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 (B)</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 (A), Testing for safety and efficacy (B), Approval for health claims made on labels (C)</p> Signup and view all the answers

Flashcards

Dietary Supplement Regulation

The FDA regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA).

DSHEA's Approach to Safety

Under DSHEA, supplements can be marketed unless the FDA proves they are unsafe.

Pre-Market Approval of Supplements

Dietary supplements don't require pre-market approval from the FDA.

Allowed Health Claims on Supplements

Dietary supplement labels can make certain health-related claims, like "supports health" or "linked to a body function."

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Safety and Efficacy of Supplements

Dietary supplements don't need to be proven safe and effective before being marketed.

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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.