Updated 1/14/15: Also read: Test Campaign to Revive Omega-3 Sales Is Working

Just about everybody knows somebody who takes fish oils, today. While fish have swam Earth’s waters for millions of years, their precious oils found an indirect path to human stomachs and hearts in forms of capsules, softgels, and spoonfuls. If sales numbers are any indication, consumers are usually quite comfortable taking their fish oils. But, last year something happened.

Nielsen data estimates that omega-3 sales declined last year, to put it lightly. Between mid-2013 and April 2014, fish oils undersold 10%–11% each month compared to the prior year. The decline even manifested in krill oil. Theories for omega-3 oil’s recent descent are many, but there are a few likely culprits. So, what happened to fish oil, and where does it go from here?

A Prostate Cancer Study

As much as factors like the introduction of fish oil drugs and sustainability concerns around fish stocks may be affecting fish oil sales, a case-cohort study published July 2013 by the Journal of the National Cancer Institute received a surprisingly high level of mainstream attention.¹ It concluded that men with high blood concentrations of omega-3s may have increased risk of prostate cancer.

A lot of spicy headlines can come out of a finding like this, and lots of them did-from FOX News, CBS News, NBC News, NPR, The New York Times, Men’s Health, and so on. Given today’s fast-paced style of following the news, a lot of consumers presumably saw initial coverage and gave up on encapsulated fishies right then and there.

A somewhat buried story, however, is based around some glaring tidbits of that 2013 study, which took some months to completely uncover but ultimately give fish oil suppliers something positive to hold on to. Once companies began publishing these findings, however-through press releases and at food industry conferences around the world-sales declines were already in motion.

To backtrack a bit, a team of researchers, led by Theodore Brasky, PhD, at the Ohio State University Comprehensive Cancer Center, tried to study omega-3 fatty acid intake in relation to prostate cancer risk by measuring blood samples of 834 men who participated in the famous SELECT study-a 10-year, multicenter analysis of over 35,000 men, designed to see if selenium and vitamin E supplements could reduce risk of prostate cancer.

While the SELECT trial ran from 2001 to 2011, Brasky et al. only pulled prostate cancer diagnoses between 2005 and 2009 to choose their 834 subjects and matching cohorts. Oh, and data from 75 additional men diagnosed with high-grade prostate cancer in the SELECT trial during 2010 and 2011 were later added to the data collection.

The particular selection of men diagnosed with prostate cancer is strange, not just because it only covers 5 of the 10 years of data collected in the SELECT study (plus 75 extra men selected with bias for high-grade cancer), but also because these cancer diagnoses were tied to blood samples drawn at the beginning of the study-and at no other time during it.

“If I look at the dates, it is theoretically possible that someone could have been enrolled in 2001, had their blood drawn in 2001, and, in 2011, could have been diagnosed with prostate cancer-which is a 10-year gap,” said Jay Udani, MD, in a video interview with the Global Organization for EPA and DHA Omega-3s (GOED; Salt Lake City). A board-certified internist, Udani was actually an original investigator for the SELECT study. He adds that Brasky et al. based their conclusions on longitudinal blood values for omega-3 fatty acids, despite the fact that the SELECT trial didn’t include any monitoring of dietary intake of fish or omega-3 supplements at any given time during the study.

“We have no idea at all of what happened to these men anywhere between 1 and 10 years, between the time blood was drawn to the time diagnosis was made,” said Udani. Men may have started or stopped taking fish oil supplements, increased or decreased their consumption of fish, or made any number of other adjustments to their lifestyles, knowing they were now included in a study on prostate cancer. The sheer fact that the SELECT trial was intended to assess the effect of selenium and vitamin E supplements, not omega-3 data of any kind, on human health is reason enough for other researchers who question Brasky’s findings, intent, and design to doubt the results.

For what it’s worth, GOED says it just commissioned its own meta-analysis of omega-3 intake and biomarker studies. The results are pending publication, but Harry Rice, PhD, GOED’s vice president of regulatory and science affairs, says no association was observed between long-chain omega-3 fatty acids and prostate cancer risk.

Positive Studies

Even if the controversial prostate cancer study is easiest for some to remember, many industry experts stress that there are literally hundredsof other published omega-3 studies to consider, many of which have reached more positive conclusions about omega-3 blood levels and/or omega-3 intake, whether from fresh fish or dietary supplements.

