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EFA Update

Essential Fatty Acids Essential Fatty Acids
Phase 2

Consumers may be asking questions about EFA drugs vs. supplements, and a published article excoriating EFA research—here’s how to respond.

One of the largest and most widely recognized dietary supplement categories, essential fatty acids are sought out and purchased by millions of men and women, many of whom were told by their physicians to either “eat more fish” or take EFA supplements. Additionally, pregnant women are likewise encouraged by their ob/gyns to regularly consume DHA and EPA.

The vigorous category, however, has suffered a few hits of late. “From a sales perspective the omega-3 market has declined over the last few years,” observed Ellen Schutt, communications director for the Global Organization for EPA and DHA Omega-3 (GOED), in Utah. One of the reasons, she said, may be a maturing market; however, GOED believes the media atmosphere has had more significance—not just negative news articles about omega-3 EFAs, but “equally important, the lack of positive news also affecting sales. Our consumer research shows that there is a ‘routine’ component to omega-3 usage and without this reminder in the shape of a positive news story, many consumers forget to take their supplements or buy a new bottle,” she commented.

They may forget, but reminders abound. Cheryl Myers, chief of education and scientific affairs at Wisconsin-based EuroPharma said, “It’s definitely telling that fish oils have become such a commodity item that you find them everywhere. I’ve seen them for sale at gas station convenience stores, so they are about as mainstream as you can get.”

Myers sees EFAs continuing to garner more mainstream attention via health media and physician recommendations, and are therefore widely recognized. “But delivery systems, sources, and dosages still seem to be contested territory in the industry,” she said. However, Andrew Aussie, executive vice president and chief operating officer, at Coromega in California, is seeing sales begin to grow again for EFA supplements, based on the rising number of credible studies showing and validating the top health benefits. As a result, new combinations, concentrations and delivery methods “will continue to flourish,” he predicted, providing as examples “easy-to-use” EFA supplements such as emulsions, liquid oils, omega-3 plus vitamin blends, and tastier alternatives to provide convenience, portability and the ability to easily incorporate into smoothies and other recipes.

Coromega has created Omega3&D Squeeze, combining 650 mg omega-3 with 1,000 IU vitamin D in a squeeze pack; and its newest EFA supplement, Be Bright, described as a tasty plant-based blend of chia, coconut, avocado, hemp and black cumin superfood oils that additionally provides vitamins and antioxidants.

“One of the most interesting developments in the past few years is the increased knowledge and expectations of customers—they’re less interested in a generic fish oil product, and have higher expectations that their specific needs will be met when they shop for EFA supplements,” said Monique Wellise, education manager at California-based Nordic Naturals. “These expectations drive the personalized nutrition movement among supplement manufacturers. Nordic Naturals has responded with new delivery forms to suit the needs of different people, especially in terms of children’s omega-3 nutrition.”

One example Wellise pointed to that has been embraced by children is strawberry-flavored Nordic Omega-3 Gummy Worms and the newer Omega-3 Fishies, offering 300 mg omega-3s in each chewy fishy. Also recently launched, Nordic Naturals’ Omega Boost Junior has the consistency of yogurt and the taste of fruit punch.

“This product is perfect for kids who have trouble swallowing soft gels, and who don’t like the consistency of liquid fish oil. These efforts to meet customers’ omega-3 needs, and their preferences, will soon become standard for supplement manufacturers,” Wellise remarked. Following suit, retailers will be expected to understand and explain customers’ options at the shelf, she added.

These new tasty EFA products reflect the observation of Jolie Root, senior nutritionist and educator, for Carlson Laboratories in Illinois, who noted that there have been many entries into the market. She pointed to frequent television advertising of Mega Red, a krill product that introduced a new category for phospholipid-bound EPA and DHA at lower potencies but higher prices compared to fish oils.

“Fish oil concentration processes have enabled higher potency EPA/DHA and EPA-only SKUs to compete with prescription fish oils at a much more affordable price per dose,” she explained. “EPA/DHA combined with other nutrients (such as phosphatidyl serine or CoEnzyme Q-10) have expanded the EFA category. And multivitamins that feature EPA and DHA have been introduced and are selling quite steadily.”

And although there are more EFA products that have entered the arena, Herb Joiner-Bey, ND, medical science consultant at Washington-based Barlean’s pointed out that that there are only a scant few original sources. “There are only several fish oil extractors on earth with the fishing boats, fishing licensure, extraction facilities, purification capacity, laboratory testing and purity certification programs established to offer high quality fish oil safe enough for human consumption,” he said. “All responsible manufacturers of consumer products are buying their fish oil wholesale from these few extractors. The only difference among finished products is the handling, processing, storage, and sale of fish oil to ensure its freshness and prevent rancidity.”

The Lovaza Effect

When the pharmaceutical EFA product Lovaza came on the market, it drew much attention—and also some confusion among consumers, who wondered what the difference was between an expensive EPA-DHA drug and what’s widely available on supplement shelves. Bey explained, “The advent of Lovaza as an FDA (U.S. Food and Drug Administration)-approved pharmaceutical fish oil drew the attention of that industry and the public to the value of omega-3 supplements. Unfortunately, some consumers, health care providers, and insurance companies may not yet realize that equal quality fish oil has been readily available in health food stores nationwide at a fraction of the cost of Lovaza. Drug manufacturers have neither fishing boats roaming the seven seas in search of clean fish sources nor facilities for the extraction and purification of fish oil. Pharmaceutical companies merely do what nutraceutical companies do—they purchase wholesale fish oil from reputable extractors. Drug companies can charge the highest prices the market will bear due to FDA backing, a fancy drug company label, and willingness of health insurance companies to cover the costs at pharmaceutical prices.”

