08.17.12
In August, The Global Organization of EPA & DHA Omega 3s (GOED), Salt Lake City, UT, met with representatives from both FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and the Institute of Medicine (IOM). The purpose of the meeting was to have a dialogue about areas of interest to the omega 3 industry. Topics discussed included nutrient content claims, health claims, recommended intakes, upper limits and the economic impact of omega 3 consumption.
Key Takeaways
Nutrient Content Claims: FDA has drafted a ruling on nutrient content claims, which is currently at OMB (Office of Management and Budget). GOED does not know the content of the draft ruling, how many more rounds of review there may be or an expected publication date.
Health Claims: GOED and FDA had a discussion regarding using blood pressure as a surrogate endpoint for coronary heart disease. As indicated in the Agency’s letters responding to the qualified health claim petitions for omega 3s, the agency remains comfortable with this approach. The result of this discussion might be that GOED seeks more than one health claim in the heart health category.
Recommended Intakes: The big learning here was that the DRI (Dietary Reference Intakes) Steering Committee is considering a DRI review process, which may 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 question marks, including that indicators of chronic disease risk reduction, not just essentiality, can be considered during a DRI review and that there is no need for an established Upper Limit in order to set a DRI. However, until the DRI review process is finalized, it is unlikely that IOM will consider setting DRIs for omega 3s.
Upper Limits: The parties discussed the recent EFSA Tolerable Upper Limit decision as well as the safety assessment GOED commissioned and whether or not there might be an 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, in order to increase FDA’s Upper Limit, the decision needs to go through CFSAN’s Office of Food Additive Safety as part of a company’s GRAS Notification, not as part of an industry-wide effort by a trade association.
Economic Impact: Lastly, GOED presented economic impact data on omega 3s, and FDA and IOM found this information important. They stated that 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. However, remains to be seen what this means for omega 3s being chosen for the next DRI review.
