A client who is considering taking a dietary supplement recommended by the nurse asks how to determine whether the supplement is safe
Which requirements by the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2007 will the nurse educate the client about?
1. Include their contact information on the label so consumers can report adverse effects.
2. Notify the Food and Drug Administration (FDA) within 15 days of receiving a report of an adverse effect.
3. Keep records of adverse effects for at least 6 years and make these records available for inspection by the Food and Drug Administration (FDA).
4. Demonstrate product effectiveness prior to release of the product to the public.
5. State which conditions the product is intended to cure or prevent.
Correct Answer: 1,2,3
Rationale 1: This legislation requires that the marketing company's contact information be listed on the label.
Rationale 2: The marketing company must notify the FDA of any reported adverse effects within 15 days.
Rationale 3: The marketing company must keep records of reported adverse effects for at least 6 years and make those records available to the FDA for inspection.
Rationale 4: The marketing company is not required to demonstrate the effectiveness of a product prior to release to the public.
Rationale 5: The marketing company cannot make the claim that a product can cure or prevent any conditions.
Global Rationale: This legislation requires that the marketing company's contact information be listed on the label. The marketing company must notify the FDA of any reported adverse effects within 15 days. The marketing company must keep records of reported adverse effects for at least 6 years and make those records available to the FDA for inspection. The marketing company is not required to demonstrate the effectiveness of a product prior to release to the public. The marketing company cannot make the claim that a product can cure or prevent any conditions.
You might also like to view...
A nurse is caring for a client with a severe head trauma. Each shift, the nurse pays attention to the lighting, atmosphere, and surroundings the client is exposed to. The nurse is functioning according to the assumptions of which nursing theorist?
1. Dorothea Orem 2. Martha Rogers 3. Florence Nightingale 4. Jean Watson
Which of the dramatic and emotional cluster of personality characteristics is least prevalent?
a. antisocial personality disorder b. borderline personality disorder c. histrionic personality disorder d. narcissistic personality disorder
A student nurse caring for a patient diagnosed with depression reads in the patient's medical record, "This patient shows vegetative signs of depression." Which nursing diagnoses most clearly relate to the vegetative signs? Select all that apply
a. Imbalanced nutrition: less than body requirements b. Chronic low self-esteem c. Sexual dysfunction d. Self-care deficit e. Powerlessness f. Insomnia
A disease that causes involuntary movements that disturb the patient's balance is
A) stroke. B) arthritis. C) Huntington's disease. D) MREA.