Fish oil safety violations continue to cast a wide net that places consumers of omega-3 products for arthritis and other issues in a kettle of fish. Alarming percentages of failed quality and safety inspections by dietary supplement makers, including producers of adulterated fish oil, waves a red flag. Discoveries of PCBs in some fish oil products on market shelves threatens consumer trust....
In a seven-year period, nearly two-thirds of all supplement companies inspected failed to pass the most elementary of the industry’s safety guidelines. From 2010 through 2016, government inspectors found an average of 65.3% of dietary supplement makers in non-compliance of industry safe-manufacturing rules.1,2
Industry watchdogs have long been critical of the looseness of the current Good Manufacturing Practices (cGMP) safety regulations enforced by the Food & Drug Administration (FDA). Limited resources restrict the agency to inspect only a fraction of 13,000 registered supplement facilities annually. In spite of lax statutes, most manufacturers fall short of safety and purity aspects during facilities inspections. During fiscal year 2016, FDA conducted 583 inspections that yielded 362 non-compliance Form 483 letters, a failure rate of 62%.1,3 .Failed inspections frequently address supplement problems across all brands in a manufacturer’s product line. Many omega-3 supplement makers also market other health related compounds
Non-compliance companies are required to reply with corrective action plans for the observed infractions for each of the products named. When these offenses are reviewed by higher FDA officials, some are
evaluated as serious violations. In such cases, the agency issues Warning Letters, formal notifications that call for prompt reform by the maker. See the section below titled Fish oil safety violations cited in FDA Warning Letters for actual examples. In 2016, FDA issued 61 Warning Letters.1,3 Some serious enforcement situations result in supplement recalls.3
After a dietary supplement, such as one that contains omega-3, for example, enters the stream of commerce, the FDA may recall the product to ensure fish oil safety if it is “adulterated” or “misbranded.” A product is considered adulterated if it contains unlisted ingredients or is not prepared or packaged in accordance with manufacturing rules. It is misbranded if its labeling is false or misleading.
The government has enforced more than 600 supplement recalls just for supplements “spiked” with hidden pharmaceuticals since the full implementation of the cGMP in 2010.4
Dietary supplements, which are sold without prescriptions and include fish oil omega-3 products, have mushroomed into a $37 billion industry with as many as half of American adults using them. But critics argue than many supplements are ineffective or dangerous and that federal oversight of the industry is too lax. Supplements cause more than 20,000 emergency room visits annually.4
Consumers in the United States spend about $1.2 billion annually for fish oil pills and related supplements, according to the Washington Post.in 2015. Many studies point towards the benefits of omega-3 fatty acids for heart health, as well as for rheumatoid arthritis and health benefits for several other issues. There are 200 million dietary supplement consumers in the U.S., according to Stephen Ostroff, M.D., Acting Commissioner of the FDA in 2016. 5,6,7,8Dietary supplements are classified as food, not drugs. Based on the nomenclature in which FDA publishes yearly Inspectional Observation Summaries it’s difficult to determine how many Form 483 citations are dietary supplements (not food-related). By the same token, recalls that are adulterated with hidden pharmaceuticals are not listed under the food category, but under the drug category, as an unapproved drug, sometimes difficult to identify it was originally manufactured as a dietary supplement. One cannot in good faith argue that omega-3 manufacturers fail fish oil safety regulations at approximately the same percentage as supplement makers of other products. But research turns up many examples where omega-3 fish oil safety may have been compromised for unwary consumers attempting to relieve symptoms of arthritis and other health issues.
The following FDA warning letter examples characterize serious fish oil safety compromises for quality and manufacturing violations, nearly all for adulterated omega-3 supplements:
A still unsettled 2010 lawsuit filed by environmentalists in California Superior Court in San Francisco claims popular brands of fish oil dietary supplements contain unsafe and illegal levels of the carcinogenic chemicals known as polychlorinated biphenyls, or PCBs (banned by Congress in 1979). 20
The plaintiff, Mateel Environmental Justice Foundation, targeted world-leading Omega Protein, a Houston-based corporation, and the companies they produce and label fish oil for, including CVS, GNC, Rite Aid, Solgar, Twinlab, Now Health and Pharmavite. The suit charged the defendants for marketing fish oil dietary supplements containing PCB levels that exceed California’s Proposition 65’s limit for human consumption of the contaminants, and illegally failing to disclose this to consumers on product labels.
The Mateel group alleged it only tested 10 omega-3 supplements manufactured by Omega Protein and found PCBs in all of them, ranging from 12 nanograms a day to more than 852 nanograms a day, based on the daily recommended label dosage.
California is the only state that requires labeling to warn consumers a product may contain trace amounts of PCBs, which have been tied to cancer and birth defects.
