Featuring General Bert, Doctor Rima and Counsel Ralph
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 ..."
The portal is here: https://www.safetyreporting.hhs.gov/fpsr/WorkflowLoginIO.aspx?metinstance=0AA55778888D1638B9111B3C7655A47D82FD5D6F
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.
In short, you need the Vitamin Lawyer SOP/GMP Training Program!
#914.966.8053 - SOPclienthelp@gmail.com