Dietary Supplements Flashcards
1
Q
How common is the use of dietary and herbal medications in the US?
A
- 50% >20 used dietary supplemets, alternative stuff
- 33% take TOGETHER with prescription meds
- 30 billion spent
2
Q
What is a dietary supplement?
A
- supplements diet
- contains (concentrate, metabolite, constituent, extract):
- vitamins
- herbs or other botanicals
- amino acids
- COMBO
3
Q
Dietary Supplement Health and Education (DSHE) Act 1994
A
- 1994 Act of Congress
- restricted FDA’s ability to regulate the industry…as long as manufacturers made NO CLAIMS a/b their products:
- treating
- preventing
- curing dz
- restricted FDA’s ability to regulate the industry…as long as manufacturers made NO CLAIMS a/b their products:
- supplements=food supplements NOT drugs
- places burden on FDA to prove that supplement is unsafe/ineffective
4
Q
Regulation and Role of FDA…Wild Wild West
A
- makers NOT required to prove EFFICACY and SAFETY of a product prior to marketing
- just need adequate evidence…which they dont have to give to the FDA
5
Q
Safety?
A
- ingredient sold pre-Oct 15 1994 is considered to be safe based upon their prior use by humans
- post 10/15/94 safety testing is not reliably enforced
6
Q
What are the three types of claims that the DSHE act allows regarding dietary supplements and herbal medications?
A
- Nutrient claim
- health claim
- structure-function claim
7
Q
DSHE-allowed: Nutrient Claim (1/3)
A
- relative amt of a nutrient or dietary ingredient in a product
- limite to nutrients that have FDA-established DC:
- vitamins, minerals, dietary fiber, AA
8
Q
DSHE-allowed: Health Claim (2/3)
A
- VERY restrictive
- ability of dietary supplement ingredient to reduce r/o dz or health condition
- must be:
- pre-approved by FDA
- Ex: vit/folate/mineral/fish oils
- based on significant scientific agreement
- evidence-based w/ strong evidence (RCT)
- Ex: folate-NTD; Ca/Vit D-osteoporosis
- Ex text: “adequate ca as pt of a healthy diet MAY help REDUCE the r/o osteroporosis”
- pre-approved by FDA
9
Q
DSHE-allowed: Structure-Function Claim (3/3)
A
- most dietary supplements and herbals
- how the dietary supplement may affect or maintain nml body structure/fxn:
- CANNOT imply that supplement will affect a dz or condition
- claim does NOT need FDA approval, BUT claim must be provided within 30 days of marketing
- Ex good: antioxidants help maintain cell integrity
- Ex good: Echinea supports the bodys immune system
- Ex bad: antioxidants prevent the onset of ca
- Ex bad: Echinea is useful in preventing colds
- ***product label must contain the following statement: “this product has not been evaluated by the FDa. This product is no tintended to diagnose, treat, cure or prevent any diseases”
10
Q
DSHE modification in 2007
A
- companies must now inform the FDA of any serious SE
- Manufacturers responsible for Good Manufacturing Practices (GMP)
- ensure QUALITY of manufacturing PROCESS
- supplements shouldn’t contain contaminants or impurities
- supplements should be accurately labeled
- lies, fairytales, and fallicies
- >70% supplements are mislabeled
- 50% dx recalls due to dietary supplements
11
Q
Why are dietary supplements basically useless in the genpop (3)?
A
- body only needs LOW LEVELS
- typically in HEALTHY DIET
- supplements dont replace fresh fruit/veggies (balanced diet)
12
Q
Who may benefit from vitamin and mineral supplements?
A
- pregnant/nursing
- vegetarians/vegan
- crash dieters/chronic low-cal diet (bariatric sx)
- elderly (disabled or chronically ill)
- malabsorption problems (diarrhea, celic dz)
- food allergies (lactose intolerant)
13
Q
Excessive intake of vitamins and minerals can be toxic
A
- U-shaped curve for micronutrients and health
- risk assoc w/ BOTH insufficient and xs intake
- Vit D/Ca insufficiency=INC r/o osteoporosis
- Vit D/Ca overconsumption=INC r/o CVD & overall mortality
14
Q
Vit A <nah></nah>
A
- Deficiency: uncommon
- Supplementation (other than deficiency): not recommended
- Toxicity (PC CHAT):
- painful joints
- coma
- chronic: INC ICP
- hyper-vitaminosis A
- acute: nausea/vision
- Teratogenic
15
Q
Vit D <nd></nd>
A
- Deficiency:
- overt-rare: rickets.osteomalacia
- some SUBclinical deficieny (po folk)
- Supplementation (other than deficiency): <biologi>
</biologi><ul>
<li>blk</li>
<li>institutionalized</li>
<li>obese</li>
<li>limited sunlight</li>
<li>old</li>
<li>Gi d/o</li>
</ul></biologi> - Toxicity <hv>:
</hv><ul>
<li>damage: heart, blood vessels, kidney</li>
<li>N/V/weight loss</li>
<li>HYPERcalcemia</li>
<li>vascular tissue calcification</li>
</ul></hv>
16
Q
Vit E
A
- Deficiency: uncommon
- Supplementation (other than deficiency): not recommended
- Toxicity:
- INC all causes of mortality
- INC bleeding with anticoagulants
17
Q
Vit K <babies></babies>
A
- Deficiency: common in NBN (VKDB)
- Supplementation (other than deficiency):
- NBN given IM Vit K @ birth to prevent hemorrhagic dz of the NBN
- Toxicity: rare
18
Q
Vit C
A
- Deficiency: uncommon
- Supplementation (other than deficiency): not recommended
- Toxicity: GI issues + kidney stones
19
Q
Vit B1
A
- Deficiency: poor countries Beriberi
- Supplementation (other than deficiency):
- chronic alcholics: WKS (psychotic encephalopathy)
- vision changes/ataxia/memory loss
- chronic alcholics: WKS (psychotic encephalopathy)
- Toxicity:
20
Q
Vit B12 <gvape></gvape>
A
- Deficiency: common: 2-15%
- Supplementation (other than deficiency):
- elderly (poor absorption)
- vegan/veggies
- alcoholics
- pernicious anemia
- GI malabsorption d/o
- Toxicity:
