WHAT IS THE FDA REGISTRATION ALL ABOUT ?
DO I NEED IT TO IMPORT INTO USA ?
YES you do need this registration if you want to do business in USA.
It’s been a long time in coming, but after nearly 10 years, there is a new requirement by the FDA that any facility, within or without the USA, that deals with products for human and/or pet consumption, must file a “facility registration” with the FDA every 2nd year, starting in 2012, renewal required in 2014.
NOTE—the FDA requirements are NOT limited to food items, nor to imported items. Please read on to see who and what is covered.
A BRIEF HISTORY OF THE FDA “FACILITY REGISTRATION” REQUIREMENT
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 called the Bioterrorism Act directs the FDA to take steps to protect the public in America from a terrorist attack on the US’s supplies.
To carry out certain provisions of the Bioterrorism Act, the FDA put into place these 2 general requirements:
The Bioterrorism Act was enacted December 12, 2003.
Nearly 10 years later, the FDA Food Safety Modernization Act (FSMA) became the law that provided the actual infrastructure under which the FDA can implement and enforce the Bioterrorism Act of 2003.
FSMA, signed into law by President Obama on January 4, 2011, requires that certain entities submit an additional “facility registration” to FDA, which includes an assurance that FDA will be permitted to inspect the facility at times.
It also requires these facilities renew such registrations every other year and provides FDA with authority to suspend the registration in certain circumstances. Started in 2012, 2014 is the next re-registration period.
Specifically, if FDA determines that food manufactured, processed, packed, received, or held by a registered facility has a reasonable probability of causing serious adverse health consequences to humans or our pets, FDA may suspend the registration of said facility. The CBP (Customs and Border Patrol) might then be called upon to seize your goods in port or already distributed.
These are, of course, worst case scenario, but since you have nothing to worry about in your product integrity or your process control, why not simply pay the nominal fee for the 2 year registration period?
The first “facility registrations” were accepted in October 2012. The government was not ready until late October, even though E-Trademark Universe and many were.
The second period of registrations opens October 1, 2014 and closes December 31, 2014. Anyone who does not file within this period must file outside the period and then yet again within the period….
Only $198 to submit the (re-)registration your facility for the next 2 year period.
WHICH FACILITIES MUST FILE WITH THE FDA ?
Owners, operators, and agents in charge of a facility that deals with certain products used by humans and our pets:
Any facility which:
WHAT PRODUCTS REQUIRE A FACILITY REGISTRATION WITH THE FDA ?
Any facility processing product(s) for human or animal use, such as:
The law pertains to both USA and imported products and facilities.
E-Trademark Universe is a duly authorized agent of the FDA, allowed by law to assist foreign and domestic companies to comply with the bi-annual “facilities (re-)registration”. When you use our services we become your duly authorized agent, and can receive FDA documentation on your behalf.
We can also be available as your representatives with the FDA for onsite inspections as needed to represent your interests. Call us to discuss your specific need when it arises.
Only $198 to submit the (re-)registration your facility for the next 2 year period.
ORDER NOW
DO I NEED IT TO IMPORT INTO USA ?
YES you do need this registration if you want to do business in USA.
It’s been a long time in coming, but after nearly 10 years, there is a new requirement by the FDA that any facility, within or without the USA, that deals with products for human and/or pet consumption, must file a “facility registration” with the FDA every 2nd year, starting in 2012, renewal required in 2014.
NOTE—the FDA requirements are NOT limited to food items, nor to imported items. Please read on to see who and what is covered.
A BRIEF HISTORY OF THE FDA “FACILITY REGISTRATION” REQUIREMENT
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 called the Bioterrorism Act directs the FDA to take steps to protect the public in America from a terrorist attack on the US’s supplies.
To carry out certain provisions of the Bioterrorism Act, the FDA put into place these 2 general requirements:
- Facilities register with FDA, and
- FDA be given advance notice on shipments of certain imported items
The Bioterrorism Act was enacted December 12, 2003.
Nearly 10 years later, the FDA Food Safety Modernization Act (FSMA) became the law that provided the actual infrastructure under which the FDA can implement and enforce the Bioterrorism Act of 2003.
FSMA, signed into law by President Obama on January 4, 2011, requires that certain entities submit an additional “facility registration” to FDA, which includes an assurance that FDA will be permitted to inspect the facility at times.
It also requires these facilities renew such registrations every other year and provides FDA with authority to suspend the registration in certain circumstances. Started in 2012, 2014 is the next re-registration period.
Specifically, if FDA determines that food manufactured, processed, packed, received, or held by a registered facility has a reasonable probability of causing serious adverse health consequences to humans or our pets, FDA may suspend the registration of said facility. The CBP (Customs and Border Patrol) might then be called upon to seize your goods in port or already distributed.
These are, of course, worst case scenario, but since you have nothing to worry about in your product integrity or your process control, why not simply pay the nominal fee for the 2 year registration period?
The first “facility registrations” were accepted in October 2012. The government was not ready until late October, even though E-Trademark Universe and many were.
The second period of registrations opens October 1, 2014 and closes December 31, 2014. Anyone who does not file within this period must file outside the period and then yet again within the period….
- this means if you filed prior to October 1, 2014 you must again file a re-registration or renewal now
- this means if you file after December 31, 2014, you must file again in the renewal period in 4th quarter 2016
- this means that to file within this renewal period is the most cost effective method of filing because you file only once in two years instead of twice
Only $198 to submit the (re-)registration your facility for the next 2 year period.
WHICH FACILITIES MUST FILE WITH THE FDA ?
Owners, operators, and agents in charge of a facility that deals with certain products used by humans and our pets:
Any facility which:
- manufactures
- processes
- packs
- holds (such as your distributor’s or customs brokers’ warehouse)
- identify and implement preventive controls
- monitor the performance of those controls
- maintain records of the monitoring
WHAT PRODUCTS REQUIRE A FACILITY REGISTRATION WITH THE FDA ?
Any facility processing product(s) for human or animal use, such as:
- beverages
- food
- wine & spirits
- cosmetics
- pet products
The law pertains to both USA and imported products and facilities.
E-Trademark Universe is a duly authorized agent of the FDA, allowed by law to assist foreign and domestic companies to comply with the bi-annual “facilities (re-)registration”. When you use our services we become your duly authorized agent, and can receive FDA documentation on your behalf.
We can also be available as your representatives with the FDA for onsite inspections as needed to represent your interests. Call us to discuss your specific need when it arises.
Only $198 to submit the (re-)registration your facility for the next 2 year period.
ORDER NOW