Regulation of Dietary Supplements

It's often useful to check FDA's website - www.FDA.gov - from time to time to gain insights into how the Agency thinks. On March 9, 2006, the Director of FDA's Center for Food Safety and Applied Nutrition testified before a Congressional committee focused on "The Regulation of Dietary Supplements: A Review of Consumer Safeguards."

(Do you think the news about steroids and certain baseball players had anything to do with this hearing?)

You can read the Director's testimony yourself and learn a bit about how FDA is thinking these days.

Go to www.GMPTrainingSystems.com/asp/resources.asp where you can download a document containing the testimony.

One important piece of this testimony is the following:

"From October 2002 through February 2006, FDA has conducted 588 domestic inspections of dietary supplement manufacturers, issued more than 350 "warning letters" and "cyber letters" to marketers of dietary supplement products, seized products worth more than $13.4 million, supervised the voluntary destruction of more than $3 million worth of products marketed as dietary supplements that were promoted with unsubstantiated claims or that were unapproved drugs or were unsafe, and obtained permanent injunctions against five firms distributing misbranded or unapproved drugs as dietary supplements."

For manufacturers of dietary supplements, the above statistics indicate that they have much work to do to become compliant.

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