Abstract

Background: Fish oil supplement use continues to rise. Although prescription eicosapentaenoic acid (EPA) at 4 gm/day did lower cardiovascular risk, the vast majority of randomized trials have shown no benefit to fish oil dietary supplements. Information on health claims and contents of fish oil supplements is limited. Methods: Label information for on-market fish oil supplements was obtained from the National Institute of Health Dietary Supplement Label Database as of February 2022. Label text was analyzed to categorize health claims by type and organ system referenced. The total daily dose of EPA and docosahexaenoic acid (DHA) was evaluated for supplements made by 16 of the leading retailers and manufacturers of fish oil. Results: We evaluated 2,192 fish oil supplement labels, among which 1,647 (75.1%) made at least one health claim. Of these, only 22.0% (n=362) used from the FDA-approved qualified health claim for fish oil. The remaining 78.0% of labels made “structure & function” claims (e.g., “promotes heart health”, “supports brain and vision function”, etc.) across a variety of organ systems (Figure). Heart-health related claims were the most common (n=1,390, 63.4% of labels). Across 16 different brands/manufacturers, 239 product labels were reviewed for dose information. Wide variation in the doses of EPA and DHA was observed (median EPA+DHA dose 600 mg, interquartile range 250-1100 mg). Only 9.2% of supplements reviewed contained at least 2 gm of EPA+DHA, the minimum recommended for triglyceride lowering, and none contained an EPA dose shown to prevent cardiovascular events (≥4 gm/day). Conclusions: Fish oil supplement labels commonly make vaguely worded claims that imply a range of health benefits, almost none of which are supported by randomized trial data. The doses of EPA and DHA available in commonly used fish oil supplements vary substantially, yet none contain levels shown to reduce cardiovascular risk.

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