[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR101.69]

[Page 115-119]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 101_FOOD LABELING--Table of Contents
 
       Subpart D_Specific Requirements for Nutrient Content Claims
 
Sec.  101.69  Petitions for nutrient content claims.

    (a) This section pertains to petitions for claims, expressed or 
implied, that:
    (1) Characterize the level of any nutrient which is of the type 
required to be in the label or labeling of food by section 403(q)(1) or 
(q)(2) of the Federal Food, Drug, and Cosmetic Act (the act); and
    (2) That are not exempted under section 403(r)(5)(A) through 
(r)(5)(C) of the act from the requirements for such claims in section 
403(r)(2).
    (b) Petitions included in this section are:
    (1) Petitions for a new (heretofore unauthorized) nutrient content 
claim;
    (2) Petitions 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) Petitions for the use of an implied claim in a brand name.
    (c) An original and one copy of the petition to be filed under the 
provisions of section 403(r)(4) of the act shall be submitted, or the 
petitioner may submit an original and a computer readable disk 
containing the petition.

[[Page 116]]

Contents of the disk should be in a standard format, such as ASCII 
format. Petitioners interested in submitting a disk should contact the 
Food and Drug Administration's (FDA) Center for Food Safety and Applied 
Nutrition for details. If any part of the material submitted is in a 
foreign language, it shall be accompanied by an accurate and complete 
English translation. The petition shall state the petitioner's post 
office address to which published notices as required by section 403 of 
the act may be sent.
    (d) Pertinent information may be incorporated in, and will be 
considered as part of, a petition on the basis of specific reference to 
such information submitted to and retained in the files of FDA. 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any reference to unpublished information furnished by a person other 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 are included in a petition 
submitted under section 403(r)(4) of the act, the petition shall 
include, with respect to each nonclinical study contained in the 
petition, 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 this chapter 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 are included in a petition submitted 
under section 403(r)(4) of the act, the petition shall include a 
statement regarding each such clinical investigation relied upon in the 
petition that the study either was conducted in compliance with the 
requirements for institutional review set forth in part 56 of this 
chapter or was not subject to such requirements in accordance with Sec.  
56.104 or Sec.  56.105 of this chapter, and that it was conducted in 
compliance with the requirements for informed consent set forth in part 
50 of this chapter.
    (g) The availability for public disclosure of petitions submitted to 
the agency under this section will be governed by the rules specified in 
Sec.  10.20(j) of this chapter.
    (h) All petitions submitted under this section shall include either 
a claim for a categorical exclusion under Sec.  25.30 or 25.32 of this 
chapter or an environmental assessment under Sec.  25.40 of this 
chapter.
    (i) The data specified under the several lettered headings should be 
submitted on separate sheets or sets of sheets, suitably identified. If 
such data have already been submitted with an earlier application from 
the petitioner, the present petition may incorporate it by specific 
reference to the earlier petition.
    (j) The petition must be signed by the petitioner or by his attorney 
or agent, or (if a corporation) by an authorized official.
    (k) The petition shall include a statement signed by the person 
responsible for the petition, that to the best of his knowledge, it is a 
representative and balanced submission that includes unfavorable 
information, as well as favorable information, known to him pertinent to 
the evaluation of the petition.
    (l) All applicable provisions of part 10--Administrative Practices 
and Procedures, may be used by FDA, the petitioner or any outside party 
with respect to any agency action on the petition.
    (m)(1) Petitions for a new nutrient content claim shall include the 
following data and be submitted in the following form.

(Date) ------------
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Office of Nutritional Products, Labeling and Dietary Supplements (HFS-
800)
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
    The undersigned, ------------------------ submits this petition 
under section 403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the 
act) with respect to (statement of the claim and its proposed use).
    Attached hereto and constituting a part of this petition, are the 
following:

[[Page 117]]

    A. A statement identifying the descriptive term and the nutrient 
that the term is intended to characterize with respect to the level of 
such nutrient. The statement should address why the use of the term as 
proposed will not be misleading. The statement should provide examples 
of the nutrient content claim as it will be used on labels or labeling, 
as well as the types of foods on which the claim will be used. The 
statement shall specify the level at which the nutrient must be present 
or what other conditions concerning the food must be met for the use of 
the term in labels or labeling to be appropriate, as well as any factors 
that would make the use of the term inappropriate.
    B. 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 under section 403(r)(2)(A)(i) of 
the act. If the claim is intended for a specific group within the 
population, the analysis should specifically address nutritional needs 
of such group, and should include scientific data sufficient for such 
purpose.
    C. Analytical data that shows the amount of the nutrient that is the 
subject of the claim and that is present in the types of foods for which 
the claim is intended. The assays should be performed on representative 
samples using the AOAC INTERNATIONAL (AOAC International) methods where 
available. If no AOAC International method is available, the petitioner 
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 should include a statistical analysis of the analytical 
and product variability.
    D. A detailed analysis of the potential effect of the use of the 
proposed claim on food consumption and of any corresponding changes in 
nutrient intake. The latter item 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.
    E. The petitioner is required to submit either a claim for 
categorical exclusion under Sec.  25.30 or Sec.  25.32 of this chapter 
or an environmental assessment under Sec.  25.40 of this chapter.
    Yours very truly,
    Petitioner ------------
    By ------------
    (Indicate authority)

