GOED Reports Back from Meeting with IOM and FDA.
The Institute of Medicine’s (IOM) Dietary Reference Intakes (DRI) steering committee is paving the way for a new DRI review process, which in turn raises hope that the next DRI review could be done on omega-3 fatty acids, said the Global Organization for EPA and DHA Omega-3s (GOED). The omega-3 trade association reported back from an August 1 meeting it had requested with IOM and FDA’s Center for Food Safety and Applied Nutrition (CFSAN), to discuss key omega-3 regulatory topics.
The last time GOED met with these bodies was back in June 2010. GOED said that the meeting’s purpose was “to have a dialogue about areas of interest to the omega-3 industry,” including nutrient content claims, health claims, recommended intakes, upper limits, and the economic impact of omega-3 consumption.
Neither IOM nor FDA have confirmed that omega-3s will be the focus of a future DRI review, but since 2009 GOED has continued to request that a DRI on omega-3 be performed. “We’ve heard rumors that the omega-3s are at the top of the list for consideration, along with possibly choline,” states Harry B. Rice, PhD, GOED’s vice president, regulatory and scientific affairs.
Rice says that while a DRI review has never been done specifically on omega-3s, FDA did provide some recommendations for alpha-linolenic acid (ALA) back in 2002, within a collective DRI review of energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein, and amino acids.
Coming away from the August 1 meeting, GOED reported that “the DRI 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.”
According to Rice, omega-3’s strong-and growing-body of scientific study merit a DRI review. “Consideration is being given to establishing a DRI review process because of the recognition that the body of science associated with nutrients can change, and there needs to be a mechanism in place for reviews to occur in the interest of public health,” he stated. “For example, the number of published randomized clinical trials since the last paper cited in the [aforementioned 2002 DRI review on ALA] has grown by 224%. That’s a lot of science.”
GOED said that the meeting also clarified that a DRI review considers a nutrient’s indication for chronic disease reduction and is not based only on whether a nutrient is an essential nutrient, as has been historically presumed. As Rice explains, “In nutrition, an essential nutrient is one that humans and animals must obtain via the diet because they are not able to synthesize it. Because EPA and DHA are synthesized in the body from ALA, they are not considered essential, but ALA is considered essential because it cannot be synthesized in the body from any other nutrient. The calcium and vitamin D DRI review was the first of its kind in that it was based on reducing chronic disease risk, not just on reducing diseases that occur because of a lack or absence of an essential nutrient.”
In conclusion, Rice said, while “we didn’t conclude the meeting with any action items, GOED is optimistic that the review process will be established sooner rather than later, but no promises were made.”
Other omega-3 aspects discussed at the meeting were nutrient content claims (GOED says that a draft ruling is currently still in FDA’s Office of Management and Budget), health claims (FDA remains comfortable with using blood pressure as a surrogate endpoint for coronary heart disease), upper limits, and economic impact of omega-3s.