GFI Notification of Health Claim

Labeling & Nutrition > Guidance for Industry: Notification of a Health C...

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsReg...

Contains Nonbinding Recommendations
June 11, 1998
Additional copies are available from:
Office of Nutrition, Labeling, and Dietary Supplements
Nutrition Program Staff, HFS-830
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
(Tel) 240-402-1450
You may submit written or electronic comments regarding this guidance at any time.
Submit written comments on the guidance to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments to http://www.regulations.gov
(http://www.regulations.gov/). All comments should be identified with the docket
number listed in the notice of availability that publishes in the Federal Register.
OMB Control No. 0910-0374
Expiration Date: 04/30/2018
*See additional PRA statements at the end of this guidance
Note: This document was modified on February 10, 2009. The agency added the
standard cover page for final guidances that contain information collection provisions
subject to review by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 (PRA), as well as the standard PRA text at the end of the
document. FDA did not modify the recommendations in the guidance.

Prior to the Food and Drug Administration Modernization Act of 1997 (FDAMA),
companies could not use a health claim or nutrient content claim in food labeling
unless the Food and Drug Administration (FDA) published a regulation authorizing

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such a claim. Two new provisions of FDAMA (specifically sections 303 and 304 which
amend, respectively, sections 403(r)(3) and 403(r)(2) (21 U.S.C. 343(r)(3) and (2)) of
the Food, Drug, and Cosmetic Act, known as the Act) will now permit distributors and
manufacturers to use claims if such claims are based on current, published,
authoritative statements from certain federal scientific bodies, as well as from the
National Academy of Sciences. These provisions are intended to expedite the
process by which the scientific basis for such claims is established.
Since the passage of FDAMA, FDA has been reviewing both the statute and the
accompanying legislative history in order to determine the most appropriate approach
for implementing these new provisions. Due to the speed with which the FDAMA
provisions became effective, the agency has decided to issue this guidance
document during the initial phase of implementing these new provisions.
Submission procedures and use of a public docket for claims
Notifications should be submitted in duplicate to Center for Food Safety and Applied
Nutrition, 200 C Street SW, Washington, DC 20204 5100 Paint Branch Parkway,
College Park, MD 20740 or by email at label.claims@cfsan.fda.gov
(mailto:label.claims@cfsan.fda.gov). The notification should be clearly marked as
"Notification for a Health Claim (or Nutrient Content Claim) Based on an Authoritative
Statement." Whether notifications will be placed in a public docket upon receipt will be
addressed in notice and comment rulemaking for an implementing regulation.
When a notification is received, FDA intends to review whether the notification
includes the information necessary for the claim to be authorized under sections 303
and 304 of FDAMA. This may include, for example, a review for the submission of all
the required elements and the identification of an appropriate statement from an
appropriate scientific body (as identified below). The agency intends to notify the
submitter by letter as soon as possible within the 120 days after submission when the
notification does not comply with sections 303 and 304. When a notification does not
meet the requirements of sections 303 and 304, the use of the claim is not authorized
under FDAMA. The submitter may choose to revise the notification and resubmit it, in
which case a food could not be marketed with the claim until at least 120 days after
resubmission. As provided by FDAMA, FDA also may act to prohibit or modify a claim
by regulation or a United States district court may find that the requirements of
section 303 or 304 of FDAMA have not been met.
Scientific body
FDAMA permits claims based on current, published authoritative statements from "a
scientific body of the United States with official responsibility for public health
protection or research directly related to human nutrition . . . or the National Academy
of Sciences (NAS) or any of its subdivisions." The National Institutes of Health (NIH)
and the Centers for Disease Control and Prevention (CDC) are federal government
agencies specifically identified as scientific bodies by FDAMA.
FDA believes that other federal agencies may also qualify as appropriate sources for
such authoritative statements. Along with NAS (or any of its subdivisions), the agency
currently considers that the following federal scientific bodies may be sources of

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authoritative statements: the CDC, the NIH, and the Surgeon General within
Department of Health and Human Services; and the Food and Nutrition Service, the
Food Safety and Inspection Service, and the Agricultural Research Service within the
Department of Agriculture.
Authoritative statement
FDA also believes it is necessary to clarify what constitutes an authoritative statement
under FDAMA. FDAMA itself states that an authoritative statement: (1) is "about the
relationship between a nutrient and a disease or health-related condition" for a health
claim, or "identifies the nutrient level to which the claim refers" for a nutrient content
claim, (2) is "published by the scientific body" (as identified above), (3) is "currently in
effect," and (4) "shall not include a statement of an employee of the scientific body
made in the individual capacity of the employee."
In addition, given the legislative history of sections 303 and 304 of FDAMA, FDA
currently believes authoritative statements also should: (5) reflect a consensus within
the identified scientific body if published by a subdivision of one of the Federal
scientific bodies, and (6) be based on a deliberative review by the scientific body of
the scientific evidence.
Not all pronouncements by the designated scientific bodies would meet these criteria.
For example, authoritative statements by the Surgeon General would normally be
found only in the Surgeon General Reports.
FDA intends to consult, as appropriate, with the scientific body that is the source of a
statement cited as the basis for a claim, as well as with the other federal scientific
bodies that have public health responsibilities and expertise relative to the claim. The
agency has already begun this liaison process.
Scientific standard with respect to health claims
FDAMA upholds the "significant scientific agreement" standard for health claims. This
conclusion is based on FDAMA and its legislative history. FDAMA provides that FDA
may issue a regulation under section 403(r)(3)(B)(i) of the Act to prohibit or modify a
claim. Section 403(r)(3)(B)(i) permits FDA to promulgate regulations authorizing
health claims only if FDA "determines, 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), that 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."
Consistent with this provision, FDA intends to determine whether the standard of
significant scientific agreement is met by a health claim based on an authoritative
statement. And consistent with earlier regulations, FDA does not believe this standard
would allow for a claim based on, for example, findings characterized as preliminary
results, statements that indicate research is inconclusive, or statements intended to
guide future research.
Content of notification and other statutory requirements

