Since 2004, products that contain 32mg of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) omega-3s per serving can claim to be an “excellent source” of the fatty acids.
However, at the end of 2007, the US Food and Drug Administration (FDA) published a proposed rule to prohibit the use of this claim because it is not based on an authoritative statement that identifies a nutrient level for EPA/DHA omega-3s. To access the proposed rule, click here.
FDA is currently in the process of reviewing comments received in response to this proposed rulemaking, and industry expects the agency to arrive at a final ruling by the end of this year.
Regardless of FDA’s final decision, however, the omega-3 nutrient content claims in their current form will be valid for use until at least January 1, 2012, which is the earliest date for modifications in accordance with label change regulations.
Uniform compliance for new labeling regulations takes place on January 1 every two years, and FDA must give industry a one year transition period when label changes are required.
As the agency has not yet notified industry of any changes to the omega-3 nutrient content claim, the deadline has already passed for implementation on the next uniform labeling date – January 1, 2010. This essentially leaves the status quo in place for another three years.
What prompted revisions?
FDA’s proposed regulatory revision was the result of three notifications submitted to the agency under the Federal Food, Drug, and Cosmetic Act.
The first notification referred to by FDA was the so-called seafood processors notification - which included the companies Alaska General Seafoods, Ocean Beauty Seafoods, and Trans-Ocean Products. The second notification was submitted by Martek Biosciences Corporation, while the third notification came from Ocean Nutrition Canada.
The justification behind FDA's impending decision is that there is no established benchmark of what constitutes a recommended daily intake of omega-3 for general health and that the bulk of existing scientific research on the fatty acids pertains to condition-specific dosing.
The 32mg dosage currently needed to qualify for an “excellent source” claim is based on an ‘adequate intake’ level of 160mg/day established by the US Institute of Medicine (IOM). Like all nutrient content claims in the US, a product can claim to be an “excellent source” of a nutrient if it contains 20 percent of the average daily requirement levels of that nutrient.
Omega-3 trade association Global Organization for EPA and DHA (GOED) opposes the regulatory revision on the basis that it would generate consumer confusion by limiting the ways in which manufacturers can communicate meaningful omega-3 references on their products.
To hear comments from Adam Ismail, executive director of GOED, click here.
Redundant in the interim
However, according to Ismail, the entire issue may no longer be relevant in three years as clear guidance on omega-3 recommended daily intake levels may well be issued in the interim.
GOED is preparing to petition the US Institute of Medicine (IOM) to establish a recommended daily allowance for omega-3 EPA/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,” Ismail told NutraIngredients-USA.com.
The general consensus in the scientific community is that a recommended daily intake level for omega-3 EPA/DHA should be set at a minimum of 500mg.