Schutt takes a different view, asserting that Lovaza and the newer generic pharmaceutical introductions help bolster the credibility of the supplement market and are complementary to existing products.

Wellise is somewhere in between, seeing “mixed effects.” On the good side, she said, the fact that cardiologists are prescribing Lovaza lends strong credibility to omega-3 supplementation to achieve sound health status. But conversely, “Lovaza is an ethyl ester omega-3 product, which is not as effective as triglyceride-form omega-3 supplements. Studies have consistently shown that better absorption of omega-3s is achieved when taking triglyceride-form fish oil. This is likely due to the fact that the triglyceride form is the form of 97 percent of the fats entering the body, and it is the same molecular form in which omega-3s naturally occur in fish.”

These are substantial talking points you may use for customers who likely continue to ask about the differences. But there’s been a more nefarious spanner in the omega-3 works.

NYT Smackdown

On March 30, the New York Times (NYT) printed an article with the bold headline, “Fish Oil Claims Not Supported by Research.” The article’s author, Anahad O’Connor, told readers worldwide, essentially, that the vast majority of the sizable clinical studies examining health benefits of EPA and DHA “have not translated into notable benefits.”

GOED, said Schutt, immediately replied: “The article leads with the headline that claims made on fish oils are not supported by research, but fails to differentiate between pharmaceutical and dietary supplement claims. The newspaper emphasized that the vast majority of evidence does not show that fish oils lower your risk of heart attacks or strokes, but these claims are not allowed on either dietary supplements or pharmaceuticals, which is a key flaw in the regulatory logic of the article.

“The only approved pharmaceutical claim in the U.S. today is for reduction of very high triglycerides, of which there is ample evidence,” Schutt continued. “In the dietary supplement space, there are of course the qualified health claim and the more frequently used structure-function claims. There is ample evidence that EPA and DHA play a beneficial role in the health of the heart, aside from heart attack or stroke risk.”

About the article and its inflammatory headline, Bey exclaimed, “Such a statement is absolutely preposterous.” Further, he asserts that this “specious assault on EFAs—at a time when conventional authorities are encouraging Americans to take more statin drugs for heart health—is reminiscent of the unwarranted FDA attack on L-tryptophan in the 1990s to shut down competition relative to the new anti-depressant drugs emerging at that time—Prozac, Paxil and Zoloft.”

Wellise noted how difficult it is to think of another nutrient/nutraceutical that has been the subject of as much research that omega-3 EFAs have; it is one of the most widely researched natural ingredients with more than 27,000 published studies, 8,000 of which are clinical trials. So therefore, she said, a key conclusion of the NYT article (that there is not sufficient evidence to support omega-3s’ cardio-protective properties) “just isn’t true. Hundreds of these studies have found specific positive effects of EPA and DHA in cardiovascular health. That’s one reason why many physicians around the world, and the American Heart Association, recommend adequate omega-3 nutrition. In some cases, this means upwards of 4,000 mg per day,” she commented.

GOED reviewed published data on EPA and DHA between 2005 and 2012 (the time period mentioned in the article), and found that 77 percent of 136 randomized controlled clinicals of the EFAs on cardiovascular health had positive outcomes. “We think it’s unfortunate the press has focused on a limited number of challenged studies at the exclusion of so many others,” remarked Douglas M. Bibus, MS, PhD, scientific advisory board of Coromega. “Why the press decided to emphasize no benefit of omega-3 for cardiovascular health in the face of overwhelming data is a real question.”

Others have questions about the NYT article, too. Myers said she noticed that there was a lack of discussion in the article about what types of EFA oils were used in the studies cited, dosage levels, whether or not any rancidity testing had been performed on them, and whether there were other mitigating issues, including adherence and diet.

And, with the fact that the article stated in theory that EPA and DHA should improve cardiovascular health, combined with the fact that the FDA had approved several prescription fish oils for the treatment of high triglycerides, Root responded to the question, why would a study or several studies fail to find benefit? “One reason, as explained by Dr. Bill Harris, might be a sharp increase in background intake of fish or fish oil due to heightened consumer awareness and availability of fish oil supplements off-study. Placebo-treated patients can easily take fish oil pills off-study ‘just in case.’ These behaviors would raise tissue levels of omega-3 fatty acids to the point where an additional 1 gram of EPA and DHA could have nothing to improve upon. In recent studies treatment groups and placebo groups might have had very similar omega-3 levels,” she surmised.

Again, these are some more keenly accurate talking points for customers who may be quite sure to ask about the NYT report. Armed with a tremendous amount of research plus industry support from your chosen brand marketers and the raw materials suppliers of EFAs—who are all pledged to support their retailers—retailers can confidently assuage any misinformation, confusion and even some fears about ineffectiveness, and continue to ensure all customers purchase and use the most appropriate EFA product for them and their families. VR

For More Information:
Barleans, (800) 445-3529
Coromega, (877) 275-3725
Europharma, (866) 598-5487
GOED, (801) 746-1413
Nordic Naturals, (800) 662-2544

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