The U.S. Food and Drug Administration (FDA) has announced that it will not object to claims that "consuming eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) omega-3 fatty acids in food or dietary supplements may reduce the risk of hypertension and coronary heart disease." FDA's research on the claim included reviewing more than 700 studies and 22 public comments submitted on the subject. The approved qualified health claims include that EPA and DHA "may help lower blood pressure" and "reduce the risk for hypertension" but also reference that "FDA has concluded that the evidence is inconsistent and inconclusive."
Tag Archives omega-3
After JAMA Cardiology published a meta-analysis purporting to find “no significant association” between consumption of omega-3 fatty acids and “fatal or nonfatal coronary heart disease or any major vascular events,” industry groups reportedly criticized the conclusion, arguing that other meta-analyses find statistically significant reductions in cardiac death risks. The JAMA meta-analysis examined 10 randomized trials that involved at least 500 participants and a treatment duration of at least one year. “The U.S. Food and Drug Administration would seem to disagree with the conclusion of this study, as it has already approved at least one prescription medication for fish oil that provides benefits for people with cardiovascular issues,” the president of the Natural Products Association was quoted as saying.
A California court held that Bumble Bee Foods, LLC did not act illegally by claiming its tuna was an “excellent source” of omega-3 fatty acids despite a U.S. Food and Drug Administration (FDA) proposal to prohibit the practice. Garrett v. Bumble Bee Foods, LLC, No. 14-264322 (Cal. Sup. Ct. Santa Clara Cty., order entered March 30, 2017). The plaintiffs alleged Bumble Bee began making the omega-3 claim in 2008, one year after FDA published its proposed rule, but the court found that Bumble Bee ended the claim after the rule was finalized in April 2014. “The fact that Bumble Bee engaged in conduct that was proscribed by a ‘proposed’ rule does not make it unlawful or illegal,” the court said. Bumble Bee began using the omega-3 claim after a supplement maker notified FDA in 2005 that it intended to use an omega-3 nutrient content claim on its product labels. Because…
The U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition has published a report finding that 77 percent of surveyed adults use the Nutrition Facts label at least some of the time when buying a food product. Intended to help the agency regulate food and dietary supplement labeling, the 11th edition of the FDA Health and Diet Survey relies on data from 2,480 participants interviewed by telephone or cellphone about their use of nutrition labels and understanding of nutrition claims, purchasing practices and general attitudes toward nutrition and health issues. The results highlight consumer attitudes about salt reduction, with almost all respondents agreeing “the nation eats more salt than we should.” Of these, 50 percent believe individuals are most effective in curbing their own salt consumption, while 25 percent believe the responsibility lies with food manufacturers and retailers, 5 percent with restaurants, and 5 percent with…
A federal magistrate in Florida has denied the plaintiffs’ request in multidistrict litigation challenging marketing claims that DHA Omega-3-fortified milk supports brain health to reconsider an earlier order excluding the testimony of their expert. In re Horizon Organic Milk Plus DHA Omega-3 Mktg. & Sales Practice Litig., MDL No. 2324 (S.D. Fla., order entered June 17, 2014). Details about the magistrate’s ruling excluding the plaintiffs’ expert appear in Issue 522 of this Update. The magistrate rejected the plaintiffs’ arguments for their failure to raise them when the motion to exclude the evidence was before him and determined that an intervening U.S. Food and Drug Administration final nutrient content rule on DHA is not new evidence and does not address the ground on which the magistrate struck the expert—his failure to show how the studies on which he relied could be extrapolated to cover the broad class of product purchasers. Issue…
A recent review has reportedly identified several flaws in the widely cited 1970s study which found that diets rich in omega-3 fatty acids could help fight coronary artery disease (CAD). George J. Fodor et al., “‘Fishing’ for the origins of the ‘Eskimos and heart disease’ story. Facts or wishful thinking? A review,” Canadian Journal of Cardiology, April 2014. In the original study, Danish researchers examined the diet of Greenland Eskimos and linked the high amount of fish oil to the purportedly low incidence of CAD. A team of researchers has reexamined the original study as well as more recent studies on the Eskimo population and found that Eskimos actually suffer CAD at the same rate as Caucasians. The 2014 study identifies several reasons why the original study’s source for CAD rates in the Greenland Eskimos—the annual reports produced by the Chief Medical Officer of Greenland—were likely insufficient, including poor reporting…
A federal magistrate in Florida has decided that the opinion proffered by the plaintiffs’ expert in litigation challenging “brain health” marketing claims for algal-derived DHA Omega-3 fortified milk products is unreliable, thus granting the defendant’s motion to exclude it. In re Horizon Organic Milk Plus DHA Omega-3 Mktg. & Sales Practices Litig., MDL No. 12-2324 (S.D. Fla., order entered April 28, 2014). The ruling affects claims brought by consumers in six states alleging that the defendant violated state laws by falsely claiming that the DHA in its products “Supports Brain Health” and “Supports a Healthy Brain,” and that “competent, scientific evidence shows that these claims are false.” While the court found that most of the defendant’s arguments in support of exclusion went to the weight of the testimony rather than its admissibility, it agreed that the expert failed to show how small studies involving 49 women and 658 children in the…
The U.K. Food Standards Agency (FSA) has requested public comments on a novel foods application submitted by a Swiss company seeking permission to use algal oil in its food products. The company suggests in its application that the oil, extracted from a newly isolated strain of microalgae, is a rich source of omega-3 fatty acid and proposes to use it as a source of the fatty acid in infant formula. The omega-3 fatty acid currently used in infant formula is derived from tuna fish oil or the microalgae, Crypthecodinium cohnii. FSA has also requested public comments on a second application, submitted by Unilever, seeking permission to extend the use of phytosterol esters. Used in the food industry for their cholesterol-lowering properties, phytosterol esters are naturally present at low levels in vegetable oils. This is the third application made by the Unilever for this ingredient. An application for margarines with added…
A federal court in New York has denied in part and granted in part the motion to dismiss filed by the defendants to consumer-fraud litigation claiming that their Smart Balance® Fat-Free milk products with added omega-3s are misbranded because they contain 1 gram of fat from the omega-3 oil blend ingredient. Koenig v. Boulder Brands, Inc., No. 13-1186 (S.D.N.Y., order entered January 31, 2014). The court determined that the state law-based claims were not preempted by federal food labeling laws, whether the claims involve the application of milk regulations as argued by the plaintiffs or combination product requirements as argued by the defendants. Among other things, the court refused to find the defendants’ “combination products” preemption theory tenable because (i) it was based on FDA compliance policy guides, “which constitute advisory opinions”; (ii) the defendants failed to cite any FDA policy or regulations directly addressing the milk products at issue…
A recent study has reportedly revealed that organic milk contains a healthier balance of omega-6 and omega-3 fatty acids compared with milk from cows raised on conventionally managed dairy farms. Benbrook, et al., “Organic Production Enhances Milk Nutritional Quality by Shifting Fatty Acid Composition: A United States–Wide, 18-Month Study,” PLOS One, December 9, 2013. The finding, writes New York Times writer Kenneth Chang, is the “most clear-cut instance of an organic food’s offering a nutritional advantage over its conventional counterpart,” as “studies looking at organic fruits and vegetables have been less conclusive.” According to the researchers, who note that the ratio of omega-6 to omega-3 fatty acids in the U.S. diet have risen to “nutritionally undesirable levels,” the healthier fatty acid profile of organic milk is likely a result of cows foraging on grass. By comparison, cows fed a corn-based diet apparently produce milk that contains higher levels of omega-6 fatty acids, which…
