'product'," "50 percent less saturated fat than our regular 'product'"'); and

(B) Quantitative information comparing the level of saturated fat in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., "saturated fat content has been reduced from 2.5 g per 3 oz to 1.5 g per 3 oz”).

(iii) Claims described in paragraph (c)(5) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for "low saturated fat."

(d) Cholesterol content claims. (1) The terms "cholesterol free," "free of cholesterol," "zero cholesterol," "without cholesterol," "no cholesterol," "trivial source of cholesterol," "negligible source of cholesterol," or "dietarily insignificant source of cholesterol" may be used on the label or in labeling of products, provided that:

(i) The product contains less than 2 milligrams (mg) of cholesterol per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product as defined in §317.313(1), less than 2 mg of cholesterol per labeled serving size;

(ii) The product contains no ingredient that is generally understood by consumers to contain cholesterol, unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: "Adds a trivial amount of cholesterol," "adds a negligible amount of cholesterol," or "adds a dietarily insignificant amount of cholesterol";

(iii) The product contains 2 g or less of saturated fat per reference amount customarily consumed or, in the case of a meal-type product as defined in $317.313(1), 2 g or less of saturated fat per labeled serving size; and

(iv) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which it attaches; or

(v) If the product meets these conditions only as a result of special processing, alteration, formulation, or reformulation, the amount of cholesterol is reduced by 25 percent or more from the reference product it replaces as described in §317.313(j)(1) and for which it substitutes as described in §317.313(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share. As required in §317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the cholesterol was reduced are declared in immediate proximity to the most prominent such claim (e.g., "cholesterol free 'product', contains 100 percent less cholesterol than 'reference product'"); and

(B) Quantitative information comparing the level of cholesterol in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., "contains no cholesterol compared with 30 mg in one serving of 'reference product'").

(2) The terms "low in cholesterol," "low cholesterol," "contains a small amount of cholesterol," "low source of cholesterol," or "little cholesterol" may be used on the label or in labeling of products, except meal-type products as defined in §317.313(1), provided that:

(i)(A) If the product has a reference amount customarily consumed greater than 30 g or greater than 2 tbsp:

(1) The product contains 20 mg or less of cholesterol per reference amount customarily consumed; and

(2) The product contains 2 g or less of saturated fat per reference amount customarily consumed; or

(B) If the product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less:

(1) The product contains 20 mg or less of cholesterol per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients per reference amount customarily consumed, the per-50-g criterion refers to the "as prepared" form); and

(2) The product contains 2 g or less of saturated fat per reference amount customarily consumed.

(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches; or

(iii) If the product contains 20 mg or less of cholesterol only as a result of special processing, alteration, formulation, or reformulation, the amount of cholesterol is reduced by 25 percent or more from the reference product it replaces as described in §317.313(j)(1) and for which it substitutes as described in §317.313(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share. As required in §317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., "low cholesterol 'product', contains 85 percent less cholesterol than our regular 'product' "'); and

(B) Quantitative information comparing the level of cholesterol in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., "cholesterol lowered from 30 mg to 5 mg per serving").

(3) The terms defined in paragraph (d)(2) of this section may be used on the label or in labeling of a meal-type product as defined in §317.313(1), provided that:

(i) The product contains 20 mg or less of cholesterol per 100 g of product;

(ii) The product contains 2 g or less of saturated fat per 100 g of product; and

(iii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.

(4) The terms "reduced cholesterol," "reduced in cholesterol," "cholesterol reduced," "less cholesterol," "lower cholesterol," or "lower in cholesterol" may be used on the label or in labeling of products or products that substitute for those products as specified in §317.313(d), excluding meal-type products as defined in §317.313(1), provided that:

(i) The product has been specifically formulated, altered, or processed to reduce its cholesterol by 25 percent or more from the reference product it replaces as described in §317.313(j)(1) and for which it substitutes as described in §317.313(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share;

(ii) The product contains 2 g or less of saturated fat per reference amount customarily consumed; and

(iii) As required in §317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., "25 percent less cholesterol than 'reference product'"'); and

(B) Quantitative information comparing the level of cholesterol in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., "cholesterol lowered from 55 mg to 30 mg per serving”).

(iv) Claims described in paragraph (d)(4) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for "low cholesterol."

