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Hello, and welcome to Andy’s Take.
You might be interested to read on our website about recent actions by the FDA to warn consumers about certain liquid dietary supplement products containing hazardous levels of selenium. Our warning was based on 43 reports from nine states of people experiencing serious problems including significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue.
This kind of rapid response to threats to your health is our #1 commitment.
My take on this is that although the vast majority of companies are marketing safe and effective products, from time to time products will get into circulation that turn out to be dangerous to you. Protecting you against these dangerous products can be enhanced with you, the public, as a partner with FDA.
In your neighborhood, you may have something called Neighborhood Watch to protect your homes, in partnership with your neighbors. FDA has a similar program, called MedWatch. This is our early alert system -- where you tell us when something is suspicious, so that armed with that information we can protect you.
Thanks to this partnership, in the last few weeks FDA initiated the seizure of $1.3 million worth of potentially risky dietary supplements, and requested a $2.2 million penalty for a manufacturer whose implantable hearing aids exposed patients to the risk of additional hearing loss.
In the last 15 years, FDA’s criminal investigations resulted in more than 4,500 arrests, more than 3,500 convictions, and more than $5.7 billion in fines and restitution of illegal profits. The FDA is committed to always being a strong force to protect your health by using all of our enforcement tools including warning letters, product seizure, injunction and prosecution.
With your cooperation in an early warning system like MedWatch, and when you inform us of your concern about a medical or dietary product, then FDA can be even more effective in protecting the health of you and your family.
I look forward to sharing with you my next Andy’s Take.
For more information on FDA’s MedWatch program visit
http://www.fda.gov/medwatch/index.html
Andy
Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs
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