Frivolous class action lawsuits plague omega-3 industry

Image by gwendolyn salas / MJH Life Sciences using AI

Throughout my 20+ year career, I’ve seen a lot of regulatory changes, some bad, some good; however, the uptick in the last five plus years of class action suits is disheartening, particularly given the frivolousness of the complaints. I am particularly appalled at the rash of omega-3-related class action lawsuits with a range of allegations, from false and misleading labeling to challenges on claims associated with cardiovascular health. Too many omega-3 companies have been the victims of these lawsuits, the majority of which are filed in what are often considered the class action hotbed states: California and New York.

In 2021 and 2022, six class action complaints were filed against omega-3 companies alleging that the products being sold - omega-3 fatty acid ethyl esters, also known as omega-3 concentrates - were not fish oils and therefore should not be labelled as fish oil. The plaintiffs claimed that they had been deceived and had they known that the products were concentrated omega-3s, they wouldn’t have purchased them. The reality is that most consumers don’t know the difference between EPA/DHA attached to a triglyceride versus EPA/DHA attached to an ethyl ester, but it doesn’t really matter as long as you are taking your supplement on a regular basis. The bottom line is that these consumers sought to purchase an EPA/DHA-rich oil and that’s exactly what they got.

Of the six lawsuits, five have been dismissed, while the sixth against Mimi’s Rock (owner of the Dr. Tobias brand) remains active, at least for now. On August 26, 2024, the defendant’s motion to dismiss was denied in part and granted in part. Among the dismissed claims was the plaintiff’s allegation associated with labelling ethyl esters as fish oil because of a failure to prove that a reasonable consumer was likely to be deceived. While this particular claim was dismissed, it was done so with the ability to be amended and on September 23, 2024, a third amended complaint was filed. The defendant’s response is due by October 21, 2024

After a quiet 2023 with no significant class action complaint filings against omega-3 companies, 2024 started off with a bang. Thus far, four class action lawsuits have been filed against companies selling fish oils, all alleging some variation of using false and misleading cardiovascular claims (i.e. ‘supports heart health’). In addition, at least three demand letters have been sent to omega-3 companies regarding their use of ‘supports heart health.’ Only time will tell if any of these companies will end up having a class action complaint filed against them. As far as the four active cases are concerned, they are in the early stages, so there’s little to report.

From a scientific perspective, these four cases are undeniably without merit. Fish oil supports heart health. While there are many benefits associated with fish oil, there’s no more substantiated benefit than for heart health. There are now over 5,000 clinical (i.e. conducted in humans) trials on the effects of EPA/DHA on a wide range of outcomes, and a large percentage of those are on cardiovascular health. Of course, EPA/DHA isn’t a panacea, but when it comes to heart health, the preponderance of the scientific evidence supports multiple heart health benefits of EPA/DHA.

Four years ago, GOED’s vice president of data science, Aldo Bernasconi, and several colleagues, including a practicing cardiologist, coauthored a peer-reviewed publicationof their rigorous meta-analysis linking an increase in omega-3 intake to positive cardiovascular outcomes. The meta-analysis of 40 studies and 135,267 participants included data from ASCEND (A Study of Cardiovascular Events in Diabetes), VITAL (Vitamin D and Omega-3 Trial) and REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial) and found that higher omega-3 dosages are correlated with statistically significant increases in risk reduction for a variety of cardiovascular outcomes, including: fatal myocardial infarction (MI) (35%), MI (13%), coronary heart disease (CHD) events (10%) and CHD mortality (9%). In addition, there was a 5% non-statistically significant reduction in cardiovascular disease (CVD) events. Based on the results, the authors concluded that “supplementation with EPA and DHA is an effective lifestyle strategy for CVD prevention.”

Less than a year later, the meta-analysis was updated and publishedwith results from STRENGTH (Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia) and OMEMI (Omega-3 Fatty acids in Elderly with Myocardial Infarction), two subsequent, not to mention controversial, trials published after the publication of the aforementioned meta-analysis. With the addition of the two trials, the analysis included 42 studies and 149,359 participants. While the new results change the meta-analysis estimates slightly for CVD events (4% non-statistically significant reduction) and CHD events (9% statistically significant reduction), estimates for all other outcomes remained unchanged as did the overall conclusions – “supplementation with EPA and DHA is an effective lifestyle strategy for CVD prevention.”

The data don’t lie. Fish oil helps support a healthy heart.

References

1. Bernasconi, A.A.; Wiest, M.M.; Lavie, C.J.; Milani, R.V.; Laukkenen, J.A. Effect of Omega-3 Dosage on Cardiovascular Outcomes. Mayo Clinic Proceedings. 2021. 96 (2), 304-313. DOI: 10.1016/j.mayo
2. Bernasconi, A.A.; Wiest, M.M.; Lavie, C.J.; Milani, R.V.; Laukkenen, J.A. Omega-3 Benefits Remain Strong Post-STRENGTH. Mayo Clinic Proceedings. 2021. 96 (5), 1371-1372. DOI: 10.1016/j.mayocp.2021.03.004