Prepared Foods July 25, 2005 enewsletter

The minor differences between a rejected health claim last April for eggs enriched with omega-3 fatty acids and a recent narrowly approved health claim for green tea may give industry an idea of where FDA draws the line on approving food health claims. FDA says both claims were based on weak evidence, but the green tea claim was based on a controlled trial.

FDA in April rejected a health claim linking omega-3 fatty acids in eggs to a reduction in heart disease because the agency say there is not enough credible evidence to support the claim.

However, FDA recently approved a health claim linking green tea consumption and a reduced risk of breast and prostate cancer, even though the claim was based on, in FDA's words, "a weak, more limited study." FDA is requiring that the health claim include a disclaimer stating, "FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer."

A spokesperson from FDA's Center for Food Safety and Applied Nutrition says there were minor differences between the data presented in the petitions. The egg petition contained more uncontrolled, preliminary studies that provided no credible evidence. The green tea claim was based on a controlled trial. Belgium-based Belovo makes the omega-3 enriched eggs. The eggs were found to have an unusually high amount of cholesterol and saturated fat that could counteract omega-3 benefits.

FDA also specified that the Belovo egg cannot bear a general health claim that was approved last fall for omega-3 fatty acids.

Note: The preceding article was an edited version of an article found in the July 15th edition ofFDA Week. Belovo has contacted Prepared Foods to counter the accusations made regarding the cholesterol content of its eggs. The company's response follows:

Belovo/Christopher Eggs: "The official decision of the FDA regarding Belovo's petition for a qualified health claim references the eggs' cholesterol and saturated fat content only to state that the data provided does not justify overriding their usual maximum allowable levels for qualified foods. In fact, Belovo eggs contain less or at least the same amount of cholesterol and saturated fat per serving as standard eggs."