The nurse prepares to teach patients about the safety and efficacy of herbal preparations. Which statement would be included in the best plan by the nurse?

Question

1. "Herbal preparations must be tested for safety and efficacy prior to marketing."
2. "The label on the herbal preparation is required by the Dietary Supplement Health and Education Act (DSHEA) to be accurate."
3. "Herbal preparations have to meet the same safety and efficacy standards as prescription and over-the-counter (OTC) drugs."
4. "The manufacturer does not have to prove the safety or efficacy of the herbal preparation."

Answer 1

Correct Answer: 4
Rationale: Herbal products are not regulated by the Food and Drug Administration (FDA) for safety standards. They are regulated by a far less rigorous law, the Dietary Supplement Health and Education Act (DSHEA) of 1994, which does not require the manufacturer to demonstrate efficacy or safety of the herbal product. The federal government does not require herbal preparations to be tested for safety and efficacy prior to marketing. The Dietary Supplement Health and Education Act DSHEA does not regulate the accuracy of the label; the product may or may not contain the product listed, in the amounts claimed. Herbal preparations do not have to meet the same safety standards as prescription and over-the-counter (OTC) drugs.