Most Common Questions
Our Answers
This section answers common questions about FDA registration, product approval, licensing requirements, and compliance processes. It is designed to help businesses and individuals understand FDA regulations, application steps, and important guidelines in a simple and straightforward way.
"If I have a food facility registration, does that mean I can go ahead and sell my food in the US?"
Food facility registration is only one of FDA’s regulatory requirements for marketing foods in the United States. Having a food facility registration does not mean that FDA endorses or approves your foods. When your company is registered, it enters FDA’s Official Establishment Inventory which allows FDA to locate your firm and determine whether it wishes to inspect your facility.
“Do I need to have a US Agent for FDA food facility registration?”
Foreign registrants must have a US Agent for US FDA food facility registration.
“What are the responsibilities of the FDA food facility registration US agent?”
The FDA food facility registration’s US agent must be located in the US and be able to receive communications from FDA and assist FDA with scheduling inspections of the foreign facility if needed.
“Can I obtain my food facility registration now and hire a US agent later?”
No. FDA’s registration system requires a US agent to activate the registration.
“Can I change my FDA food facility registration’s US agent later if I want to?”
Yes, you can always change the US agent for the food facility registration.
“I am a foreign company and do not have anyone in the US who can be our US agent. What can we do?”
You may hire a third-party such as FDA Specialist to act as the US Agent for FDA food facility registration. Ask us about our US Agent services.
“What documents do we need to obtain a US FDA food facility registration?”
The registrant must enter details about its company and the foods it manufactures, processes, packs, prepares, or holds for consumption in the US market. If you use FDA Specialist’s services,we would simply provide you a questionnaire after services begin to obtain the information we will need to register your company. Please note that that registrants must now have a DUNS number for FDA food facility registration. DUNS numbers can be obtained from https://www.dnb.com.
“Our manufacturer already has FDA food facility registration. Does that mean their food is approved in the US?”
No. FDA food facility registration does NOT constitute or indicate FDA’s endorsement or approval of your product. The products must meet FDA’s labeling, food safety, and all other FDA requirements. FDA does NOT review these compliance issues or pre-approve your products during the registration process. Food facility registration merely provides your facility’s details to FDA so that the agency may conduct any surveillance or other regulatory actions for your facility.
“Can my US food facility registration US agent be located in a country other than the US?”
No. The US agent for the FDA food facility registration must be located in the United States.
“We have food facility registration issued by a non-US government. Does FDA accept this registration?”
24 Years of Expertise
About FDA Specialists and Our Expertise
At FDA Specialist, we have experts in all the major spaces of FDA regulation covering foods, medical devices, pharmaceuticals, cosmetics, and other areas. Our experts are former investigators, reviewers, compliance officers, and headquarters officials. We also have technical experts from the regulated industries. Having this broad array of experts, each focusing on specific areas of FDA regulation, allows us to provide the most effective solutions for the needs of our clients.