A client asks the nurse whetherthere are any regulatory controls on herbal or dietary supplements. Which response by the nurse is most appropriate?
1. The Dietary Supplement Health and Education Act (DSHEA) regulates herbal and dietary supplements.
2. The Joint Commission (TJC) regulates herbal and dietary supplements.
3. The Food, Drug, and Cosmetic Act regulates herbal and dietary supplements.
4. The Department of Health and Human Services (HHS) regulates herbal and dietary supplements.
1
Rationale 1: The Dietary Supplement Health and Education Act (DSHEA) regulates dietary supplements, but by a far less restrictive law than the FDA. According to the DSHEA, dietary supplements are exempted from the FDA, and are not approved as drugs by the FDA. The DSHEA does give the FDA power to remove from the market any product that poses a "significant or unreasonable" risk to the public.
Rationale 2:The Joint Commission (TJC)regulates herbal and dietary supplements is incorrect because the Joint Commission provides accreditation to hospitals and healthcare agencies.
Rationale 3:Food, Drug, and Cosmetic Actregulates herbal and dietary supplementsis incorrect because the FDA regulates OTC and prescription drugs and assures the public that standards of safety have been met prior to marketing.
Rationale 4:Department of Health and Human Services (HHS)regulates herbal and dietary supplementsis incorrect because HHS does not regulate products.
Global Rationale: The Dietary Supplement Health and Education Act (DSHEA) regulates dietary supplements, but by a far less restrictive law than the FDA. According to the DSHEA, dietary supplements are exempted from the FDA, and are not approved as drugs by the FDA. The DSHEA does give the FDA power to remove from the market any product that poses a "significant or unreasonable" risk to the public. The Joint Commission provides accreditation to hospitals and healthcare agencies. The FDA, not the Food, Drug, and Cosmetic Act, regulates OTC and prescription drugs, and assures the public that standards of safety have been met prior to marketing. The Department of Health and Human Services(HHS) does not regulate products.
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