Source: https://www.law.cornell.edu/cfr/text/9/381.469
Timestamp: 2015-02-28 02:06:00
Document Index: 282327602

Matched Legal Cases: ['art 381', '§ 381', 'art 58', 'art 56', '§ 56', '§ 56', 'art 50', 'art 381']

9 CFR 381.469 - Labeling applications for nutrient content claims. | LII / Legal Information Institute
CFR › Title 9 › Chapter III › Subchapter A › Part 381 › Subpart Y › Section 381.469 9 CFR 381.469 - Labeling applications for nutrient content claims.
§ 381.469
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.
Labeling applications included in this section are:
Labeling applications for a new (heretofore unauthorized) nutrient content claim,
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
Labeling applications for the use of an implied claim in a brand name.
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.
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.
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.
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:
The undersigned, ______ submits this labeling application pursuant to 9 CFR 381.469 with respect to (statement of the claim and its proposed use).
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.
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.
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 381.409(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.
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 above 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.
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 shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed nutrient content claim.
If the labeling application is not summarily denied by the Administrator, the Administrator shall publish in the Federal Register a proposed rule to amend the regulations to authorize the use of the nutrient content claim. The proposal shall also summarize the labeling application, including where the supporting documentation can be reviewed. The Administrator's proposed rule shall seek comment from consumers, the industry, consumer and industry groups, and other interested persons on the labeling application and the use of the proposed nutrient content claim. After public comment has been received and reviewed by the Agency, the Administrator shall make a determination on whether the proposed nutrient content claim shall be approved for use on the labeling of poultry products.
If the claim is denied by the Administrator, the Agency shall notify the applicant, in writing, of the basis for the denial, including the reason why the claim on the labeling was determined by the Agency to be false or misleading. The notification letter shall also inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed nutrient content claim.
The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of the notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.
If the claim is approved, the Agency shall notify the applicant, in writing, and shall also publish in the Federal Register a final rule amending the regulations to authorize the use of the claim.
Labeling applications for a synonymous term 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:
The undersigned, ______ submits this labeling application pursuant to 9 CFR 381.469 with respect to (statement of the synonymous term and its proposed use in a nutrient content claim that is consistent with an existing term that has been defined under subpart Y of part 381).
A statement identifying the synonymous term, the existing term defined by a regulation with which the synonymous term is claimed to be consistent, and the nutrient that the term is intended to characterize the level of. The statement shall address why the use of the synonymous 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 whether any limitations not applicable to the use of the defined term are intended to apply to the use of the synonymous term.
A detailed explanation supported by any necessary data of why use of the proposed term is requested, including whether the existing defined term is inadequate for the purpose of effectively characterizing the level of a nutrient. 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 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, 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.
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 synonymous term is false or misleading. The notification letter shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed synonymous term.
If the claim is approved, the Agency shall notify the applicant, in writing, and shall publish in the Federal Register a notice informing the public that the synonymous term has been approved for use.
Labeling applications for the use of an implied nutrient content claim in a brand name 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:
The undersigned, ______ submits this labeling application pursuant to 9 CFR 381.469 with respect to (statement of the implied nutrient content claim and its proposed use in a brand name).
A statement identifying the implied nutrient content claim, the nutrient the claim is intended to characterize, the corresponding term for characterizing the level of such nutrient as defined by a regulation, and the brand name of which the implied claim is intended to be a part. The statement shall address why the use of the brand-name as proposed will not be misleading. The statement shall provide examples of the types of products on which the brand name will appear. It shall also include data showing that the actual level of the nutrient in the food would qualify the label of the product to bear the corresponding term defined by regulation. Assay methods used to determine the level of a nutrient shall meet the requirements stated under labeling application format in paragraph (k)(1)(iii) of this section.
A detailed explanation supported by any necessary data of why use of the proposed brand name is requested. This explanation shall also state what nutritional benefit to the public will derive from use of the brand name as proposed. If the branded product 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.
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 implied nutrient content claim is false or misleading. The notification letter shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed implied nutrient content claim.
If the labeling application is not summarily denied by the Administrator, the Administrator shall publish a notice of the labeling application in the Federal Register seeking a comment on the use of the implied nutrient content claim. The notice shall also summarize the labeling application, including where the supporting documentation can be reviewed. The Administrator's notice shall seek comment from consumers, the industry, consumer and industry groups, and other interested persons on the labeling application and the use of the implied nutrient content claim. After public comment has been received and reviewed by the Agency, the Administrator shall make a determination on whether the implied nutrient content claim shall be approved for use on the labeling of poultry products.
If the claim is denied by the Administrator, the Agency shall notify the applicant, in writing, of the basis for the denial, including the reason why the claim on the labeling was determined by the Agency to be false or misleading. The notification letter shall also inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed implied nutrient content claim.
If the claim is approved, the Agency shall notify the applicant, in writing, and shall also publish in the Federal Register a notice informing the public that the implied nutrient content claim has been approved for use.
[58 FR 675, Jan. 6, 1993, as amended at 59 FR 45198, Sept. 1, 1994; 60 FR 217, Jan. 3, 1995]