FDA proposes to ban Omega-3 Fatty Acid claims from food labels; GOED, urges review of science and authoritative statement on a recommended intake for EPA and DHA
The Food and Drug Administration (FDA) proposes to issue a rule finding that certain nutrient content claims for foods, including conventional foods and dietary supplements, that contain omega-3 fatty acids, do not meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) and may not appear in food labeling.
This rule is being proposed in response to three notifications submitted to FDA under the act. One notification concerning nutrient content claims for alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) was submitted collectively by Alaska General Seafoods, Ocean Beauty Seafoods, Inc., and Trans-Ocean Products, Inc. (the seafood processors notification); a second notification concerning nutrient content claims for ALA, DHA, and EPA was submitted by Martek Biosciences Corp. (the Martek notification); and a third notification concerning nutrient content claims for DHA and EPA was submitted by Ocean Nutrition Canada, Ltd. (the Ocean Nutrition notification).
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 authority.
FDA is also proposing to prohibit the nutrient content claims for ALA set forth in the seafood processors notification because they are 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 to set the daily value, the ALA claims set forth in the seafood processors notification 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, as required by the controlling statutory authority.
FDA is proposing to take no regulatory action with respect to the nutrient content claims for ALA set forth in the Martek notification. Therefore, if this proposed rule is finalized without change, these claims will be allowed to remain on the market.
More: Information on the FDA's proposed rule and how to comment [PDF]
In response to the FDA notice, the Global Organization for EPA and DHA Omega-3s, or 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.”
GOED is a proactive and accountable association of processors, refiners, manufacturers, distributors, marketers, retailers and supporters of products containing Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) – Omega-3 Long Chain Polyunsaturated Fatty Acids (LCPUFAs). The Organization's objectives are to promote and protect the category and to educate consumers about the health benefits of EPA/DHA and work with government groups, the healthcare community and the industry, while setting high standards for our business sector. We are committed to personal integrity, ethical corporate behavior, public safety and quality assurance.
Information on the FDA's proposed rule and how to comment: [PDF]
