Under section 403(r)(3)(C) (21 U.S.C. §343(r)(3)(C)) of the Federal Food, Drug, and Cosmetic Act (Act), a manufacturer may submit to the Food and Drug Administration (FDA) a notification of a health claim based on an authoritative statement from an appropriate scientific body of the United States Government or the National Academy of Sciences (NAS) or any of its subdivisions. The notification must be submitted to FDA at least 120 days before the food is introduced into intestate commerce. The claim may be made after 120 days from the date of submission of the notification until such time as 1) FDA issues a regulation prohibiting or modifying the claim or finding that the requirements for making the claim have not been met, or 2) a district court in an enforcement proceeding has determined that the requirements for making the claim have not been met.
On July 18, 2006, the FDA received a notification from the law firm of Hogan & Hartson LLP on behalf of the Kraft Foods Global, Inc. (Kraft) regarding a health claim for the relationship between dietary consumption of saturated fat, cholesterol, and trans fat, and the risk of heart disease. The 120-day period from the date of submission of the Kraft notification was November 15, 2006. Therefore, after this date, manufacturers may use the claim specified in the notification, as modified by the notifier in a letter to FDA dated November 10, on the label and in labeling of any food product that meets the eligibility criteria described below, unless or until FDA or a court acts to prohibit the claim.
The letter dated November 10 cites statements from the 2005 Dietary Guidelines for Americans as authoritative statements for this claim. The following statements are considered authoritative for purposes of this notification.
Executive Summary (page viii) or Key Recommendations (page 30):
"Consume less than 10 percent of calories from saturated fatty acids and less than 300 mg/day of cholesterol, and keep trans fatty acid consumption as low as possible."
Overview to the Fats chapter (page 29):
"High intake of saturated fats, trans fats, and cholesterol increases the risk of unhealthy blood lipids levels, which, in turn, may increase the risk of coronary heart disease."
According to the July 18 Kraft notification and the letter to FDA dated November 10, the food(s) eligible to bear the claim must (1) meet the FDA regulatory definitions for "low saturated fat" and "low cholesterol" as defined in 21 CFR 101.62 (c)(2) and (3) and 21 CFR 101.62(d)(2) and (3), respectively; (2) contain less than 0.5 g of trans fat per reference amount customarily consumed (RACC) or must meet any FDA definition of "low" trans fat if a definition is established; (3) contain less than 6.5 grams total fat per RACC; (4) be in accordance with all general health claim requirements found in 21 CFR 101.14 except for the requirement that the claim be specifically provided for in subpart E of 21 CFR part 101. The general health claim requirements include, in part, a requirement that the food must not exceed 480 mg of sodium per RACC. The foods must also meet the minimum nutrient contribution requirement for health claims (21 CFR § 101.14 (e)(6)). To meet the definitions in (1) noted above, the qualifying foods must contain 1 gram or less of saturated fat and 20 milligrams or less of cholesterol per RACC. The exact wording of the claim is: "Diets low in saturated fat and cholesterol, and as low as possible in trans fat, may reduce the risk of heart disease."
The notification and materials regarding the claim are publicly available from the FDA Division of Dockets Management (Docket No. 2006Q-0458). Persons interested in these documents may view them at the Division of Dockets Management from 9am to 4pm, Monday through Friday at 5630 Fishers Lane, room 1061, Rockville, MD 20852. The Division of Dockets Management may be contacted at 301-827-6860. FDA also intends to make the documents available on the Dockets web site, under Docket No. 2006Q-0458.