The Omega-3 Index test was invented by Dr William Harris, PhD, of the Sanford School of Medicine at the University of South Dakota, along with a collaborator. Dr Harris is also the president of OmegaQuant, the company he founded to manufacture and market the test kits. The minimally invasive test, which has been on the market for several years, easily measures omega-3 levels in the blood.
Bigger players wanted certainty
Dr Harris said up to now the regulatory status of the test was unclear. It had no official approval, yet the low-risk nature of the test made it likely that regulators were not overly concerned about its use. Nevertheless, as market experience with the test grew, and Dr. Harris sought to widen distribution of the test, he started to run up against the risk-averse nature of bigger players.
“We had beed doing this a little bit under the radar. Then we started having discussions with some major retail chains, like Walmart, CVS and Walgreens. They were all concerned about the regulatory status of the test, as you can well imagine. So when they’d ask, I’d say, well . . . it’s kind of a gray zone. They don’t like gray. I don’t either,” Dr Harris said.
Dr Harris said a decision was made to submit a full dossier to FDA to get the test approved as a medical device, joining the thousands of such devices on the market. But then came a surprise: FDA came back to suggest an alternative.
“We submitted a full on application for an over the counter medical device, and they got back to us fairly quickly on the phone to say that there would be a lot of obstacles getting it approved as a traditional medical device. But they suggested submitting the application as a ‘wellness device,’ something in the same category as bathrooms scales, thermometers and exercise DVDs,” Dr Harris said.
“The test does involve pricking your finger (to get a spot of blood to dab on a card). But they said, people prick their fingers all the time, so they weren’t very concerned with that,” he said.
“FDA was concerned about the quality of the assay. But at the end of the day they are really concerned with what you are telling people, when you don’t have a doctor involved,” Dr Harris said.
Several years ago DNA testing firm 23andMe got into a high profile tussle with FDA over the kinds of information it was providing to customers when it sent them the results of its tests. Dr Harris said learning from that episode, and using the feedback from FDA, his company was able to slightly alter the messaging around the test to address the agency’s concerns.
“We don’t make specific recommendations about dosages of supplements people ought to take. We tell them, ‘Your omega-3 levels are low and you ought to increase your intake,’” he said.
Official status could open doors
Dr Harris said that it’s important to note that FDA doesn’t ‘approve’ devices like this. Rather, in much the same way the agency makes determinations about New Dietary Ingredient Notifications, FDA has told OmegaQuant that it has no objection to the assertion that the test functions as advertised and that its messaging doesn’t cross the line into providing medical advice. Dr Harris said having the FDA acknowledgement in hand means the test might soon appear on big box shelves or could more likely be comarketed with an omega-3 supplement.
Adam Ismail, executive director of the Global Organization for EPA and DHA Omega-3s (GOED), said wider distribution of the test could not only be good for his organization’s members, but could boost public health as well.
“Omega-3 blood tests have been around for some time, and the emerging evidence is demonstrating how important it is to understand one's omega-3 status. This agreement with FDA will make it possible for more consumers to learn their personal omega-3 status, and if they act on that information and increase their EPA and DHA omega-3 intake, then improved health outcomes should follow,” he said.
The Omega-3 Index test measures the level of long-chain omega-3 fatty acids, EPA+DHA, in red blood cell membranes expressed as a percent of total fatty acids. An Omega-3 Index in the range of 8-12% is one indicator of better overall health. As a part of an overall healthy lifestyle, an Omega-3 Index in the 8-12% range may help to maintain heart, brain, eye and joint health.
Both the 2015-2020 Dietary Guidelines for Americans (DGA) and the American Academy of Nutrition and Dietetics recommend the consumption of at least 2 servings (i.e., about 8 ounces) per week of a variety of seafood, preferably omega-3 rich fish. This will provide between 250 and 500 mg per day of EPA and DHA on average. The Dietary Guidelines state that this intake has been "associated with reduced cardiac deaths among individuals with and without pre-existing cardiovascular disease."
A recent study published by Dr Harris and research collaborators showed that despite increased public awareness about the importance of omega-3s, much more needs to be done. In looking at data from the United States and Germany, the study concluded that almost no one is reaching these optimum Omega-3 Index levels.