As things stand, however, the US and Canada were the “only leading economies in the world that have not established clear DRIs for omega-3s yet”, said GOED executive director Adam Ismail.
“We do not believe this is an enviable position, particularly since multiple US government agencies have found there is a benefit in the general population increasing its EPA/DHA intakes.”
And while there was no evidence that uncertainty over this issue was seriously damaging the market, it certainly wasn’t helping, said Ismail.
“Food companies want to be clear about what they will be able to communicate, so it has caused some to put product launches on hold or slowed the development process down.
"But the problem is not an industry issue, it is a public health issue. Our industry has grown and continues to grow without a DRI, and even the categories where recommended intakes matter, like foods, are still seeing success (although it would probably be much higher with the DRI). The fact of the matter is consumers do not know how much EPA and DHA they need in their diet, they cannot get the information from a nutrition label."
FDA, omega-3 claims and legal limbo
In Europe, conditions of use for ‘source of’ and ‘high in’ omega-3 claims have been established under the EU Nutrition and Health Claims Regulation. However, the situation in the US is more confused, which meant firms were operating in a climate of uncertainty, he said.
“The FDA proposed a prohibition on omega-3 nutrient content claims in 2007… but it has not issued a final ruling yet and we are not sure when it will be completed.“
In the meantime, companies were still making EPA and DHA nutrient content claims based on a statement from the IOM made in 2002 thatthe FDA did not consider to be clear or authoritative, he said.
“Most DRIs are explicitly stated, like with ALA (alpha-linolenic acid) where IOM said 1.6g per day was considered the adequate intake. With EPA and DHA, however, it never stated that 160mg was considered the adequate intake, only that EPA and DHA contribute 10% of the adequate intake for ALA."
He added: “We don't think the FDA feels omega-3s are not important, it really seems to be procedural issues that prompted FDA to take the action [to propose a prohibition in 2007]."
What happens next?
The main problem, said Ismail, “is there is no set review procedure for getting a DRI from IOM, so if FDA has a procedural objection to the authoritative statement, the only way to get IOM to review the statement is to get FDA and other groups to fund a review.
“Ultimately this is going to require marshaling the efforts of multiple agencies. We hope this will be done soon, and in fact over 18 months ago GOED, other trade, consumer advocacy, and scientific groups petitioned the IOM to do so.
“They distributed our petition to the DRI steering committee agencies, and we have heard positive signs that if and when a new DRI project is commissioned, omega-3s will be near the top of the list.”
Money: The main stumbling block
Securing funding in the current political climate would be tough, however, he predicted. “A year ago I think it looked very promising, but today we are reading about how budgets are being slashed in the federal government.
”However, to us the case is clear. Large government-funded studies show that more Americans can be saved by increasing EPA/DHA intakes to 250mg per day than nearly any other dietary cause. It is a cost-effective way to help reduce healthcare costs and could potentially save the government money.”
Will the US follow Europe’s lead?
As to whether regulatory developments in Europe would influence matters in the US, this was unlikely, predicted Ismail.
“We know the FDA and other regulators are watching what is happening in Europe, but the US has its own systems of evaluation and processes so it will not influence how things are done here.”
How much EPA/DHA do we need?
While the "prevailing level around the world today seems to be 250mg per day”, noted Ismail, “new research has shown that this is really a minimal intake level and that increasing your intakes to levels near 500mg per day can further reduce your heart disease risks by 35%.
“I would expect an RDI to fall in between these targets. But it is worth noting that Japan, which has one of the lowest rates of heart disease in the world, recommends more than 1,000mg per day.”