The Omega-3 Index Test was carried out by Dr. Invented by William Harris, PhD, of the Sanford School of Medicine at the University of South Dakota with a co-worker. Dr. Harris is also president of OmegaQuant, the company he founded to manufacture and commercialize the test kits. The minimally invasive test, which has been on the market for several years, easily measures the omega-3 levels in the blood.
Bigger players wanted security
Dr. Harris said the regulatory status of the test is unclear as of now. There was no official approval, but given the low risk of the test, it was likely that regulators weren’t overly concerned about its use. However, as market experience with the test increased and Dr. Harris tried to widen the spread of the test when he encountered risk aversion from larger players.
“We did that a little under the radar. Then we started talking to some big retail chains like Walmart, CVS and Walgreens. They were all concerned about the regulatory status of the test, as you can well imagine. So if you asked, I’d say fine. . . It’s kind of a gray area. They don’t like gray. Neither do I, ”said Dr. Harris.
Dr. Harris said it had decided to submit a full dossier to the FDA to get the test approved as a medical device and join the thousands of such devices on the market. But then came a surprise: the FDA came back to propose an alternative.
“We filed a full application for an over-the-counter medical device and they got in touch with us pretty quickly to say that there would be many barriers to getting it approved as a traditional medical device. However, they suggested submitting the application as a “wellness device” which falls into the same category as bathroom scales, thermometers and exercise DVDs, ”said Dr. Harris.
“The test involves pricking your finger (to dab a blood stain on a card). But they said people stab the fingers all the time, so they weren’t very worried about it, ”he said.
“The FDA was concerned about the quality of the assay. But at the end of the day they are really concerned about what you tell people when you don’t have a doctor, ”said Dr. Harris.
Several years ago, the DNA testing company 23andMe got into a heated argument with the FDA over the type of information it was providing its customers with when it was giving them the results of their tests. Dr. Harris said his company learned from this episode and used the feedback from the FDA to make minor changes to the news surrounding the test and to address the agency’s concerns.
“We don’t make specific recommendations about the dosage of dietary supplements that people should take. We tell them, “Your omega-3 levels are low and you should increase your intake,” he said.
The official status could open doors
Dr. Harris said it was important to note that the FDA does not “approve” such devices. Similarly, the FDA has told OmegaQuant that the agency has no objection to claims that the test is working as advertised and that its messages do not cross the line into medical advice. Dr. Harris said having the FDA endorsement in hand means the test could soon hit big shelves or, sooner, be marketed with an omega-3 supplement.
Adam Ismail, executive director of the Global Organization for EPA and DHA Omega-3 (GOED), said wider dissemination of the test could not only benefit members of his organization but also promote public health.
“Omega-3 blood tests have been around for a while, and the emerging evidence shows the importance of understanding your omega-3 status. This agreement with the FDA will allow more consumers to know their personal omega-3 status. If they respond to this information and increase their EPA and DHA-omega-3 intake, improved health outcomes should follow, ”he said.
Recommendations for admission
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 percentage of total fatty acids. An omega-3 index in the 8-12% range is an indicator of better overall health. As part of an overall healthy lifestyle, an omega-3 index in the 8 to 12% range can help maintain heart, brain, eye, and joint health.
Both 2015-2020 Dietary Guidelines for Americans(DGA) and the American Academy of Nutrition and DieteticsRecommend consuming at least 2 servings (i.e., about 8 ounces) per week of a variety of seafood, preferably omega-3 rich fish. This results in an average of between 250 and 500 mg EPA and DHA per day. The dietary guidelines state that this intake was “linked to reduced cardiac death in those with and without pre-existing cardiovascular disease.”
A recent study by Dr. A study published by Harris and researchers showed that despite the increased public awareness of the importance of omega-3s, much more needs to be done. When looking at data from the USA and Germany, The study concluded that almost no one gets these optimal omega-3 index values..