Editorial: Let the Registrations Begin

By Len Monheit
[email protected]

Yesterday, a key milestone was reached by the US FDA when they launched the site and posted the form for Food Facility registration, part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). It seems appropriate to devote this column to some observations about the process.

After a year of anticipation, between 300,000 and 400,000 food companies worldwide now have access to register their facilities with the FDA, and from first appearances, it appears as though the on-line registration system will be both easy to use and capable of handling the registrations effectively. If this is in fact the case, then it will allow FDA to reach its deadline of December 12th of this year to have all food facilities registered and in possession of their assigned numbers so the second phase, that of pre-notification of shipments, can then be implemented.

The registration site is located at: http://www.cfsan.fda.gov/~furls/ovffreg.html and there is both an administrative area where you set up your company account, and then the actual facility registration area itself.

Dietary supplement and ingredient companies need to register, whether they are in the US or abroad. As always, a percentage will be eager to comply, to put the wheels in motion and immediately make the necessary steps a priority. In fact, several botanical extract manufacturers have already been to the site and begun their registration.

Others will wait for a few weeks before beginning their registration process. This, by itself, is not necessarily a bad thing, except that there's a bit of background information to be gathered and some decisions to be made before you can complete the registration process. And, once you start the registration, there's no saving your work. If you don't complete it, it's gone and there's a mandatory 30 minute logout function so that if you are inactive for 30 minutes, you've lost everything.

Taking a look at what needs to be accomplished, there are a few obvious things that companies should either already have considered, or should make their immediate priority:

  • Designate your internal champion to manage the registration process
  • Designate the executive with formal responsibility
  • Have the champion go to the form now to review it
  • Use the on-line tutorial and 'help' function to get clarification (ignore the spelling mistakes in the tutorial)
  • Print a copy of the form as a worksheet if you need to
  • Make sure, using on-line help and other experts and resources, that you have all the proper responses available
  • If you’re not a US-based facility, designate your US-based agent (on call 24/7 for FDA inquiries) whether this person is internal to your company or whether it is a service you acquire (and we know of at least two industry groups who have indicated they are setting up to offer these services - one group at a fee of $500 per year.)
  • Even if you are US-based, you still need to designate an emergency contact
  • Setup your account information
  • Pass this checklist to all of your suppliers impacted by the regulation

Once you've gone though this list, the rest of the registration process is a matter of minutes, and although the registration form can be submitted non-electronically, (mail or fax) electronic submission is definitely a better way to go.

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