Dietary Supplements
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Questions and Answers

According to the regulation, what is required to ban a product?

  • Failure to comply with Good Manufacturing Practices (GMPs)
  • Significant or unreasonable risk to consumers
  • Imminent hazard to consumers (correct)
  • False or misleading labeling or advertising

    • What type of claim is allowed on a dietary supplement label?

  • Structure/function claim, e.g., 'Supports immune system'
  • Health maintenance claim, e.g., 'Maintains a healthy urinary tract' (correct)
  • Express disease claim, e.g., 'Treats diabetes'
  • Implied disease claim, e.g., 'Controls blood sugars'

    • Under DSHEA, what is a dietary supplement?

  • A product that requires FDA pre-approval
  • A product that can be represented as a food or drug
  • A product that must be formulated as a capsule or tablet
  • A product including vitamins, minerals, herbs, or amino acids, labeled as a dietary supplement (correct)

    • What is required to accompany all claims on a dietary supplement label?

    <p>A disclaimer stating the claim has not been evaluated by the FDA</p> Signup and view all the answers

    What is the purpose of the Office of Dietary Supplement Programs?

    <p>To oversee the regulation of dietary supplements</p> Signup and view all the answers

    What is the role of the FDA in regulating dietary supplements under the Dietary Supplement Health and Education Act (DSHEA)?

    <p>The FDA has the authority to remove unsafe products from the market, but does not review products before they are introduced.</p> Signup and view all the answers

    What is required of manufacturers under the Dietary Supplement Health and Education Act (DSHEA)?

    <p>They are responsible for substantiating claims made about their products if challenged.</p> Signup and view all the answers

    What is the main difference between a dietary supplement and a conventional food?

    <p>Dietary supplements are intended to supplement the diet, while conventional foods are intended to provide nutrition.</p> Signup and view all the answers

    What is the purpose of good manufacturing practices (GMPs) in the regulation of dietary supplements?

    <p>To ensure the purity and potency of dietary supplements.</p> Signup and view all the answers

    What is the primary goal of the Dietary Supplement Health and Education Act (DSHEA)?

    <p>To promote the maintenance of health using structure/function claims.</p> Signup and view all the answers

    What type of warning did the FDA issue for Hyland Teething products?

    <p>Voluntary recall</p> Signup and view all the answers

    What is the primary concern related to Fish Oil/Omega-3 fatty acids?

    <p>Bleeding risk</p> Signup and view all the answers

    What is the recommended daily dose of Fish Oil/Omega-3 fatty acids?

    <p>1-4 grams</p> Signup and view all the answers

    What is the primary mechanism of action of Ginkgo biloba?

    <p>All of the above</p> Signup and view all the answers

    Why should Ginkgo biloba be discontinued prior to surgery?

    <p>Due to increased risk of bleeding</p> Signup and view all the answers

    What is the primary mechanism of action of St. John's Wort in relation to neurotransmitters?

    <p>Inhibits serotonin, norepinephrine, and dopamine reuptake</p> Signup and view all the answers

    What is a potential adverse effect of St. John's Wort that is not commonly seen with other antidepressants?

    <p>Photosensitivity</p> Signup and view all the answers

    Which of the following medications is likely to have its metabolism increased by St. John's Wort?

    <p>All of the above</p> Signup and view all the answers

    What is the primary concern with the use of Kava in pregnancy?

    <p>Teratogenic risk</p> Signup and view all the answers

    What is the effect of St. John's Wort on digoxin levels?

    <p>Decreases digoxin levels by 25%</p> Signup and view all the answers

    What is the purpose of the USP Dietary Supplement Verification Program?

    <p>To test products submitted voluntarily by manufacturers</p> Signup and view all the answers

    What is the purpose of the statement 'This product is not intended to diagnose, treat, cure, or prevent any disease'?

    <p>To disclaim any therapeutic benefits</p> Signup and view all the answers

    What type of contaminants are commonly found in herbal remedies?

    <p>All of the above</p> Signup and view all the answers

    What is the purpose of Consumerlab.com?

    <p>To provide independent testing and evaluation of dietary supplements</p> Signup and view all the answers

    What is the risk associated with animal-origin products in dietary supplements?

    <p>Transmission of diseases from diseased animals</p> Signup and view all the answers

    How does the FDA regulate probiotics in the United States?

    <p>As a dietary supplement, drug, or food, with no approved health claims</p> Signup and view all the answers

    What is a limitation of the early studies on probiotics?

    <p>Lack of strong clinical evidence</p> Signup and view all the answers

    What is a safety concern related to probiotics?

    <p>Limited availability of safety data</p> Signup and view all the answers

    What is a crucial aspect of Good Manufacturing Practice (GMP) compliance for probiotics?

    <p>Facility design and equipment maintenance</p> Signup and view all the answers

    What is a key factor in the classification of probiotics as a dietary supplement, drug, or food?

    <p>Intended use of the product</p> Signup and view all the answers

    What is the mechanism of action of allicin in garlic?

    <p>Interfering with thromboxane synthesis</p> Signup and view all the answers

    What is a potential drug interaction of garlic supplements?

    <p>Warfarin</p> Signup and view all the answers

    What is the recommended duration of ginseng use?

    <p>Up to 3 consecutive months</p> Signup and view all the answers

    What is the mechanism of action of ginsenosides in ginseng?

    <p>Exhibiting steroid-like actions</p> Signup and view all the answers

    What is a common adverse experience of melatonin supplements?

