This draft document has been superceded by the Final Guidance issued on May 12, 2006.

FDA's Implementation of "Qualified Health Claims":
Questions and Answers

Background

1. Why is FDA providing for "qualified" health claims?

   Through the Better Nutrition Information for Consumer Health Initiative (see Consumer Health Information for Better Nutrition Initiative), FDA has acknowledged that consumers will benefit from more information on food labels concerning diet and health and this, in turn, has prompted the agency to establish interim procedures whereby "qualified" health claims can be made not only for dietary supplements but for conventional foods as well. Moreover, recent court decisions have clarified the need to provide for health claims based on somewhat settled science rather than just on the standard of significant scientific agreement, as along as the claims do not mislead the consumers. FDA will begin considering qualified health claims under its interim procedures September 1, 2003.

2. What are the similarities and differences between "unqualified" health claims that were provided for by the 1993 regulations and the newer "qualified" health claims?

   Both types of health claims characterize a relationship between a substance (specific food component or a specific food) and a disease or health-related condition, and are supported by scientific evidence. All health claims must undergo review by FDA through a petition process. All unqualified health claims must meet the Significant Scientific Agreement standard as provided for by Congress in 1990 (see Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements). The recent court decisions resulting in qualified health claims focused on a manufacturer's right to make statements about diet/disease relationships when the science supporting the claim did not meet the Significant Scientific Agreement standard, provided that the claim about the relationship was stated or "qualified" in such a way as to not mislead consumers. Thus, qualified health claims differ from unqualified ones in that they must be accompanied by a disclaimer or otherwise qualified.

3. Why are the procedures for qualified health claims "interim"?

   FDA believes that more information is needed before the agency can establish final procedures to provide for qualified health claims, and will be issuing an Advanced Notice of Proposed Rulemaking (ANPR) to solicit comments on the agency's options. FDA plans to conduct research in order to obtain information about appropriate qualifying language for use with the claims and the extent to which consumers can understand different levels of supporting science. The agency is also interested in knowing if there are better formats for presenting the supporting science than through the use of words alone. Moreover, FDA is interested in comment and input about how scientific data should be evaluated and ranked so as to best determine the ranking of the levels of scientific support in the absence of Significant Scientific Agreement.

   The interim procedures for qualified health claims are available on the FDA website in the form of two documents: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (see Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements) and Interim Guidance for Evidence-based Ranking System for Scientific Data (see Interim Evidence-based Ranking System for Scientific Data).

4. Will rulemaking for qualified health claims take place?

   FDA anticipates that the needed information can be gathered by the Spring of 2004, and at that point the agency will consider its options and the input received in order to develop proposed regulations related to qualified health claims. In the meantime, the agency plans to review qualified health claim petitions on a case-by-case basis to determine whether to issue a letter concerning the use of enforcement discretion for the qualified claim or to deny the qualified claim.

5. What is a letter of enforcement discretion?

   A letter of enforcement discretion is a letter issued by FDA to the petitioner specifying the nature of the qualified health claim for which FDA intends to consider the exercise of its enforcement discretion. If a letter of enforcement discretion has been issued, FDA does not intend to object to the use of the claim specified in the letter, provided that the products that bear the claim are consistent with the stated criteria.

   All letters of enforcement discretion will be posted on the FDA website. Once the letter is posted on the website, all manufacturers will have notice about how the agency intends to exercise its enforcement discretion on the use of the qualified claim.

6. How are health claims different from structure/function claims?

   Both unqualified and qualified health claims characterize the relationship between a substance and its ability to reduce the risk of a disease or health-related condition. Structure/function claims describe the effect that a substance has on the structure or function of the body and do not make reference to a disease. An example of a structure/function claim is "Calcium builds strong bones." Structure/function claims must be truthful and not misleading and are not pre-reviewed or authorized by FDA. [21 U.S.C. 343(r)(6); 21 CFR 101.93]

7. Recently FDA has indicated interest in "dietary guidance." How are health claims different from statements about dietary guidance?

