Developed by members of the Omega-3 Working Group at the Council for Responsible Nutrition, predecessor to the Global Organization for EPA and DHA Omega-3s (GOED), the monograph has served as the industry definition of quality since 2002.
“The reason for the working group was that fish oils were becoming popular but there was no standard,” explained Andrew Shao, PhD, who became involved with the working group after joining CRN in 2005. “This was even before USP had a standard. There wasn’t a standard for fish oil anywhere. And there was a concern that the industry was heading towards the lowest common denominator, which is price.”
“I think this was one of the first voluntary approaches for self-regulation in the industry,” said Shao, who is now VP of global nutrition policy at Herbalife. “There have been many following over the years, from probiotics to botanicals to enzymes, but this was really the first one.”
“This was precedent setting and prevented a nosediving in quality in the category. It also set the precedent for other self-regulatory initiatives.”
The origins of the monograph are inextricably linked to health claims. Annette Dickinson, PhD, was VP of Scientific and Regulatory Affairs at CRN when the working group was established, and recalls its complicated origins. “This goes back to the 80s and a time when there were no authorized health claims and FDA was taking a hard line on foods,” she said.
“Because of a number of reports in the late 70s and 80s about fiber and health, there was ferment in the food industry to say something, and companies started doing that. Then you had Kellogg, working with the National Cancer Institute, make fiber-cancer claims on its All-Bran products in 1984. This was a breakthrough and set off excitement in the industry. And it became clear that FDA was going to have to allow claims [which arrived in 1990 with the Nutrition Labeling and Education Act].
“Besides fiber, omega-3s were the strongest for a health claim because of all the reports of omega-3 fatty acids and heart disease,” explained Dickinson.
Work on a health claim for dietary supplements containing EPA (eicosapentaenoic acid), DHA (docosahexaenoic acid) and coronary heart disease (CHD) risk began in the 1990s, recalls Bjorn Rene, who was with Pronova/EPAX at the time (he’s now with Golden Omega). A qualified health claim was approved in 2000 (and a similar claim for conventional foods was approved in 2004).
The working group
“And we then asked the question how can we now increase the market,” said Rene. CRN established the working group in 2001 at a meeting at Expo West. “The meeting had more than 50 people attending,” he said.
“One of the problems we were hearing was about quality. So, we formed a committee to work on behalf of industry to raise the quality and promote the benefits. The technical committee was tasked with raising the quality and we did that via the monograph,” said Rene, who was a member of that four-person technical committee.
Rene remembers a very smooth process in producing the first version of the monograph. “We wanted to follow the strictest regulations, and set the limits for contaminants that were the lowest of any around the world,” he said. “We set values on how to measure EPA and DHA, contaminants (heavy metals), and so on. I remember many conversations with Robert Orr [then CEO of Ocean Nutrition Canada] and the other committee members. It was a very smooth process.”
Shao has similar recollections: “There was a great alignment among the members of that working group. Part of what made it very successful was that everyone and everything came together relatively smoothly.”
Once complete, the monograph was pretty rapidly adopted by the key players in the sector, said Adam Ismail, GOED’s executive director. “Had it not been so readily adopted I’m not sure GOED would have been formed at that time,” he said. The association is now celebrating its 10th anniversary.
This rapid adoption allayed fears about nosediving quality, and the impact was easily measured. “Prior to the monograph, about 80% of the industry was above the limits for oxidation,” said Ismail. “Within a couple of years 80% were compliant with the levels in the monograph.”
The monograph has changed little by little over years, and is now in its fifth iteration - the monograph's last major update coming in November 2015. “The initial draft was really good but some product types were not included, which is why later versions were expanded,” said Ismail. “An example of this is the explosion in flavored products (omega-3 oils flavored with lemon oil or orange oil) for a better sensory experience.
“The monograph is based on the strictest regulatory standards from around the world for oxidation, contamination, and fatty acid measurements. When the regulations change, we update the monograph,” he added.
The monograph is a voluntary standard for the industry to follow, but compulsory for GOED members, explained Ismail. The association ensures compliance by randomly testing its members’ products and other products from markets around the world. GOED conducts two rounds of testing every year.
Regulatory agencies around the world also use the monograph as a go-to document. “From a regulatory perspective, it’s a unified standard that a very large portion of the industry follows,” he said. “When regulators are looking for limits it’s an easy document for them to look at.”
The legacy – the formation of GOED
The CRN working group had clearly achieved its goal to move the standards forward, but then the question became “now what?”
Shao remembers the various factors at play: “There was a concern that short-chain fatty acid suppliers – the flax and canola suppliers – would encroach on the market developing for long chain omega-3s, and some in the group were really paranoid about that, and so they wanted to promote long chain omega-3s as beneficial and not the short chain ones. This was all being run by CRN still, and a trade association doesn’t get into those kind of disputes.
“The other issue was that, with the exception of a few companies, many members of the working group were not CRN members, and they didn’t want to become members or pay some kind of special assessment.
“Both of these issues – the non-CRN members and the desire for promotion of specific omega-3s – led to GOED being founded,” he said.
Quality and science
So has the monograph and the increase in quality helped grow the category over the years as much as the explosion in science? “The foundational science [for omega-3s] was done with oils prior to the monograph, but the overall bulk of the science is post-monograph,” said GOED’s Ismail. “I don’t know if quality was a driver as much as the science. What quality does do is prevent people from leaving the category.
“We know in an era when consumers demand more and more and if you create a standard and leave it static then consumers will demand greater quality. The lesson is to continue to get better and better over time.”
The impact and legacy of the monograph are hard to deny: “The monograph was the starting point for GOED. It is a key pillar of quality and doesn’t allow quality to drift downwards. This is something leveled at supplements in general – that there’s poor quality and a lack of transparency,” says Shao.
“GOED and the monograph have done a great job keeping that issue out of the conversation around omega-3s. On the other side, you’ve even had fish oil approved as drugs.”