Intake, Safety and Economic Assessments
Intake Assessments
GOED commissioned Exponent to perform an EU intake assessment of EPA/DHA rich oils compared to vegetable oils.
- Intake Assessment of EPA/DHA Omega-3 Oils using Data from the European Union (2023)
- Intake Assessment of Vegetable Oil using Food Consumption Data from the European Union (2023)
- Summary of the Intake Assessment of EPA/DHA Omega-3 Oils and Vegetable Oil using Food Consumption Data from the European Union (2023)
GOED has commissioned several assessments to document the safety of EPA and DHA omega-3s.
Safety Assessments
Several geographies have published safety/upper limit assessments. Click on the links below for more information.
- Australia: TGA Safety Assessment of Fish Oil and Omega-3 Fatty Acids (2010)
- EU: EFSA Scientific Opinion on Upper Intake Levels for EPA and DHA (2012)
- Germany: BFR Recommendation for Omega-3 Maximum Levels in Fortified Foods (2009)
- Norway: Norwegian Scientific Committee for Food Safety (VKM) Fish Oil Risk Assessment (2011)
Economic Assessments
Documenting the economic benefits of increasing EPA and DHA intake is an important path to growing the category. Below are several economic assessments performed on the category (revised February 28, 2023).
Abdelhalima SM, Murphy JE, Meabed MH, Elberry AA, Gamaleldin MM, Alshaeri HK, Mohammad BA, Hussein RRS. Cost-effectiveness analysis of adding omega-3 or vitamin D supplementation to standard therapy in treating painful crises of pediatric sickle cell disease patients. Eur Rev Med Pharmacol Sci. 2022 Oct;26(20):7506-7513. doi: 10.26355/eurrev_202210_30021. PMID: 36314321. OPEN ACCESS
Ademi Z, Ofori-Asenso R, Zomer E, Owen A, Liew D. The cost-effectiveness of icosapent ethyl in combination with statin therapy compared with statin alone for cardiovascular risk reduction. Eur J Prev Cardiol. 2021 Jul 23;28(8):897-904. doi: 10.1177/2047487319896648. Epub 2020 Jan 10. PMID: 34298556. OPEN ACCESS
Ahmed S, Makrides M, Sim N, McPhee A, Quinlivan J, Gibson R, Umberger W. Analysis of hospital cost outcome of DHA-rich fish-oil supplementation in pregnancy: Evidence from a randomized controlled trial. Prostaglandins Leukot Essent Fatty Acids. 2015 Dec;102-103:5-11. doi: 10.1016/j.plefa.2015.08.002. Epub 2015 Sep 3. PMID: 26432510.
Cheema N, Frangou S, McCrone P. Cost-effectiveness of ethyl-eicosapentaenoic acid in the treatment of bipolar disorder. Ther Adv Psychopharmacol. 2013 Apr;3(2):73-81. doi: 10.1177/2045125312464105. PMID: 24167678; PMCID: PMC3805392. OPEN ACCESS
Cowie MR, Cure S, Bianic F, McGuire A, Goodall G, Tavazzi L. Cost- effectiveness of highly purified omega-3 polyunsaturated fatty acid ethyl esters in the treatment of chronic heart failure: results of Markov modelling in a UK setting. Eur J Heart Fail. 2011 Jun;13(6):681-9. doi: 10.1093/eurjhf/hfr023. Epub 2011 Apr 6. PMID: 21474462. OPEN ACCESS
Franzosi MG, Brunetti M, Marchioli R, Marfisi RM, Tognoni G, Valagussa F; GISSI-Prevenzione Investigators. Cost-effectiveness analysis of n-3 polyunsaturated fatty acids (PUFA) after myocardial infarction: results from Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto (GISSI)-Prevenzione Trial. Pharmacoeconomics. 2001;19(4):411-20. doi: 10.2165/00019053-200119040-00008. PMID: 11383757.
Frolov MY, Salasyuk AS, Rogov VA. Analysis of the impact on the health care budget and consumers of the use of the preparation of omega-3 acid ethyl esters90 in the treatment of patients with atherogenic dyslipidemia. Kardiologiia. 2021 Oct 30;61(10):36-45. Russian, English. doi: 10.18087/cardio.2021.10.n1722. PMID: 34763637.
Frost & Sullivan. Health Care Cost Savings from the Targeted Use of Dietary Supplements. 2022.
Frost & Sullivan. Healthcare Cost Savings of Omega 3 Food Supplements in the European Union: Economic Implication of Managing CVD through Targeted Enhanced Nutrition. 2016.
Frost & Sullivan Report: Targeted Use of Complementary Medicines: Potential Health Outcomes & Cost Savings in Australia. 2014.
Hwang JY, Kim WS, Jeong S, Kwon O. Evidence-based estimation of health care cost savings from the use of omega-3 supplementation among the elderly in Korea. Nutr Res Pract. 2015 Aug;9(4):400-3. doi: 10.4162/nrp.2015.9.4.400. Epub 2015 Jul 27. PMID: 26244079; PMCID: PMC4523484. OPEN ACCESS
Kodera S, Morita H, Kiyosue A, Ando J, Komuro I. Cost-Effectiveness of Statin Plus Eicosapentaenoic Acid Combination Therapy for Cardiovascular Disease Prevention in Japanese Patients With Hypercholesterolemia - An Analysis Based on the Japan Eicosapentaenoic Acid Lipid Intervention Study (JELIS). Circ J. 2018 Mar 23;82(4):1076-1082. doi: 10.1253/circj.CJ-17-0995. Epub 2018 Jan 23. PMID: 29367520. OPEN ACCESS
Kyeremanteng K, Shen J, Thavorn K, Fernando SM, Herritt B, Chaudhuri D, Tanuseputro P. Cost analysis of Omega-3 supplementation in critically ill patients with sepsis. Clin Nutr ESPEN. 2018 Jun;25:63-67. doi: 10.1016/j.clnesp.2018.04.003. Epub 2018 Apr 19. PMID: 29779820.
