Lecture 5: Vitamins, Herbals and Minerals Flashcards
(71 cards)
Nonprescriptions Medications
- Regulated by FDA Center for Drug Evaluation and research
- held to same standards as prescription medications as far as efficacy, labeling, purity, safety, and stability
Dietary Supplement Health and Education Act (DSHEA)
- Products intended to supplement the diet
- contain at least one dietary ingredient ( amino acid, herb, mineral and/or vitamin
FDA requirements (Supplement Labeling)
- Evidence of safety and good manufacturing practices
- “Supplements facts”
- Name of product and “dietary supplement”
- Net quantity of contents
- Manufacturers, packers, or distributor’s name and address
- Directions of use
- “supplement facts” panel
Dietary Supplement Labeling
- Serving Size
- List of Dietary Supplements
- Amount per Serving Size
- Percent of Daily Value
- Plant’s Scientific Name of Latin Binomial
- Specific Plant part used
Proprietary Blend Label
List of total weight of blend and individual component names in order or predominance
Dietary Supplement Claims
- Health Claim
- Nutrient Claim
- Structure-Function Claim
Health Claim
- Relationship between a substance and resulting reduction in risk of disease or health-related condition
- Requires FDA approval
- Ex “ Diets low in sodium “may” reduce the risk of high blood pressure, a disease associated with many factors
Nutrient Claim
- Relative amount of nutrient/ dietary substance in a product
- Requires FDA approval
- Ex “ fat free”, “reduced sodium”, “no added sugars”
Structure-Function Claim
- Description of how a product may mantain the normal healthy structure of function of the body without discussing a specific disease state
- Does not require FDA approval
- Ex “ supports healthy cholesterol levels”, “promotes the body’s natural immune function
All claims state
“This product is not intended to diagnose, treat, cure, or prevent disease.”
Consumer Protection Act
- Applies to dietary supplements and nonprescription drugs
- Reporting of serious adverse effects to FDA
- Manufacturing reporting (Manufacturers, packers, distributors)
- Voluntary reporting (consumers, health care providers)
Counseling on Dietary Supplements
- Only use for a limited amount of time
- Inform doctors of dietary supplement use
- FDA does not require data on efficacy or safety prior to marketing
- Recommend : products with seal on label
- large, reputable companies
- maintain therapy with the same brand and formulation
Fat Soluble Vitamins
A,D, E
Water Soluble Vitamins
C, B12, B9
Minerals
Calcium, Magnesium and Iron
Herbal
St. John’s Wort, Glucosamine
Vitamin A Ingredients
Alpha-carotene, Beta-carotene, Retinol
Vitamin D Ingredients
Ergocalciferol (D2), Cholecalciferol (D3)
Vitamin E Ingredient
Alpha-tocopherol
Vitamin C Ingredient
Ascorbic Acid
Vitamin B12 Ingredient
Cyanocobalamin
Vitamin B9
Folic Acid
Calcium Compounds
various salts like carbonate, citrate, gluconate
Iron Compounds
various salts like fumarate, gluconate, sulfate