US FDA/CFSAN - Legal Context of Consumer Research on Health Claims and Other Food Labeling Claims - Slide 5 - Elements of a Health Claim

US FDA/CFSAN - Legal Context of Consumer Research on Health Claims and Other Food Labeling Claims November 17, 2005

US FDA/CFSAN

Legal Context of Consumer Research on Health Claims and Other Food Labeling Claims

November 17, 2005

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Elements of a Health Claim

"Substance"

A specific food or component of food, whether in conventional food or dietary supplement form.
See 21 C.F.R. 101.14(a)(2).

"Disease or health-related condition"

"Damage to an organ, part, structure, or system of the body such that it does not function properly ... or a state of health leading to such dysfunctioning ... " 21 CFR 101.14(a)(5).

Nutrient deficiency diseases (e.g., scurvy) are not included in this definition.

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