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

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




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.”


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


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 See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance.

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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.

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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In the Federal Register of July 9, 2007 (72 FR 37246), FDA announced the availability of a draft guidance entitled “Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims.”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 Start Printed Page 3060Budget (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​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,​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.

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Dated: January 13, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

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[FR Doc. E9-957 Filed 1-15-09; 8:45 am]