08.07.12
GOED last week met with representatives from both the U.S. 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. Click here for the slides presented by GOED at the meeting.
The key takeaways from the meeting were:
The key takeaways from the meeting were:
- Nutrient Content Claims: FDA has drafted a ruling on nutrient content claims, which is currently at OMB (Office of Management and Budget). We do not know the content of the draft ruling, how many more rounds of review there may be or an expected publication date. See November 27, 2007 Notice of Proposed Rulemaking for the Agency’s last opinion on record concerning these claims.
- 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 O-3s, the FDA remains comfortable with such approach. The result of this discussion may be that we seek 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. It remains to be seen what this means for omega-3s being chosen for the next DRI review.