   Health claims characterize a relationship between a substance (specific food or food component) and a disease or health-related condition (see 21 CFR 101.14). Both of these elements are present in a health claim, a substance and a disease. Dietary guidance does not contain both elements (and therefore does not constitute a health claim (see 58 FR 2478 at 2487; January 6, 1993), but may contain one element or another. Typically, current dietary guidance makes reference to a category of foods (i.e., a grouping that is not readily characterized compositionally) and not to a specific substance. The following illustrations may be helpful:

   An example of an authorized health claim, which by definition must contain the elements of a substance and a disease, is: "Calcium may reduce the risk of osteoporosis" (or also "Yogurt, a calcium-containing food, may reduce the risk of osteoporosis"). While FDA has not issued a regulation for a health claim for a specific food (e.g., a banana, which is a "substance" that can be consistently characterized), with adequate evidence such a health claim could be authorized

   An example of dietary guidance, which does not refer to a substance (e.g., a claim about the benefits of a broad class of foods that does not make an express or implied connection to any of the substances that are found in foods that comprise that class) but makes reference to a disease is: Diets rich in fruits and vegetables may reduce the risk of some types of cancer. One element is present, but not both.

   A dietary guidance statement that refers to a specific food or food component but not a disease or health-related condition is: "Carrots are good for your health," or "Calcium is good for you." Again, one element is present, but not both. This type of dietary guidance statement is in essence a structure/function claim or a claim of general well-being from consumption of the substance.

8. How is dietary guidance provided for on food labels?

   Truthful, non-misleading dietary guidance statements may be used on food labels, and do not undergo pre-review by FDA. However, once the food is marketed with the statement, FDA can consider whether the statement meets the requirement to be truthful and not misleading.

   FDA, as part of its recent Better Nutrition Information for Consumer Health Initiative, recognized that scientifically sound and non-misleading dietary guidance statements may be useful to consumers when placed on food labels. FDA will soon be issuing an ANPR that will include a discussion and requests for comments about the use of dietary guidance on food labels, including the utility of a "positive list" of dietary guidance statements.

Procedures for Qualified Health Claims

9. What are the regulatory procedures associated with qualified health claims?

   All health claims, whether unqualified or qualified, require that a petition be submitted to FDA. The requirements for health claim petitions are specified in 21 CFR 101.70, and the general requirements for health claims are in 21 CFR 101.14. Both types of health claims can be applicable to conventional foods and dietary supplements, must characterize the substance's ability to reduce the risk of disease, and cannot be about mitigating or treating disease.

   Qualified health claims have differences that relate to scientific support, wording of the claim, use of enforcement discretion, and timelines.

10. How is the science supporting a qualified health claim different from that for an unqualified health claim?

    Unqualified health claims require significant scientific agreement based on the totality of publicly available scientific evidence. Qualified health claims are still based on the totality of publicly available evidence but the scientific support does not have to be as strong as that for Significant Scientific Agreement. Under its interim final guidance (see Interim Evidence-based Ranking System for Scientific Data), FDA is tentatively providing for 3 levels of science below the Significant Scientific Agreement standard: good to moderate level of scientific agreement, low level of scientific agreement, and very low level of scientific agreement. The criteria for the scientific review are described in the interim final guidance.

11. How is the language for qualified health claims different?

    Qualified health claims language must be worded ("qualified") in such a way that consumers are not misled about the nature of the supporting science. As part of its interim guidance (see Interim Evidence-based Ranking System for Scientific Data) FDA has specified qualifying language for the 3 levels of scientific support below the Significant Scientific Agreement standard. FDA also notes that it may consider other qualifying language on a case-by-case basis.

12. How do the regulatory procedures for qualified health claims differ from unqualified health claims?

    Petitions requesting an unqualified health claim are evaluated under the Significant Scientific Agreement standard (see Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements). If FDA decides that standard is met, it authorizes the claim through notice-and-comment rulemaking.

    Petitions requesting a qualified health claim are posted on the FDA web page for a 60-day public comment period. Qualified health claims meeting the interim procedures criteria are provided for by letters of enforcement discretion (as described above). The letter of enforcement discretion will be posted on the FDA web page. Petitions for a qualified health claim that do not meet the interim procedures criteria may be denied.

13. What is the procedural timeline for qualified health claims?
    
    
    • Within 15 days of receipt, FDA will acknowledge the petition.
    • Within 45 days of receipt, FDA will file the petition and a docket number will be assigned. Note: Petitions that do not meet content requirements as specified in 21 CFR 101.70 will not be filed and will be returned to the petitioner.
    • At the time of filing, FDA will post the petition on the FDA webpage for a 60-day public comment period. During this time, written comments may be submitted to the docket.
    • On or before 270 days after receipt of the petition, a final decision will be sent to the petitioner in the form of a letter as to whether FDA intends to exercise enforcement discretion with respect to a qualified health claim. The letter will be posted on FDA's website.

