In late November, FDA filed a notice of proposed rulemaking to prohibit nutrient content claims on products with certain omega 3 fatty acids. This rule was formulated in response to three notifications submitted to FDA. One notification concerning nutrient content claims for alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) was submitted collectively by Alaska General Seafoods, Ocean Beauty Seafoods, Inc. and Trans-Ocean Products, Inc.; a second notification concerning nutrient content claims for ALA, EPA and DHA was submitted by Martek Biosciences Corp.; and a third notification, discussing nutrient content claims for DHA and EPA, was submitted by Ocean Nutrition Canada, Ltd.

After reviewing the information included in the three notifications, FDA proposed to prohibit nutrient content claims for EPA and DHA 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 authority.”

The agency also proposed to prohibit the seafood processors’ nutrient content claims for ALA because they were based on a daily value that was determined by a different method than daily values already established for other nutrients. Because of the “different methodology” used by the seafood processors to set the daily value, their ALA claims do not enable the public to “comprehend the information provided in the claims and to understand the relative significance of such information in the context of the daily diet.”

The FDA’s proposed rule would ban nutrient content claims for products containing EPA and DHA on the basis that the Institute of Medicine (IOM) has made no authoritative statement that identifies a daily required or recommended nutrient level for EPA and DHA. But Adam Ismail, executive director of the Global Organization for EPA and DHA, or GOED, sees things differently. “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,” he said.
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.
“The market for EPA and DHA omega 3 products is very dynamic in the U.S., and in this case we believe the regulatory environment needs to catch up to the market,” added Mr. Ismail. According to Nutrition Business Journal, Boulder, CO, the U.S. market for dietary supplements with EPA and DHA grew from $100 million in 2001 to $489 million in 2006, while Packaged Facts estimates the U.S. market for food products fortified with EPA and DHA grew 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 (the Nutrition Labeling & Education Act), is for the FDA and/or the IOM to 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 3’s and the FDA’s recent request for comment on adding new nutrients to the Nutrition Facts panel,” Mr. Ismail said.
To create a deeper level of understanding around this topic, GOED has engaged the Life Sciences Research Office (LSRO) to hold a workshop in early 2008 to explore the issues related to developing a recommended daily intake (RDI) for EPA and DHA as a means of furthering discourse on the topic.