FDA Won’t Allow DHA/EPA Content Claims

Confirming its proposed rule from 2007, FDA says it will prohibit DHA and EPA nutrient content claims through a final rule, effective January 1, 2016.

The decision is a response to seafood processors and ingredient suppliers who wanted products to be allowed to run omega-3 content claims like “high in EPA” or “rich in DHA.” Because authoritative statements, such as Daily Recommended Intakes (DRIs), do not exist for these particular fatty acids, FDA says it won’t authorize those claims. The news is concerning for industry members such as the Global Organization for EPA and DHA Omega-3s (GOED; Salt Lake City), which says that mean U.S. intake of these nutrients is just 113 mg/day, compared to much higher counts around the world.

“Hopefully, by the time the final rule is effective, a DRI review for EPA and DHA will have commenced and result in a DRI for EPA and DHA,” said GOED in its members newsletter. The organization requested a review last summer.

Somewhat buried within the news of FDA shunning DHA and EPA claims was a victory for ALA content claims requested by Martek Biosciences Corp. The Institute of Medicine already recognizes an adequate intake (AI) values for this plant-based omega-3 fatty acid, including 1.6 g daily for males 14 years and older, and 1.1 g daily for females of the same age range.

When the rule becomes effective, marketers of omega-3 products (even DHA and EPA products) will still have an opportunity to communicate omega-3 content using amount or percentage statements, and qualified health claims. These claims just might not be as effective as nutrient content claims.