Guidance for Industry and FDA

Interim Procedures for Qualified Health Claims in the Labeling of
Conventional Human Food and Human Dietary Supplements

***GUIDANCE***

Comments and suggestions regarding this document may be submitted at any
time. Submit comments to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number listed
in the notice of availability that publishes in the *Federal Register*.

For questions regarding this draft document contact the Center for Food
Safety and Applied Nutrition (CFSAN) at 301-436-1450.

**U.S. Department of Health and Human Services**

**Food and Drug Administration**

**Center for Food Safety and Applied Nutrition**

**July 2003**

Guidance for Industry and FDA

Interim Procedures for Qualified Health Claims in the Labeling of
Conventional Human Food and Human Dietary Supplements

*Additional copies are available from:*

*Office of Nutritional Products, Labeling, and Dietary Supplements*

*Division of Nutrition Programs and Labeling HFS-800*

*Center for Food Safety and Applied Nutrition*

*Food and Drug Administration*

*5100 Paint Branch Parkway*

*College Park, MD 20740*

*(Tel) 301-436-1450*

[***www.cfsan.fda.gov/guidance.html***](../www.cfsan.fda.gov/guidance.html)

**U.S. Department of Health and Human Services**

**Food and Drug Administration**

**Center for Food Safety and Applied Nutrition (CFSAN)**

**July 2003**

##  {#section .TOC-2}

**TABLE OF CONTENTS**

# 

# I. Introduction 1 {#i.-introduction-1 .TOC-1}

# II. Background 1 {#ii.-background-1 .TOC-1}

# III. Objective 1 {#iii.-objective-1 .TOC-1}

## A. Criteria for Exercise of Enforcement Discretion [2](#a.-criteria-for-exercise-of-enforcement-discretion) {#a.-criteria-for-exercise-of-enforcement-discretion-2 .TOC-2}

## B. Procedures [3](#procedures) {#b.-procedures-3 .TOC-2}

### 1. Filing Review 3 {#filing-review-3 .TOC-3}

### 2. Prioritization 3 {#prioritization-3 .TOC-3}

### 3. Opportunity for Public Comment 3 {#opportunity-for-public-comment-3 .TOC-3}

### 4. Scientific Review 3 {#scientific-review-3 .TOC-3}

### 5. Consolidation of Like Petitions 4 {#consolidation-of-like-petitions-4 .TOC-3}

### 6. Consultation with Other Federal Agencies 4 {#consultation-with-other-federal-agencies-4 .TOC-3}

### 7. Regulatory Decision 4 {#regulatory-decision-4 .TOC-3}

### 8. Notification to Petitioner 5 {#notification-to-petitioner-5 .TOC-3}

### 9. Extensions 5 {#extensions-5 .TOC-3}

### 10. Reconsideration 5 {#reconsideration-5 .TOC-3}

## C. Content of Petitions 5 {#c.-content-of-petitions-5 .TOC-2}

### 1. Requirements 5 {#requirements-5 .TOC-3}

### 2. Summary of Scientific Information 5 {#summary-of-scientific-information-5 .TOC-3}

#####  {#section-2 .TOC-5 .unnumbered}

**Guidance for Industry and FDA**[^1]

**Interim Procedures for Qualified Health Claims in the Labeling of
Conventional Human Food and Human Dietary Supplements**

This guidance represents the Food and Drug Administration\'s (FDA\'s)
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. You
can use an alternative approach if the approach satisfies the
requirements of the applicable statutes and regulations. If you want to
discuss an alternative approach, contact the FDA staff responsible for
implementing this guidance. If you cannot identify the appropriate FDA
staff, call the appropriate number listed on the title page of this
guidance.

**I. INTRODUCTION**

This guidance is intended to notify the public of interim procedures
that the Food and Drug Administration (FDA) is implementing for
petitioners who submit qualified health claim petitions to the agency.
This guidance describes the procedures that FDA intends to use, on an
interim basis, to respond to qualified health claim petitions until the
agency can promulgate regulations under notice-and-comment rulemaking;
it also provides a linkage between the ranking of scientific evidence
and the wording of qualified health claims. In addition, this guidance
updates the agency's approach outlined in December 2002 (Guidance for
Industry: Qualified Health Claims in the Labeling of Conventional Foods
and Dietary Supplements) and the agency's approach to implementing
*Pearson v. Shalala* (164 F.3d 650 (D.C. Cir. 1999)) to include
conventional foods. This guidance does not apply to unqualified health
claims, which must meet the "Significant Scientific Agreement" (SSA)
standard.[^2]

FDA\'s guidance documents, including this guidance, do not establish
legally enforceable responsibilities. Instead, guidances describe the
Agency\'s current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited. The use of the word *should* in Agency guidances means that
something is suggested or recommended, but not required.

