NHM 101 Lecture Notes - Lecture 11: Center For Drug Evaluation And Research, Dietary Supplement Health And Education Act Of 1994, Multivitamin
2 May 2018
School
Department
Course
Professor
Dietary Supplements
Highlights 10, 14, 18
● $24 billion spent each year on supplements
● 1 of 3 people takes a multivitamin infusion (MVI)
● Many others take a specific vitamin/mineral supplement
● Most people self-prescribe supplements
Reasons for Dietary Supplements
● Prevent or correct deficiencies
○ Nutrient deficiencies
○ Low calorie intake
● Reduce disease risks
● Individuals who omit certain foods
● Meet needs during life stages where needs are high
Arguments Against Dietary Supplements
● Toxicity
● Provide people with a false sense of security
○ Prevent or ure diseases
○ Provide energy
○ Enhance athletic performance
● Marketing is misleading
● Scientific evidence is usually insufficient
Regulation of Prescription Drugs
● FDA’s Center for Drug Evaluation and Research
(CDER)
○ Covers prescription & nonprescription drugs
● Responsibility of drug company to submit evidence that the drug is safe and
effective
● CDER reviews study data and proposed labeling
● Typically takes years from initial application to the drug being on the shelf
Regulation of Dietary Supplements
● Regulated by the FDA
● Defined by the Dietary Supplement and Health Education Act of 1994 (
DSHEA
)
○ Labeling is required
find more resources at oneclass.com
find more resources at oneclass.com
Document Summary
billion spent each year on supplements. 1 of 3 people takes a multivitamin infusion (mvi) Many others take a specific vitamin/mineral supplement. Meet needs during life stages where needs are high. Provide people with a false sense of security. Fda"s center for drug evaluation and research (cder) Responsibility of drug company to submit evidence that the drug is safe and effective. Cder reviews study data and proposed labeling. Typically takes years from initial application to the drug being on the shelf. Defined by the dietary supplement and health education act of 1994 (dshea) Labels may make health claims but cannot be brand specific. Labels may claim to diagnose, treat, cure/relieve common symptoms. (cid:781)this statement has not been evaluated by the food and drug. This product is not intended to diagnose, treat, cure, or prevent any disease. (cid:782) Do require good manufacturing practices but are not tested.
