(a) Any interested person may petition the Food and Drug Administration (FDA)
to issue a regulation regarding a health claim. An original and one copy of
the petition 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 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 any correspondence required by section
403 of the Federal Food, Drug, and Cosmetic Act may be
(b) 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. Such information may include
any findings, along with the basis of the findings, of an outside panel with
expertise in the subject area. Any reference to published information shall
be accompanied by reprints, or easily readable copies of such
(c) If nonclinical laboratory studies are included in a petition, the
petition shall include, with respect to each nonclinical study contained in
the petition, either a statement that the study has been 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.
(d) If clinical or other human investigations are included in a petition, the
petition shall include a statement that they were either conducted in
compliance with the requirements for institutional review set forth in part 56 of this
chapter, or were not subject to such requirements in accordance with § 56.104 or § 56.105, and a statement that they were conducted in compliance with the
requirements for informed consent set forth in part 50 of this chapter.
(e) All data and information in a health claim petition are available for
public disclosure after the notice of filing of petition is issued to the
petitioner, except that clinical investigation reports, adverse reaction
reports, product experience reports, consumer complaints, and other similar
data and information shall only be available after deletion of:
(1) Names and any information that would identify the person using the
(2) Names and any information that would identify any third party involved
with the report, such as a physician or hospital or other
(f) Petitions for a health claim shall include the following data and be
submitted in the following form:
Name of petitioner ______
Post office address ______
Subject of the petition ______
Food and Drug Administration,
Office of Nutritional Products, Labeling and Dietary Supplements
5100 Paint Branch Pkwy.,
College Park, MD 20740,
The undersigned, _________ submits this petition pursuant to section 403(r)(4) or 403(r)(5)(D) of the Federal
Food, Drug, and Cosmetic Act with respect to (statement of the substance and
its health claim).
Attached hereto, and constituting a part of this petition, are the
A. Preliminary requirements. A complete explanation of how the substance
conforms to the requirements of § 101.14(b) (21 CFR 101.14(b)). For petitions where the subject substance is a food ingredient or
a component of a food ingredient, the petitioner should compile a
comprehensive list of the specific ingredients that will be added to the
food to supply the substance in the food bearing the health claim. For each
such ingredient listed, the petitioner should state how the ingredient
complies with the requirements of § 101.14(b)(3)(ii), e.g., that its use is generally recognized as safe (GRAS), listed as a food additive, or authorized by a prior sanction
issued by the agency, and what the basis is for the GRAS claim, the food
additive status, or prior sanctioned status.
B. Summary of scientific data. The summary of scientific data provides the
basis upon which authorizing a health claim can be justified as providing
the health benefit. The summary must establish that, based on the totality
of publicly available scientific evidence (including evidence from
well-designed studies conducted in a manner which is consistent with
generally recognized scientific procedures and principles), there is
significant scientific agreement among experts qualified by scientific
training and experience to evaluate such claims, that the claim is supported
by such evidence.
The summary shall state what public health benefit will derive from use of
the claim as proposed. If the claim is intended for a specific group within
the population, the summary shall specifically address nutritional needs of
such group and shall include scientific data showing how the claim is likely
to assist in meeting such needs.
The summary shall concentrate on the findings of appropriate review articles,
National Institutes of Health consensus development conferences, and other
appropriate resource materials. Issues addressed in the summary shall
include answers to such questions as:
1. Is there an optimum level of the particular substance to be consumed
beyond which no benefit would be expected?
2. Is there any level at which an adverse effect from the substance or from
foods containing the substance occurs for any segment of the population?
3. Are there certain populations that must receive special consideration?
4. What other nutritional or health factors (both positive and negative) are
important to consider when consuming the substance?
In addition, the summary of scientific data shall include a detailed analysis
of the potential effect of the use of the proposed claim on food
consumption, specifically any change due to significant alterations in
eating habits and corresponding changes in nutrient intake resulting from
such changes in food consumption. The latter item shall specifically address
the effect on the intake of nutrients that have beneficial and negative
consequences in the total diet.
