Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims, 3059-3060 [E9-957]

Download as PDF Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices mstockstill on PROD1PC66 with NOTICES would not make sense in a particular context. The guidance states that a certification body should immediately notify FDA and the establishment it is certifying if an auditor finds or discovers a situation in which there is a reasonable probability that the food or feed from the audited establishment will cause serious adverse health consequences or death to humans or animals. We believe that such reporting is appropriate. Although the certification body is not a regulatory entity, we believe it would help protect public health for such circumstances to be reported to FDA so that we can investigate the situation. The guidance also notes that an establishment that receives this information may be subject to the requirement imposed by section 1005 of the Food and Drug Administration Amendments Act of 2007 to report certain information to FDA via an electronic portal. The guidance states that while FDA may provide incentives for participation, neither establishments nor certifying bodies are under an obligation to participate. FDA does not intend to target uncertified establishments or products for inspection or sampling, for example, based solely on their lack of certification. One comment raised a concern regarding the ability of a foreign Government to serve as a certification body. As in the draft guidance, the guidance states that foreign Governments may be certification bodies. More specifically, the definition of certification body states that it could be a Federal, State, local, or foreign Government agency, as well as a nonGovernment entity that is independent of the businesses it certifies and free from conflicts of interest. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on voluntary thirdparty certification programs for foods and feeds. 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 requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the guidance. Submit a single copy of electronic comments or two paper copies of any VerDate Nov<24>2008 19:02 Jan 15, 2009 Jkt 217001 mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in the brackets in the heading of this document. A copy of the guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS athttps://www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/oc/guidance/ thirdpartycert.html or https:// www.regulations.gov. Dated: January 12, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–861 Filed 1–15–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0371 (formerly Docket No. 2007D–0125)] Guidance for Industry: EvidenceBased Review System for the Scientific Evaluation of Health Claims AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ‘‘Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims.’’ This guidance outlines the agency’s approach to the review of the scientific evidence for health claims that meet the significant scientific agreement standard (SSA) and qualified health claims. Elsewhere in this issue of the Federal Register, FDA is announcing the withdrawal of the guidance documents entitled ‘‘Guidance for Industry and FDA: Interim Evidence-Based Ranking System for Scientific Data’’ and ‘‘Guidance for Industry: Significant Scientific Agreement in the Review of PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 3059 Health Claims for Conventional Foods and Dietary Supplements.’’ DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Nutrition, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, (HFS– 830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your requests. 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 on the guidance to https://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Paula R. Trumbo, Center for Food Safety and Applied Nutrition (HFS–830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–1191. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of July 9, 2007 (72 FR 37246), FDA announced the availability of a draft guidance entitled ‘‘Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims.’’ The agency considered received comments as it finalized this guidance. The primary purpose of this guidance is to provide a description of the scientific evaluation process that FDA uses in determining the strength of the relationship of a substance to decreasing the risk of a disease or health-related condition. FDA is issuing this guidance document as a level 1 guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This guidance represents the agency’s current thinking on the evaluation of scientific evidence for health claims. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and E:\FR\FM\16JAN1.SGM 16JAN1 3060 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR 101.14 and 101.70 have been approved under OMB control no. 0910– 0381. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the guidance at https:// www.cfsan.fda.gov/guidance.html. mstockstill on PROD1PC66 with NOTICES V. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to this Web site after this document publishes in the Federal Register.) 