A patient who is considering taking a dietary supplement recommended by the nurse asks how to determine if the supplement is safe
The nurse explains that the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2007 requires that companies marketing herbal and dietary supplements
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.
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