Thursday, January 16, 2014

AER Reporting Portal: New from the FDA

VITAMIN LAWYER UPDATE eMEMO

Natural Solutions Tenth Anniversary Retrospective Video
Featuring General Bert, Doctor Rima and Counsel Ralph
http://youtu.be/dtWoKqrb8eY  



Memorandum from Ralph Fucetola JD
FDA Unveils New Website

January 16, 2014

To: Vitamin Lawyer Contact List

Latest "shot across the bow" from the FDA: it will now be easier than ever before to report dietary supplement "adverse reactions." You may remember last year when certain Congressional critics of dietary supplements were surprised at the very low numbers of "adverse reactions" being reported for dietary supplements, as compared to, for example, drugs.

This couldn't be due to the relative safety of dietary supplements, could it? Of course it could be! It must be a "reporting problem" to be corrected by more bureaucracy...

Natural Products Insider reports:

"Distributors, manufacturers and packers of dietary supplements now can submit AERs (adverse event reports) through an electronic filing system, FDA announced Monday. Companies can submit the AERs through the Safety Reporting Portal ..."


If you have your own dietary supplement label, you need to be aware of the increased level of regulation you need to prepare for in 


You really and truly understand that this is the year when you must get your paperwork in order!

That means having meaningful Standard Operating Procedures for your company or practice. In means being in a "state of control" with your manufacturer, shipper and other service providers.

AND BEING ABLE TO PROVE THAT TO THE INEVITABLE FDA INSPECTION! 

In short, you need the Vitamin Lawyer SOP/GMP Training Program!
#914.966.8053 - SOPclienthelp@gmail.com

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