June 12, 2009
The FDA has proposed a rule that would prohibit food manufacturers from marketing any product as an “excellent source” of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
Since 2004, the FDA has allowed “excellent source” claims on any foods containing at least 32 milligrams of DHA and EPA per serving. Under FDA guidelines, any food that supplies at least 20 percent of the recommended daily value of a nutrient may contain such a claim.
In late 2007, however, the FDA proposed a ban on such claims. According to the agency, there is no authoritative U.S. Institute of Medicine (IOM) recommended daily allowance for EPA and DHA, making “excellent source” claims misleading. The agency also says that because most omega-3 research has focused on doses producing specific results rather than those leading to overall nutritional well-being, there is little data on how much EPA and DHA people should actually be consuming.
The 32 milligram threshold is based on the IOM’s “adequate intake” estimate of 160 milligrams per day. Most researchers recommend that the recommended daily intake be set significantly higher, at 500 milligrams.
Because FDA rules say that labeling changes can only be implemented on Jan. 1 every two years, however, and also require that companies be given at least one year’s advance notice, no changes to omega-3 nutritional claims could be implemented until Jan. 1, 2012.
According to omega-3 trade association the Global Organization for EPA and DHA (GOED), manufacturers are hoping that the FDA will issue an omega-3 nutritional recommendation before 2012, thereby bypassing the issue entirely. The GOEM already plans to petition the IOM to set an official recommended daily allowance for EPA and DHA.
“We’re hoping that within three years we can convince them to revise reference intakes for EPA/DHA, which would then make this whole issue a mute point,” said GOED’s executive director, Adam Ismail.