1. American Cancer Society, Cancer Facts and Figures, 2004. 2. The Alpha-Tocopherol, Beta Carotene Cancer Prevention Study Group, ‘‘The Effect of Vitamin E and Beta Carotene on the Incidence of Lung Cancer and Other Cancers in Male Smokers, New England Journal of Medicine, 330:1029–1035, 1994. 3. Barton S., ‘‘Which Clinical Studies Provide the Best Evidence? The Best RCT Still Trumps the Best Observational Study,’’ British Medical Journal, 321:255–256, 2000. 4. Cade, J., R. Thompson, V. Burley, et al., ‘‘Development, Validation and Utilization of Food-Frequency Questionnaires—A Review, Public Health Nutrition, 5:567–587, 2002. 5. Federal Judicial Center, Reference Manual on Scientific Evidence, 2d ed., 2000. 6. Flegal K.M., ‘‘Evaluating Epidemiological Evidence of the Effects of Food and Nutrient Exposures,’’ American Journal of Clinical Nutrition, 69:1339S– 1344S, 1999. 7. Greer N., G. Mosser, G. Logan, et al., ‘‘A Practical Approach to Evidence Grading,’’ Joint Commission Journal on Quality Improvements, 26:700–712, 2000. 8. Hill A.B., ‘‘The Environment and Disease: Association or Causation?,’’ Proceedings of the Royal Society of Medicine, 58:295–300, 1965. 9. Hord N.G. and J.I. Fenton, ‘‘Context is Everything: Mining the Normal and VerDate Nov<24>2008 19:02 Jan 15, 2009 Jkt 217001 Preneoplastic Microenvironment for Insights Into the Diet and Cancer Risk Conundrum,’’ Molecular Nutrition and Food Research, 51:100–106, 2007. 10. IOM, Institute of Medicine, ‘‘Dietary Supplements: A Framework for Evaluating Safety,’’ National Academies Press, Washington, DC, 2005. 11. Kraemer H.C., K.K. Lowe, D.J. Kupfer, To Your Health: How to Understand What Research Tell Us About Risk, Oxford University Press, 2005. 12. Kris-Etherton, P.M. and J. Dietschy, ‘‘Design Criteria for Studies Examining Individual Fatty Acid Effects on Cardiovascular Disease Risk Factors: Human and Animal Studies,’’ American Journal of Clinical Nutrition, 1590S–1596S, 1997. 13. Lichtenstein, A.H. and R.M. Russell, ‘‘Essential Nutrients: Food or Supplements?’’ Journal of American Medical Association, 294:351–358, 2005. 14. Milner J.A., ‘‘Diet and Cancer: Facts and Controversies,’’ Nutrition and Cancer, 56: 216–224, 2006. 15. National Cancer Institute, Dictionary of Cancer Terms, https://www.cancer.gov/ dictionary. 16. National Research Council, ‘‘Diet and Health: Implications for Reducing Chronic Disease Risk,’’ National Academy Press, Washington, DC, 1989. 17. Omenn, G.S., G.E. Goodman, M.D. Thornquist, et al., ‘‘Effects of a Combination of Beta Carotene and Vitamin A on Lung Cancer and Cardiovascular Disease,’’ New England Journal of Medicine, 334:1150–1155, 1996. 18. Peto, R., R. Doll, J.D. Buckley, et al., ‘‘Can Dietary Beta-Carotene Materially Reduce Human Cancer Rates?,’’ Nature, 290:201–208, 1981. 19. Sempos C.T., K. Liu, N.D. Earnst, ‘‘Food and Nutrient Exposures: What to Consider When Evaluating Epidemiologic Data,’’ American Journal of Clinical Nutrition, 69:1330S–1338S, 1999. 20. Torun B., ‘‘Protein-Energy Malnutrition,’’ In: Modern Nutrition in Health and Disease, Williams and Williams, New York, 2006. 21. Spilker, B., Guide to Clinical Studies, Raven Press, New York, 1991. 22. Subar, A., et al., ‘‘Comparative Validation of the Block, Willett, and National Cancer Institute Food Frequency Questionnaires,’’ American Journal of Epidemiology, 154:1089–1099, 2001. 23. Szklo M. and F.J. Nieto, Epidemiology Beyond the Basics, Aspen Publishing, 2000. 24. Willett, W.C., ‘‘Overview of Nutritional Epidemiology,’’ Nutritional Epidemiology, Oxford University Press, Oxford, 1990. 25. Willett, W.C., ‘‘Issues in Analysis and Presentation of Dietary Data,’’ In Nutritional Epidemiology, 2d ed., Oxford University Press, Oxford, 1998. 26. Wilson, E.B., ‘‘An Introduction to Scientific Research,’’ General Publishing Co., Toronto, 1990. Dated: January 13, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–957 Filed 1–15–09; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1999–D–0170] (formerly Docket No. 1999D–5424) Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. SUMMARY: The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance entitled ‘‘Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements,’’ that was issued December 1999. DATES: The withdrawal is effective January 16, 2009. FOR FURTHER INFORMATION CONTACT: Paula R. Trumbo, Center for Food Safety and Applied Nutrition (HFS–830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD, 20740, 301–436–2579. SUPPLEMENTARY INFORMATION: In a notice published in the Federal Register of December 22, 1999 (64 FR 71794), FDA announced the availability of a guidance entitled ‘‘Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements.’’ This guidance is being withdrawn because it is obsolete. Dated: January 13, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–964 Filed 1–15–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2003–N–0103] (formerly Docket No. 2003N–0069) Release of Task Force Report; Guidance for Industry and FDA: Interim Evidence-Based Ranking System for Scientific Data; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: E:\FR\FM\16JAN1.SGM Notice; withdrawal. 16JAN1