    (2) Within 15 days of receipt of the petition, the petitioner will 
be notified by letter of the date on which the petition was received by 
the agency. Such notice will inform the petitioner:
    (i) That the petition is undergoing agency review (in which case a 
docket number will be assigned to the petition), and the petitioner will 
subsequently be notified of the agency's decision to file or deny the 
petition; or
    (ii) That the petition is incomplete, e.g., it lacks any of the data 
required by this part, it presents such data in a manner that is not 
readily understood, or it has not been submitted in quadruplicate, in 
which case the petition will be denied, and the petitioner will be 
notified as to what respect the petition is incomplete.
    (3) Within 100 days of the date of receipt of the petition, FDA will 
notify the petitioner by letter that the petition has either been filed 
or denied. If denied, the notification shall state the reasons therefor. 
If filed, the date of the notification letter becomes the date of filing 
for the purposes of section 403(r)(4)(A)(i) of the act. If FDA does not 
act within such 100 days, the petition shall be deemed to be denied 
unless an extension is mutually agreed upon by the FDA and the 
petitioner. A petition that has been denied, or has been deemed to be 
denied, without filing shall not be made available to the public. A 
filed petition shall be available to the public as provided under 
paragraph (g) of this section.
    (4) Within 90 days of the date of filing FDA will by letter of 
notification to the petitioner:
    (i) Deny the petition; or
    (ii) Inform the petitioner that a proposed regulation to provide for 
the requested use of the new term will be published in the Federal 
Register. FDA will publish the proposal to amend the regulations to 
provide for the requested use of the nutrient content claim in the 
Federal Register within 90 days of the date of filing. The proposal will 
also announce the availability of the petition for public disclosure.
    (iii) If FDA does not act within 90 days of the date of filing, the 
petition

[[Page 118]]

shall be deemed to be denied unless an extension is mutually agreed upon 
by FDA and the petitioner.
    (5) If FDA issues a proposal, the rulemaking shall be completed 
within 540 days of the date of receipt of the petition.
    (n)(1) Petitions for a synonymous term shall include the following 
data and be submitted in the following form.

(Date)------------
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Office of Nutritional Products, Labeling and Dietary Supplements (HFS-
800)
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
    The undersigned, ------------ submits this petition under section 
403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the act) 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 section 403(r)(2) of the act).
    Attached hereto and constituting a part of this petition, are the 
following:
    A. A statement identifying the synonymous descriptive term, the 
existing term defined by a regulation under section 403(r)(2)(A)(i) of 
the act with which the synonymous term is claimed to be consistent. The 
statement should address why the proposed synonymous term is consistent 
with the term already defined by the agency, and why the use of the 
synonymous term as proposed will not be misleading. The statement should 
provide examples of the nutrient content claim as it will be used on 
labels or labeling, as well as the types of foods on which the claim 
will be used. The statement shall specify whether any limitations not 
applicable to the use of the defined term are intended to apply to the 
use of the synonymous term.
    B. A detailed explanation, supported by any necessary data, of why 
use of the proposed term is requested, including an explanation of 
whether the existing defined term is inadequate for the purpose of 
effectively characterizing the level of a nutrient. This item 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 term defined by regulation. If the claim is intended for a 
specific group within the population, the analysis should specifically 
address nutritional needs of such group, and should include scientific 
data sufficient for such purpose.
    C. The petitioner is required to submit either a claim for 
categorical exclusion under Sec.  25.30 or Sec.  25.32 of this chapter 
or an environmental assessment under Sec.  25.40 of this chapter.
    Yours very truly,
    Petitioner ------------
    By ------------
    (Indicate authority)

