GOED analysis supports quality levels for majority of US omega-3 supplements

05-Feb-2020 - Last updated on 05-Feb-2020 at 18:50 GMT

The majority of the 48 most widely sold retail EPA/DHA omega-3 dietary supplements on the US market are of good quality, according to a new analysis by GOED that the trade groups calls “a timely snapshot of product quality in the US”.

Data published in the Journal of Food Composition and Analysis indicated that all of the products tested contained at least 80% of the levels of EPA and DHA claimed on the label, thereby complying with US regulations for naturally occurring Class II nutrients.

In addition, almost 60% of the products tested had at least 100% of the label claims of EPA and DHA.

The study was performed by staff from GOED (the Global Organization for EPA and DHA Omega-3s) in collaboration with laboratories from six GOED members and the University of California, Davis.

Oxidation

The products were also analyzed in terms of oxidation, and results showed that, while there are no regulatory guidelines for oxidative quality of omega-3 supplements in the US, just over 85% of all the products (unflavored and flavored) complied with the Peroxide levels stipulated by the GOED Voluntary Monograph, and the USP Fish Oil and Krill Oil monographs.

In addition, 96% of the unflavored oils complied with Para-Anisidine Values (p-AV), which is one measure of secondary oxidation. The mean level for the 23 products tested was 9.0, versus the limit of 20, as set by the GOED Voluntary Monograph and the USP Fish Oil monograph.

For TOTOX, another measure of secondary oxidation, 87% of the unflavored oils complied with the limits: The mean level for the 23 unflavored products was 19.2, versus a limit of 26, as set by GOED Voluntary Monograph and the USP Fish Oil monograph.

“A timely snapshot of product quality in the US”

Commenting on the study’s findings, Ellen Schutt, executive director of GOED, said: “While room for improvement exists, the results show that a significant portion of products available to American consumers comply with regulatory requirements in the US or are of good quality.”

Schutt added that the study aimed to provide “a timely snapshot of product quality in the US - the largest consumer market for these products”.

“The report should also be seen as an educational outreach by GOED to explain to academic colleagues how omega-3 products could be analyzed in a respectable manner, while highlighting current limitations in methodologies, inter-laboratory variability and the need to place findings in the correct regulatory framework,” she said. “This work is also important to counteract poorly executed studies claiming poor product quality compliance as these can still have a major influence in the academic literature.”

Limitations

The p-AV and TOTOX values only applied to the unflavored oils, because the researchers note that aldehyde compounds present in flavors and colors themselves will generate false-positives,

Another limitation linked to methodology concerned products with the omega-3s in the phospholipid form.

“The main challenge was that the solubility of these products was found to be insufficient in the organic solvents specified by the methods,” wrote the researchers, led by GOED’s Gerard Bannenberg.

Wiley’s: “This level of rigor is in marked contrast to the ‘Wild West’ atmosphere of … CBD oils”

Omega-3 Fish oil © Getty Images areeya_ann — © Getty Images / areeya_ann

Sam Wiley, CEO of Wiley’s Finest, welcomed the paper’s publication. The company’s Peak EPA product was one of the 48 products tested and was found to contain 95.3% of the EPA + DHA claimed on the label. It also contained the lowest p-AV and TOTOX levels of all the products tested (at 1.9 and 7.5, respectively).

“Our low TOTOX values have always been a point of pride for our team, as we know this is a top barrier to use of Omega-3 supplements by consumers; this recent testing study demonstrates continued clear evidence for the Wiley family’s AlaskOmega ingredient as the global leader in freshness for Omega-3 fish oils,” he said.

“My key takeaway as a member of the Omega-3 supplements industry is: I’m proud of the level of scientific rigor and collaboration (even among fierce competitors) to pursue accurate testing standards that our industry consistently demonstrates,” added Wiley.

“This level of rigor is in marked contrast to the ‘Wild West’ atmosphere of the recently popular category of CBD oils. Our Omega-3 industry has a great track record – this paper also shows that there is always room for continued improvement as we seek to serve our consumer’s needs with great quality, effective supplements.”

Commitment to analytical excellence

The GOED paper notes that Pharmavite’s Nature Made Fish Oil 1200 mg has the highest sales of all of the 48 products tested.

Dr Susan Hazels Mitmesser, Pharmavite’s Vice President of Science and Technology, told us: “Data published by GOED confirmed that dietary supplements manufactured by Pharmavite (PHV) containing EPA and DHA meet the amount claimed on the label.

“It is our commitment, in partnership with GOED, to meet quality specifications for products containing omega-3 fatty acids. We believe in the need for robust and precise methods to determine the levels EPA and DHA in dietary supplement products. We, along with GOED, understand the analytical challenges and high variability in results obtained and reported for oxidation and stability of these products through shelf-life.

“As part of our commitment to analytical excellence, PHV is committed to addressing such challenges to improve the accuracy of results reported. This is imperative to ensure consumers get enough EPA and DHA to benefit their overall health and to help fill the nutrient gaps the US population currently faces,” said Dr Mitmesser.

Source: Journal of Food Composition and Analysis
Published online ahead of print, doi: 10.1016/j.jfca.2020.103435
“Ingredient label claim compliance and oxidative quality of EPA/DHA omega-3 retail products in the U.S.”
Authors: G. Bannenberg et al.