Sunday, April 1, 2012

Update on FDA's NDI Guidelines - now a political issue

House Energy & Commerce Committee members call on FDA to ‘re-examine’ NDI draft guidance

Select members of the highly influential House Energy & Commerce Committee have written to FDA calling for a 'significant reworking' of the controversial new dietary ingredient (NDI) draft guidance.


Finding a better way to work with FDA
Mar. 26, 2012

"...So, 18 years after passage of DSHEA, we find ourselves revisiting these very same issues once again. There is, however, one big difference. This time, the public debate will focus on whether FDA has overstepped its authority—a similar debate to the one that preceded the passage of DSHEA. But the other issue will be, has the industry underperformed in meeting the safety and quality provisions laid out in DSHEA? Dietary supplement consumers are upset about the prospect of FDA overreaching. But they are also unsettled to hear that FDA’s reasons for doing so are based on a lack of compliance..."

Members of Congress Unhappy with FDA Draft Guidance entitled, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”
"...on February 29, 2012, 17 members of Congress sent a letter to Dr. Margaret Hamburg, Commissioner of the FDA, “strongly urging FDA to withdraw this guidance and begin work on a new draft that does not undermine the balance Congress struck in [the Dietary Supplement Health and Education Act of 1994 (DSHEA)] to provide consumers with access to safe, affordable dietary supplement products...” http://www.fuerstlaw.com/wp/index.php/27/members-of-congress-unhappy-with-fda-draft-guidance-entitled-dietary-supplements-new-dietary-ingredient-notifications-and-related-issues/


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