It is a reasonably straightforward matter to register your company (foreign or domestic) as a food manufacturer with FDA. It may be done online through the following link: https://www.access.fda.gov/oaa/
Registration is free of charge and it does not expire, although FDA would like timely updates regarding relevant changes. When you register online, you will simply provide your contact information, choose a secret question the answer to which will help you access your account should you forget your password, choose the service area of your account (food manufacturer or low acid canned food) and choose a password to open account. Note that FDA has specific requirements on passwords. They want you to select a strong password. There is a special help section on choosing an appropriate password that meets FDA requirements (PASSWORD HELP). In fact, this section contains a random password generator. Click the associated button and it will make up a password for you. Of course, a strong password is one that will be hard to remember. It is recommended that you highlight the new password and copy it to the clipboard on your computer and then paste it into a secure file you then keep in a safe place. This approach will avoid transcriptional errors such as mistaking the number "1" for a lower case "l" or the number "0" for the capital letter "O". Probably the best course of action would be to use the password generator to quickly get your application to FDA completed. After FDA accepts your application it will send you your account number. Once you have the account number you may, if you choose, sign in to your account and change your password to whatever you find easier to remember (that is still within FDA's password rules).
FDA Registration may also be done by means of Form 3537, which may be either mailed or Faxed to FDA. This form may be downloaded from FDA's website or requested by telephone or mail..
U.S. AGENT FOR FOREIGN PRODUCERS
Foreign entities manufacturing/processing, packing or holding food intended for consumption in the United States are now required to have a U.S Agent. The purpose of a U.S. Agent is primarily to ensure reasonably rapid communication with the foreign entity exporting food to the U.S. should problems rise with one or more shipments. Please note that Food Safety Analysis, LLC will take its responsibilities seriously. This means that the time it takes the exporter to respond to a letter, e-mail, phone call or FAX will always be recorded, as will the amount of time that has elapsed between communications received from FDA and the transfer. Both sets of communications will be plotted as QC Charts so that communications efficacy may be easily reviewed by all concerned. Please note that while it is legally necessary for a foreign entity to have a U.S. Agent, it is not necessary to use your U.S. Agent as a normal communications go-between between FDA and itself. Designating an emergency contact within an exporter's own organization will save on fees generated by the U.S. Agent. When filing out a registration form, a foreign entity may designate an emergency contact other than its U.S. Agent. However, if FDA receives no response from the person designated to be your emergency contact, it will, of necessity, still contact your U.S. Agent.
Before choosing a U.S. Agent or deciding upon a registration strategy, it would be wise to read a letter and additional information FDA has put together and published 1 March 2008, regarding what FDA apparently sees as some U.S. private businesses causing unnecessary confusion about the FDA registration process. This letter is from Stephen F. Sundlof, D.V.M., Ph.D., Director, Center for Food Safety and Applied Nutrition (CFSAN) and resides on the the FDA website. It was written in English and then translated into both French and Spanish and is well worth the read.
As part of issuing its final ruling on the subject of registration, FDA has investigated the costs involved in contracting a U.S. Agent and reported that costs range roughly between $400 and $1,400 per year. Of course, costs will vary according to the work that needs to be done. If you look elsewhere on this site, you will see that Food Safety Analysis, LLC offers a number of useful services designed to assist both foreign and domestic food manufactures with issues that may come up in the conduct of their business. Examination of a number of companies engaged in what seems to have become an FDA U.S. Agent "business," it seems curious that most of them focus only upon the paperwork and offer no other technical assistance at all. Furthermore, none of them offer to compile communications response times as QC Charts, a recognized standard method for evaluating regulatory compliance in the manufacture of food. If, in future, a food safety problem develops and communications delays were seen to have complicated its resolution, your attorney may wish that the need for this precaution had been adequately foreseen and that such hard data on communications efficacy were already in hand. Obviously, investigation of communication efficacy AFTER a problem has developed will not do much good.
So, if a foreign entity intends to handle its own registration process, designate its own emergency contact and send its own export notices there should be little left for the U.S Agent to do (and little to pay for) beyond documenting the state of communications efficacy by sending out a number of test letters, e-mail, faxes and telephone calls. Any communications sent to your company will be either to the person designated on the FDA registration form as the owner, operator or agent in charge of the facility registered. Alternatively, these communications will be sent to the emergency contact listed on your registration form.
Foreign or domestic, it is possible for Food Safety Analysis, LLC to handle your FDA Registration for you, based upon the following directives quoted from FDA's final ruling:
"Although the Bioterrorism Act imposes the legal obligation to register on the owner, operator or agent in charge of a facility, FDA believes that this provision does not prevent the owner, operator or agent in charge from authorizing an individual to fill out, sign and submit this registration."
" . . . the person authorized must have written authorization and be able to identify who authorized him (name, address and phone number are needed. Fax number and email are optional."
To begin the process, just go to the contacts page of this website, send a letter, e-mail or FAX (or telephone) stating exactly what you need to have done and you will receive two proposals, one containing prepaid costs and another containing invoice costs. Sign and return one (but not both) of these along with the needed information, execute the authorization form you will be sent and the registration will be completed for you. Please note that (to avoid any possibility of miscommunication) all communications and/or documents must be in English.