If the claim is intended for a significant subpopulation within the general
U.S. 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 (e.g., adolescents
or the elderly).
If appropriate, the petition shall explain the prevalence of the disease or
health-related condition in the U.S. population and the relevance of the
claim in the context of the total daily diet.
Also, the summary shall demonstrate that the substance that is the subject of
the proposed claim conforms to the definition of the term “substance” in
C. Analytical data that show the amount of the substance that is present in
representative foods that would be candidates to bear the claim should be
obtained from representative samples using methods from the AOAC
INTERNATIONAL (AOAC), where available. If no AOAC method is available, the
petitioner shall submit the assay method used and data establishing the
validity of the method for assaying the substance in food. The validation
data should include a statistical analysis of the analytical and product
D. Model health claim. One or more model health claims that represent label
statements that may be used on a food label or in labeling for a food to
characterize the relationship between the substance in a food to a disease
or health-related condition that is justified by the summary of scientific
data provided in section C of the petition. The model health claim shall
1. A brief capsulized statement of the relevant conclusions of the summary,
2. A statement of how this substance helps the consumer to attain a total
dietary pattern or goal associated with the health benefit that is
E. The petition shall include the following attachments:
1. Copies of any computer literature searches done by the petitioner (e.g.,
2. Copies of articles cited in the literature searches and other information
a. All information relied upon for the support of the health claim, including
copies of publications or other information cited in review articles and
used to perform meta-analyses.
b. All information concerning adverse consequences to any segment of the
population (e.g., sensitivity to the substance).
c. All information pertaining to the U.S. population.
F. 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
Yours very truly,
(g) The data specified under the several lettered headings should be
submitted on separate pages or sets of pages, suitably identified. If such
data have already been submitted with an earlier application from the
petitioner or any other final petition, the present
petition may incorporate it by specific reference to the earlier
(h) The petition shall include a statement signed by the person responsible
for the petition that, to the best of his/her knowledge, it is a
representative and balanced submission that includes unfavorable information
as well as favorable information, known to him/her to be pertinent to the
evaluation of the proposed health claim.
(i) The petition shall be signed by the petitioner or by his/her attorney or
agent, or (if a corporation) by an authorized official.
(j)Agency action on the petition.
(1) 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 that the petition is undergoing agency
review and that the petitioner will subsequently be notified of the agency's
decision to file for comprehensive review or deny the petition.
(2) 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 for
comprehensive review or denied. The agency will deny a petition without
reviewing the information contained in “B. Summary of Scientific Data” if
the information in “A. Preliminary Requirements” is inadequate in explaining
how the substance conforms to the requirements of § 101.14(b). If the petition is denied, the notification will state the reasons
therefor, including justification of the rejection of any report from an
authoritative scientific body of the U.S. Government. If filed, the date of
the notification letter becomes the date of filing for the purposes of this
regulation. 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 FDA and
the petitioner. A petition that has been denied, or has been deemed to be
denied, without filing will not be made available to the public. A filed
petition will be available to the public to the extent provided under
paragraph (e) of this section.
(3) 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 health claim will be published in the Federal
Register. If the petition is denied, the notification will state the
reasons therefor, including justification for the rejection of any report
from an authoritative scientific body of the U.S. Government. FDA will
publish the proposal to amend the regulations to provide for the requested
use of the health 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 review.
(iii) 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.
(i) Within 270 of the date of publication of the proposal, FDA will publish a
final rule that either authorizes use of the health claim or explains why
the agency has decided not to authorize one.
(ii) For cause, FDA may extend, no more than twice, the period in which it
will publish a final rule; each such extension will be for no more than 90
days. FDA will publish a notice of each extension in the Federal
Register. The document will state the basis for the extension, the
length of the extension, and the date by which the final rule will be
published, which date shall be within 540 days of the date of receipt of the