    (2) Within 15 days of receipt of the petition the petitioner will be 
notified by letter of the date on which the petition was received. Such 
notice will inform the petitioner:
    (i) That the petition is undergoing agency review (in which case a 
docket number will be assigned to the petition) and the petitioner will 
subsequently be notified of the agency's decision to grant the 
petitioner permission to use the proposed term or to deny the petition; 
or
    (ii) That the petition is incomplete, e.g., it lacks any of the data 
required by this part, it presents such data in a manner that is not 
readily understood, or it has not been submitted in quadruplicate, in 
which case the petition will be denied, and the petitioner will be 
notified as to what respect the petition is incomplete.
    (3) Within 90 days of the date of receipt of the petition that is 
accepted for review (i.e., that has not been found to be incomplete and 
consequently denied, FDA will notify the petitioner by letter of the 
agency's decision to grant the petitioner permission to use the proposed 
term, with any conditions or limitations on such use specified, or to 
deny the petition, in which case the letter shall state the reasons 
therefor. Failure of the petition to fully address the requirements of 
this section shall be grounds for denial of the petition.
    (4) As soon as practicable following the agency's decision to either 
grant or deny the petition, FDA will publish a notice in the Federal 
Register informing the public of his decision. If the petition is 
granted the Food and Drug Administration will list, the approved 
synonymous term in the regulations listing terms permitted for use in 
nutrient content claims.
    (o)(1) Petitions for the use of an implied nutrient content claim in 
a brand name shall include the following data and be submitted in the 
following form:


[[Page 119]]


(Date)------------
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Office of Nutritional Products, Labeling and Dietary Supplements (HFS-
800),
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
    The undersigned, ---------------------- submits this petition under 
section 403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the act) 
with respect to (statement of the implied nutrient content claim and its 
proposed use in a brand name).
    Attached hereto and constituting a part of this petition, are the 
following:
    A. 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 
under section 403(r)(2)(A)(i) of the act, and the brand name of which 
the implied claim is intended to be a part. The statement should address 
why the use of the brandname as proposed will not be misleading. It 
should address in particular what information is required to accompany 
the claim or other ways in which the claim meets the requirements of 
sections 201(n) and 403(a) of the act. The statement should provide 
examples of the types of foods on which the brand name will appear. It 
shall also include data showing that the actual level of the nutrient in 
the food qualifies the food to bear the corresponding term defined by 
regulation. Assay methods used to determine the level of a nutrient 
should meet the requirements stated under petition format item C in 
paragraph (k)(1) of this section.
    B. A detailed explanation, supported by any necessary data, of why 
use of the proposed brand name is requested. This item 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 should specifically address 
nutritional needs of such group and should include scientific data 
sufficient for such purpose.
    C. The petitioner is required to submit either a claim for 
categorical exclusion under Sec.  25.30 or Sec.  25.32 of this chapter 
or an environmental assessment under Sec.  25.40 of this chapter.
    Yours very truly,
    Petitioner ------------
    By ------------

    (2) Within 15 days of receipt of the petition the petitioner will be 
notified by letter of the date on which the petition was received. Such 
notice will inform the petitioner:
    (i) That the petition is undergoing agency review (in which case a 
docket number will be assigned to the petition); or
    (ii) That the petition is incomplete, e.g., it lacks any of the data 
required by this part, it presents such data in a manner that is not 
readily understood, or it has not been submitted in quadruplicate, in 
which case the petition will be denied, and the petitioner will be 
notified as to what respect the petition is incomplete.
    (3) FDA will publish a notice of the petition in the Federal 
Register announcing its availability to the public and seeking comment 
on the petition. The petition shall be available to the public to the 
extent provided under paragraph (g) of this section. The notice shall 
allow 30 days for comments.
    (4) Within 100 days of the date of receipt of the petition that is 
accepted for review (i.e., that has not been found to be incomplete and 
subsequently returned to the petitioner), FDA will:
    (i) Notify the petitioner by letter of the agency's decision to 
grant the petitioner permission to use the proposed brand name if such 
use is not misleading, with any conditions or limitations on such use 
specified; or
    (ii) Deny the petition, in which case the letter shall state the 
reasons therefor. Failure of the petition to fully address the 
requirements of this section shall be grounds for denial of the 
petition. Should FDA not notify the petitioner of his decision on the 
petition within 100 days, the petition shall be considered to be 
granted.
    (5) As soon as practicable following the granting of a petition, the 
Commissioner of Food and Drugs will publish a notice in the Federal 
Register informing the public of such fact.

[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993, as amended at 58 
FR 44033, Aug. 18, 1993; 62 FR 40598, July 29, 1997; 63 FR 26718, May 
14, 1998; 63 FR 40024, July 27, 1998; 67 FR 9585, Mar. 4, 2002; 69 FR 
16481, Mar. 30, 2004]