The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2007 represented an update of the Dietary Supplement Health and Education Act of 1994 (DSHEA)
What was required in the marketing of dietary supplements as a result of this act?
1. Testing the safety of the supplements
2. Notifying the FDA of serious adverse events reported by consumers
3. Stating which conditions the product is designed to treat
4. Carrying a USP verification mark on labels
Correct Answer: 2
Rationale 1: Neither law specifies that the manufacturer has to test the safety of a supplement before marketing it.
Rationale 2: Companies must report to the FDA serious adverse events resulting in death, life-threatening experience, disability, birth defect, or hospital admission.
Rationale 3: The label on a dietary supplement must state that the product is not intended to diagnose, treat, cure, or prevent any disease.
Rationale 4: Obtaining a USP verification mark is a voluntary process the manufacturer may choose to undergo. It is not mandatory.
Global Rationale: Companies must report to the FDA serious adverse events resulting in death, life-threatening experience, disability, birth defect, or hospital admission. Neither law specifies that the manufacturer has to test the safety of a supplement before marketing it. The label on a dietary supplement must state that the product is not intended to diagnose, treat, cure, or prevent any disease. Obtaining a USP verification mark is a voluntary process the manufacturer may choose to undergo. It is not mandatory.
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