Module 8: Complementary Nutrition Flashcards
What is:
Healthcare approaches that are not typically part of conventional medical care, OR that may have origins outside of usual Western practice
PLUS
If a non-mainstream practice is used TOGETHER WITH conventional medicine
COMPLEMENTARY NUTRITION
What is:
Healthcare approaches that are not typically part of conventional medical care, OR that may have origins outside of usual Western practice
PLUS
If a non-mainstream practice is used IN PLACE OF conventional medicine
ALTERNATIVE NUTRITION
What is:
Bringing conventional and complementary health care and wellness approaches together in a coordinated way. It is holistic, patient-focused, whole-person.
INTEGRATIVE NUTRITION
What is DSHEA?
Dietary Supplement Health and Education Act of 1994
-it was passed with the goal of amending the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements
What is:
a product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamin, mineral, an herb or botanical, AA, dietary substance used for by man to supplement the diet by increasing the total daily intake, or concentrate, metabolite, consituent, extract, or combinations of these ingredients
Dietary supplement (defined per DSHEA)
Name the 4 major results of DSHEA.
- Defined ‘dietary supplement’
- Reclassified botanicals as dietary supplements, making them distinct from food or drugs
- Allowed supplements available without a prescription and to carry ‘STRUCTURE-FUNCTION’ CLAIMS.
- Requires specific components to be listed on the supplement label
What is a Structure-Function Claim?
It outlines special regulatory requirements and procedures for using these structure function claims and 2 related types of dietary supplement labeling claims. IT CANNOT CLAIM TO PREVENT OR CURE SPECIFIC CONDITIONS.
- May describe the role of a nutrient that is intended to affect the normal structure or functions of the human body
- May also characterize the means by which a nutrient acts to maintain such structure
- Must include disclaimer
What 5 components are required to be labeled on dietary supplements?
- Name of supplement
- Ingredient information
- Disclaimer
- Supplement Facts Panel
- Name & address of the manufacturer
(TRUE/FALSE)
Dietary supplements are not subject to the same standards as prescription or over-the-counter drugs.
TRUE d/t DSHEA
(TRUE/FALSE)
Manufacturers do have to prove their products are safe or effective before they put them on the market.
FALSE
They do NOT d/t DSHEA
(TRUE/FALSE)
FDA can pull supplements proven to be dangerous at any time.
FALSE
FDA can pull them but only after the fact; it is up to the FDA to make its case that the supplement is dangerous d/t DSHEA
What 2 FDA systems can be used to report possible adverse reactions to dietary supplements?
FDA Medwatch System
FDA Safety Reporting Panel