Setting a Daily Value for Omega-3s an Industry Priority

Changes to the Nutrition Facts and Supplement Facts panels in the United States happen very infrequently, despite the fact that the panels don’t always address consumer needs. The fats section of the Nutrition Facts panel is perhaps one of the most confusing, because it doesn’t differentiate types of fats. FDA recently asked for public comment on how and whether nutrition labels should change, posing a series of questions to determine the best way to list the various types of fats so consumers can make educated dietary choices. Unfortunately, none of the questions centered specifically on long-chain omega-3 essential fatty acids (EFAs).

The problem, from an industry perspective, is there is currently no Daily Value (DV) established for the omega-3s eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), despite the overwhelming proof that EPA and DHA are beneficial to human health. In order for a nutrient to appear on the Nutrition Facts panel with an established DV, an authoritative scientific body of the U.S. government must review the science and make its own determination, which must then be accepted by FDA.

In reality, FDA seems to be putting priority and weight on the opinion of the Institute of Medicine (IOM) over all other government bodies; however, IOM has not revisited the science behind omega-3s since 2001.

However, there are other mechanisms within the government to review nutrition guidelines regularly. The Dietary Guidelines for Americans are revised every five years based on a report by the Dietary Guidelines Advisory Committee (DGAC). The DGAC reviewed the science behind omega-3s in its last report in 2005 and recommended consumers should take approximately 500 mg/d of EPA and DHA, which translated into two servings of fish per day. In addition, the Agency for Healthcare Research and Quality (AHRQ) has published numerous reports on omega-3s, and proactively updates them frequently. Their reports also concluded consumers should take approximately 500 mg/d of EPA and DHA to reduce the risk of cardiovascular disease (CVD).

Further, momentum seems to be increasing behind this issue. During May and June there were four independent workshops and sessions held on the questions around establishing recommended intakes for EPA and/or DHA. Some significant findings from these workshops shed light on the burden of proof and courses of action industry needs to consider in order to establish a DV for a new nutrient. First, nutrition policy is set for the overall population, rather than for at-risk or diseased populations, and much of the omega-3 data focuses on populations with CVD risk factors. Second, observational and epidemiological studies may provide some of the most compelling evidence for the role EPA and DHA can play in the reduction of CVD; but, FDA and IOM put a heavy emphasis on randomized, controlled human clinical trials to confirm the findings from the observational studies. Also, CVD risk is not as clear-cut as one might believe and, in fact, many risk factors like high triglyceride levels are not recognized by FDA as a risk factor. However, there is compelling evidence that omega-3s reduce all-cause mortality, and this may provide another means of establishing a DV.

During the FDA question period on revisions to nutrition labels, GOED asked FDA to consider the advancements of the science behind omega-3s and establish daily intakes for EPA and DHA that could be used to communicate their value to consumers. GOED was not alone in this effort, as the Center for Science in the Public Interest (CSPI), National Fisheries Institute, ILSI, the Grocery Manufacturers Association, the American Heart Association, and the American Society for Nutrition all urged similar actions on EPA and DHA omega-3s.

When industry and expert scientific organizations are all in agreement that something needs to be done to clarify the situation, then regulators generally start to take notice. The burden for industry on this issue will be to present evidence and take action in a manner that allows FDA and other authoritative bodies to take action within the existing regulatory framework. FDA and regulators want certainty about the exact levels that are optimal for achieving nutrition objectives and proof of the benefits in all portions of the population. GOED and industry believe any recommended level is better than the current situation where consumers are left confused about the impact of fats and long-chain omega-3s on their health. It is therefore important that we work to bridge these positions and obtain a recommended intake for EPA and DHA.

Adam Ismail is the executive director of the Global Organization for EPA and DHA Omega-3s (GOED), an association of manufacturers and marketers of omega-3 products, whose members are united in protecting and promoting the market for these vital nutrients. Ismail previously worked at Cargill, Health Strategy Consulting and Health Business Partners.