Consumer Reports conducted its own study of fish oil brands (but not all brands) commonly found on the shelves of retail outlets in America, published in its January 2012 issue.20A
Entitled Fish Oil Pills versus Claims, their testing revealed discrepancies in quality of 33% of those tested.
According to the article, “Americans are buying more fish-oil supplements than ever, but in industry-standard tests of 15 top-selling brands conducted by an outside lab for Consumer Reports, five fell a bit short.”
None of the fish oil supplements contained contaminants, such as lead, mercury, or PCBs that exceeded levels set by USP or the European Union. However, four of the fish oil supplements contained total PCBs in levels that would require warning labels under California’s Proposition 65, a consumer right-to-know law.20B
A 2013 journal study of fish oil safety, Children’s daily exposure to PCBs from dietary supplements containing fish oils, detected PCBs in all 13 over-the-counter children’s dietary supplements containing fish oil they assessed.21
The study was published in the journal Food Additives and Contaminants. Its introduction comments that in children, omega-3 polyunsaturated fatty acids (PUFAs) may elicit a suite of health benefits, including enhancement of cognitive development, and these dietary supplements had increased in popularity. Because the largest source of omega-3 PUFA;s is fish oil, which may contain significant levels of contaminants such as PCBS, the study objectives were to evaluate congener-specific PCB concentrations in children’s omega-3 fatty acids products from daily exposure.21
Every supplement analyzed contained PCBs. The researchers found when following serving size suggestions, mean daily exposure values ranged from 2.5 to 50.3 nanograms PCBs per day, significantly lower than those previously reported for adult supplements which generally had variability in the amount of fish oil (and PUFA content). In a serving size.21
In its conclusion, study authors said factors such as fish oil purification methods (e.g., molecular distillation) and the trophic level of the fish species used to make the fish oil cannot be used as indicators of PCB levels within children’s supplements, which may decrease or increase daily PCB exposure compared with the ingestion of fresh fish. However, eating fish high in omega-3 PUFAs and low in PCBs may reduce PCB exposure compared with daily supplementation with fish oils for some products studied. 21
In a related but separate article, PCBs in Children’s Fish Oil Supplements, by Michael Greger, M.D. FACLM, published October 20, 2014 in NutritionFacts.org, Dr. Greger commented on the above study: “….they found no significant difference in PCB levels between the supplements labeled as molecularly distilled or how high up the food chain the fish were.” He added, “it’s bad enough when supplement manufacturers exploit adults when they’re sick and vulnerable with pills that are often useless or worse; but taking advantage of our parental drive to do what’s best for our children with contaminated products that may make them sick, makes me sick.” 22
(Editor’s note: Which, when it comes down to fish oil safety, leaves supplement consumers for arthritis symptoms backed into the proverbial ‘buyer beware’ corner).
An article Are your omega-3 supplements bogus? in Prevention Magazine January 27, 2014 by Markham Heid commented on a report from LabDoor, a private company that tests consumer health products, that showed many fish oil supplements skimp when it comes to their omega-3 content—meaning you’re not getting what you pay for.23
Five of the 30 fish oil products tested fell 10% or more short of their advertised quantity of docosahexaenoic acid (DHA)—a type of omega-3 fatty acid that several studies have linked to improved heart and brain health, among other benefits. Whether too high or too low, the average supplement label was off by 24% when it came to both DHA and eicosapentaenoic acid (EPA) content, according to the report.
The article commented that another private laboratory, ConsumerLab.com, has conducted multiple tests of omega-3 supplements since 2001, with similar results. Eleven of 35 supplements they examined in 2012 did not contain their labeled quantities of omega-3. They also found that two products exceeded international limits for PCB safety.23
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Fish Oil Safety Disclaimer: Health statements on this fish oil safety page have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.