Agencies

[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Notices]
[Pages 3059-3060]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-957]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0371 (formerly Docket No. 2007D-0125)]


Guidance for Industry: Evidence-Based Review System for the 
Scientific Evaluation of Health Claims

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document entitled ``Guidance for Industry: 
Evidence-Based Review System for the Scientific Evaluation of Health 
Claims.'' This guidance outlines the agency's approach to the review of 
the scientific evidence for health claims that meet the significant 
scientific agreement standard (SSA) and qualified health claims. 
Elsewhere in this issue of the Federal Register, FDA is announcing the 
withdrawal of the guidance documents entitled ``Guidance for Industry 
and FDA: Interim Evidence-Based Ranking System for Scientific Data'' 
and ``Guidance for Industry: Significant Scientific Agreement in the 
Review of Health Claims for Conventional Foods and Dietary 
Supplements.''

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Nutrition, Labeling, and Dietary Supplements, Center for 
Food Safety and Applied Nutrition, (HFS-830), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send 
two self-addressed adhesive labels to assist that office in processing 
your requests.
    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 on the 
guidance to https://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT:  Paula R. Trumbo, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1191.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 9, 2007 (72 FR 37246), FDA 
announced the availability of a draft guidance entitled ``Guidance for 
Industry: Evidence-Based Review System for the Scientific Evaluation of 
Health Claims.'' The agency considered received comments as it 
finalized this guidance. The primary purpose of this guidance is to 
provide a description of the scientific evaluation process that FDA 
uses in determining the strength of the relationship of a substance to 
decreasing the risk of a disease or health-related condition.
    FDA is issuing this guidance document as a level 1 guidance 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). This guidance represents the agency's current thinking on the 
evaluation of scientific evidence for health claims. It does not create 
or confer any rights for or on any person and does not operate to bind 
FDA or the public. An alternate approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and

[[Page 3060]]

Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR 101.14 and 101.70 have 
been approved under OMB control no. 0910-0381.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
https://www.cfsan.fda.gov/guidance.html.

V. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site address, but FDA is not responsible for 
any subsequent changes to this Web site after this document publishes 
in the Federal Register.)

