Which of the following is a legal requirement contained in the DSHEA?
The herbal product must contain only one active ingredient
Effectiveness must be demonstrated by the manufacturer
Dietary supplements must state that the product is not intended to diagnose, treat, cure, or prevent any disease
Dietary supplements must be tested for safety prior to marketing
The Correct Answer is C
A. The herbal product must contain only one active ingredient:
This statement is not a legal requirement contained in DSHEA. Many dietary supplements contain multiple active ingredients, such as vitamins, minerals, herbs, amino acids, and other substances. DSHEA does not mandate that dietary supplements contain only one active ingredient.
B. Effectiveness must be demonstrated by the manufacturer:
DSHEA does not require manufacturers to demonstrate the effectiveness of dietary supplements before marketing. Unlike pharmaceutical drugs, which must undergo premarket approval by the Food and Drug Administration (FDA) to demonstrate safety and efficacy, dietary supplements do not need to prove effectiveness to be marketed. Instead, manufacturers are responsible for ensuring the safety of their products and making truthful claims on product labels.
C. Dietary supplements must state that the product is not intended to diagnose, treat, cure, or prevent any disease:
This statement accurately reflects a legal requirement contained in DSHEA. Under DSHEA, dietary supplement labels must include a disclaimer stating that the product is not intended to diagnose, treat, cure, or prevent any disease. This disclaimer helps to clarify that dietary supplements are intended to support general health and well-being rather than to treat specific diseases or medical conditions.
D. Dietary supplements must be tested for safety prior to marketing:
While DSHEA requires manufacturers to ensure the safety of their dietary supplements, it does not mandate standardized premarket testing for safety by regulatory authorities. Instead, manufacturers are responsible for conducting safety assessments and ensuring that their products are safe for consumers. The FDA may take action against manufacturers if a product is found to be unsafe or if it violates regulatory requirements, but premarket testing is not a specific legal requirement under DSHEA.
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Related Questions
Correct Answer is C
Explanation
A. Echinacea:
Echinacea is commonly used to support the immune system and may be used to prevent or reduce the severity of colds and other infections. However, it is not typically used specifically for treating menopause-related hot flashes.
B. Saw palmetto:
Saw palmetto is primarily used for managing symptoms related to the prostate gland, such as benign prostatic hyperplasia (BPH), and is not commonly used for treating menopause-related hot flashes in women.
C. Black cohosh:
Black cohosh is one of the most widely studied herbal remedies for managing menopause-related symptoms, including hot flashes. Research suggests that black cohosh may help reduce the frequency and severity of hot flashes in some women experiencing menopausal symptoms.
D. Cranberry juice:
Cranberry juice is often used to promote urinary tract health and prevent urinary tract infections (UTIs). While it may have some health benefits, cranberry juice is not typically used for managing menopause-related hot flashes.
Correct Answer is D
Explanation
A.Goldenseal:
Goldenseal is a plant commonly used in herbal medicine, but it is not a drug that specifically inhibits bacterial beta-lactamase. While goldenseal may have antimicrobial properties, it is not typically used as a beta-lactamase inhibitor in the treatment of bacterial infections.
B. Ceftriaxone (Rocephin):
Ceftriaxone is a third-generation cephalosporin antibiotic. While it is an effective antibiotic for treating a wide range of bacterial infections, it does not have beta-lactamase inhibitor properties. Instead, ceftriaxone is susceptible to degradation by beta-lactamase enzymes produced by certain bacteria.
C. Penicillin:
Penicillin is one of the earliest discovered and most widely used beta-lactam antibiotics. However, many bacteria have developed resistance to penicillin by producing beta-lactamase enzymes. Penicillin itself does not inhibit beta-lactamase; instead, it is often combined with beta-lactamase inhibitors to enhance its effectiveness against beta-lactamase-producing bacteria.
D. Zosyn (piperacillin/tazobactam):
Zosyn is a combination antibiotic containing piperacillin, a broad-spectrum penicillin antibiotic, and tazobactam, a beta-lactamase inhibitor. Tazobactam inhibits the action of beta-lactamase enzymes produced by bacteria, allowing piperacillin to exert its antibacterial effects without being degraded by beta-lactamase. Therefore, Zosyn is the correct answer as it contains a drug that inhibits bacterial beta-lactamase.
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