Washington D.C.—A new report titled "Health Claims and Doses of Fish Oil Supplements in the US" that was published in JAMA Cardiology suggests that most fish oil supplement labels make claims about health benefits without trial data to support their efficacy. Researchers from University of Texas Southwestern Medical Center, Dallas, evaluated health claims made on the labels of fish oil supplements in the U.S., and examined doses of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in commonly available formulations. The researchers determined that, of 2,819 unique fish oil supplements, 73.9% made at least one health claim. Of those, they said, 19.2% used an FDA-approved qualified health claim; the rest made only structure/function claims, such as “promotes heart health”). Cardiovascular health claims were made by 62%, making this the most common claim area in the study.

The study authors concluded: "Results of this cross-sectional study suggest that the majority of fish oil supplement labels make health claims, usually in the form of structure/function 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+DHA in available supplements, leading to potential variability in safety and efficacy between supplements. Increasing regulation of dietary supplement labeling may be needed to prevent consumer misinformation."

Mainstream media headlines following the release of the study on fish oil claims include:

CRN responds to Report on Health Claims, Doses of Fish Oil Supplements

The Council for Responsible Nutrition (CRN) pointed out that the report criticizes dietary supplement companies’ use of structure/function (S/F) claims—yet this type of claim is permitted for dietary supplements and regulated by FDA. The study authors suggest theseS/F claims are inferior to FDA-reviewed qualified health claims, CRN notes, but the report "appears to ignore" that S/F claims and Qualified Health Claims (QHCs) serve different purposes.

The difference between Structure/Function Claims and Qualified Health Claims

As CRN explained, S/F claims provide general non-disease specific health information to consumers; QHCs are permitted to discuss the relationship between a nutrient and disease risk. S/F claims must be supported by scientific evidence, but the type of evidence required for S/F claims is different from the evidence required to support QHCs that discuss disease risk. A key point: S/F claims may not have the same level of scientific substantiation as QHC, they still require evidence to support their validity and provide consumers with valuable health information.

CRN further noted that claims on existing product labeling reflect researched health benefits associated with these ingredients, and offered an example according to NIH’s Office of Dietary Supplements: “…fish oil and other [long-chain] omega-3 supplements lower triglyceride levels and might reduce the risk of some cardiovascular endpoints, especially among people with low dietary omega-3 intakes.”

In addition, existing labeling carries the appropriate legal disclaimers regarding the limitations of those claims.

Allowed Qualified Health Claims for EPA and DHA : The JAMA Cardiology report references that, in 2004, and in 2019, the FDA allowed QHCs regarding health benefits associated with coronary heart disease and high blood pressure, respectively, for conventional foods and dietary supplements that contain EPA and DHA.

Regarding doses, CRN noted that the report highlights variability in the daily doses of EPA and DHA across different fish oil supplements. "However," CRN explained, "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, and 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."

CRN's final point: The study suggests that increasing regulation of dietary supplement labeling is necessary to prevent consumer misinformation. "Yet, the current regulations permitting structure/function claims provide consumers with the information they need to make informed choices. CRN believes that 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 personal preferences and needs."

“The call for ‘additional regulation of dietary supplement labeling’ is both predictable and unsupported by the research,” said CRN Steve Mister, President and CEO. “Consumers should always discuss their supplement regimens with their healthcare providers, but there is nothing in this study that should persuade 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.”