August 8, 2012
SALT LAKE CITYThe Global Organization for EPA and DHA Omega-3 (GOED) met with officials from FDA's Center for Food Safety and Applied Nutrition (CFSAN) and the Institute of Medicine (IOM) to discuss omega-3 industry issues such as nutrient content claims, health claims, recommended intakes, upper limits and the economic impact of omega-3 consumption.
According to GOED, FDA has drafted a ruling on nutrient content claims that is currently at the Office of Management and Budget (OMB), but there is no further information on its content or timeline for review and publication.
On health claims, GOED and FDA discussed the use of blood pressure as a surrogate endpoint for coronary heart disease (CHD), a position the agency has seemingly OK'd in it s resposne letters to qualified health claim petitions. GOED said based on the discussions, it may seek more than one health claim in the heart health category.
The takeaway from talks on recommended intakes was that the DRI (Dietary Reference Intakes) Steering Committee is considering a DRI review process to either set criteria for IOM to determine which nutrient should be considered for a new DRI or set up a submission process through which interested parties could file for a particular nutrient to be considered. The discussion also clarified a few points: indicators of chronic disease risk reduction, not just essentiality, can be considered during a DRI review, and there is no need for an established Upper Limit (UL) in order to set a DRI. GOed cautioned, however, until the DRI review process is finalized, it is unlikely IOM will consider setting DRIs for omega-3s.
The matter of ULs brought up discussion of the recent EFSA Tolerable Upper Limit decision as well as the safety assessment GOED commissioned and the potential opportunity to increase the current U.S. upper limit recommendation of 3 grams/day, resulting from the 1997 Final Rule affirming Menhaden Oil as GRAS. However, GOED reported any decision by FDA to increase UL needs to go through CFSANs Office of Food Additive Safety as part of a companys GRAS Notification, not as part of an industry-wide effort by a trade association.
As part of the talks, GOED presented economic impact data on omega-3s, which it said was welcomed by both FDA and IOM, both which agreed growth in the body of science and understanding the actual impact of a nutrient are two of the most important considerations in moving policy forward. GOED concluded it is hard to predict what this does for omega-3s being chosen for the next DRI review.
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