The FDA's Role in Reviewing the Safety & Efficacy of Dietary Supplements

Vasilios FrankosThe U.S. Food and Drug Administration (FDA) makes clear that it does not conduct a pre-market review of dietary supplements. Dietary supplements are not approved by the government for safety and effectiveness before they are marketed.

However, Vasilios H. Frankos, former director of the Division of Dietary Supplement Programs at the Center for Food Safety and Applied Nutrition, says: “All dietary supplements that are marketed must be safe. The onus is on the manufacturer to ensure that dietary supplements are safe, but if FDA does identify a problem, through the literature or through adverse event reports, then we can take action against those supplements…”

According to the FDA’s website, “The Center for Food Safety and Applied Nutrition, known as CFSAN, is one of six product-oriented centers, in addition to a nationwide field force, that carry out the mission of the Food and Drug Administration (FDA).”

Watch and learn about the Role of the FDA in reviewing the safety and efficacy of dietary supplements »

More Information

See related HelpingYouCare® reports on:

What You Need to Know About Dietary Supplements

U.S. Preventive Services Task Force Recommends Against Vitamin D & Calcium Supplements

NIH Features New Report on Good Nutrition for Healthy Bones

Vitamin E Supplements May Weaken Bones, New Mouse Study Suggests

For information on medications and medication management, see the HelpingYouCare® resource pages on
Medications/ Management & Information.

For information on a healthy diet, exercise and other lifestyle factors that promote wellness and prevent diseases, see the HelpingYouCare® resource pages on Wellness/ Healthy Living for Seniors & Caregivers, including:

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