The nurse explains that is regard to regulation by the Dietary Supplement Health and Education Act, dietary supplements:
do not have to demonstrate effectiveness
are determined to be safe before being placed on the market
are checked for label accuracy
are tested prior to marketing
The Correct Answer is A
- Do not have to demonstrate effectiveness:
This statement is generally true under DSHEA regulations. Unlike pharmaceutical drugs, dietary supplements are not required to undergo rigorous testing to demonstrate their effectiveness in treating, preventing, or curing specific health conditions before they are marketed. However, manufacturers are prohibited from making unsubstantiated claims about the effectiveness of their products.
B. Are determined to be safe before being placed on the market:
Under DSHEA regulations, dietary supplement manufacturers are responsible for ensuring the safety of their products before they are marketed. However, unlike pharmaceutical drugs, dietary supplements do not undergo premarket approval by the Food and Drug Administration (FDA) to verify their safety and efficacy. Instead, manufacturers are required to notify the FDA of their intent to market a new dietary ingredient (NDI) and provide evidence of the ingredient’s safety.
C. Are checked for label accuracy:
The FDA regulates dietary supplements to ensure that their labels are accurate and truthful. However, the extent of label accuracy checking varies, and the FDA does not routinely test every dietary supplement product on the market. Instead, the FDA relies on postmarket surveillance, consumer complaints, and other mechanisms to identify and address inaccuracies or violations of labeling regulations.
D. Are tested prior to marketing:
Unlike pharmaceutical drugs, dietary supplements are not required to undergo premarket testing to demonstrate their safety or efficacy before they are marketed. While manufacturers are responsible for ensuring the safety of their products, there is no formal premarket testing requirement under DSHEA regulations.
Nursing Test Bank
Naxlex Comprehensive Predictor Exams
Related Questions
Correct Answer is B
Explanation
A. Never take with prescription medications:
This statement is not accurate. Many herbal products can interact with prescription medications, potentially leading to adverse effects or reduced efficacy. However, avoiding taking herbal products with prescription medications altogether may not be practical or necessary in all cases. Instead, it's essential to assess for potential interactions and consult with healthcare professionals.
B. Use only one herbal preparation at a time:
This is the correct approach. Using only one herbal preparation at a time allows for better identification of any allergic reactions or adverse effects. If multiple herbal products are taken simultaneously, it can be challenging to determine which product is causing a particular reaction. Starting with one product also simplifies monitoring for efficacy and safety.
C. Take less than the recommended dose initially:
While starting with a lower dose initially may be a prudent approach for some individuals, it is not necessarily the best way to identify allergic or adverse reactions. Taking less than the recommended dose may not provide a full assessment of the product's effects and may not adequately identify potential adverse reactions.
D. Check with a reputable pharmacist:
Consulting with a reputable pharmacist is essential for obtaining information about herbal products, including potential interactions, side effects, and recommended dosages. While a pharmacist can provide valuable guidance, they may not be present during the initial use of the herbal product to monitor for adverse reactions directly.
Correct Answer is A
Explanation
A. Refers to an infection that is resistant to conventional antibiotics:
This statement is partially correct. Acquired resistance does indeed refer to bacteria becoming resistant to antibiotics, but it is not specific to conventional antibiotics. Bacteria can develop resistance to various types of antibiotics, including conventional antibiotics and newer antimicrobial agents.
B. Superinfection that has significant antifungal resistance:
This statement is incorrect. Acquired resistance specifically pertains to bacteria and their ability to resist antibiotics. It does not involve antifungal resistance or superinfections.
C. Refers to a term used for antibiotic coverage:
This statement is incorrect. Acquired resistance is not a term used to describe antibiotic coverage. It describes the phenomenon of bacteria becoming resistant to antibiotics.
D. There is no such phenomenon of acquired resistance:
This statement is incorrect. Acquired resistance is a well-documented phenomenon in microbiology and is a significant challenge in the treatment of bacterial infections. Ignoring or denying the existence of acquired resistance would overlook a critical aspect of antibiotic stewardship and management of bacterial infections.
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