Defining the "Dietary Substance": Insights on FDA Guidance and Statutory Intent

Speaking at SupplySide Connect New Jersey, Megan Olsen, the SVP and general counsel for the Council for Responsible Nutrition (CRN), shares her insights on the public meeting hosted by FDA on March 27, 2026. The meeting, titled “Exploring the Scope of Dietary Supplement Ingredients,” focused on language found in the Dietary Supplement Health and Education Act (DSHEA) of 1994, the influence of new innovations in the industry on the framework, and specific classes of ingredients.

In the meeting, Kyle Diamantas, deputy commissioner of human foods at FDA, explained that goal of the agency is to modernize its oversight of dietary supplements to keep pace with the growing and expanding industry. Additionally, Cara Welch, director of the Office of Dietary Supplement Program, Human Foods Program at FDA, discussed the scope of the phrase in DHSEA that defines a dietary substance.

Our interview with Olsen explores what insights CRN took away from the meeting, specifically the future direction of the definition of a dietary substance, the intersection of the generally recognized as safe (GRAS) pathway and the New Dietary Ingredient Notification (NDIN) pathway, and what what advocacy actions CRN is currently taking.

A transcript of his conversation can be found below.

Nico Saraceno: I know a few weeks ago or several months ago, FDA actually held a public meeting exploring the scope of dietary supplements. We were watching remotely with NO. Did you find it, in your opinion, to be a productive meeting overall? And what were some of the insights that you took away from that?

Megan Olsen: So I found it to be a very productive meeting. We were very pleased that FDA decided that the time was ripe to revisit this issue. I should say. Some of the viewers may recall there was a meeting in 2019 that was exploring the scope of what is a dietary ingredient, in particular, what is a dietary substance, which is one of the definitional terms for when an ingredient can be a dietary ingredient.

I'm sure for a variety of reasons of, you know, least of which are Covid, it changed the trajectory of what the agency was looking for. And so CRN was actually approached, by staff at FDA, Cara Welch, indicating that they were going to propose a public meeting around this issue. And in fact, they mentioned some concerns. FDA staff have mentioned some concerns around how the new dietary ingredient pathway could be affected by the FDA's review of how the GRAS pathway is supposed to function.

Is there a, as many of your viewers will know, FDA is also looking at the way that companies notify and even get ingredients reviewed that are GRAS. On the food side, dietary supplements can use that pathway, in a variety of ways. If they have an ingredient that's in the food supply, they can use GRAS. And then there's, the new dietary ingredient notification process takes that into account as probably the, the easiest way to explain that without getting into the weeds there.

So, FDA staff have expressed concern about how anything that they're putting out in this proposed GRAS rule, which we haven't seen, we're waiting on, could affect the new dietary ingredient pathway, but at the same time, they seem to have an interest in really wanting to understand how dietary ingredients come to the market and having them go through that NDIN pathway, rather than a potentially more circuitous route. And, and one of the reasons there's a concern is because FDA has taken a narrower definition of what is a dietary substance. And that was a lot of what the meeting was discussing and whether or not FDA's interpretation, which has just been put out there as guidance, is correct. And if there is another way that FDA can look at the issue that still stays within, I think Cara used the train tracks of the statutory definition. So I think it was a great opportunity for industry to come together to show that this is an issue that is beneficial to consumers. Even FDA has mentioned they've seen situations where an ingredient really should be a dietary ingredient. It's beneficial for consumers, it can be made in a more sustainable way or a safer way, more consistent way. But they've had to turn down the NDIN and the notification because it didn't fit this narrow definition.

So we're optimistic that this is a opportunity. FDA seems really ready to dig in and have that discussion. There's an opportunity for, we provided public comments at that meeting. Andrew, Doctor Andrew Wong also spoke at that meeting.

But we also have an opportunity now to provide written comments, which CRN is developing. And we think the time is ripe. I mean, there's a lot of talk about how important these products are to consumers' health among this FDA staff, among HHS. And so we think the time is right to let's really have a real conversation about what Congress intended with that definition, and ensure that dietary supplements have clear guidance and a clear pathway to work with FDA to provide these ingredients to consumers.