FDA Food Facility Registration in 5 Easy Steps

FDA Food Facility Registration

Starting a food business?

The first thing you must do is register your business with the state. Learn what steps are necessary in this Food Facility Registration guide.

FDA Food Facility registration requirements can be complex, but they’re also essential. When you’re getting ready to register your food facility with the Food and Drug Administration (FDA), there are a number of checklists, forms and other information to understand.

If you are a food facility located in USA or outside USA, then it is essential to submit an initial registration to the Food and Drug Administration (FDA). This registration is required to be renewed every alternate year with the FDA.

The Public Health Security Bioterrorism Preparedness and Response Act of 2002 demands that every domestic and foreign food facility must be registered under the FDA (Food and Drug Administration).The US Food and Drug Administration (FDA) has been recognized as the food regulatory agency that ensures public protection from the food being supplied in the country.

FDA Food facility registration was further amended by FDA Food Safety Modernization Act (FSMA) and it requires to submit additional registration information and an assurance that FDA can inspect the facility as per the provisions of FD&C Act.

To fulfil the provisions under the Bioterrorism Act, the US FDA has established the following regulations for FDA Food Registration –

All Food establishments must register with FDA
FDA requires an advance notice on shipments of imported food (Prior Notice for Shipments)

Who needs a FDA Food Facility Registration?

Food Facility – Rice, wheat, Fruits, Ready to eat food, masalas etc.
Dietary Supplements Facility – Proteins Supplements, Herbal Supplements etc.
Food Canning Establishment – Like – canned Corn, Canned Tomato, Canned Juices etc.
All owners, operators, or agents who oversee domestic or foreign food facilities in the US are required to register their facility with the US FDA.

What is a Food Facility or Food Establishment ?

A food facility is a unit that prepares, packages, serves, stores, and distributes food for human consumption. This occurs primarily at the retailer level. The operation could also be a wholesale food producer and it is not necessary that the food is consumed in the same premises.

What is the procedure for FDA Food Facility Registration?

1: Appoint a US Agent

All foreign facilities must appoint a FDA Regulatory Expert and a US Agent for Registration.

2: DUNS Request

Before you register, you need to furnish your Data Universal Numbering System (DUNS). This is a unique, universal, 9-digit number assigned by the FDA to identify and verify your business information. FDApals can assist you with the same it usually takes 7-14 days for generation of a DUNS number.

3: Submit Application

We will help you submit the application. The Regulatory experts / US Agents will also apply for FDA registration.

4: FDA Food Facility Registration Number

Once the application is accepted, you will be given a 11-digit food facility registration number. This is generated automatically and will be sent to your registered email ID only.

5: FDA Registration Certificate

US Agent will provide you with a registration certificate. This is your proof to show your business partners, shopping companies, and potential customers. Your details regarding the registration are confidential and kept private by the FDA.

Stressed about your FDA Food Facility Registration?

We are here to ease your registration process without any hiccups. Since the smallest of mistakes can land you in a major crisis, we are here to help you get through the entire process smoothly.

FDApals experts are here to support your food facility dream and speedup the process of regulatory compliance. With a team of highly experienced experts and an experience of over 30 years, we are focused on providing regulatory excellence at all levels. Our Turnaround time is 12-24 Hours for FOOD Facility Registration.

FDA Food Facility Registration - Top 10 Questions and Answers

1: Does FDA Regulates Animal Feed?

Yes as per the FDC Act food for both people and animal should be safe, produced under sanitary condition and properly labelled.

Unlike Animal Drugs one does not need prior FDA approval for marketing Animal Feed.

2: Do Dietary Supplements need to be approved by FDA?

NO FDA Dose note approve or disapprove any Dietary supplement but it does regulate them.
The Manufacture or seller is responsible for evaluation the safety and labelling of the product before placing the product in the market the product should meet the guidelines set by FDA and DSHEA Act (Dietary Supplement Health and Education Act).

Dietary supplements are not approved drugs hence they cannot claim to treat or cure any disease or condition. All dietary supplement must carry a disclaimer stating that the dietary supplement product is not intended to “diagnose, treat, cure or prevent any disease

They are allowed to have certain claim structure or functional claim if they meet the requirement.

We at FDApals can evaluate your Dietary Supplements for FDA Compliance talk to us now.

3: What is the renewal period for FDA food facility registration?

As per Section 415 of FD&C Act (Federal Food Drug and cosmetic Act) all food facilities are required to renew their registration every other year. These renewals need to be done in between October 1 to 31st December of every even number year. And the current renewal period is from 1st October 2022 to 31st Dec 2022.

We at FDApals having 30 years of experience can renew your FDA food facility registration and provide Renewal FDA Registration Certificate our fees are one of the lowest and have a quick turnaround time of 24 to 48 hours. Talk to us now.

4: Who is exempt from FDA Food facility registration?

Primary Farms, secondary activities farm, retail food establishments, restaurants, or non profit food establishments are exempted from food facility registration. This exemption for above activities is only valid if your business falls in the definition as provided under section 21 CFR 1.2227

5: Do Vitamins and Proteins supplements need FDA Approval?

Vitamins and Proteins supplements are regulated under DEHS Act of FDA and they don’t need pre-approval for marketing the product, however the product should comply with DEHS Act and FDA regulation. Food establishment Registration is one of the key steps to be followed for exporting vitamin and protein supplements to US market.

6: What is FSMA?

FSMA is Food Safety Modernization Act it was signed into law on 4th Jan 2011 by president of United States.
FSMA Is based on below Major Rules –
1) Preventive Controls for Human Food
2) Preventive Controls for Animal Food
3) Produce Safety –
4) Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
5) Accredited Third-Party Certification
6) Mitigation Strategies to Protect Food Against Intentional Adulteration
7) Sanitary Transportation of Human and Animal Food
8) Laboratory Accreditation for Analyses of Foods (LAAF)
9) Amendments to Registration of Food Facilities

7: What is Unique Facility Identifier?

As a provisions in the Federal Food, Drug & Cosmetic Act of 2016 UFI-Unique facility identifier requirement was introduced by the FDA.

UFI is a unique number designated to a facility and currently FDA is accepting DUNS number as a valid UFI.

Requirement of updating UFI with FDA is for both new registration and renewal. 31st Dec 2022 is the last date to submit UFI after which the registration will not be considered valid.

UFI helps the FDA to verify facility address with the one given during registration and in DUNS Database, it is important for both to match to consider a valid UFI for food facility registration.

8:What is FDA Registration Number?

When a FOOD Facility registers with FDA they are assigned an registration number this number acts as an identification for the facility. Food Facility Registration Certificate generally have this number published on the certificate.

9:Does FDA Provide Food Facility Registration Certificate?

US FDA dose not provide any establishment registration Certificate, such certificates are provided by third party organization one should note FDA dose not promote or accept any such certificates.

10:What is Prior Notice?

As a part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 one must send prior notification to FDA of food, animal feed, dietary supplements, beverages, canned products which are offered for import or imported in USA.

With help of advance notification and US Customs and border protection force FDA is able to target inspection more effectively.

As per of FSMA( FOOD Safety Modernization ACT) information with regards to refusal to entry for imported food article by any country has to be disclosed.

We at FDApals can help you file prior notice accurately and on time . Contact us Now.