(5) The terms defined in paragraph (d)(4) of this section may be used on the label or in labeling of a meal-type product as defined in §317.313(1), provided that:

(i) The product has been specifically formulated, altered, or processed to reduce its cholesterol by 25 percent or more from the reference product it replaces as described in §317.313(j)(1) and for which it substitutes as described in §317.313(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share;

(ii) The product contains 2 g or less of saturated fat per 100 g of product; and

(iii) As required in §317.313(j)(2) for relative claims:

(A) The identity of the reference product and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., "25% less cholesterol than 'reference product'"); and

(B) Quantitative information comparing the level of cholesterol in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., "cholesterol content has been reduced from 35 mg per 3 oz to 25 mg per 3 oz).

(iv) Claims described in paragraph (d)(5) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for "low cholesterol."

(e) "Lean" and "Extra Lean" claims. (1) The term "lean" may be used on the label or in labeling of a product, provided that the product contains less than 10 g of fat, 4.5 g or less of saturated fat, and less than 95 mg of cholesterol per 100 g of product and per reference amount customarily consumed for individual foods, and per 100 g of product and per labeled serving size for meal-type products as defined in §317.313(1).

(2) The term "extra lean" may be used on the label or in labeling of a product, provided that the product contains less than 5 g of fat, less than 2 g of saturated fat, and less than 95 mg of cholesterol per 100 g of product and per reference amount customarily consumed for individual foods, and per 100 g of product and per labeled serving size for meal-type products as defined in §317.313(1).

[60 FR 193, Jan. 3, 1995]

§317.363 Nutrient content claims for "healthy."

(a) The term "healthy," or any other derivative of the term "health," may be used on the labeling of any meat or meat food product, provided that the

(2) The product shall not contain more than 60 milligrams (mg) of cholesterol per reference amount customarily consumed, per labeled serving size, and, only for foods with reference amounts customarily consumed of 30 grams (g) or less or 2 tablespoons (tbsp) or less, per 50 g, and, for dehydrated products that must be reconstituted with water or a diluent containing an insignificant amount, as defined in §317.309(f)(1), of all nutrients, the per50-g criterion refers to the prepared form, except that:

(i) A meal-type product, as defined in §317.313(1), and including meal-type products that weigh more than 12 ounces (oz) per serving (container), shall not contain more than 90 mg of cholesterol per labeled serving size;

and

(ii) Single-ingredient, raw products may meet the cholesterol criterion for "extra lean"in § 317.362.

(3) The product shall not contain more than 360 mg of sodium, except that it shall not contain more than 480 mg of sodium effective through January 1, 2003, per reference amount customarily consumed, per labeled serving size, and, only for foods with reference amounts customarily consumed of 30 g or less or 2 tbsp or less, per 50 g, and, for dehydrated products that must be reconstituted with water or a diluent containing an insignificant amount, as defined in §317.309(f)(1), of all nutrients, the per-50-g criterion refers to the prepared form, except that:

(i) A meal-type product, as defined in § 317.313(1), and including meal-type products that weigh more than 12 oz per serving (container), shall not contain more than 480 mg of sodium, except that it shall not contain more than 600 mg of sodium effective through January 1, 2003, per labeled serving size; and

(ii) The requirements of this paragraph (b)(3) do not apply to single-ingredient, raw products.

(4) The product shall contain 10 percent or more of the Reference Daily Intake or Daily Reference Value as defined in §317.309 for vitamin A, vitamin C, iron, calcium, protein, or fiber per reference amount customarily consumed prior to any nutrient addition, except that:

(i) A meal-type product, as defined in §317.313(1), and including meal-type products that weigh at least 6 oz but less than 10 oz per serving (container), shall meet the level for two of the nutrients per labeled serving size; and

(ii) A meal-type product, as defined in §317.313(1), and including meal-type products that weigh 10 oz or more per serving (container), shall meet the level for three of the nutrients per labeled serving size.

[59 FR 24228, May 10, 1994, as amended at 60 FR 196, Jan. 3, 1995; 63 FR 7281, Feb. 13, 1998; 64 FR 72492, Dec. 28, 1999]

88317.364-317.368 [Reserved]

$317.369 Labeling applications for nutrient content claims.

(a) This section pertains to labeling applications for claims, express or implied, that characterize the level of any nutrient required to be on the label or in labeling of product by this subpart.

(b) Labeling applications included in this section are:

(1) Labeling applications for a new (heretofore unauthorized) nutrient content claim,

(2) Labeling applications for a synonymous term (i.e., one that is consistent with a term defined by regulation) for characterizing the level of a nutrient, and

(3) Labeling applications for the use of an implied claim in a brand name.

(c) Labeling applications and supporting documentation to be filed under this section shall be submitted in quadruplicate, except that the supporting documentation may be submitted on a computer disc copy. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The labeling appli

cation shall state the applicant's post office address.

