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Dietary Supplement Regulation Overview

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Questions and Answers

What is required for dietary supplements to be marketed under the DSHEA?

Supplements can be sold unless proven unsafe (correct)

Prior notice of intent to sell is mandatory

Evidence of safety must be demonstrated

Pre-market approval by FDA must be obtained

Which statement about dietary supplement labeling is correct?

Labels must be approved by the FDA before marketing

Health claims do not require any disclaimer

Labels can make any health claim without restriction

Certain claims about health may be made but must include a disclaimer (correct)

What is a characteristic of dietary supplement regulation compared to prescription medications?

Regulatory standards are less strict for supplements (correct)

Supplements must undergo clinical trials before marketing

Dietary supplements are subject to the same safety and efficacy requirements

They are strictly regulated and frequently recalled

Which of the following claims must accompany dietary supplement labels?

<p>This claim has not been evaluated by the FDA</p> Signup and view all the answers

What does DSHEA not require from dietary supplements before they are marketed?

<p>Pre-market review by the FDA</p> Signup and view all the answers

Study Notes

Dietary Supplement Regulation

The FDA (Food and Drug Administration) is the primary regulatory body for dietary supplements.
Under the DSHEA (Dietary Supplement Health and Education Act), supplements can be sold unless the FDA proves them unsafe.
Pre-market review or approval by the FDA is not required for dietary supplements.
Prior notice of intent to sell is not needed, except for supplements containing a new dietary ingredient.
Supplements can make claims regarding nutritional deficits, support for health, and links to bodily functions.
Regulations are less stringent compared to those for prescription or over-the-counter medications.
Proof of safety and efficacy is not necessary before a supplement is marketed.
The FDA monitors label claims and inserts after a product is on the market.
All claims on labels must include a disclaimer stating that the claim hasn't been evaluated by the FDA and that the product isn't meant to diagnose, cure, or prevent diseases.
There might not be testing data on the use of products in children or pregnant women.

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Description

This quiz explores the regulations surrounding dietary supplements under the FDA and the DSHEA. Learn about the lack of pre-market approval and the claims allowed on supplement labels. Test your knowledge on the safety and efficacy requirements for these products.