Omega-3/Heart Disease Amended Health Claim Without Disclaimer Proposed

FDA should amend the approved health claim linking omega-3 fatty acids to a reduced risk of coronary heart disease by removing the disclaimer and extending the claim to foods, supplement industry members maintain in a June 23 petition.

The current FDA-required disclaimer for dietary supplements containing omega-3 fatty acids states the scientific evidence in support of a CHD risk reduction claim is "not conclusive."

However, the petition points out "it is now generally accepted in the scientific community that omega-3 fatty acids do reduce the risk of coronary heart disease and the science on the point has established the risk-reducing effect beyond reasonable doubt."

"Accordingly, the claim should now be approved by FDA under the significant scientific agreement standard or, if not so approved, at a minimum allowed consistent with the First Amendment but without requiring the present disclaimer," the petition maintains.

The petition was filed by Washington, D.C.-based Emord & Associates on behalf of supplement marketer Wellness Lifestyles and the nonprofit organization Life Extension Foundation Buyers Club.

The proposal comes on the heels of a "prompt letter" sent to HHS and USDA by the Office of Management & Budget. In the letter, OMB urged the agencies to make information about the link between omega-3 fatty acids and CHD "as widely available as possible" (¹ 'The Tan Sheet' June 2, 2003, In Brief).

An amended omega-3 health claim would further this directive, Emord points out. "The truthful, succinct and accurate health information conveyed by the...amended health claim will enable consumers to make prudent and effective dietary choices, cognizant of omega-3 fatty acids' [CHD] risk-reducing effects."

Furthermore, extending the claim to foods "will inform consumers at the point of sale of the strong scientific evidence now extant concerning dietary means by which omega-3 fatty acids lessen the risk of coronary heart disease," the petition says.

The petitioners propose the following amended health claim: "Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease."

"Multiple studies have shown that consumption of omega-3 fatty acid-containing foods and dietary supplements reduces the risk of coronary heart disease. Moreover, recent clinical trials have proven to a near conclusive degree its safety and efficacy for use by the general population," the amended claim states.

To support the health claim amendment, the petition notes that since 1999, when FDA first began examining the relationship between omega-3s and CHD, "several major studies have been published that support the claim and render the present required disclaimer unnecessary and inaccurate."

Specifically, Emord notes that since 2000, eight clinical trials have evaluated the effects of omega-3 consumption on the incidence of CHD.

The petition points to the Harvard Physicians' Study and the Nurses' Health Study, which both found that higher consumption of fish and omega-3 fatty acids led to a reduced risk of coronary heart disease and CHD deaths (² (Also see "Omega-3 Protective Effects Against Sudden Death Start Early – Study" - Pink Sheet, 15 Apr, 2002.), p. 12).

Emord also cites the Italian GISSI-Prevenzione trial, which was conducted in 1999 and reanalyzed in 2002. The study found total mortality among myocardial infarction survivors was significantly lowered after only three months of omega-3 supplementation.

The proposed amended health claim does not identify specific intake quantities for omega-3 fatty acids, which represents a departure from the current claim's requirements.

In approving the omega-3/CHD claim in November 2000, FDA stipulated supplements bearing the claim must recommend a maximum daily intake of 2 g of eicosapentaenoic and docosahexaenoic acids (³ (Also see "Omega-3/Heart Disease Qualified Supplement Health Claim Allowed" - Pink Sheet, 6 Nov, 2000.), p. 3).

However, the petition points out that "studies have measured omega-3 fatty acid supplementation to have nutritive value from 200 mg to 28 grams a day."

Moreover, the petition states there are "no serious adverse events reported in conjunction with consumption of omega-3 fatty acid supplements, even up to 15 grams per day of omega-3 fatty acids for prolonged periods of time." Emord acknowledges mild side effects from omega-3s such as nausea, diarrhea and "fishy" smelling breath and skin have been reported.