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

Answer and Explanation

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.

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Correct Answer is C

Explanation

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.

A. refers to an infection that is resistant to conventional antibiotics B. superinfection that has significant antifungal resistance C. refers to a term used for antibiotic coverage D. There is no such phenomenon of acquired resistance

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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The nurse explains that is regard to regulation by the Dietary Supplement Health and Education Act, dietary supplements:

Nursing Test Bank

Naxlex Comprehensive Predictor Exams

Which of the following is a legal requirement contained in the DSHEA?

Correct Answer is C

Explanation

A client has been prescribed an antibiotic and overhears the prescriber talking about acquired resistance. The client asks the nurse what this means. What is the nurse's best statement regarding acquired resistance?

Correct Answer is A

Explanation

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