1 Recalls and Warnings, Article: FDA Finds Problems at 62% of Supplement Manufacturing Sites in U.S. and Abroad (for 2016) Non-compliance percentages 2013-2016, published ConsumerLab.com (requires log in), March 17, 2017. https://www.consumerlab.com/recall_detail.asp?recallid=14053
2 Henkel, Janine; Article: Supplements 101 for Law Enforcement (non-compliance percentages 2010, 2011, 2012, published Lawofficer.com, August 29, 2017 http://lawofficer.com/exclusive/supplements-101-for-law-enforcement/
3 Lehmann, John, Article: FDA Warning Letters and Form 483—what’s the difference?, published imarc.com, April 2, 2013 http://www.imarcresearch.com/blog/bid/280993/FDA-Warning-Letters-and-Form-483-What-s-the-Difference
4 Weeks, Jennifer, Article: Dietary Supplements: Is regulation of industry too lax? (20,000 ER visits, 600 recalls), Published by CQ Researcher, October 30, 2015 Vol 25 Issue 38 http://library.cqpress.com/cqresearcher/document.php?id=cqresrre2015103000 Accessed 11-4-
5 Whoriskey, Peter, Article: Fish oil pills: A $1.2 billion industry built, so far, on empty promises, published Business Section, Washington Post, July 8, 2015. https://www.washingtonpost.com/business/economy/claims-that-fish-oil-boosts-health-linger-despite-science-saying-the-opposite/2015/07/08/db7567d2-1848-11e5-bd7f-4611a60dd8e5_story.html?noredirect=on&utm_term=.d21285cd35f7
6 Bradley, John, Content Director & Editor in Chief, Nutrition Business Journal; Article: NBJ: ‘The US supplement industry is $37 billion, not $12 billion’, reprinted with permission by Nutra-Ingredients-USA.com, June 1, 2015 HTTPS://WWW.NUTRAINGREDIENTS-USA.COM/ARTICLE/2015/06/01/NBJ-THE-US-SUPPLEMENT-INDUSTRY-IS-37-BILLION-NOT-12-BILLION
7 Ostroff, S. M.D.,Blog Post, Food & Drug Administration (FDA), Making Progress in Protecting Consumers from Unsafe Supplements (200 million supplement users), published FDA Voice, January 20, 2016 https://blogs.fda.gov/fdavoice/index.php/2016/01/making-progress-in-protecting-consumers-from-unsafe-supplements/
8 Webpage, Food & Drug Administration (FDA), Dietary Supplements 101, accessed July 11, 2018 https://www.fda.gov/forconsumers/consumerupdates/ucm050803.htm
9A Warning Letter, Food & Drug Administration (FDA), Young Health Products LLC, January 14, 2018 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm594208.htm
10 Warning Letter, Food & Drug Administration (FDA), Maine Natural Health, Inc. December 19, 2017https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm590003.htm
11 Warning Letter, Food & Drug Administration (FDA), BioTE Medical, LLC, May 22, 2017https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm561444.htm
12 Warning Letter, Food & Drug Administration (FDA), Positive Power Nutrition, September 15, 2016 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521441.htm
13 Warning Letter, Food & Drug Administration (FDA), Viva Nutraceuticals (J&E International Corporation), July 22, 2016 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515082.htm
14 Warning Letter, Food & Drug Administration (FDA), Rocky Fork Formulas, Inc., May 13, 2016. https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm501556.htm
15 Warning Letter, Food & Drug Administration (FDA), MPH Nutrition, LLC, October 1, 2015 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm465731.htm
16 Warning Letter, Food & Drug Administration (FDA), Dr Dennis Black, LLC, May 4, 2015 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm447204.htm
17 Warning Letter, Food & Drug Administration (FDA), Y.S. Health Corp, August 29, 2013 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm367832.htm
18 Warning Letter, Food & Drug Administration (FDA), Sunset Natural Products Inc, March 19, 2013 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm349017.htm
19 Warning Letter, Food & Drug Administration (FDA), Capco Custom Packaging Inc, February 20, 2013 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm340946.htm
20 Millstone, Ken, Article: Lawsuit: Disclose PCB Levels in Fish Oil, posted CBS News, March 2, 2010 https://www.cbsnews.com/news/lawsuit-disclose-pcb-levels-in-fish-oil/
0A Article, Fish-oil pills vs. claims, published Consumer Reports Magazine, January 2012. https://www.consumerreports.org/cro/magazine/2012/01/fish-oil-pills-vs-claims/index.htm
20B Warner, Jennifer, Article: Some Fish Oil Supplements Fishy on Quality, published from WebMD Archives, December 7, 2011 https://www.webmd.com/diet/news/20111206/some-fish-oil-supplements-fishy-on-quality#1
21 Jeffrey, T.F; Ashley, J.S., et al. Study: Children’s daily exposure to PCB’s from dietary supplements containing fish oils. Jnl Food Additives & Contaminants, published online January 2, 2013. https://doi.org/10.1080/19440049.2012.753161; http://www.tandfonline.com/doi/abs/10.1080/19440049.2012.753161?journalCode=tfac20
22 Greger, Michael, M.D.FACLM, Article/Video PCB’s in Children’s Fish Oil Supplements, published NutritionFacts.org, October 20th, 2014 Volume 21 https://nutritionfacts.org/video/pcbs-in-childrens-fish-oil-supplements/
23 Heid, Markham, Article: Are Your Omega-3 Supplements Bogus? published Prevention Magazine, January 27, 2014 https://www.prevention.com/health/healthy-living/fish-oil-supplements-wrongly-labeled
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