(d) Pertinent information will be considered as part of an application on the basis of specific reference to such information submitted to and retained in the files of the Food Safety and Inspection Service. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized (with the understanding that such information may in whole or part be subject to release to the public) in a written statement signed by the person who submitted it. Any reference to published information should be accompanied by reprints or photostatic copies of such references.

(e) If nonclinical laboratory studies accompany a labeling application, the applicant shall include, with respect to each nonclinical study included with the application, either a statement that the study has been, or will be, conducted in compliance with the good laboratory practice regulations as set forth in part 58 of chapter 1, title 21, or, if any such study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(f) If clinical investigations accompany a labeling application, the applicant shall include, with respect to each clinical investigation included with the application, either a statement that the investigation was conducted in compliance with the requirements for institutional review set forth in part 56 of chapter 1, title 21, or was not subject to such requirements in accordance with §56.194 or §56.105, and that it was conducted in compliance with the requirements for informed consents set forth in part 50 of chapter 1, title 21.

(g) The availability for public disclosure of labeling applications, along with supporting documentation, submitted to the Agency under this section will be governed by the rules specified in subchapter D, title 9.

(h) The data specified under this section to accompany a labeling application shall be submitted on separate sheets, suitably identified. If such data has already been submitted with an earlier labeling application from the

applicant, the present labeling application must provide the data.

(i) The labeling application must be signed by the applicant or by his or her attorney or agent, or (if a corporation) by an authorized official.

(j) The labeling application shall include a statement signed by the person responsible for the labeling application, that to the best of his or her knowledge, it is a representative and balanced submission that includes unfavorable information, as well as favorable information, known to him or her pertinent to the evaluation of the labeling application.

(k)(1) Labeling applications for a new nutrient content claim shall be accompanied by the following data which shall be submitted in the following form to the Director, Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, Washington, DC 20250.

(Date)

submits this

The undersigned, labeling application pursuant to 9 CFR 317.369 with respect to (statement of the claim and its proposed use).

Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part of this labeling application, are the following:

(i) A statement identifying the nutrient content claim and the nutrient that the term is intended to characterize with respect to the level of such nutrient. The statement shall address why the use of the term as proposed will not be misleading. The statement shall provide examples of the nutrient content claim as it will be used on labels or labeling, as well as the types of products on which the claim will be used. The statement shall also specify the level at which the nutrient must be present or what other conditions concerning the product must be met for the appropriate use of the term in labels or labeling, as well as any factors that would make the use of the term inappropriate.

(ii) A detailed explanation supported by any necessary data of why use of the food component characterized by the claim is of importance in human nutrition by virtue of its presence or absence at the levels that such claim would describe. This explanation shall also state what nutritional benefit to the public will derive from use of the claim as proposed and why such benefit is not available through the use of existing terms defined by regulation. If the claim is intended for a specific group within the population, the analysis shall specifically address

nutritional needs of such group, and scientific data sufficient for such purpose, and data and information to the extent necessary to demonstrate that consumers can be expected to understand the meaning of the term under the proposed conditions of use.

(iii) Analytical data that demonstrates the amount of the nutrient that is present in the products for which the claim is intended. The assays should be performed on representative samples in accordance with 317.309(h). If no USDA or AOAC methods are available, the applicant shall submit the assay method used, and data establishing the validity of the method for assaying the nutrient in the particular food. The validation data shall include a statistical analysis of the analytical and product variability.

(iv) A detailed analysis of the potential effect of the use of the proposed claim on food consumption, and any corresponding changes in nutrient intake. The analysis shall specifically address the intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is intended for a specific group within the population, the analysis shall specifically address the dietary practices of such group, and shall include data sufficient to demonstrate that the dietary analysis is representative of such group.

Yours very truly, Applicant

By

(Indicate authority)

(2) Upon receipt of the labeling application and supporting documentation, the applicant shall be notified, in writing, of the date on which the labeling application was received. Such notice shall inform the applicant that the labeling application is undergoing Agency review and that the applicant shall subsequently be notified of the Agency's decision to consider for further review or deny the labeling application.

(3) Upon review of the labeling application and supporting documentation, the Agency shall notify the applicant, in writing, that the labeling application is either being considered for further review or that it has been summarily denied by the Administrator.

(4) If the labeling application is summarily denied by the Administrator, the written notification shall state the reasons therefor, including why the Agency has determined that the proposed nutrient content claim is false or misleading. The notification letter