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FDAMA requires that a person must submit a notification of the claim at least 120
days before the first introduction into interstate commerce of the food with a label
containing the claim. FDA notes that, as indicated by FDAMA, the notification is to
include: (1) "the exact words used in the claim," (2) "a concise description of the basis
upon which such person relied for determining that the requirements" for an
authoritative statement "have been satisfied," (3) "a copy of the statement referred to .
. . upon which such person relied in making the claim," and (4) for a health claim, "a
balanced representation of the scientific literature relating to the relationship between
a nutrient and a disease or health-related condition to which the claim refers," or, for a
nutrient content claim, "a balanced representation of the scientific literature relating to
the nutrient level to which the claim refers."
FDA expects that to provide a "balanced representation of the scientific literature," a
bibliography of the scientific literature on the topic of the claim would be compiled. A
brief, balanced account or analysis of how this literature either supports or fails to
support the authoritative statement should be submitted.
FDAMA imposes several additional conditions on claims based on authoritative
statements and the foods for which such claims are made. For example, FDAMA
requires that such a claim be "stated in a manner so that the claim is an accurate
representation of the authoritative statement referred to" and "so that the claim
enables the public to comprehend the information provided in the claim and to
understand the relative significance of such information in the context of a total daily
diet."
FDAMA requires, with respect to health claims, that the food for which such a claim is
made not exceed the disqualifying amounts of nutrients that may increase the risk of
a disease or health-related condition in the general population. FDAMA also requires,
for example, that nutrient content claims use the terms already defined in regulations
by the agency, in, e.g., Title 21, Code of Federal Regulations (CFR) sections 101.13
and 101.54. Finally, FDAMA requires that a claim based on an authoritative
statement, with the food for which the claim is made, not be false or misleading in any
particular.
Under FDAMA, persons submitting notifications must include "the exact words used
in the claim." Submitted health claims should use the word "may" to characterize the
relationship between the nutrient and the disease or health related condition so as to
indicate that the disease or health-related condition is caused by many factors.
Likewise, a claim for a health effect attributed to a single brand name product would
be misleading. Foods bearing health claims based on authoritative statements should
comply with the provisions of 21 CFR 101.14. These include, for example,
requirements that the substance that is the subject of a claim is safe and lawful and
that its level is sufficiently high and in an appropriate form to justify the claim.
A nutrient content claim based on an authoritative statement that uses terms the
agency has defined, such as "good source" or "high," must, under FDAMA, refer to a
nutrient level (i.e., a daily value) that is identified by the authoritative statement. In
addition, foods bearing such nutrient content claims should comply with 21 CFR
101.13.

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To ensure that compliance with all relevant regulations can be assessed, the FDA
believes that information on analytical methodology for the nutrient that is the subject
of a claim should be submitted as part of the notification, consistent with 21 CFR
101.69 and 21 CFR 101.70.
Dietary Supplements
Finally, FDA believes that there is need for further consideration concerning dietary
supplements. FDAMA does not provide for health claims based on authoritative
statements for dietary supplements. This is because FDAMA amended the section of
the Act that deals with procedures and standards for health claims for conventional
foods, but did not amend the section that deals with procedures and standards for
health claims for dietary supplements. That is, section 403(r)(3) of the Act specifies
the procedure and standard by which health claims may be made for conventional
foods. Section 403(r)(5)(D) specifies that health claims with respect to dietary
supplements shall not be subject to section 403(r)(3), but rather to a procedure and
standard established by regulation by FDA. Section 303 of FDAMA amended section
403(r)(3) of the Act to allow for health claims based on authoritative statements, but
did not address section 403(r)(5)(D).
The FDA intends to propose that health claims based on authoritative statements be
permitted for dietary supplements.
In contrast, with respect to nutrient content claims, FDAMA amended section
403(r)(2) of the Act, which applies to both conventional foods and dietary
supplements. Thus, dietary supplements may make nutrient content claims based
upon authoritative statements in accordance with FDAMA and the applicable
regulations for nutrient content claims, and the contents of this guidance document
would apply.

Paperwork Reduction Act of 1995
This guidance contains information collections that are subject to review by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520).
The time required to complete this information collection is estimated to average
250-450 hours per response, depending upon the nature of the claim, including the
time to review instructions, search existing data resources, gather the data needed,
and complete and review the information collection. Send comments regarding this
burden estimate or suggestions for reducing this burden to: Office of Nutrition,
Labeling, and Dietary Supplements, Nutrition Program Staff, HFS-830, Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Parkway, College Park, MD 20740.
An agency may not conduct or sponsor, and a person is not required to respond
to, a collection of information unless it displays a currently valid OMB control

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number. The OMB control number for this information collection is 0910-0374
(expires 04/30/2018).
(1)

This guidance has been prepared by the Office of Food Labeling in the Center for
Food Safety and Applied Nutrition at the Food and Drug Administration. This
guidance represents the Agency's current thinking on the procedures for a firm to
notify FDA of their intent to use a health claim or nutrient content claim based on an
authoritative statement of a scientific body. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirement of the applicable
statute, regulations, or both.

Federal Register Notice: June 11, 1998
This document was issued on June 11, 1998
For more recent information see Food Labeling (/Food/IngredientsPackagingLabeling/LabelingNutrition/default.htm)

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