    1. American Cancer Society, Cancer Facts and Figures, 2004.
    2. The Alpha-Tocopherol, Beta Carotene Cancer Prevention Study 
Group, ``The Effect of Vitamin E and Beta Carotene on the Incidence 
of Lung Cancer and Other Cancers in Male Smokers, New England 
Journal of Medicine, 330:1029-1035, 1994.
    3. Barton S., ``Which Clinical Studies Provide the Best 
Evidence? The Best RCT Still Trumps the Best Observational Study,'' 
British Medical Journal, 321:255-256, 2000.
    4. Cade, J., R. Thompson, V. Burley, et al., ``Development, 
Validation and Utilization of Food-Frequency Questionnaires--A 
Review, Public Health Nutrition, 5:567-587, 2002.
    5. Federal Judicial Center, Reference Manual on Scientific 
Evidence, 2d ed., 2000.
    6. Flegal K.M., ``Evaluating Epidemiological Evidence of the 
Effects of Food and Nutrient Exposures,'' American Journal of 
Clinical Nutrition, 69:1339S-1344S, 1999.
    7. Greer N., G. Mosser, G. Logan, et al., ``A Practical Approach 
to Evidence Grading,'' Joint Commission Journal on Quality 
Improvements, 26:700-712, 2000.
    8. Hill A.B., ``The Environment and Disease: Association or 
Causation?,'' Proceedings of the Royal Society of Medicine, 58:295-
300, 1965.
    9. Hord N.G. and J.I. Fenton, ``Context is Everything: Mining 
the Normal and Preneoplastic Microenvironment for Insights Into the 
Diet and Cancer Risk Conundrum,'' Molecular Nutrition and Food 
Research, 51:100-106, 2007.
    10. IOM, Institute of Medicine, ``Dietary Supplements: A 
Framework for Evaluating Safety,'' National Academies Press, 
Washington, DC, 2005.
    11. Kraemer H.C., K.K. Lowe, D.J. Kupfer, To Your Health: How to 
Understand What Research Tell Us About Risk, Oxford University 
Press, 2005.
    12. Kris-Etherton, P.M. and J. Dietschy, ``Design Criteria for 
Studies Examining Individual Fatty Acid Effects on Cardiovascular 
Disease Risk Factors: Human and Animal Studies,'' American Journal 
of Clinical Nutrition, 1590S-1596S, 1997.
    13. Lichtenstein, A.H. and R.M. Russell, ``Essential Nutrients: 
Food or Supplements?'' Journal of American Medical Association, 
294:351-358, 2005.
    14. Milner J.A., ``Diet and Cancer: Facts and Controversies,'' 
Nutrition and Cancer, 56: 216-224, 2006.
    15. National Cancer Institute, Dictionary of Cancer Terms, 
https://www.cancer.gov/dictionary.
    16. National Research Council, ``Diet and Health: Implications 
for Reducing Chronic Disease Risk,'' National Academy Press, 
Washington, DC, 1989.
    17. Omenn, G.S., G.E. Goodman, M.D. Thornquist, et al., 
``Effects of a Combination of Beta Carotene and Vitamin A on Lung 
Cancer and Cardiovascular Disease,'' New England Journal of 
Medicine, 334:1150-1155, 1996.
    18. Peto, R., R. Doll, J.D. Buckley, et al., ``Can Dietary Beta-
Carotene Materially Reduce Human Cancer Rates?,'' Nature, 290:201-
208, 1981.
    19. Sempos C.T., K. Liu, N.D. Earnst, ``Food and Nutrient 
Exposures: What to Consider When Evaluating Epidemiologic Data,'' 
American Journal of Clinical Nutrition, 69:1330S-1338S, 1999.
    20. Torun B., ``Protein-Energy Malnutrition,'' In: Modern 
Nutrition in Health and Disease, Williams and Williams, New York, 
2006.
    21. Spilker, B., Guide to Clinical Studies, Raven Press, New 
York, 1991.
    22. Subar, A., et al., ``Comparative Validation of the Block, 
Willett, and National Cancer Institute Food Frequency 
Questionnaires,'' American Journal of Epidemiology, 154:1089-1099, 
2001.
    23. Szklo M. and F.J. Nieto, Epidemiology Beyond the Basics, 
Aspen Publishing, 2000.
    24. Willett, W.C., ``Overview of Nutritional Epidemiology,'' 
Nutritional Epidemiology, Oxford University Press, Oxford, 1990.
    25. Willett, W.C., ``Issues in Analysis and Presentation of 
Dietary Data,'' In Nutritional Epidemiology, 2d ed., Oxford 
University Press, Oxford, 1998.
    26. Wilson, E.B., ``An Introduction to Scientific Research,'' 
General Publishing Co., Toronto, 1990.

    Dated: January 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-957 Filed 1-15-09; 8:45 am]
BILLING CODE 4160-01-S

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