The importance of transparency

Reputation requires a lot of time and effort to build up, but only a moment can tear it down. That is why the Global Organisation for EPA & DHA Omega-3s (GOED) exists to help the industry meet, and maintain, quality standards through bestpractice guidelines and recommendations in order to accurately measure product quality.

Ingredients Insight met with Chris Gearheart, director of member communications and engagement, and Harry Rice, GOED VP, to discuss the importance of transparency among its members so that regulations are adhered to and ethical standards are maintained. It is the fundamental recipe for survival considering the vast consumer markets that members provide for, and the pressure to remain competitive in the face of costs and resources. Of course, increasing public awareness and education is crucial in order to further advance the broad benefits of eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA) in high-quality products, but in a fast-paced world of immediacy and distraction, one of the primary challenges is getting the right information at the top of the search results.

In its annual report last year, GOED certainly emphasised its commitment to an organisational focus on quality for their membership, as well as education of industry, consumers, healthcare providers and global regulatory bodies. Something that is at the forefront of both pursuits is a recent randomised controlled trial (RCT) into cardiovascular risk reduction that focused on patients with elevated triglyceride levels. Rice described as “staggering” the results from the trial, called REDUCE-IT, which indicated that just under 4g a day of EPA, combined with a statin, were statistically equivalent to a statin alone, when used as a prevention in reducing long-term cardiovascular events, and when the treatment group was compared with the placebo. Specific studies and broader insights into sustainability, market trends and preparations for Vitafoods in Geneva in May are further discussed here.

At the Omega 3 Summit in February in Singapore, GOED’s director of compliance and scientific outreach, Gerard Bannenberg, spoke about safeguarding the sector’s reputation and the importance of adhering to correct methods. What are some of the most efficient sources to extract omega-3s that are environmentally sustainable?

Chris Gearheart: GOED focuses specifically on EPA and DHA for any source and are beneficial for human health. Fisheries that supply the most common marine sources are managed sustainably.

As mentioned in your 2018 annual report, monitoring and analysing omega-3 science, as well as furthering the body of research, is essential. With this aim in mind, how do you ensure your members adhere to regulatory and ethical standards?

CG: The backbone of the GOED quality standard is the GOED Voluntary Monograph and members’ public commitment to adhere to its requirements. Our randomised testing programme monitors compliance and confirms that consumers are getting quality supplements that they can trust.

What are the primary challenges of educating consumer behaviour so that promoting and consuming EPA and DHA in high-quality products is a longterm benefit?

CG: As far as nutrition coverage in the mainstream consumer media goes, EPA and DHA omega-3s attract a lot of attention, and the challenge is that too often neutral clinical trial results are framed as negative in the headlines. The science performed today is difficult to understand in 280 characters on Twitter and consumers need to look at the full body of evidence – more than 4,000 human clinical trials – to understand the importance of omega-3s for their health.

As we approach another edition of Vitafoods in Geneva in May, what presence will GOED have there, and how does a platform like this help build momentum for the future of omega-3 production and consumption?

CG: The Vitafoods Omega-3 Resource Centre will feature the exhibits of 15-plus GOED members; theatre presentations on regulatory, scientific, marketing and technical topics of importance to the industry; iPad presentations that summarise new top-level insights from GOED’s work in the industry; and a first look at a brand-new clinical study database that will catalogue the entire universe of omega-3 science.

In light of a recent RCT into cardiovascular risk reduction that looked at patients with elevated triglyceride levels, what do you find that is encouraging in terms of the conclusions reached and what more work needs to be done?

Harry Rice: The Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT) evaluated in 8,171 men and women was on whether just under 4g a day of EPA, combined with a statin, is superior to a statin alone, when used as a prevention in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidemia. The following risk reduction results from REDUCE-IT were statistically significant when compared with the placebo group:

¦ 25%: primary end-point composite of the first occurrence of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, coronary revascularisation, or unstable angina requiring hospitalisation.

¦ 26%: key secondary composite of cardiovascular (CV) death, MI, or stroke.

¦ 25%: CV death or non-fatal MI.

¦ 31%: fatal or non-fatal MI.

¦ 35%: urgent or emergent revascularisation.

¦ 20%: CV death.

¦ 32%: hospitalisation or unstable angina.

¦ 28%: fatal or non-fatal stroke.

¦ 23%: total mortality, non-fatal MI or non-fatal stroke.

<4,000
The number of human clinical trials carried out on the connection between omega-3 and health.
GOED

While GOED believed the results would be positive, it did not anticipate such staggering results. Based on the data from this study, in addition to our review of past research, it seems clearer now than ever before that many of the failed (neutral results) trials beginning in 2010 were due to too low a dose. Obviously, further research will need to be conducted in order to substantiate such position.

What responsibilities do supplement companies have to the general population when it comes to promoting and marketing omega-3s as something that can reduce risks of cardiovascular disease and cancer, considering the recent National Institutes of Health (NIH)-funded study that concluded that supplementation with n-3 fatty acids didn’t result in a lower incidence of major cardiovascular events or cancer than a placebo?

HR: All companies promoting the benefits of omega- 3s to consumers have the responsibility of providing truthful and not misleading information. Research should be interpreted conservatively, and the results should be qualified so they are not overstated. While the Vitamin D and OmegaA-3 Trial (VITAL) did not achieve the trial’s primary outcome of significantly reducing major cardiovascular disease (CVD) events, the following results were statistically significant, providing long-awaited evidence that omega-3s do provide benefits for primary prevention:

¦ Total MI: 28% risk reduction – omega-3s 145 events versus placebo (200 events).

¦ Total CHD: 17% risk reduction – omega-3s (308 events) versus placebo (370 events).

In addition, the greatest reductions were demonstrated in those with low dietary fish intake and in African Americans. While GOED considers this noteworthy, scrutiny of the data is required to better understand these findings.

With respect to cancer, while there is a large body of evidence supporting omega-3’s benefits, GOED does not recommend supplement companies talk about cancer. In the EU, there are no permitted health claims associated with cancer. On the other hand, the heart health benefits of EPA/DHA are acknowledged in approved claims related to normal heart functioning, maintenance of normal blood triglyceride levels and maintenance of normal blood pressure.

Each disease is unique in terms of treatment, so through recent studies, how do you better understand the role omega-3s play in the cardiovascular system?

HR: As much as we know about omega-3s, there remains a great deal we still don’t understand. While benefits (for example, blood pressure lowering) are demonstrated in clinical trials, understanding the mechanism(s) of action is still somewhat of a mystery. While not definitively known, lowered vascular resistance through changes in endothelial function is considered a primary mechanism by which EPA/DHA may lower blood pressure. For other benefits, we are very much in the dark. In fact, according to the coauthors of REDUCE-IT, the mechanisms responsible for the benefits demonstrated in the trial are currently not known.

Omega-3 facts

¦ GOED’s newest market data shows that the omega-3 sector is now a $1.29 billion industry, providing EPA and DHA for use in dietary supplements, infant formula, pharmaceutical, medical nutrition, pet food, and clinical nutrition markets worldwide. More than 26% of that volume serves the European market, where demand for omega-3s is increasing fastest in the clinical nutrition, and food and beverage categories.

¦ The Global Burden of Disease Project estimates that more than 280,000 European consumers died in 2017 due to a diet too low in EPA and DHA.

¦ According to GOED proprietary consumer data, when consumers in some of the largest European markets start taking omega-3s, they are seeking improved overall wellness, brain health and heart health, in that order.

Source: GOED