CRN rejects researchers’ calls for more robust regulation on fish oil supplement labeling

24 Aug 2023 --- The US-based Council for Responsible Nutrition (CRN) has dismissed a research recommendation published on JAMA Network calling for additional regulation on dietary labeling of fish oil supplements, describing the proposition as “predictable and unsupported by the research.”

Based on the findings of the cross-sectional study of 2,819 fish oil supplements, the researchers concluded that the majority of fish oil supplement labels make health claims in the form of structure/function (S/F) claims that imply a health benefit across a variety of organ systems despite a lack of trial data showing efficacy.

“Significant heterogeneity exists in the daily dose of EPA and DHA (eicosapentaenoic acid and docosahexaenoic acid) in available supplements, leading to potential variability in safety and efficacy between supplements,” the study claims.

As a result, increasing regulation of dietary supplement labeling “may be needed” to prevent consumer misinformation, suggest the authors.

To which the president and CEO of CRN, Steve Mister, responds: “Consumers should always discuss their supplement regimens with their healthcare providers, but there is nothing in this study that should dissuade consumers to change their omega 3 regimens for better health.” 

“Ultimately, this study demonstrates an amazing lack of understanding of the many different reasons why consumers choose to use supplements for better health.”

Root of the discussion
Labeling dietary supplements containing fish oil has come under heavy discussion between the CRN and researchers published in JAMA Network.
According to CRN, the report appears to ignore that S/F claims and Qualified Health Claims (QHCs) serve different purposes – one to provide general non-disease specific health information to consumers and the other to discuss the relationship between a nutrient and disease risk.  

CRN acknowledges that S/F claims must be supported by scientific evidence. However, the required evidence differs from that needed for QHCs that discuss disease risk.

The study’s objective was to evaluate health claims on fish supplement labels in the US and examine doses of EPA and DHA in commonly available formulations.  

The researchers found that 74% of supplements had at least one health claim, usually related to heart health, followed by brain and joint health. The FDA-approved qualified health claim language is infrequently used and the total daily dose of EPA plus DHA was highly variable between supplements.

The CRN states that while S/F claims may not have the same scientific substantiation as qualified health claims, they still require evidence to support their validity and provide consumers with valuable health information. Therefore, claims on existing product labeling reflect researched health benefits associated with these ingredients. 

The study’s researchers maintain that based on their results, additional regulation of the claims made on fish oil supplement labels may be needed to prevent consumer misinformation.

Best course of action
One in five US adults over 60 takes fish oil supplements, mainly for heart health, despite there being no data for cardiovascular benefits for supplement-range doses in several clinical trials, the study finds. In addition, it finds that statements on labels may influence consumer beliefs about the health benefits.

According to CRN, however: “Current regulations permitting structure/function claims provide consumers with the information they need to make informed choices.” 

“Any attempt to limit the diversity of claims and dosages available to consumers would only hinder their ability to choose supplements that align with their preferences and needs.”Fish oil supplements are mainly taken for heart health benefits.

CRN cites the JAMA Cardiology report, which in 2004 and 2019 references that the FDA additionally allowed QHCs regarding health benefits associated with coronary heart disease and high blood pressure, respectively, for conventional foods and dietary supplements containing EPA and DHA.

The report highlights variability in the daily doses of EPA and DHA across different fish oil supplements. 

CRN states: “It’s important to recognize that individual nutritional needs vary, and people consume different amounts of omega 3 fatty acids in their diets. Not all consumers require the same dosage or take fish oil supplements for the same reasons.”

“The presence of various dosage options allows consumers to choose a supplement that aligns with their specific needs, dietary habits, and based upon the advice of their health care practitioner,” notes the CRN.

Earlier this year, the CRN urged the FDA to refrain from carrying out its reorganization plan to eliminate the Office of Dietary Supplement Programs. The organization argued that the move “downgrades attention to the sector” and “sends an unhealthy message to industry and consumers.” 

By Inga de Jong