December 8, 2006

Dear Mr. Smith:

Mahalo for taking the time to write to me to voice your opposition
to the Dietary Supplement and Non-Prescription Drug Consumer
Protection Act (S.3546).  I appreciate your interest in this
important matter.

As you may know, S. 3546 would amend the Federal Food, Drug
and Cosmetic Act to require a manufacturer, distributor or
packager whose name appears on the label of a nonprescription
drug or dietary supplement marketed in the U.S. to submit to the
Secretary of Health and Human Services any report received of
serious adverse effect of any drug along with any related medical
information. They must then retain these records for six years, and
the records may be inspected upon request.

S. 3546 also contains provisions that would make reporting
adverse events easier and would allow the Secretary to issue
exemptions if the public health would not be affected.

The bill was introduced in the Senate on June 21, 2006 and was
subsequently referred to the Committee on Health, Education,
Labor and Pensions.  There is no vote scheduled on the Senate
floor at this time.

There is currently no similar legislation in the House of
Representatives.  However, if the House does decide to take up this
issue, I will be sure to keep your thoughts in mind.

Again, mahalo for writing to me.  Please do not hesitate to contact
me with your questions or concerns in the future



Sincerely,

Neil Abercrombie
Member of Congress


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