FDA NEEDLESSLY HOSTILE??

Sent in by Mark FeDuke
I know the subject line is very provocative but it is a sign of my frustration.
I don't know if it is due to a lack of resources, the agency's management culture or the on again / off again waiting for passage of pending food safety legislation but we increasingly find it challenging to deal with the FDA and I'm curious if others in the food import biz feel the same way.

We may not be perfect but we do take pride in being a responsible importer. We joined C-TPAT the second we heard about it. We piloted ISF before it became ISF and on a personal note I joined the Nexus program the second I heard about it...merrily giving my finger prints and retina scan to CBP/FBI. I know the civil libertarians would say I've given up part of my soul but I'm all about compliance. I can't count how many times I've heard Richard DiNucci comment at webinars, conferences etc on how CBP will handle ISF issues. Folks who have a hiccup but who've been submitting ISFs will be handled on a case by case basis and the fact that they've had a good compliance history will be taken into account if there's an issue while folks who haven't been filling.....well, the fact that you haven't been filling ( and ergo not following through on your compliance ) the fact that you haven't been filing will be held against you. As a responsible importer Mr. DiNucci's comments have been music to my ears.....a regulator who will reward and work with responsible companies while throwing the book at folks who don't seem to care about compliance. The fact that Director Skinner is in DHS' Partnership Programs division speaks volumes about how CBP views industry.

As for the FDA....well they do have PREDICT based in part on MIDs which we all know is a rock solid problem free issue ( yeah...right).

We aren't perfect and with volume comes the increased chance for hiccups. With CBP our experience has been very positive. By contrast our experience with the FDA has been quite frustrating, especially because of inconsistencies from district to district. Some districts go out of their way to work with and educate importers/brokers....districts where, as long as you show good faith in compliance, you can expect to be treated fairly and even benefit from having the chance to dialogue with the agency. Other districts seem to operate on a shoot first ask questions later philosophy regardless of your approach to compliance. I've reached out to compliance officers listed on NOAs only to get a reply from some underling advising that he was doing me a favor 'cause the officer listed on the NOA really doesn't like talking to importers and if I called her again I might tick her off....or...after days of waiting replies are made by compliance offices who seem to be of the opinion that the fact that an NOA has been issued must indicate that you are bad guy and you must be up to no good.

In a post 9/11 world where CBP realized it can't inspect its way to security but needs by in from trade through meaningful partnership programs and a philosophy of working with compliant stakeholders....is it really too much to expect the same from the FDA?

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