Qualified Omega-3 Fatty Acid Health Claim Proposed By Industry Group

A qualified health claim concerning the relationship between omega-3 fatty acids and a reduced risk for coronary heart disease should be cleared by FDA, a joint industry group states in Nov. 21 comments to the agency.

The group, composed of the Consumer Healthcare Products Association, the Council for Responsible Nutrition and the National Fisheries Institute, submitted the remarks in response to FDA's Sept. 8 request for comments and/or scientific data on the four potential health claims the agency must consider as a result of the Pearson v. Shalala court decision ("The Tan Sheet" Sept. 13, p. 3). The comment period ended Nov. 22.

The claim submitted for FDA review states: "Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease." In its place, the task group recommends: "Consumption of long chain omega-3 fatty acids (EPA and DHA) may reduce your risk of coronary heart disease through lowering triglycerides and other possible mechanisms. The evidence is compelling but further research is needed."

The statement follows the Pearson court's guidelines for allowing claims with disclaimers when the resulting claim is nonmisleading. CRN, CHPA and NFI submitted 120 pages of scientific data supporting the proposed claim, and noted they will submit further information on other possible mechanisms for reducing the risk of coronary heart disease (such as arrhythmia, anti-platelet action and the vascular inflammatory effects of omega-3 fatty acids) when the "docket is reopened for comment."

In an Oct. 27 letter to the Center for Food Safety & Applied Nutrition, the group asked that the comment period be extended from Nov. 22 to Dec. 20 due to the amount of time needed to organize the information.

In a Nov. 12 response, FDA denied the request, but noted it would be reopening the docket following the publication of its "significant scientific agreement" guidance, after which the task group could submit additional comments. FDA is reopening the dockets on the four claims in response to a letter from Pearson plaintiffs' counsel Emord & Associates ("The Tan Sheet" Oct. 18, In Brief).

The joint commenters maintain, however, that FDA should publish a notice of proposed rulemaking authorizing their proposed health claim "for all types of foods, including both conventional foods and dietary supplement products." Moreover, the claim should be allowed to appear in labeling "immediately at the time of proposal," they assert.

In separate Nov. 22 comments regarding two of the other Pearson claims - "consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers" and".8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form" - CRN again proposes modified versions.

Regarding antioxidants and reduced risk of cancer, CRN says that sufficiently suggestive but inconclusive evidence exists linking the two. Therefore, the trade group concludes, a general claim concerning the relationship could be qualified to read: "Diets rich in fruits and vegetables may reduce the risk of some types of cancer. The evidence suggests antioxidant vitamins such as vitamin C and vitamin E may be responsible for at least part of that benefit. More research is needed."

For cases where "the evidence strongly suggests a relationship between one or more antioxidant vitamins and a specific type of cancer...language appropriately describing the state of the evidence" should be considered, CRN opines.

An example of such a claim, CRN adds, would be: "Higher intake of vitamin C and increased blood levels of vitamin C may help protect against cancer of the stomach. The evidence is not conclusive, and more research is needed."

For the folic acid claim, CRN says significant evidence exists showing that women of childbearing age should get .4 mg of "synthetic folic acid daily, in addition to the folate that occurs naturally in their diets." However, the trade association does not believe .8 mg is a necessary dose, stating numerous studies show".4 mg of folic acid is as effective as supplementation with larger amounts." As a result, CRN maintains the Pearson claim needs to be altered; however, the group does not appear to believe the resulting claim would need a disclaimer.

The Pearson plaintiffs, along with Julian Whitaker, MD, Mycology Research Labs, Pure Encapsulations, Weider Nutrition and XCEL Medical Pharmacy, also submitted comments Nov. 22, stating sufficient evidence exists to support each claim and any inherent confusion may be cleared up with the addition of a disclaimer.