Volumes 7, 8
1 - “Interim Procedures for Qualified Health Claims
in the Labeling of Conventional Human Food and Human Dietary
Supplements” (July 10, 2003). [http://www.cfsan.fda.gov/~dms/nuttf-e.html]
2 - See guidance entitled “Interim Evidence-based
Ranking System for Scientific Data,” July 10, 2003. [http://www.cfsan.fda.gov/~dms/hclmgui4.html]
3 - In an intervention study, subjects similar to each other
are randomly assigned to either receive the intervention or
not to receive the intervention, whereas in an observational
study, the subjects (or their medical records) are observed
for a certain outcome (i.e., disease). Intervention studies
provide the strongest evidence for an effect. See Guidance entitled
“Significant Scientific Agreement in the Review of Health
Claims for Conventional Foods and Dietary Supplements”
(December 22, 1999). [http://www.cfsan.fda.gov/~dms/ssaguide.html]
Footnote 4 - Replication of scientific findings is important
for evaluating the strength of scientific evidence (An Introduction
to Scientific Research, E. Bright Wilson Jr., pages 46-48, Dover
Publications, 1990) and Ioannidis JPA. Contradicted and initially
stronger effects in highly cited clinical research. JAMA, 294:
218-228, 2005. Published
Footnote 5 - Consistency of findings among similar and different
study designs is important for evaluating causation and the
strength of scientific evidence (Hill A.B. The environment and
disease: association or causation? Proc R Soc Med 1965; 58:
See also Systems to rate the scientific evidence, Agency for
Healthcare Research and Quality
defining “consistency” as “the extent to which
similar findings are reported using similar and different study
6 - Kidney Stones in Adults, National Institute of Diabetes
and Digestive and Kidney Diseases (NIDDK), National Institutes
of Health, U.S. Department of Health and Human Services
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Reference 7 - Federal Judicial Center. Reference Manual on
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