Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

What is required for dietary supplements to promote health claims under DSHEA?

1. The FDA approves the claim by regulation or scientific agreement

2. Claims must be based solely on anecdotal evidence

3. Claims require no regulation or approval

4. Health claims must include a warning label only

The correct answer is: The FDA approves the claim by regulation or scientific agreement

The correct response is that health claims related to dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) must be scientifically substantiated and, in some cases, approved by the FDA. Specifically, any health claims that a dietary supplement is intended to prevent or treat a disease must be supported by significant scientific evidence and ideally, go through a regulatory process with the FDA. This ensures that the claims are accurate and not misleading to consumers. The other choices do not align with the requirements outlined in DSHEA. Claims based solely on anecdotal evidence do not meet the standard of scientific substantiation necessary for health claims. Claims requiring no regulation or approval do not reflect the FDA's oversight for dietary supplements making certain health claims. Lastly, while warning labels can be necessary depending on the ingredients and claims made, they do not suffice as a standalone requirement for health claims to be valid under DSHEA regulations.