FDA Announces Qualified Health Claim for Omega-3 Fatty Acids 34490

FDA Announces Qualified Health Claim for Omega-3 Fatty Acids

WASHINGTONThe Food and DrugAdministration (FDA) announced Sept. 8 the allowance of a qualified health claimfor omega-3 fatty acids. The health claim links reduced risk of coronary heartdisease (CHD) with consumption of the long-chain omega-3 polyunsaturated fattyacids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). This claim isthe second qualified health claim FDA has announced for conventional food sinceit began considering them in 2003.

Coronary heart disease is one of the top killers ofAmericans today, said Lester M. Crawford, acting FDA commissioner. Itcauses approximately 500,000 deaths annually in the United States. The newqualified health claim for omega-3 fatty acids will empower consumers with moreinformation to help combat this disease and improve their health by identifyingfoods that contain these important compounds. This is also an important step forFDAs Better Nutrition Initiative announced in December 2002.

Qualified health claims for conventional foods must besupported by credible scientific evidence. Based on a systematic evaluation ofthe available scientific data, FDA concluded that while these two particularfatty acids are not essential to the diet, they may be beneficial to reducingCHD risk factors. EPA and DHA omega-3 fatty acids are found in fatty fish suchas salmon, lake trout, tuna and herring, and are available in dietarysupplements.

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

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

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

The Council for Responsible Nutrition (CRN) commended FDAsaction in extending this qualified health claimwhich was previously availableonly for supplementsto include conventional foods, but suggested FDA fellshort of recommending what the science supports.

We are disappointed that FDA established no minimumrequirement for the amount of omega-3 EPA/DHA that a conventional food mustcontain in order to use the qualified health claim, said Annette Dickinson,Ph.D., president of CRN (www.crnusa.org). We further believe it will doconsumers a disservice if foods with insignificant amounts of these fatty acidscarry the claim.

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

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

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

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

At this point in the process, we are not categorizing theclaims by the A, B, C, D levels, Schneeman said. Weare evaluating the level of the sciencecertainly this would be considered ata higher level in terms of the type of science that is supporting the claim, butwe are not assigning that type of letter designation for these claims. Theagency is still involved in doing consumer studies about consumer perception ofthat type of designation.

The qualified health claim comes in response to many petitionssubmitted to FDA. Petitioners, including CRN, requested a full health claim foromega-3 EPA/DHA and reducing the risk of CHD. Todays decision dramaticallywidens FDAs former position regarding the relationship between dietarysupplements containing omega-3 fatty acids and the resulting reduced risk ofCHD, said Jonathan Emord, legal counsel to American Longevity and LifeExtension Foundation Buyers Club, one of the petitioners. The formerqualified health claim contained a substantively limiting disclaimer that failedto adequately assess the benefits of omega-3 fatty acids in reducing the risk ofCHD. FDAs current qualified health claim more accurately describes thecurrent state of the scientific evidence on the benefits of omega-3 fatty acids.

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

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

Several nutritional industry suppliers cheered FDAsdecision. Ocean Nutrition Canada released a statement that it is pleased withthe decision and is prepared to supply its GRAS (generally recognized as safe)omega- 3 powdered food ingredient to manufacturers looking to take advantage ofthe health claim. Similarly, Omega Protein Corp. noted consumers should look forthe combination of EPA and DHA to receive the comprehensive benefits oflong-chain omega-3s; the company supplies a GRAS odorless, taste-free fish oil.