    <p>Dizziness</p> Signup and view all the answers

    What is the typical dose range of melatonin supplements for insomnia?

    <p>0.5-5 mg</p> Signup and view all the answers

    What is the recommended duration of garlic supplement cessation before dental surgery?

    <p>7-14 days</p> Signup and view all the answers

    What is a benefit of melatonin supplements in cancer patients?

    <p>Increased immune function</p> Signup and view all the answers

    What is a potential effect of garlic supplements on cholesterol levels?

    <p>Decrease in total cholesterol</p> Signup and view all the answers

    What is a potential interaction of ginseng supplements with warfarin?

    <p>Increased risk of bleeding</p> Signup and view all the answers

    What action is taken if there is an “imminent hazard” related to a dietary supplement?

    <p>Ban the product</p> Signup and view all the answers

    What is the purpose of the disclaimer on dietary supplement labels?

    <p>To disclaimer any health claims made by the manufacturer</p> Signup and view all the answers

    What is not allowed on a dietary supplement label?

    <p>Disease claims</p> Signup and view all the answers

    What is the main difference between a dietary supplement and a conventional food?

    <p>Dietary supplements can be represented as a food or drug</p> Signup and view all the answers

    What is the purpose of the Office of Dietary Supplement Programs?

    <p>To regulate dietary supplements</p> Signup and view all the answers

    What type of claim is not allowed on a dietary supplement label?

    <p>Express disease claim</p> Signup and view all the answers

    What is the purpose of the regulation of dietary supplements under DSHEA?

    <p>To ensure the safety of dietary supplements</p> Signup and view all the answers

    What is a common contaminant found in herbal remedies, which is also a type of bacteria?

    <p>E. coli</p> Signup and view all the answers

    Which of the following is NOT a type of contaminant found in non-herbal remedies?

    <p>Microorganisms</p> Signup and view all the answers

    What is the primary mechanism of action of allicin in garlic?

    <p>Inhibiting HMG-CoA reductase</p> Signup and view all the answers

    What is the purpose of the seal of approval from Consumerlab.com?

    <p>To verify the safety of dietary supplements</p> Signup and view all the answers

    What is the primary concern related to the use of animal-origin products in dietary supplements?

    <p>Mad cow disease</p> Signup and view all the answers

    What is the primary effect of ginseng on platelet aggregation?

    <p>Inhibition</p> Signup and view all the answers

    Which of the following is a type of drug that may be found as an adulterant in herbal remedies?

    <p>All of the above</p> Signup and view all the answers

    What is the recommended duration of melatonin supplementation for insomnia?

    <p>1-3 months</p> Signup and view all the answers

    What is the purpose of the USP Dietary Supplement Verification Program?

    <p>To test products for contaminants and adulterants</p> Signup and view all the answers

    What is the potential effect of garlic supplements on cholesterol levels?

    <p>Reduction</p> Signup and view all the answers

    What is the significance of the NEJM 2002;347:2046-56 publication?

    <p>It highlighted the risk of contaminants in non-herbal remedies</p> Signup and view all the answers

    What is the primary concern with the use of ginseng supplements in conjunction with warfarin?

    <p>Bleeding risk</p> Signup and view all the answers

    What is the mechanism of action of melatonin in regulating sleep?

    <p>Regulation of sleep cycle</p> Signup and view all the answers

    What is the recommended duration of garlic supplement cessation before dental surgery?

    <p>7-14 days</p> Signup and view all the answers

    What was the global sales value of the probiotics market in 2011?

    <p>24 B USD</p> Signup and view all the answers

    What is the primary mechanism of action of oral probiotics in caries prevention?

    <p>Competing with cariogenic bacteria for adhesion sites</p> Signup and view all the answers

    What is a limitation of early studies on probiotics?

    <p>Methodological limitations</p> Signup and view all the answers

    What is the primary effect of feverfew on platelet function?

    <p>Irreversible platelet inhibition</p> Signup and view all the answers

    What is the recommended daily dose of evening primrose?

    <p>3 gm qd</p> Signup and view all the answers

    What is the primary use of valerian?

    <p>Sedative effect</p> Signup and view all the answers

    What is the primary mechanism of action of vitamin E?

    <p>Antioxidant effect</p> Signup and view all the answers

    What is a potential adverse effect of St. John's Wort?

    <p>Hepatotoxicity</p> Signup and view all the answers

    What is the primary mechanism of action of oral probiotics in gingivitis?

    <p>Competing with periodontal bacteria for adhesion sites</p> Signup and view all the answers

    What is the primary mechanism of action of St. John's Wort in relation to neurotransmitters?

    <p>Inhibits serotonin, norepinephrine, and dopamine reuptake</p> Signup and view all the answers

    What is the primary concern with the use of St. John's Wort in pregnancy?

    <p>Risk of teratogenicity</p> Signup and view all the answers

    What is the effect of St. John's Wort on the metabolism of alprazolam?

    <p>Increases the metabolism of alprazolam</p> Signup and view all the answers

    What is the recommended daily dose of St. John's Wort for depression?

    <p>600-1200 mg</p> Signup and view all the answers

    What is the primary mechanism of action of Kava in relation to neurotransmitters?

    <p>Potentiates GABA inhibitory transmission</p> Signup and view all the answers

    What is the primary concern with the use of Kava in heavy users?

    <p>Risk of kava dermopathy</p> Signup and view all the answers

    What is the effect of St. John's Wort on the levels of digoxin?

    <p>Decreases the levels of digoxin</p> Signup and view all the answers

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