FDA Authorizes Health Claim about Consumption of Saturated Fat, Trans Fat, and Cholesterol and Risk of Heart Disease
Provided by Olsson, Frank and Weeda, P.C.
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Monday, November 27, 2006
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The Food and Drug Administration (FDA) has issued an announcement authorizing a new health claim about consumption of saturated fat, trans fat, and cholesterol and reduced risk of heart disease (copy attached). The health claim, which may be used beginning November 15, 2006, reads as follows:
"Diets low in saturated fat and cholesterol, and as low as possible in trans fat, may reduce the risk of heart disease."
To qualify for this health claim, a food must meet the following requirements: 1. It must qualify as "low saturated fat" and "low cholesterol" (i.e., contain 1 gram (g) or less of saturated fat and 20 milligrams (mg) or less of cholesterol per reference amount customarily consumed (RACC));
2. It must contain less than 0.5 g of trans fat per RACC or meet any definition of "low trans fat" that FDA may establish in the future;*
3. It must contain less than 6.5 g of total fat per RACC; and
4. It must comply with all of the general requirements for health claims set forth in 21 C.F.R. § 101.14 (except for the requirement that the claim be specifically provided for in FDA regulations).
The new health claim is authorized pursuant to the notification procedure established by the FDA Modernization Act of 1997 (FDAMA). See generally 21 U.S.C. § 343(r)(3)(C). Under that provision, a person may submit to FDA a notification of a health claim based on an authoritative statement of a scientific body of the U.S. government with official responsibility for public health or the National Academy of Sciences. The notification must be submitted at least 120 days before the food bearing the claim is introduced into interstate commerce. If FDA authorizes the claim, it may be used in labeling until such time as FDA issues a regulation modifying or prohibiting the claim or a U.S. federal court issues a ruling prohibiting the claim. This new health claim is based on a notification submitted by the law firm of Hogan & Hartson on behalf of Kraft Foods Global, Inc.
------------------------------- *FDA has not yet established a definition for "low trans fat."
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