Alerts

FDA warns consumers about caffeine powder. 

FDA advises consumers to stop using any supplement products labeled as OxyElite Pro or VERSA-1. Please see the following advisories: FDA -10/08/13, FDA - 10/11/13 and CDC - 10/08/13.

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Announcements

New article on reporting side effects of supplements
Just published in The New England Journal of Medicine: A recent article brings up dietary supplement issues you need to be aware of and discusses how dietary supplement side effects could be monitored better. A PDF of the April 3rd article is available free online.

3rd International Congress on Soldiers’ Physical Performance
August 18-21, 2014
The ICSPP delivers innovative scientific programming on soldiers’ physical performance with experts from around the world.

DMAA list updated for April 2014

Fueling Performance Photo Campaign
Share photos of how you fuel your performance and be featured on our Facebook page!

Dietary supplement module
Earn continuing education credits (if eligible) for this two-hour online module.

Operation LiveWell

Performance Triad

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HPRC's human performance optimization (HPO) website is for U.S. Warfighters, their families, and those in the field of HPO who support them. The goal is Total Force Fitness: Warfighters optimized to carry out their mission as safely and effectively as possible.

You are here: Home / Dietary Supplements / OPSS: Operation Supplement Safety / OPSS: Operation Supplement Safety / OPSS Frequently Asked Questions (FAQs) / Why doesn’t FDA stop unsafe supplements from reaching the market?

Question

Why doesn’t FDA stop unsafe supplements from reaching the market?

    OPSS' Answer

    By law, dietary supplement manufacturers are responsible for ensuring that their dietary supplement products are safe before they are marketed. Unlike drug products, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. Once a product is marketed, FDA must show that a dietary supplement is "unsafe" before it can take action to restrict a product's use or remove it from the marketplace. Evidence comes largely from reports of adverse events submitted by healthcare providers consumers, and manufacturers (who must report any serious adverse event). FDA also monitors the marketplace for potentially illegal products (that is, products that may be unsafe or make false or misleading claims) through inspections, complaints, and again, reports of adverse events. For extensive information about how FDA deals with dietary supplements, see their website section on Dietary Supplements.

    Last reviewed 17 April 2014

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