Lamotte M, Annemans L, Kawalec P, Zoellner Y. A multi-country health economic evaluation of highly concentrated N-3 polyunsaturated fatty acids in secondary prevention after myocardial infarction. Pharmacoeconomics. 2006;24(8):783-95. doi: 10.2165/00019053-200624080-00005. PMID: 16898848.
Marquina C, Zomer E, Vargas-Torres S, Zoungas S, Ofori-Asenso R, Liew D, Ademi Z. Novel Treatment Strategies for Secondary Prevention of Cardiovascular Disease: A Systematic Review of Cost-Effectiveness. Pharmacoeconomics. 2020 Oct;38(10):1095-1113. doi: 10.1007/s40273-020-00936-0. PMID: 32583316.
Michaeli DT, Michaeli JC, Boch T, Michaeli T. Cost-Effectiveness of Icosapent Ethyl, Evolocumab, Alirocumab, Ezetimibe, or Fenofibrate in Combination with Statins Compared to Statin Monotherapy. Clin Drug Investig. 2022 Aug;42(8):643-656. doi: 10.1007/s40261-022-01173-3. Epub 2022 Jul 11. PMID: 35819632; PMCID: PMC9338124.
Pradelli L, Eandi M, Povero M, Mayer K, Muscaritoli M, Heller AR, Fries- Schaffner E. Cost-effectiveness of omega-3 fatty acid supplements in parenteral nutrition therapy in hospitals: a discrete event simulation model. Clin Nutr. 2014 Oct;33(5):785-92. doi: 10.1016/j.clnu.2013.11.016. Epub 2013 Dec 4. PMID: 24345520. OPEN ACCESS
Pradelli L, Klek S, Mayer K, Omar Alsaleh AJ, Rosenthal MD, Heller AR, Muscaritoli M. Cost-Effectiveness of Parenteral Nutrition Containing ω-3 Fatty Acids in Hospitalized Adult Patients From 5 European Countries and the US. JPEN J Parenter Enteral Nutr. 2021 Jul;45(5):999-1008. doi: 10.1002/jpen.1972. Epub 2020 Aug 18. PMID: 32713007; PMCID: PMC8451886. OPEN ACCESS
Pradelli L, Klek S, Mayer K, Omar Alsaleh AJ, Rosenthal MD, Heller AR, Muscaritoli M. Omega-3 fatty acid-containing parenteral nutrition in ICU patients: systematic review with meta-analysis and cost-effectiveness analysis. Crit Care. 2020 Nov 3;24(1):634. doi: 10.1186/s13054-020-03356-w. PMID: 33143750; PMCID: PMC7607851.
Quilici S, Martin M, McGuire A, Zoellner Y. A cost-effectiveness analysis of n-3 PUFA (Omacor) treatment in post-MI patients. Int J Clin Pract. 2006 Aug;60(8):922-32. doi: 10.1111/j.1742-1241.2006.01009.x. Erratum in: Int J Clin Pract. 2007 Apr;61(4):711-2. PMID: 16893435.
Samuel S, Peskin B, Arondekar B, Alperin P, Johnson S, Blumenfeld I, Stone G, Jacobson TA. Estimating health and economic benefits from using prescription omega-3 fatty acids in patients with severe hypertriglyceridemia. Am J Cardiol. 2011 Sep 1;108(5):691-7. doi: 10.1016/j.amjcard.2011.04.019. PMID: 21840433.
Shireman TI, Kerling EH, Gajewski BJ, Colombo J, Carlson SE. Docosahexaenoic acid supplementation (DHA) and the return on investment for pregnancy outcomes. Prostaglandins Leukot Essent Fatty Acids. 2016 Aug;111:8-10. doi: 10.1016/j.plefa.2016.05.008. Epub 2016 May 13. PMID: 27499448; PMCID: PMC4978141. OPEN ACCESS
Weintraub WS, Bhatt DL, Zhang Z, Dolman S, Boden WE, Bress AP, King JB, Bellows BK, Tajeu GS, Derington CG, Johnson J, Andrade K, Steg PG, Miller M, Brinton EA, Jacobson TA, Tardif JC, Ballantyne CM, Kolm P. Cost-effectiveness of Icosapent Ethyl for High-risk Patients With Hypertriglyceridemia Despite Statin Treatment. JAMA Netw Open. 2022 Feb 1;5(2):e2148172. doi: 10.1001/jamanetworkopen.2021.48172. PMID: 35157055; PMCID: PMC8844997. OPEN ACCESS
Zhang D, Cogswell ME, Wang G, Bowman BA. Evidence of Dietary Improvement and Preventable Costs of Cardiovascular Disease. Am J Cardiol. 2017 Nov 1;120(9):1681-1688. doi: 10.1016/j.amjcard.2017.07.068. Epub 2017 Aug 1. PMID: 28847593.