FDA Announces Qualified Health Claim for Omega-3 Fatty Acids

WASHINGTON--The Food and Drug Administration (FDA) announced Sept. 8 the allowance of a qualified health claim for omega-3 fatty acids. The health claim links reduced risk of coronary heart disease (CHD) with consumption of the long-chain omega-3 polyunsaturated fatty acids eicosapentaenoic acid (EPA) and/or docosahexaenoic acid (DHA). This claim is the second qualified health claim FDA has announced for conventional food since it began considering them in 2003.

Coronary heart disease is one of the top killers of Americans today, said Lester M. Crawford, acting FDA commissioner. It causes approximately 500,000 deaths annually in the United States. The new qualified health claim for omega-3 fatty acids will empower consumers with more information to help combat this disease and improve their health by identifying foods that contain these important compounds. This is also an important step for FDAs Better Nutrition Initiative announced in December 2002.

Qualified health claims for a conventional foods must be supported by credible scientific evidence. Based on a systematic evaluation of the available scientific data, FDA concluded that while these two particular fatty acids are not essential to the diet, they may be beneficial to reducing CHD risk factors. EPA and DHA omega-3 fatty acids are found in fatty fish such as salmon, lake trout, tuna and herring, and are available in dietary supplements.

The qualified health claim label, which manufacturers can use immediately, reads: Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of food] provides [x] grams of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat and cholesterol content.] No deviation from this wording will be allowed.

Barbara Schneeman, director of the Office of Nutritional Products, Labeling and Dietary Supplements in the FDAs Center for Food Safety and Applied Nutrition, said the claim can be used on all products containing both EPA and DHA, though no minimum amount of the two is as yet required.

In our review of the science that is available for this qualified health claim, we determined that we couldnt really set a minimum amount so we felt it was more important that consumers be informed about how much they would be consuming in a particular product, Schneeman said.

The Council for Responsible Nutrition (CRN) commended FDAs action in extending this qualified health claim--which was previously available only for supplements--to include conventional foods, but suggested FDA fell short of recommending what the science supports.

We are disappointed that in todays action FDA established no minimum requirement for the amount of omega-3 EPA/DHA that a conventional food must contain in order to use the qualified health claim, said Annette Dickinson, Ph.D., president of CRN (www.crnusa.org). We further believe it will do consumers a disservice if foods with insignificant amounts of these fatty acids carry the claim.

However, various disqualifying levels for saturated fat and cholesterol are in place. In addition, dietary supplements exceeding the § 101.14(a)(4) total fat disqualifying level must have a disclosure statement immediately adjacent to the claim.

FDA recommends consumers not exceed more than a total of 3 g/d of EPA and DHA omega-3 fatty acids, with no more than 2 g/d from a dietary supplement.

The concern with excess consumption of long chain fatty acids is it can lead to slower clotting time, Schneeman said. There are some risks from consuming very high levels of the omega-3 long chain fatty acids, so its mainly a caution to consumers to not consume these fatty acids to excess.

FDA health claims generally are rated in a ranking system at A, B, C or D levels, with the A ranking being the highest and indicating a significant scientific agreement. However, this omega-3 health claim is not categorized into any one of these levels.

At this point in the process, we are not categorizing the claims by the A, B, C, D levels, Schneeman said. We are evaluating the level of the science--certainly this would be considered at a higher level in terms of the type of science that is supporting the claim, but we are not assigning that type of letter designation for these claims. The agency is still involved in doing consumer studies about consumer perception of that type of designation.

The qualified health claim comes in response to many petitions submitted to FDA. Petitioners, including CRN, requested a full health claim for omega-3 EPA/DHA and reducing the risk of CHD. Todays decision dramatically widens FDA's former position regarding the relationship between dietary supplements containing omega-3 fatty acids and the resulting reduced risk of CHD, said Jonathan Emord, legal counsel to American Longevity and Life Extension Foundation Buyers Club, one of the petitioners. The former qualified health claim contained a substantively limiting disclaimer that failed to adequately assess the benefits of omega-3 fatty acids in reducing the risk of CHD. FDAs current qualified health claim more accurately describes the current state of the scientific evidence on the benefits of omega-3 fatty acids.

Dickinson said CRN is still hopeful FDA will move ahead on an unqualified health claim in the near future. While it is logical for FDA to have extended the qualified health claim to conventional foods, as well as supplements, given they both provide the same beneficial nutrients, we hope that as the positive science continues to build FDA will move towards a full health claim, she said. A full list of companies that petitioned for this health claim is available online (www.fda.gov/ohrms/dockets/dockets/03q0401/03q0401.htm).

Additional information about qualified health claims also is available online (www.cfsan.fda.gov/~dms/lab-qhc.html), and a 36-page letter that defines the specifics for the qualified health claim is expected to be posted soon on the FDA Web site (www.fda.gov).