The US Food and Drug Administration (FDA) this week issued proposed rulemaking to prohibit nutrient content claims on products with EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) omega-3 fatty acids. The document was the result of three notifications submitted to FDA in recent years under the Federal Food, Drug, and Cosmetic Act. According to GOED, the proposed prohibiting of nutrient content claims - such as a "good source of omega-3" - would unjustly restrict the burgeoning market for omega-3 fatty acid ingredients. "The competitive impact is that it essentially stops companies from making general wellness claims," GOED executive director Adam Ismail told NutraIngredients-USA. Under the proposed rule, companies would still be allowed to make specific structure/function claims surrounding omega-3, but not to specifically cite a product as a "good" or "excellent" source of the fatty acids for general health and wellness. The proposed rule could specifically impact functional food marketers as most foods fortified with omega-3s currently hold nutrient content claims, while this is much less the case with dietary supplements, which tend to be sold entirely on the virtue that they are comprised of omega-3s. 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. "FDA ought to look at chronic disease prevention and reapply these exceptions to this case," said Ismail. According to Ismail, FDA has made exceptions in the past and chalked up daily values for nutrients based on disease prevention - such as was the case with nutrient content claims agreed upon for fiber. As the situation stands, lack of nutrient content claims will only confuse the market, claim GOED. "It will affect consumer understanding of omega-3 products," said Ismail. "Because there will be more confusion as companies will have a harder time communicating the benefits to them." 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. "FDA has reviewed the information included in the three notifications and is proposing to prohibit the nutrient content claims for DHA and EPA set forth in the three notifications because they are not based on an authoritative statement that identifies a nutrient level to which the claims refer, as required by the controlling statutory," states the FDA report, entitled Food labeling: nutrient content claims; alpha-linolenic acid, eicosapentaenoic acid, and docosahexaenoic acid omega 3 fatty acids. Due to the lack of a clear benchmark for such content claims, GOED is calling on either FDA or the Institute of Medicine to review the clinical science on omega-3s and make an authoritative statement on a recommended intake for EPA and DHA. The group warns the regulatory environment in the US for the fatty acids is already lagging behind the market. "The market for EPA and DHA omega-3 products is very dynamic in the US, and in this case we believe the regulatory environment needs to catch up to the market," said Ismail. The upshot of prohibiting nutrient content claims, said Ismail, is that companies may chose to focus on marketing to target specific disease risks. "Companies may begin focusing on condition-specific marketing, which is generally a smaller area of opportunity than products claiming an excellent source," said Ismail. Recently formed, GOED's membership has grown to include at least 40 companies. The trade association's mandate is to help maintain market growth for EPA and DHA products by educating consumers, healthcare professionals and governmental bodies about the benefits of these fatty acids. The association is filing a comment with its recommendations as part of the federal agency's public comment policy.
The Global Organization for EPA and DHA omega-3s (GOED) is urging FDA to review the clinical science on the fatty acids so as to make an authoritative statement on recommended intake.