Submitting a Petition

14. How will FDA know that I wish to have my petition reviewed under the standards for a qualified health claim rather than those for an unqualified health claim (i.e., under the Significant Scientific Agreement standard)?

    The petitioner may indicate within the petition's cover letter that he/she is waiving the right to a review under the Significant Scientific Agreement standard and request that the petition be reviewed under the interim procedures for a qualified health claim. This request will result in FDA proceeding directly to the qualified health claim procedures and its 270-day timeline (see next question). In the absence of such a request, FDA will proceed to review the petition under the Significant Scientific Agreement standard.

15. What information is required to be included in the petition?

    The requirements of 21 CFR 101.70 apply. A general summary of these requirements follows.

    1. Preliminary Requirements (see 21 CFR 101.70(f)(A))
       Explanation of how substance conforms to the requirements of CFR 101.14(b):
       • Relationship between substance and disease in U.S;.
       • Substance contributes taste, aroma, nutritive value, or a technical effect listed in 21 CFR 170.3(o);
       • Substance is a food, food ingredient, or component that has been shown to be safe and lawful at levels necessary to justify a claim.

    2. Summary of Scientific data (see 21 CFR 101.70(f)(B))

    3. Analytical data to show amount of substance that is present in representative foods (see 21 CFR 101.70(f)(C))

    4. Proposed model health claim(s) (see 21 CFR 101.70(f)(D))

    5. Attachments (see 21 CFR 101.70(f)(E))
       • Scientific data supporting a claim:
         • Copies of computer literature searches;
         • Copy of all research articles relied upon for support of petition -- English only;
         • Information concerning adverse consequences pertinent to any segment of the US population.

    6. A claim for categorical exclusion or an environmental assessment (see 21 CFR 101.70(f)(F))

       NOTE: FDA encourages petitioners to specify whether they are requesting that their petition be reviewed as a qualified health claim, and that they waive review under the Significant Scientific Agreement standard. If this specification is not included in the petition, FDA will proceed to review the petition under the Significant Scientific Agreement standard.

16. Where should I send the petition?

    Mail the original and one copy of the petition (or a computer readable disk containing the petition) to the following address:

    Food and Drug Administration
    Office of Nutritional Products, Labeling and Dietary Supplements (HFS-800)
    5100 Paint Branch Parkway
    College Park, MD 20740
    

    Electronic submissions may also be emailed to: label.claims@cfsan.fda.gov.

    NOTE: FDA encourages that petitions be submitted in electronic form so as to speed the process for posting the petition on our website. As noted below, a disk copy of the petition is one of the components that increase the priority of the petition. Electronic submissions should be forwarded as a Word or Word Perfect file including all the information described above. Lengthy electronic submissions should be divided into easily retrievable files.

Other

17. FDA has mentioned "prioritization" of qualified health claim petitions. Why is this necessary?

    Because FDA has limited resources for reviewing health claims, it may be possible that the receipt of a large number of petitions will require that FDA prioritize its review of the petitions.

18. What are the factors relevant to prioritization?

    FDA will consider a number of factors including:

    • Significance and seriousness of the chronic disease that is subject of the claim
    • Strength of the scientific evidence
    • Whether consumer research has been provided to show that the qualified health claim is not misleading
    • Whether the substance that is the subject of the claim has undergone an FDA safety review
    • Whether the substance that is the subject of the claim has been adequately characterized
    • Whether the disease that is the subject of the claim is defined and evaluated in accordance with generally accepted criteria established by a recognized body of qualified experts
    • Whether there has been prior review of the claim or evidence by a recognized body of experts

      In addition to the above criteria, providing the following information will increase the priority of the petition:

    • A disk copy of the petition (along with the two paper copies).
    • An inventory sheet that lists all of the major components of the petition, including an alphabetized bibliography that is grouped based on type of study (e.g., human intervention studies, observational studies).
    
    
19. Are there circumstances when FDA will not file a petition?

    Yes, there are several reasons for not filing a petition including (1) if the petition is incomplete in that it does not provide the required information that is summarized above, and (2) if none of the scientific evidence provided is for the general population.

This draft document has been superceded by the Final Guidance issued on May 12, 2006.