Source: https://www.law.cornell.edu/cfr/text/21/101.69?qt-cfr_tabs=3
Timestamp: 2015-08-29 09:27:44
Document Index: 738763898

Matched Legal Cases: ['art 101', 'art 101', '§ 101', 'art 58', 'art 56', '§ 56', '§ 56', 'art 50', '§ 10', '§ 25', '§ 25', 'art 10', '§ 25', '§ 25', '§ 25', 'art 101', 'arts 11', 'arts 11', 'art 101']

21 CFR 101.69 - Petitions for nutrient content claims. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter B › Part 101 › Subpart D › Section 101.69 21 CFR 101.69 - Petitions for nutrient content claims.
There are 4 Updates appearing in the Federal Register for 21 CFR Part 101. View below or at eCFR (GPOAccess)
§ 101.69
Petitions for nutrient content claims.
This section pertains to petitions for claims, expressed or implied,
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
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).
Petitions included in this section are:
Petitions for a new (heretofore unauthorized) nutrient content
Petitions for a synonymous term (i.e., one that is consistent with a term
defined by regulation) for characterizing the level of a nutrient;
Petitions for the use of an implied claim in a brand name.
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. 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.
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unpublished information furnished by a person other than the applicant will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.
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.
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 § 56.104 or § 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.
The availability for public disclosure of petitions submitted to the
agency under this section will be governed by the rules specified in § 10.20(j) of this chapter.
All petitions submitted under this section shall include either a claim
for a categorical exclusion under § 25.30 or
of this chapter or an environmental assessment under § 25.40 of this chapter.
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.
The petition must be signed by the petitioner or by his attorney or
agent, or (if a corporation) by an authorized official.
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
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
Petitions for a new nutrient content claim shall include the following
data and be submitted in the following form. (Date) ______
Name of petitioner ______
Subject of the petition ______
(HFS-800)
Washington, DC 20204.
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
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
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
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 § 25.30 or § 25.32 of this chapter or an
environmental assessment under § 25.40 of this
Petitioner ______
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:
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
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.
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
Within 90 days of the date of filing FDA will by letter of notification
Deny the petition; or
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
If FDA does not act within 90 days of the date of filing, the petition
shall be deemed to be denied unless an extension is mutually agreed upon by
FDA and the petitioner.
If FDA issues a proposal, the rulemaking shall be completed within 540
days of the date of receipt of the petition.
Petitions for a synonymous term shall include the following data and be
submitted in the following form. (Date)______
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
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
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
C. The petitioner is required to submit either a claim for categorical
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:
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
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.
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.
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: (Date)______
(HFS-800),
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).
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.
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
such group and should include scientific data sufficient for such
number will be assigned to the petition); or
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.
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:
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;
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.
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,
Title 21 published on 2014-04-01.The following are only the Rules published in the Federal Register after the published date of Title 21.For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.2014-12-10; vol. 79 # 237 - Wednesday, December 10, 201479 FR 73201 - Uniform Compliance Date for Food Labeling Regulations
typeregulations.gov FR Doc.2014-28829 RIN Docket No.2000N-1596) DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective December 10, 2014. Submit electronic or written comments by February 9, 2015. 21 CFR Part 101 SummaryThe Food and Drug Administration (FDA or we) is establishing January 1, 2018, as the uniform compliance date for food labeling regulations that are issued between January 1, 2015, and December 31, 2016. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On November 28, 2012, we established January 1, 2016, as the uniform compliance date for food labeling regulations issued between January 1, 2013, and December 31, 2014.
2014-12-01; vol. 79 # 230 - Monday, December 1, 201479 FR 71156 - Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
typeregulations.gov FR Doc.2014-27833 RIN0910-AG57 Docket No.FDA-2011-F-0172 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. Effective date: December 1, 2015. Compliance date: Covered establishments must comply with the rule by December 1, 2015. See section XXIII for more information on the effective and compliance dates. Comment Date: Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 31, 2014 (see section XXVI, the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 11 and 101 SummaryTo implement the nutrition labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act or ACA), the Food and Drug Administration (FDA or we) is requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The ACA, in part, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), among other things, to require restaurants and similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Under provisions of the ACA, restaurants and similar retail food establishments not otherwise covered by the law may elect to become subject to these Federal requirements by registering every other year with FDA. Providing accurate, clear, and consistent nutrition information, including the calorie content of foods, in restaurants and similar retail food establishments will make such nutrition information available to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices.
typeregulations.gov FR Doc.2014-27834 RIN0910-AG56 Docket No.FDA-2011-F-0171 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. Effective Date: December 1, 2016. Compliance Date: Covered vending machine operators must comply with the rule by December 1, 2016. See section III.E for more information on the effective and compliance dates. Comment Date: Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 31, 2014 (see section V, the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 11 and 101 SummaryTo implement the vending machine food labeling provisions of the Patient Protection and Affordable Care Act of 2010 (ACA), the Food and Drug Administration (FDA or we) is establishing requirements for providing calorie declarations for food sold from certain vending machines. This final rule will ensure that calorie information is available for certain food sold from a vending machine that does not permit a prospective purchaser to examine the Nutrition Facts Panel before purchasing the article, or does not otherwise provide visible nutrition information at the point of purchase. The declaration of accurate and clear calorie information for food sold from vending machines will make calorie information available to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices. This final rule applies to certain food from vending machines operated by a person engaged in the business of owning or operating 20 or more vending machines. Vending machine operators not subject to the rules may elect to be subject to the Federal requirements by registering with FDA.
Title 21 published on 2014-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 101 after this date.2014-12-10; vol. 79 # 237 - Wednesday, December 10, 201479 FR 73201 - Uniform Compliance Date for Food Labeling Regulations
2014-05-29; vol. 79 # 103 - Thursday, May 29, 201479 FR 30763 - Proposed Rules on Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Public Meeting