Lecture 5: Vitamins, Herbals and Minerals Flashcards
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
Magnesium Compounds
various salts like oxide, sulfate
Proposed uses for vitamin A
Skin disorders like acne and psoriasis, vision
Proposed uses for vitamin D
Bone formation and calcium regulation
Proposed uses for vitamin E
Cognitive decline (dementia) , eye disorders, heart disease