Regulation of Dietary Supplements Page: 3 of 29
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Regulation of Dietary Supplements
Contents
Dietary Supplements: An Overview...................................................................... 1
FDA's Authority to Regulate Dietary Supplements ..................................................... 1
Adulterated and Misbranded Supplements...................................................... 3
How Does the FFDCA Define "Dietary Supplement"9 ........................................... 4
FDA Dietary Supplement-Specific Regulations and Guidance.................................... 4
New Dietary Ingredients ......................................................................... 5
Good Manufacturing Practices................................................................... 5
Labeling............................................................................................ 6
Claims .......................................................................................... 7
Serious Adverse Event Reporting ............................................................... 9
Compliance and Enforcement....................................................................... 11
Dietary Supplement Marketing.......................................................................... 11
Issues for Congress..................................................................................... 12
Identification of Dietary Supplements.............................................................. 13
Food and Dietary Supplements: The Case of Energy Drinks ................................ 13
Drugs and Dietary Supplements: The Case of Pyridoxal 5-Phosphate .................... 15
The Role of Dietary Supplements in Health and Health Care.................................... 16
Dietary Supplement Safety.......................................................................... 18
Concluding Comments................................................................................. 21
Figures
Figure B-i. Example of a Dietary Supplement Principal Display Panel ........................... 24
Appendixes
Appendix A. Selected Laws Regulating Dietary Supplements ....................................... 22
Appendix B. Principal Display Panel, Dietary Supplements ......................................... 24
Appendix C. Acronyms Used in This Report .......................................................... 25
Contacts
Author Contact Information ............................................................................. 26
Acknowledgments..................................................................................... 26Congressional Research Service
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Regulation of Dietary Supplements, report, December 16, 2014; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc810284/m1/3/: accessed April 24, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.