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 interstate commerce. The claim may be made after 120 days from the date of submission of the notification until such time as FDA issues a regulation: (1) prohibiting or modifying the claim or (2) finding that the requirements of the Act have not been met, or a district court in an enforcement proceeding has determined that the requirements for making such a claim have not been met.
On August 8, 2003, Kraft Foods submitted a notification (the "Kraft notification") containing the following proposed claim: "Diets rich in whole grain foods and other plant foods, and low in saturated fat and cholesterol, may help reduce the risk of heart disease." The 120-day period from the date of submission of the Kraft notification is December 9, 2003. Therefore, after December 9, 2003, manufacturers may use the specified claim on the label and in labeling of any food product that meets the eligibility criteria described in the Kraft notification (and stated below), unless or until FDA or a court acts to prohibit the claim.
The Kraft notification cites statements from the NAS report, Diet and Health: Implications for Reducing Chronic Disease Risk (pages 7, 8 and 13) as authoritative statements for the claim. The following statements within Diet and Health were included in the Kraft notification as authoritative statements.
"Diets high in plant foods - i.e., fruits, vegetables, legumes and whole-grain cereals - are associated with a lower occurrence of coronary heart disease and cancers of the lung, colon, esophagus and stomach." (page 8)
"Although the mechanisms underlying these effects are not fully understood, the inverse association with coronary heart disease may be largely explained by the usually low saturated fatty acid and cholesterol content of such diets. Such diets are also low in total fat, which is directly associated with the risk of certain cancers, but rich in complex carbohydrates (starches and fiber) and certain vitamins, minerals, trace elements, and nonnutritive constituents, and these factors probably also confer protection against certain cancers and coronary heart disease." (page 8)
"Intake of total fat per se, independent of the relative content of the different types of fatty acids, is not associated with high blood cholesterol levels and coronary heart disease. A reduction in total fat consumption, however, facilitates reduction of saturated fatty acid intake; hence, in addition to reducing the risk of certain cancers, and possibly obesity, it is a rational part of a program aimed at reducing the risk of coronary heart disease." (page 7)
"A large and convincing body of evidence from studies in human and laboratory animals shows that diets low in saturated fatty acids and cholesterol are associated with low risks and rates of atherosclerotic cardiovascular diseases. High-fat diets are also linked to a high incidence of some types of cancer and, probably, obesity. Thus, reducing total fat and saturated fatty acid intake is likely to lower the rates of these chronic diseases. Fat intake should be reduced by curtailing the major sources of dietary fats rather than by eliminating whole categories of foods. For example, by substituting fish, poultry without skin, lean meats, and low- or nonfat dairy products for high-fat foods, one can lower total fat and saturated fatty acid intake while ensuring an adequate intake of iron and calcium - two nutrients of special importance to women. Dietary fat can also be reduced by limiting intake of fried foods, baked goods containing high levels of fat, and spreads and dressings containing fats and oils." (page 13)
In May 1997, the National Research Council (NRC) Governing Board of NAS approved a policy statement regarding authoritative statements made by NAS or its subdivisions, the NRC and the Institute of Medicine (IOM). According to the policy, authoritative statements "are limited to those that represent the consensus of a duly-appointed committee or views of a duly-appointed principal investigator so that they appear explicitly as findings, conclusions or recommendations in a report that has completed the institutional report review process." As articulated in the policy statement, the Executive Summary of Diet and Health (which integrates all the evidence reviewed in the total report) provides the findings, general conclusions and recommendations, based on consensus, of the Committee of Diet and Health.
FDA reviewed the authoritative statements from Diet and Health in their context and in light of existing authorized health claims and current science for coronary heart disease. Following FDA's previously established procedures, on September 9, 2003, FDA offered NAS the opportunity to comment on the statements from Diet and Health cited in the notification. See Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body (June 11, 1998). FDA received no comment from NAS.
The Kraft notification defined "whole grain foods," as specified in the 1999 whole grain notification, as foods that contain 51% or more whole grain ingredient(s) by weight per reference amount customarily consumed (RACC). FDA intends to assess compliance with this definition in the use of the proposed health claim by reference to the dietary fiber level of whole wheat, the predominant grain in the U.S. diet. Whole wheat contains 11 grams of dietary fiber per 100 grams; thus, the qualifying amount of dietary fiber required for a food to bear the prospective claim may be determined by the following formula: 11 grams x 51% x RACC/100.
The Kraft notification states that in order for foods to qualify for the proposed claim the foods must: (1) contain a minimum of 51% whole grains (using dietary fiber as a marker); (2) meet the regulatory definitions for "low saturated fat" and "low cholesterol;" (3) bear quantitative trans fat labeling; and (4) contain less than 6.5 grams total fat and 0.5 gram or less trans fat per RACC. To meet the definitions in (2) noted above, the qualifying foods must contain 1 gram or less of saturated fat and 20 milligrams or less of cholesterol per RACC.
The notification and materials regarding the claim are publicly available from the FDA Division of Dockets Management (Docket No.03Q-0547). 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 240-402-7500. FDA also intends to make the documents available on the Dockets web site, under Docket No. 03Q-0547.
This document was published on December 9, 2003
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