[Congressional Record (Bound Edition), Volume 155 (2009), Part 6]
[House]
[Page 7833]
[From the U.S. Government Publishing Office, www.gpo.gov]




              FDA ADVERSE EVENT REPORTING LABELING CHANGES

  (Mr. CHAFFETZ asked and was given permission to address the House for 
1 minute and to revise and extend his remarks.)
  Mr. CHAFFETZ. Mr. Speaker, Americans are concerned not only about the 
safety of their food but their ability to put food on their tables. So 
it makes no sense that the Food and Drug Administration has mandated 
change to dietary supplement labels which will add no safety benefits 
or protections to consumers. These forced changes will result in higher 
prices for vitamins and minerals many Americans rely on to maintain a 
healthy diet and lifestyle.
  In December of 2006, the Dietary Supplement and Nonprescription Drug 
Consumer Protection Act was passed into law. The law requires mandatory 
reporting of serious adverse events. That is a good thing. But the FDA 
has now mandated label changes which they're only giving the industry 1 
year to comply with. Industry will make the required changes in their 
labels, but forcing them to do so in less than 9 months is not the 
answer.
  Keep in mind, however, the law underlying this guidance did not 
require any label changes. It was the FDA's decision, independent of 
legislation, to force these changes on supplement producers. And what 
is the price tag for these required changes? According to the FDA's own 
documents, compliance would exceed $220 million. Not a small amount in 
today's business environment.
  Clearly, now is the not the time for our government to find ways to 
needlessly increase costs for consumers, especially when these mandates 
provide no added benefits or protections for consumers.

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