09/01/2018
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Every month, nearly 19 million Americans take an “omega-3,” or “fish oil” dietary supplement1 that may include a mixture of DHA, EPA, saturated fats and other ingredients.2-7 In fact, omega-3s are the most-used dietary supplement in the U.S.1 Since many users are looking for heart health and other unproven benefits that go beyond simply supplementing their diets, it’s important to understand some myths and facts about these popular products.
Myth: All omega-3 products are created equal.
Fact: The process by which omega-3s are properly produced is extensive and complex. This leads to great variation from product to product. The content of most common fish oil products includes only 30 percent omega-3 and may include other unwanted ingredients including saturated fats and toxins. Also, if they aren’t handled properly, they may become spoiled. These unwanted and spoiled ingredients may lead to potential health risk.5-7 Fish oil dietary supplements are not interchangeable with a prescription medication and are not intended or approved by the FDA to treat any medical condition.8
Myth: Omega-3 dietary supplements improve cardiovascular health.
Fact: There has been no conclusive proof, to date, that getting omega-3s from common fish oil dietary supplements has a positive effect on cardiovascular health in patients at risk.9-10 Dietary supplements, unlike prescription drugs, are not intended to treat any medical condition.
Myth: Fish oil dietary supplements that are available without a prescription at pharmacies and grocery stores are reviewed by the FDA for safety and efficacy.
Fact: Fish oil dietary supplements are regulated as food, not drugs. They are not approved by the FDA to treat patients with medical conditions. Dietary supplements are not required to provide the same stringent clinical proof as drugs, including over-the-counter prescription drugs (dietary supplements are not over-the-counter drugs).11
Myth: Omega-3 products aid in lowering LDL-cholesterol (aka bad cholesterol).
Fact: Most omega-3 dietary supplements contain DHA, which may increase bad cholesterol in some people.3 The effect of this increase on cardiovascular health and safety has not been extensively studied.
Myth: Omega-3 dose levels are not important.
Fact: The content of most common fish oil dietary supplements is only 30 percent omega-3. Taking a few of these capsules provides a very low daily dose of omega-3. Taking this amount has not been conclusively proven to provide any cardiovascular benefit.12
Myth: You can get the same amount of omega-3 in a prescription by taking more fish oil capsules.
Fact: Increasing the number of capsules you take has not been shown to provide the same amount of omega-3 as taking a prescription. Prescription omega-3 products are different from dietary supplements in many ways, including purity, stability, clinical effect, safety and FDA review and oversight. The content of supplement products varies, particularly with respect to EPA (the active ingredient in one patented prescription drug is pure EPA) the molecular structure and clinical effect of which has been shown to be unique from other forms of omega-3. Labeling of drugs is FDA approved. Labeling of dietary supplements, however, is created by the manufacturers of the supplement. Calling them "prescription grade" or "clinical grade" on their labels is not an FDA recognized standard and does not make them the same as a drug. Dietary supplements are not intended to treat serious medical conditions. The effect and safety of taking dietary supplements at high dose levels is unknown.
“I often get questions from my patients about the best ways to improve their heart health, and if a supplement is right for them,” said Dr. Ann Marie Navar, Assistant Professor of Medicine at the Duke Clinical Research Institute. “For people at an increased risk of cardiovascular disease—such as those who are overweight, have diabetes or smoke—it’s important to speak with your doctor about the right course of treatment.”
References
1. National Institutes of Health. National Center for Complementary and Integrative Health. Most Used Natural Products. Available at: https://nccih.nih.gov/research/statistics/NHIS/2012/natural-products/omega3. Accessed August 8, 2018.
2. Bradberry JC, Hilleman DE. Overview of omega-3 fatty acid therapies. P&T. 2013;38(11):681-691.
3. Kleiner AC, Cladis DP, Santerre CR. A comparison of actual versus stated label amounts of EPA and DHA in commercial omega-3 dietary supplements in the United States. J Sci Food Agric. 2015;95(6):1260-1267.
4. Ritter JC, Budge SM, Jovica F. Quality analysis of commercial fish oil preparations. J Sci Food Agric. 2013;93(8):1935-1939.
5. Mason RP, Sherratt SC. Omega-3 fatty acid fish oil dietary supplements contain saturated fats and oxidized lipids that may interfere with their intended biological benefits. Biochem Biophys Res Commun.2017;483(1):425-429.
6. US Food and Drug Administration. Letter responding to health claim petition dated June 23, 2003 (wellness petition): omega-3 fatty acids and reduced risk of coronary heart disease (docket no. 2003Q-0401). http://?wayback.archive-it.org?/7993?/20171114183726/?https://?www.fda.gov/?Food/?Ingredients?Packaging?Labeling?/LabelingNutrition?/ucm072936.htm. Published September 8, 2004. Accessed August 8, 2018.
7. Department of Health and Human Services. 21 CFR Part 184 [docket no. 86G-0289]: substances affirmed as generally recognized as safe: menhaden oil. Federal Register. June 5, 1997;62(108):30751-30757.
8. Hilleman D, Smer A. Prescription omega-3 fatty acid products and dietary supplements are not interchangeable. Manag Care. 2016;25(1):46-52.
9. Aung T, Halsey J, Kromhout D, et al. Associations of Omega-3 Fatty Acid Supplement Use With Cardiovascular Disease RisksMeta-analysis of 10 Trials Involving 77?917 Individuals. JAMA Cardiol.2018;3(3):225–234. doi:10.1001/jamacardio.2017.5205
10. Abdelhamid AS, Brown TJ, Brainard JS, Biswas P, Thorpe GC, Moore HJ, Deane KHO, AlAbdulghafoor FK, Summerbell CD, Worthington HV, Song F, Hooper L. Omega 3 fatty acids for the primary and secondary prevention of cardiovascular disease. Cochrane Database of Systematic Reviews 2018, Issue 7. Art. No.: CD003177. DOI: 10.1002/14651858.CD003177.pub3.
11. FDA 101: Dietary Supplements. Available at: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm050803.htm/ Accessed August 8, 2018.
12. Selecting an omega-3 product for therapeutic use: an opportunity to educate patients. Pharmacy Times website. http://www.pharmacytimes.com/publications/ issue/2016/december2016/r817_december2016. Accessed August 8, 2018.
AMRN-00274 08/2018
Courtesy Brandpoint.
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