UNPA / UPDATE — GAO interview on prenatal supplements
Aug 31, 2023
From: Loren Israelsen <loren@unpa.com>
Date: Thu, Aug 31, 2023 at 8:07 AM
Subject: UNPA / UPDATE — GAO interview on prenatal supplements
To: UNPA Colleagues <heidi@unpa.com>
Dear Colleagues —
Thanks to those of you who provided very helpful insights on the GAO request regarding prenatal supplements. We can now advise as follows:
This, indeed, is a congressional request coming from a Senate subcommittee.
It appears the GAO has been tasked to evaluate the safety, quality, and GMPs of prenatal vitamins.
We are aware that CRN received a similar request.
Why is the GAO doing this? The GAO is really a vehicle for members of Congress to investigate issues of interest. We suspect that the underlying reasons are likely to involve questions about the safety, quality, and GMPs of prenatal dietary supplements. Prenatals are regarded as a “special category” in that they involve a sensitive population, and therefore quality is a high priority. Whether this is a competitive issue or a result of previous relevant FDA warning letters remains to be determined.
I have contacted GAO to set up an interview. We will keep you posted.
Loren Israelsen visits with Mike Kauffman, President of Facilities Consulting NW, and discusses the importance of facility design in achieving GMP compliance. Mike
The U.S. Food and Drug Administration (FDA) published a draft guidance on the submission of new dietary ingredient notification (NDIN) master files. The
