Many fish oil supplement labels make unsubstantiated health claims and contain variable daily doses of EPA plus DHA, a recent study suggests.

The authors say “additional regulation” of the claims may be needed to prevent consumer misinformation. Notably, 20% of adults over age 60 take fish oil supplements for heart health despite multiple randomized trials showing no heart benefit.

Overall, about 74% of more than 2800 supplements made at least one health claim on the label, and only 19% used a US Food and Drug Administration (FDA)-reviewed qualified health claim (a statement including qualifying language from the FDA reflecting lack of scientific consensus or uncertainty).

To evaluate the health claims and examine doses of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in commonly available formulations, the investigators analyzed labels obtained from the National Institutes of Health Dietary Supplement Label Database.

In addition to heart-health claims, many fish oil supplements also make claims implying benefit to other organ systems, such as brain/mental health, joint health, and eye health -- despite a lack of randomized clinical trial data supporting benefit. Most use language that does not require FDA review -- words such as "supports" or "promotes," as in "promotes heart health."

The dose analysis of  255 fish oil supplements across 16 major brands found “substantial variability in the daily dose of EPA, DHA, and total EPA+DHA...leading to potential variability in safety and efficacy between supplements," the authors conclude.

To read the article, published in JAMA, click here