: Yeah, I think in our industry everyone a lot of people would agree that transparency is necessary, and I think a theme here at FNIS is separating the good actors from the bad actors with the science and the clinical substantiations, so, totally see where you're coming from.