Friday, December 14, 2007

Comments filed with FDA on AERs

Filed 7:15 PM - Comment Number: 215742

Natural Solutions Foundation

December 14, 2007

To: Food and Drug Administration
Docket No. 2007D-0388

“Draft Guidance for Industry: Questions
and Answers Regarding Adverse Event

We recommend that all [dietary supplement] AERs include clear indications of any and all prescription and over the counter drugs being used by the person involved. We believe that often supposed “adverse reactions” to nutrients are actually drug – nutrient interactions or nutrient depletions caused by drugs, wherein normal structure and function are changed to the detriment of the person.

The Foundation joins in Maury Silverman’s comments below, including urging that all drugs be labeled to indicate the nutrient depletions they cause, so that truthful AERs can be filed.

For the Natural Solutions Foundation
Ralph Fucetola JD, Trustee

Mr. Silverman’s Comments


No comments: