Block 10 - L8-L9 Flashcards
What is a dietary supplement?
A product that is intended to supplement the diet, contains one or more of the following ingredients (vitamins, minerals, herbs/other botanicals, amino acids, and/or a concentrate, metabolite, constituent, extract, or combination of any of the above), is intended to be taken by mouth as a pill, capsule, table, or liquid, is not represented for use as a conventional food, and is labeled on the front as a dietary supplement.
True or false - dietary supplements do not include topicals, creams, or suppositories.
True
The 1994 Dietary Supplement Health and Education Act restricted the ability of the FDA to regulate the industry, as long as manufacturers met what conditions?
Made no claims about their products treating, preventing, or curing disease (supplements are not considered drugs, but rather food supplements)
True or false - makers of dietary supplements are required to prove efficacy and safety of a product prior to marketing.
False - they are not required to prove efficacy and safety of a product prior to marketing
What three claims can be made when advertising dietary supplements and herbal medications?
- Nutrient claim
- Health claim
- Structure-function claim
What is a nutrient claim?
Describes the relative amount of a nutrient or dietary ingredient in a product; can claim that the supplement addresses a nutrient deficiency, but is limited to those nutrients that have an FDA-established DV
What is a health claim?
Characterizes the ability of the dietary supplement ingredient to REDUCE THE RISK of a disease or health condition; must be pre-approved by the FDA (<25 are approved), requires a high standard of evidence, based upon significant scientific agreement, evidence-based review system supported by strong evidence includes high quality observation and intervention studies
What is a structure-function claim?
A statement reflecting how the dietary supplement may affect or maintain normal body structures or functions; cannot imply that a supplement will affect a disease or condition, including classic signs or symptoms of disease
What modifications have been made to the The 1994 Dietary Supplement Health and Education Act?
Companies must now inform the FDA of any serious AE (death, life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect)
Manufacturers are now responsible for Good Manufacturing Practices (ensures quality of the process, supplements should not contain contaminants or impurities, supplements should be accurately labeled)
There is little justification for widespread use of dietary supplements in the general population unless there is evidence of a symptomatic nutrient deficiency - why?
The body only needs low levels of vitamins and minerals, and these are typically provided by a healthy diet. Supplements do not replace or add to the benefits of eating fresh fruits and vegetables as part of a balanced diet.
List some populations that may benefit from vitamin and mineral supplements.
- Pregnant women/nursing mothers (especially folic acid)
- Some vegetarians and vegans (vitamin B12)
- Crash dieters or people on chronic low-calorie diets
- The elderly
- Those with malabsorption problems
- Those with food allergies
Excessive intake of vitamins and minerals can be toxic - explain.
There is a U-shaped curve for many micronutrients and health. There is risk associated with both insufficient and excessive intake.
Vitamin D and Ca2+ insufficiency increase risk of ___. Over-consumption increase risk of ___.
Osteoporosis; CVD and overall mortality
Supplementation of which vitamins (A, D, E, K, C, B1, B12, Folate) is not recommended except in deficiency?
A, E, C
When is Vitamin D supplementation recommended (beyond deficiency)?
- Older adults/people who are institutionalized
- Exposure to limited sunlight
- Dark-skinned individuals
- Obese individuals
- Individuals with G disorders
When is Vitamin K supplementation recommended (beyond deficiency)?
- All newborns at birth to prevent hemorrhagic disease of the newborn
When is Vitamin B1 (thiamine) supplementation recommended (beyond deficiency)?
- People with chronic alcohol use
2. Wernick-eKorsakoff Syndrome (vision changes, ataxia, memory loss, can be fatal if untreated)
When is Vitamin B12 supplementation recommended (beyond deficiency)?
- The elderly (poor absorption)
- Vegans and vegetarians
- Alcohol use
- Pernicious anemia
- GI malabsorption disorders
When is Folate supplementation recommended (beyond deficiency)?
- Women of childbearing age to prevent neural tube defects
Describe the toxicity of Vitamin A.
- First trimester birth defects
- Increased risk of CVD/osteoporosis
- Increased risk for lung cancer in smokers
Describe the toxicity of Vitamin D.
- Hypercalcemia
- Vascular tissue calcification
- Damage to heart, blood vessels, and kidney
- N/V, weight loss
Describe the toxicity of Vitamin E.
- Increased in all cause mortality
2. Increased bleeding with anticoagulants
Describe the toxicity of Vitamin C.
- GI issues
2. Kidney stones
Multivitamins are of little benefit in otherwise healthy individuals with a varied diet. Who may benefit from use?
People with poor nutrition, low calorie diet, vegetarians/vegans (B12), post-menopausal women (Vitamin D and Ca2+), 50+ y/o (poor absorption of B12)
