FDA's qualified health claim linking omega-3 fatty acids to coronary heart disease too narrowly interprets the beneficial relationship, dietary supplement industry stakeholders contend.

Representatives from the supplement arena, including the Council for Responsible Nutrition and the Washington, D.C. law firm Emord & Associates, maintain the claim should be unqualified and that FDA overlooked vast amounts of evidence in making its decision.

The agency said Sept. 8 that conventional foods and supplements containing the long-chain polyunsaturated fatty acids eiscosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) would be permitted to bear a qualified heart disease claim. The claim may be applied to both fish and microalgal sources of the oils.

The claim is the second in the process outlined by FDA as part of the "Better Information for Better Nutrition" initiative, announced in December 2002 and outlined in July 2003 (¹ Also see "FDA Consumer Health Information Task Force To Be Chaired By Crawford" - Pink Sheet, 23 December, 2002., p. 11 and ² Also see "Qualified Health Claims Scientific Evidence To Be Assessed, Ranked By FDA" - Pink Sheet, 14 July, 2003., p. 3). Although the agency said it would "grade" the claims via a letter system, the current claim was not specified to have received an "A," "B," "C" or "D" rating.

Martek Biosciences' petition, submitted in November 2003, proposed an unqualified heart disease claim for fish oil products and supplements, but exempted fish due to their high mercury levels (³ Also see "Martek Casts For CHD Reduction Claim For Fish Oils, Big Disclaimer For Fish" - Pink Sheet, 1 December, 2003., p. 14).

The approved claim states: "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.]"

Stakeholders concede the new claim improves upon an earlier version approved in November 2000 and later shortened in February 2002 (⁴ 'The Tan Sheet' Feb. 11, 2002, In Brief). The statement originally was cleared as a result of the Pearson v. Shalala Supreme Court case.

The previous claim, which applied only to supplements, stated: "Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease. FDA evaluated the data and determined that, although there is scientific evidence supporting the claim, the evidence is not conclusive."

As part of the new claim, FDA is recommending that the public not consume more than 3 g/day of omega-3s from fish or more than 2 g/day from a supplement; this is consistent with the previous version of the claim.

During a same-day press briefing, FDA declined to compare the two claims, or to contrast supplemental versus dietary omega-3s, noting the two sources were not compared as part of the agency's review.

The agency noted the claim only relates to omega-3s and coronary heart disease, and not to other structure/function-type claims, such as the oils' purported beneficial effect on brain and eye development. DHA and arachidonic acid, another long-chain polyunsaturated fatty acid, are included in several infant formulas and are tagged with such claims.

CRN asserts that extending the claim to conventional foods is appropriate, but says the link between CHD and omega-3s is convincing enough to merit an unqualified claim.

The group also expresses concern over the fact that there is no threshold level of omega-3s required for a label to bear the claims. In a Sept. 8 statement, CRN says the lack of threshold "will do consumers a disservice if foods with insignificant amounts of these fatty acids carry the claim."

During the call, FDA emphasized it "will work with individuals who want to use the claim to make sure they're using an appropriate database" so an accurate message is conveyed to consumers.

Attorney Jonathan Emord echoes CRN's sentiments regarding the qualified claims, but contends the new claim represents a "vast improvement" over the previous version, particularly because fewer words mean the statement can be placed on product labels.

However, he says evidence supporting the link is "not merely suggestive, but strong." His firm authored a petition in June 2003 on behalf of supplement marketer Wellness Lifestyles and the nonprofit group Life Extension Foundation Buyers Club to remove the disclaimer (⁵ Also see "Omega-3/Heart Disease Amended Health Claim Without Disclaimer Proposed" - Pink Sheet, 30 June, 2003., p. 11).

Emord vows that industry will continue to work with FDA to remove the "suggestive" statement.

Industry Qualifies Enthusiasm For Omega-3 Qualified Health Claim

More from Archive

More from Pink Sheet