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

Answer and Explanation

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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Correct Answer is A

Explanation

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.

A. penicillin will be effective in treating the infection B. penicillin will not be effective in treating the infection C. the test must be repeated to obtain accurate results D. Ms. Robertson is allergic to penicillin

Correct Answer is A

Explanation

A. Penicillin will be effective in treating the infection:

This interpretation is correct. When the culture and sensitivity test results show that the bacteria causing the infection are sensitive to penicillin, it means that penicillin will effectively inhibit the growth of these bacteria, leading to the resolution of the infection. This sensitivity indicates that penicillin is an appropriate and effective choice for treating the infection.

B. Penicillin will not be effective in treating the infection:

This interpretation is incorrect. If the bacteria are sensitive to penicillin, it means that penicillin will be effective in treating the infection. Sensitivity to penicillin indicates that the bacteria are susceptible to the antimicrobial activity of penicillin, and therefore, penicillin is expected to be effective in eradicating the infection.

C. The test must be repeated to obtain accurate results:

This interpretation is not warranted based on the information provided. If the culture and sensitivity test results indicate that the bacteria causing the infection are sensitive to penicillin, there is no need to repeat the test for accuracy. Sensitivity testing provides valuable information about the susceptibility of bacteria to specific antibiotics, helping healthcare providers make informed decisions about appropriate treatment.

D. Ms. Robertson is allergic to penicillin:

This interpretation is unrelated to the information provided in the scenario. The culture and sensitivity test results indicate the susceptibility of bacteria to penicillin, not whether the patient has an allergy to penicillin. Allergy testing is a separate diagnostic process used to determine if a patient is allergic to penicillin or other medications. Sensitivity testing does not provide information about the patient's allergy status.

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

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Naxlex Comprehensive Predictor Exams

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Correct Answer is A

Explanation

When reviewing Ms. Robertson's culture and sensitivity test results, the nurse learns that the bacteria causing Ms. Robertson's infection are sensitive to penicillin. The nurse interprets this result to mean:

Correct Answer is A

Explanation

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