GOED Encourages FDA to Review EPA and DHA Omega-3 Clinical Science

28/11/07 In response to the US Food and Drug Administration’s (FDA) notice of proposed rulemaking prohibiting nutrient content claims on products with EPA and DHA omega-3 fatty acids, the Global Organization for EPA and DHA Omega-3s (GOED), is urging the FDA and/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 FDA’s proposed rule would ban nutrient content claims for products containing EPA and DHA on the basis that the IOM has made no authoritative statement that identifies a daily required or recommended nutrient level for EPA and DHA. “Rather than prohibiting nutrient content claims on EPA and DHA because an old review of the science set no daily requirement, we believe there should be a proper examination of the current clinical science to set a level for EPA and DHA as vital nutrients for chronic disease prevention and nutrient deficiencies,” said Adam Ismail, Executive Director of GOED. 

The last review by the IOM of clinical science on EPA and DHA for the establishment of dietary reference intakes cited clinical studies and reviews through 2001.  However, according to the PubMed database, there have been 260 randomized, controlled clinical trials on humans and 347 reviews and meta-analyses published since 2002 that have not been assessed as part of the body of evidence for establishing a reference intake for EPA and DHA.  Furthermore the IOM has only considered scientific findings related to nutrient deficiencies in the general population with regard to omega-3 fatty acids; however, GOED believes the FDA should consider an approach more akin to nutrient content claims on macronutrients like fiber, where chronic disease prevention was a criterion in establishing nutrient content claims rather than just nutrient deficiencies. EPA and DHA are believed by many medical specialists to play a major role in preventing cardiovascular disease, one of the leading causes of death in the US, and a growing body of evidence indicates they may help in preventing many other chronic diseases. By allowing credible information to appear on products, the FDA will contribute to the education of consumers in making healthy dietary choices.

“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,” added Ismail.  According to the Nutrition Business Journal, the US market for dietary supplements with EPA and DHA has grown from $100 million in 2001 to $489 million in 2006, while Packaged Facts estimates the US market for food products fortified with EPA and DHA has grown from nothing in 2001 to $600 million in 2006.  This means the industry has gone from being a small emerging industry when the science was last reviewed, to exceeding $1 billion in sales today.

GOED strongly believes the best path forward, and to allow consumers to make the informed choices intended under NLEA, is for the FDA and/or the IOM make a determination about the required levels of these two vital nutrients for consumers to help prevent chronic diseases. “We believe the time is right to re-examine the science, given the growth in consumers’ and health professionals’ interest in omega-3s and the FDA’s recent request for comment on adding new nutrients to the Nutrition Facts panel,” added Ismail, “and in fact GOED has engaged the Life Sciences Research Office to hold a workshop in early 2008 that will explore the issues related to developing a recommended daily intake for EPA and DHA as a means of furthering discourse on the topic.”