Modernizing Dietary Supplement Regulation

In this Nutritional Outlook video interview, Harry Rice, PhD, vice president of regulatory and scientific affairs at the Global Organization for EPA and DHA Omega-3s (GOED) and NO editorial advisory board member, walks through two major issues currently shaping the omega-3 ingredient landscape: supply chain volatility and a pending cardiovascular health claim.

On supply, Rice explains that fish oil availability hinges heavily on the Peruvian anchovy fishery, which supplies more than 60% of the oil used in dietary supplements. The fishery's two annual seasons are governed by quotas tied to ocean conditions, and El Niño-driven disruptions have repeatedly thrown off projections, including a full cancellation of the larger fishing season in 2023. In 2026, an early season start driven by anticipated El Niño conditions led to concerns about juvenile anchovy populations, triggering a temporary fishing pause. Rice notes that microbial omega-3 oils, such as those derived from Schizochytrium, offer an alternative source but face their own regulatory hurdles.

To address inconsistent national standards, GOED proposed a Codex Alimentarius standard for microbial omega-3 oils in 2024, which was accepted for development and discussed further at a 2026 meeting, with adoption anticipated as early as 2028.

On the clinical side, Rice describes an ongoing GOED-supported, independently overseen consensus panel evaluating EPA and DHA's role in reducing cardiovascular risk in the general population. The seven-member panel includes five omega-3 researchers alongside a cardiologist and a cardiovascular dietitian, intended to ensure any resulting recommendation is both scientifically rigorous and clinically practical. The panel's systematic review has been submitted for publication, with results expected to be unveiled at the American Society for Nutrition's annual meeting in Washington, D.C. this July. Rice notes the timing is significant, since a planned U.S. and Canadian dietary reference intake review for omega-3s has been paused, leaving a gap in current guidance that this new recommendation could help fill.

A transcript of their conversation can be found below.

Nicholas Saraceno: As you know, this past April, FDA had their dietary supplement meeting. And to my understanding, when we were chatting, you mentioned how go it actually submitted comments in response to that meeting. So I'm curious, what were the main positions that GOED took in terms of some of the things that were brought up at that meeting? And in your eyes, where are you seeing the greatest regulatory risk or opportunity for the omega-3 category specifically? I know we've kind of dove into some things already, but where do you see that as it stands right now?

Harry Rice: We addressed 2 issues in our comments. I have to say that it's interesting. There was a lot of interest in this meeting. I understand that there were a thousand submissions after the meeting with comments. I think that's very encouraging that there's a lot of support for regulating dietary supplements and making certain that the right things are being done. But we address 2 different aspects of dietary supplements. One, the scope of the phrase dietary supplement for use by man to supplement the diet by increasing the total dietary intake. This is a scope that is, for lack of a better word, it's archaic at this point. You know, it's from 1994 when DSHEA passed.

We also focused a little bit on methodologies, which we expanded to new sources to produce existing dietary ingredients. Basically, our comments were very direct in that you should expand the scope of the phrase “dietary substance” and methodologies and sources that can be used, provided safety is demonstrated.

Safety is the bottom line. It all has to be about safety. If it's not safe, then it can't be used by any means. But if it's safe, then why can't it be used? Just because it wasn't in the food supply before 1994, that's ridiculous that it can't be used. Again, safety should be the litmus test. And so we used an example of omega-3s, and we're in a really good position. Fish oil has been around for a very long time. The microalgal oils have been around since I'd say early 2000s.

Companies have submitted new dietary ingredient notifications. The FDA hasn't really had any issues, and any issues that they've come back with, the companies have addressed. And the new dietary ingredient notifications have been filed without any issues. As time goes by, innovation occurs and there is the chance that additional omega-3 resources or sources will come up. And we want those to be accounted for and be eligible to be used for dietary ingredients for use in dietary supplements. And so it really, again, can't emphasize this enough. It's about safety.

Saraceno: One hundred percent. And I think everyone within the industry would agree, which is why, especially in our industry, uh, research, clinical studies, things of that nature, they're so paramount in, you know, properly justifying a lot of these ingredients and a lot of these supplements. So keeping that in mind, Harry, how does your organization evaluate and respond to research that it considers quote unquote methodological, methodologically flawed? And I guess 1B to that, what do you, in terms of research, what do you think of the weight of the evidence that shows a correlation between omega-3s and cognitive health? Like where do you stand kind of in that debate right now?

Rice: Let me give you my opinion on the different aspects of cognitive health. We have maintaining cognitive health. And then there are different aspects that are involved with diseases, mild cognitive impairment, cognitive decline, traumatic brain injury. There are just so many different areas for cognitive health. I'm going to say that I don't think that the evidence is strongest for heart health, but I think the evidence for heart health is incredibly strong. I think in different areas for cognitive health, the science is still emerging, but it's stronger in certain areas. We always say that it's easier to prevent than to treat, which is good because the FDA doesn't like to talk about treatment because they start thinking about that as being associated with a disease claim.

It really depends on what aspect of brain health you're talking about. But recently, there were 2 different studies that were released that received negative media attention, and I just want to address those briefly, in general. One was about cognitive decline and the other was traumatic brain injury. Both said that omega-3s didn't work. The way that the studies were conducted and the interpretation by the scientists, I would say that that is true, but that isn't the whole story.

There were limitations to the study. You always have to look at the limitations. In the 1 study where the scientists said that omega-3s weren't good for cognitive decline or for Alzheimer's disease, they used cognitive assessments that weren't appropriate for the populations at hand or for monitoring the progression of the conditions that they were looking at at the time. It’s just very difficult to really understand and for consumers to understand. All they see is what's being pushed by the popular press and particularly social media these days.

When I graduated 25 years ago with my nutrition degree, social media didn't exist, and so there wasn't the pressure to to push back on everything. We have to pick and choose what we push back on. We look to see what's getting the most attention. If we get contacted by our members and they're concerned and their customers are concerned, then we address it with some talking points, and which is what we had to do with these 2 recent studies.

Saraceno: That makes total sense. Harry, thank you for taking the time to break that down, and joining me today, just to provide a bit of an update piece and shed some more light on omega-3s, and to impart your knowledge and your wisdom with our listeners and our viewers. I really appreciate you joining me today and taking the time.

Rice: Thanks you for having me, I appreciate it. I'd love to come back again.