Omega 3 Showdown

FDA takes steps to prohibit omega 3 nutrient content claims.

By
Joanna Cosgrove
Online Editor

In a word, the omega 3 fatty acid market is hot. The increasing prevalence of cardiovascular disease has sent American consumers in search of natural supplement and fortified food solutions formulated to assuage the dangers of high cholesterol and blood pressure, not to mention heart attacks and strokes. According to Nutrition Business Journal, Boulder, CO, the U.S. market for dietary supplements containing omega 3’s EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) grew from $100 million in 2001 to $489 million in 2006.

It’s a trend food product suppliers have also celebrated with an array of products—the most popular being eggs—featuring omega 3 content claims emblazoned on their packaging. Packaged Facts estimated the U.S. market for food products fortified with EPA and DHA grew from nothing in 2001 to $600 million in 2006.

But the creation of a new and highly profitable market segment is bound to attract scrutiny. Last June, the Center for Science in the Public Interest (CSPI) fired off a complaint letter to the FDA regarding what it perceived to be “false and misleading claims about omega 3 fatty acids and a reduced risk of coronary heart disease.” CSPI suggested the agency issue warning letters reminding manufacturers of the requirements necessary to make health and nutrient content claims for omega 3 fatty acids. CSPI urged FDA to take action against not only egg suppliers, but also other products making “unauthorized” omega 3 health and nutrient content claims or misleading statements pertaining to the benefits of nutrient.

Flash forward to the present and it would seem the FDA has decided to give omega 3’s and their purported benefits a second, more investigative look. Late last month, FDA published a notice of proposed rulemaking that would prohibit nutrient content claims on products with EPA and DHA omega 3 fatty acids (The Federal Register, Vol. 72, No. 227, 11/27/07, 66103).

This rule was proposed in response to three notifications submitted to FDA. One notification concerning nutrient content claims for alpha linolenic acid (ALA), EPA and 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 the 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 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.” The agency added that 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.”

FDA proposed to take no regulatory action with respect to the nutrient content claims for ALA set forth in the Martek notification.

Examine the Science

In response to the FDA’s actions, the Global Organization for EPA and DHA Omega 3s (GOED) issued a statement imploring the FDA to take a closer look at the science of EPA and DHA omega 3s before issuing its final judgment. Moreover, the group urged the agency and the Institute of Medicine (IOM) to make “an authoritative statement on a recommended intake for EPA and DHA.”

GOED warned that 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.”

Adam Ismail, executive director of GOED, believes there are specific implications to the rule, if it is adopted as published. For starters, nutrient content claims enable a clear differentiation between food products fortified with omega 3s and those that aren’t. “In addition,” he said, “products will still be able to use the qualified heart health claim and structure function claims that target other health conditions, but products that focus on general wellness will have a harder time communicating that their products contain omega 3’s without the nutrient content claims. This is actually one of the fastest growing portions of the food market, so it has big implications on the future growth of the segment.”

But the broadest issue at stake relates to that of consumer education about omega 3’s—something Mr. Ismail says the FDA has adversely contributed to by failing to provide appropriate guidance. “Right now consumers do not know the difference between short-chain omega 3’s and long-chain omega 3’s, and the nutrient content claims were the most advanced way to differentiate the two,” he says. “Consumers today also have little understanding about how much omega 3 they should be taking [and] the FDA has essentially not given the consumer any guidance on the topic, the removal of the nutrient content claim will just make it more unclear.”

In addition, he added, there is a conflict between the FDA decisions on the nutrient content claims and the qualified heart health claim for omega 3’s. “The FDA has said companies cannot make any claims about products being good sources of omega 3’s because there is no authoritative statement on how much a consumer needs, but products can say their product may prevent cardiovascular disease despite the lack of a similar authoritative statement,” he pointed out. “Also, there were at least minimum requirements for use of the nutrient content claims, needing a minimum of about 30 mg of EPA and DHA to use the claims, but with the heart health claim no such requirement exists. In other words, a product containing 100 mg of EPA and DHA cannot say it is a good source of omega 3’s, but products containing 1 mg of EPA and DHA can say they may reduce the risk of cardiovascular disease, which is nonsense at that level. As you can see, there is nothing but confusion for the consumer.”

But Mr. Ismail acknowledged that even those proverbial clouds can have silver linings, especially since this new movement on the part of the FDA opens the door for interested parties to request that FDA and IOM review the science behind omega 3’s again. 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. 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, asserted GOED, the IOM has only considered scientific findings related to nutrient deficiencies in the general population with regard to omega 3 fatty acids; however, the group 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 FDA noted in their rule that EPA and DHA are important nutrients, but simply said that there was no authoritative statement on them so the claims should not be allowed,” he concluded. “This is our opportunity to press them to make an authoritative statement. It is clear that there needs to be more clarity on how to communicate the benefits of omega 3’s, and only the FDA can step in to do that in a way that is beneficial for consumers.”