“Certainly in the proposed label review FDA did not do a thorough review of all 20,000 papers on omega-3s,” Ismail told NutraIngredients-USA.
Agency: Evidence inconclusive
In its draft proposal, FDA wrote: “Based on a review of relevant scientific research, in 2004, FDA concluded in its qualified health claim review that there is supportive, but not conclusive, research to suggest that n-3 polyunsaturated fatty acids (EPA and DHA) reduce the risk of CHD.”
The agency further stated that, “Because of the lack of well-established evidence for a role of n-3 or n-6 polyunsaturated fatty acids in chronic disease risk and the lack of a quantitative intake recommendation, and consistent with the factors discussed in section I.C., we tentatively conclude that the declarations of n-3 and n-6 polyunsaturated fatty acids are not necessary to assist consumers to maintain healthy dietary practices.”
“We’ve known for a long time that what is needed is for the Institute of Medicine to consider whether there should be separate recommended intakes for EPA and DHA,” Ismail said. “FDA needs the input of an authoritative government body in order to be able to take a stance on the issue. We have suggested to IOM that they do a large-scale review of omega-3s.”
Calories are not the important factor
The issue of the efficacy of omega-3 fatty acids is bound up with the issue of fat in general. One of the key changes on the new labels is that the “calories from fat” callout has been removed, something that Ismail saw as a good thing.
“FDA says with regards to fats that the total calories from fat is so important any more because they want consumers to think about the quality of fat they are consuming. They want to treat fats differently based on the quality of the fat,” he said.
Ismail said FDA’s rejection of omega-3s as a specified nutrient on the labels was not a surprise, but the agency’s de-emphasis of fat as a calorie source was. The next step, and one that GOED will advocate for in its comments on the proposal, is to set up a framework in which information about good fats can be communicated to consumers.
“We want to make sure that there is an acknowledgment that there are some good fats out there,” Ismail said.
In the draft proposal, FDA seems to open the door for more discussion on the issue, while not providing much cause for hope that omega-3s will show up on food labels anytime soon: "We acknowledge that certain polyunsaturated fatty acids are essential and understand the interest expressed by some comments that there is a need to provide information on beneficial fats. However, the essentiality of a nutrient is not a factor considered for the mandatory or voluntary labeling of non-statutory nutrients, other than essential vitamins and minerals."