II. **BACKGROUND**

FDA is issuing this document as final guidance setting out interim
procedures that the agency intends to use for qualified health claims in
the labeling of conventional human food and dietary supplements until
the agency can promulgate regulations under notice and comment
rulemaking.

**III. OBJECTIVE**

FDA intends to use the following interim procedures to ensure that its
premarket review is consistent with the spirit of the Nutrition Labeling
and Education Act and the First Amendment. FDA will continue to evaluate
unqualified health claims under its current regulatory process and
standard for significant scientific agreement (21 CFR 101.14 and
101.70).

## 

## A. Criteria for Exercise of Enforcement Discretion

FDA plans to establish criteria for considering exercising enforcement
discretion for qualified health claims based on the extent to which the
totality of the publicly available evidence supports the claim (see
Guidance for Industry and FDA: Interim Evidence-based Ranking System for
Scientific Data). Different levels of evidence will result in different
qualifying language as described in Table 1, which provides standardized
language for the B, C, and D categories to be used as part of the
qualifying language for qualified health claims until consumer
research[^3] is complete.

Table 1. Standardized Qualifying Language for Qualified Health Claims.

  --------------- ---------------- ----------------------------------------
  **Scientific    **FDA Category** **Appropriate Qualifying
  Ranking^\*^**                    Language^\*\*^**

  Second Level    B                ... "although there is scientific
                                   evidence supporting the claim, the
                                   evidence is not conclusive."

  Third Level     C                "Some scientific evidence
                                   suggests...however, FDA has determined
                                   that this evidence is limited and not
                                   conclusive."

  Fourth Level    D                "Very limited and preliminary scientific
                                   research suggests... FDA concludes that
                                   there is little scientific evidence
                                   supporting this claim."
  --------------- ---------------- ----------------------------------------

> \*From Guidance for Industry and FDA: Interim Evidence-based Ranking
> System for Scientific Data.
>
> \*\*The language reflects wording used in qualified health claims as
> to which the agency has previously exercised enforcement discretion
> for certain dietary supplements. During this interim period, the
> precise language as to which the agency considers exercising
> enforcement discretion may vary depending on the specific
> circumstances of each case.

###  

## Procedures

### 1. Filing Review

#### 

> FDA plans to begin accepting petitions for qualified health claims on
> September 1, 2003. Within 45 days of receipt of a qualified health
> claim petition, FDA intends to determine whether the petition is
> complete (see Section C below). If the petition is incomplete, the
> agency plans to inform the petitioner of the deficiencies and what
> steps the petitioner should take to rectify these deficiencies. If FDA
> determines that the petition is complete, it intends to file the
> petition. The agency recognizes that it can evaluate petitions more
> efficiently and effectively if they are well-organized and contain all
> the relevant information. FDA encourages potential petitioners to meet
> with the agency prior to preparing a petition to discuss their plans.

### 

### 2. Prioritization

### 

> FDA has only limited resources for reviewing health claims. Thus, to
> maximize the public health benefit of its claims review process, FDA
> intends to prioritize on a case-by-case basis all complete petitions
> according to several factors, including whether the food or dietary
> supplement that is the subject of the petition is likely to have a
> significant impact on a serious or life-threatening illness; the
> strength of the evidence; whether consumer research has been provided
> to show the claim is not misleading; whether the substance of the
> claim has undergone an FDA safety review (i.e., is an authorized food
> additive, has been GRAS (generally recognized as safe) affirmed,
> listed, or has received a letter of "no objection" to a GRAS
> notification); whether the substance that is the subject of the claim
> has been adequately characterized so that the relevance of available
> studies can be evaluated; whether the disease is defined and evaluated
> in accordance with generally accepted criteria established by a
> recognized body of qualified experts; and whether there is prior
> review of the evidence or the claim by a recognized body of qualified
> experts.

### Opportunity for Public Comment

> Upon filing of a petition, FDA intends to post the petition on its
> website and request public comment for 60 days. FDA plans to post
> comments submitted by the public on FDA's website or to make comments
> available for public review at the Division of Dockets Management,
> HFA-305.

3.  *Scientific Review*

After the comment period closes, FDA may pursue any one of several
options for scientific review of data submitted in a petition in support
of the substance/disease relationship. For example, FDA may conduct the
review internally, it may convene an advisory subcommittee, or it may
use appropriate third-party reviewers under contract to FDA, e.g., the
Agency for Healthcare Quality and Research (AHRQ). In the case of a
petition forwarded to AHRQ, AHRQ plans to send the petition to an
Evidence-Based Practice Center (EPC) with which it has a contract to
review the scientific evidence in the petition and to rank the degree of
scientific certainty of the validity of the substance/disease
relationship. AHRQ also plans to ask the EPC to review those
science-related public comments received by FDA that discuss or provide
evidence. Within 120 days after the commencement of the third party
review, FDA would expect to receive a report that includes a description
of the evidence reviewed, an analysis of that evidence, a summary of and
response to public comments that pertain to the evidence, and its
assessment as to the degree of scientific certainty in support of the
substance/disease relationship.