Since the publication of another controversial study, in which Rizos et al. found omega-3 supplementation doesn’t appear to be associated with a lower risk of all-cause death and heart complications such as stroke and heart attack,² Casula et al. and Chowdhury et al. have arrived at more uplifting conclusions.^3,4 Casula’s team in Italy found 32% risk reduction of cardiac death and 25% risk reduction of heart attack when patients with heart disease supplemented with omega-3s across 11 qualified trials. Chowdhury’s research, funded in part by the British Heart Foundation, found statistically significant protective effect for coronary outcomes (a 13% risk reduction) with omega-3 supplementation.

More studies have shown and likely will continue to show benefits from omega-3 intake and increasing omega-3s in the blood, for conditions like inflammation, cognitive health, and bone and joint health. Some will yield unfavorable results, too. These, if well-designed, should earn everyone’s full attention. For curious manufacturers, most omega-3 ingredient suppliers keep extensive records of historic and ongoing research.

Dietary Reference Intakes

Forget the fuss of “the prostate cancer study” for a moment, because the omega-3 oils industry is at least getting a push in the right legislative direction. This August, a joint U.S. and Canadian nutrient assessment working group announced that the omega-3 fatty acids EPA and DHA have made the first cut in the nomination process for a Dietary Reference Intake (DRI) review. Not surprisingly, omega-3 suppliers are pumped.

“The [potential] scheduling of omega-3 EPA and DHA for Dietary Reference Intakes, and possibly assigning them daily values on foodlabels and dietary supplement labels here in the United States, would definitely elevate the importance of EPA and DHA in the North American diet,” says Bob Green, chairman of Novel Ingredient Services (West Caldwell, NJ), an exclusive U.S. distributor of omega-3 concentrates for GC Rieber Oils (Bergen, Norway).

Product manufacturers are already stoked to formulate products with omega-3s anyway. Green says that some research suggests a manufacturer preference for formulating foods with added ingredients (such as omega-3s) rather than without certain ingredients (such as fat or sugar).

While the possibility of a DRI review has the omega-3 industry poised for celebration, suppliers and manufacturers will have to be patient. The next step in the process is a joint meeting on “the potential use of chronic disease endpoints in setting DRI values,” and it won’t happen until at least next year.

An FDA Health Claim?

If imagining omega-3 daily values isn’t enough to get your jollies, there’s this: FDA just announced intentions to review an omega-3 EPA and DHA health claim for reduction of blood pressure.

Thanks to a lengthy petition from GOED last November, FDA decided to consider a qualified health claim for EPA and DHA and reduction of blood pressure. GOED says that FDA prefers the “qualified” route because the federal agency said the petition is unlikely to meet the Standard of Significant Scientific Agreement (SSA) required for non-qualified health claims. The omega-3 industry already enjoys a qualified health claim, and it reads as follows: “Supporting but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”

If, when the public comment period ends on October 7, FDA decides that more thorough scientific information is available, the agency might revert back to that SSA and consider a non-qualified health claim.

Fish Oil’s Comeback

Only time will tell if fish oils and the greater omega-3 market can return to their former glory, but the latest legislative actions, coupled with positive clinical trials and more promotion of sustainable harvesting, suggest the future probably won’t be so bad for fish oils. Industry isn’t sitting idly, either. With the help of its many member companies, GOED is forming an Omega-3 Coalition that, with at least $5 million planned for investment, should turn up public relations and advertising in big, new ways. 

Also read:

One supplier's take: DSM on Omega-3 Downturn: We Have High Confidence in Future Omega-3 Market

For years, the omega-3 market went nowhere but up. Here's a look at the omega-3 ingredient sectors comprising the omega-3 market: Everywhere Omega Fatty Acids

FDA Won’t Allow DHA/EPA Content Claims

FDA Approves Three More Omega-3 Drugs. Is This Good or Bad News for Supplements?

References

1. T Brasky et al., “Plasma phospholipid fatty acids and prostate cancer risk in the SELECT trial,” Journal of the National Cancer Institute,  vol. 105, no. 15 (Aug 7, 2013):1132–1141.

2. EC Rizos et al., “Association between omega-3 fatty acid supplementation and risk of major cardiovascular disease events: A systematic review and meta-analysis.” Journal of the American Medical Association, vol. 308, no. 10 (September 12, 2012): 1024–1033.

3. M Casula et al., “Long-term effect of high dose omega-3 fatty acid supplementation for secondary prevention of cardiovascular outcomes: A meta-analysis of randomized, placebo controlled trials,” Atherosclerosis Supplements, vol. 14, no. 2 (August 2013): 243–251.4.

4. R Chowdhury et al., “Association of dietary, circulating, and supplement fatty acids with coronary risk: A systematic review and meta-analysis,” Annals of Internal Medicine, vol. 160, no. 6 (2014): 398–406.

Robby Gardner
Associate Editor
Nutritional Outlook magazine
robby.gardner@ubm.com