Table of Contents
Dietary Supplements Health Education Act: Structure Function Claims Related to Pregnancy
March of Dimes Birth Defects Foundation
March of Dimes Birth Defects Foundation
March of Dimes Presentation
Physiological Changes Associated with Pregnancy
Pregnancy: Dynamic & Changing
Structure Function Claims Considered During Pregnancy
Five Questions Posed by FDA
1. What are the potential hazards that may be associated with the use of dietary supplements for conditions associated with pregnancy, both to the pregnant woman and the fetus? Should these hazards be considered to be different than hazards to other potential users? If so, why and on what basis under DSHEA?
2. Are there certain conditions associated with pregnancy (in addition to those already identified in the final rule) for which structure/function claims should not be permitted? If so, why and on what basis?
3. What is the potential for harm that may be associated with the use of dietary supplements during pregnancy for conditions unrelated to pregnancy?
4. Are there means to address safety concerns associated with dietary supplement use during pregnancy, for example a requirement to conduct animal studies or collect human safety information?
5. Should dietary supplements with a specific recommended use during pregnancy be required to bear specific warnings about use during pregnancy? Should all dietary supplements be required to bear such warnings?
Conclusions
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Author: Donald Mattison
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