Monday, May 14, 2007

Good Manufacturing Practices for Dietary Supplements, Waiting For The Nod

It's not as if the FDA hasn't addressed the issues about supplements I discussed in my previous post.

On March 13, 2003, the FDA published a proposed rule that "would require manufacturers to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements." It's lengthy and detailed. Although the longer it sits, the less applicable that cost analysis will be. I think it's high time these good manufacturing practices are implemented.

Here's the FDA proposed rule (not currently in practice):

Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements

Here's a summary:
FDA Proposes Manufacturing and Labeling Standards for all Dietary Supplements
"Congress gave FDA the authority to develop and implement CGMPs as part of the Dietary Supplement Health and Education Act of 1994 (DSHEA)."
That was 13 years ago. Who's holding up the approval of this rule? Why?

As far as I can tell, the FDA, having completed their rule governing CGMPs for dietary supplements, sent it on to the White House. It's been sitting there, in the Office of Management and Budget (OMB), since at least November 2005:

Meeting Record Regarding: Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements, Date: 11/29/2005

Update, June 22, 2007: Good Manufacturing Practices For Dietary Supplements, Gets The Nod
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