4.  *Consolidation of Like Petitions*

> If FDA receives more than one petition for a qualified health claim
> that describes the same relationship between a substance and a disease
> or health-related condition during its review, the agency plans to
> consolidate all of the related petitions received, if appropriate.

5.  *Consultation with Other Federal Agencies*

> To fully inform FDA's review, FDA intends, as appropriate, on a
> case-by-case-basis, to consult with other scientific Federal agencies
> with official responsibility for public health protection or research
> related to human nutrition and dietary supplements.

6.  *Regulatory Decision*

> As mentioned above, FDA plans to either conduct its own review or use
> an appropriate third party to conduct a scientific review. In the case
> of third party review, after FDA receives, for example the EPC report,
> FDA intends, based on the totality of the publicly available evidence,
> public comment, and other relevant regulatory considerations, to
> determine whether to consider exercising enforcement discretion with
> respect to the proposed claim. If FDA decides to consider exercising
> enforcement discretion, the agency plans to determine what qualifying
> statement(s) and other information should accompany the claim to
> ensure that it is truthful and not misleading. In reaching its
> determination, FDA intends to review and evaluate the third party
> report, the totality of the publicly available evidence, and all of
> the public comments submitted within the comment period, as well as
> consider how the proposed qualified claim will affect consumers'
> dietary choices. FDA also intends to consider whether to exercise
> enforcement discretion with respect to other requirements in 21 CFR
> 101.14, and what other factors, in addition to qualifying language,
> are relevant to considering the exercise of enforcement discretion.

7.  *Notification to Petitioner*

> On or before day 270 after receipt of the filed petition, FDA plans to
> notify the petitioner in a letter of: a) the agency's determination;
> b) the basis for its determination; and c) if the agency decides to
> consider exercising enforcement discretion, the qualified claim for
> which the agency intends to consider exercising such discretion and
> the provisions of 21 CFR 101.14 for which the agency intends to
> consider exercising such discretion. FDA also plans to notify the
> petitioner of any other factors the agency intends to consider in
> deciding whether to exercise enforcement discretion when the claim
> appears in labeling of conventional human food or dietary supplements.
> FDA plans to post the letter and any third party report on the
> agency's website.

8.  *Extensions*

> If the agency determines that it is appropriate, upon good cause, FDA
> may, decide to extend by 30-60 days the time period to notify the
> petitioner.

9.  *Reconsideration*

> If a petitioner or other party disagrees with an FDA determination,
> that party may request reconsideration. FDA intends to reconsider its
> determination if the party presents significant new relevant evidence
> or provides a persuasive analysis that the agency's interpretation of
> the original evidence was incorrect. FDA intends to use the same
> process described above for reconsideration of the agency's
> determination. FDA may, on its own initiative, decide to reconsider a
> determination.

B.  **Content of Petitions**

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1.  *Requirements*

> Except as described in C.2. (below), the agency believes that the
> requirements of 21 CFR 101.70 continue to apply, including the
> requirement to demonstrate that the substance that is the subject of
> the claim is safe and lawful under 21 CFR 101.14(b)(3)(ii).

2.  *Summary of Scientific Information*

> FDA intends to exercise enforcement discretion with respect to the
> requirement in 21 CFR 101.70 that the summary establish that the
> proposed claim is supported by significant scientific agreement.
> Instead, the summary should explain how credible evidence supports the
> claim as worded in the petition and why the petitioner believes that
> the specific wording of the claim, including any explanatory
> information, disclaimer or other qualification, is accurate and not
> misleading. As required by 21 CFR 101.70, the summary should include
> an analysis of the potential effect of the claim on total intakes of
> the substance (i.e., current intakes plus increases due to the claim),
> including any adverse or beneficial changes in dietary practices. The
> agency encourages petitioners to include consumer research to document
> consumer understanding. FDA recommends that the consumer research
> address the research questions set out in Attachment D of the Task
> Force Report.^3^

[^1]: This guidance has been prepared by the Center for Food Safety and
    Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration.

[^2]: FDA uses the term, "unqualified health claim," to refer to health
    claims that are or could be authorized under the Nutritional
    Labeling and Education Act of 1990 (NLEA) and regulations
    promulgated under that act, including 21 CFR 101.70.

[^3]: Attachment D of the Task Force Report (available at
    http://www.fda.gov/oc/mcclellan/chbn.html).