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FDA Registration For Shared Kitchens
 

What are the Requirements for FDA Registration Inside of a Shared Kitchen?

The FDA doesn’t offer a lot of information about shared kitchens. However, the growth of this business model means many shared kitchen operators are looking for answers, particularly around the issue of food facility registration.

Below are the answers you’re looking for.


Does the Shared Kitchen User Need to Register as an FDA Food Facility?

In brief, FDA food facility registration is required for any food business which is (1) not a retail food service establishment and which (2) packs, holds, or processes food which will enter interstate commerce.

When this type of business is operating in a shared kitchen, it means that multiple FDA food facility registrations may be associated with a single location

If you’re looking for more specific answers about registration requirements, we have sections devoted to the topic of FDA jurisdiction and FDA facility registration.


Does The Shared Kitchen Itself Need to Be Registered as an FDA Food Facility?

An FDA Draft Guidance about Shared Kitchen Facility Registration

An FDA Draft Guidance about Shared Kitchen Facility Registration

The question of whether a shared kitchen needs to register with the FDA hinges upon one critical question:

Does the shared kitchen operator (i.e. the host) pack, hold or process any food which will enter interstate commerce? In other words, does the shared kitchen operator ever take custody of any food?

If the answer is yes, then the shared kitchen must register with the FDA as a food facility. If the answer is no, then the shared kitchen does not need to be registered as an FDA food facility.

Here are examples of activities that would require the shared kitchen to register as a food facility with the FDA:

  • The shared kitchen operator receives incoming food products on behalf of the shared kitchen users and hands them over to the tenant when they arrive onsite.

  • The shared kitchen operator purchases a bulk supply of commonly-used food ingredients and sells them to the tenant businesses.

  • The shared kitchen operator purchases finished food products from the users businesses, stores them onsite, and sells them.

  • The management of the shared kitchen also has their own food brand and they manufacture their product out of the shared kitchen alongside other tenants.

Remember, if the shared kitchen packs, holds, or processes food, then they will be required to register with the FDA.

If you want to avoid registering your shared kitchen with the FDA, then you should never take physical control over any food products in your space.

If you allow tenant businesses to store product in a shared storage space onsite, it must be clear that the tenant business maintains possession of that product while it is in storage.


What’s Next

If you need to register as a food facility you can check out our step-by-step guide.

Also, if your business does less than $1mm in annual sales, then you may be a Qualified Facility (aka Very Small Business). This means fewer record keeping requirements for the business and a lower likelihood of inspection within the first several years of operation. If you think this is for you, then check out our guide to registering as a Qualified Facility

Or, return to our section on Shared Kitchens


 
Supplemental Registrations and Notifications

Products Requiring Supplemental Registrations & Notifications

Specific product types require additional registration beyond a Food Facility Registration. They include:

  • Acidified Foods & Low-Acid-Canned-Foods

  • Infant Formula

  • New Dietary Ingredient

  • Shell Egg Producer

Acidified Foods & Low-Acid-Canned-Food Registration

This category of foods includes many fermented foods, sauces, salsa, and other food that are kept shelf-stable in a sealed container.

A commercial processor created Acidified Foods (AF) or Low-Acid-Canned-Foods must file with the FDA. Their filing will include the following information:

  • Establishment details

  • List of food processed

  • Processing method

If you are unsure whether this definition applies to your product, check out the glossary below or this guidance document from the FDA:


Infant Formula Registration

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If you produce or distribute infant formula, then you must register prior to introducing your product to interstate commerce.

**Note that some of these filings must be made 90 days prior to the product entering interstate commerce so that the FDA may have the chance to respond**

This registration will require the following information:

  • Establishment details

  • Product Details

    • name and description

    • An explanation of why it is a new infant formula

    • The quantitative details of the product

    • A description of any reformulation of the product or change in process.

    • Assurance that the infant formula will not be marketed unless in meets FDA criteria.

For specific details about infant formula registrations, click here

New Dietary Ingredients

Dietary supplements that contain a "new dietary ingredient" (anything not marketed before 1994) must notify the FDA about those ingredients. This notification includes information that the new ingredient will be safe to consume as prescribed by the product label.

**Note that this filing must be submitted 75 days prior to the product entering interstate commerce so that the FDA may have the chance to respond**

This notification will contain the following information:

  • Your personal details

  • The name of the new dietary ingredient

  • A description of the supplement that contains the new product

    • Levels of the new ingredient in the product

    • Ordinary conditions of use

    • History or evidence of safe use (i.e. scientific literature, historical evidence, etc.)

Consider consulting this FDA resource about New Dietary Ingredients in Dietary Supplements

Shell Egg Producers

Producers of shell eggs (i.e. an egg hatchery or poultry house) must register the details of their facility. This is due to the high frequency of food borne illnesses associated with shell eggs, largely due to temperature abuse and the transportation of this product. This registration will require the following details:

  • Establishment details

  • Dates/Size of operations

  • Owner information

For more information about requirements for shell egg producers, click here


 
How To Apply for a Qualified Facility Exemption

The Scoop:  "Very Small businesses" can apply online for an exemption to specific parts of the FDA Regulation.

If you think you’re a qualified facility, you must attest to the FDA that this is the case. You must submit this before beginning operations or by July 31st of the applicable year if you’re changing your status from “non-qualified facility” to “qualified facility”.

You can create an account and handle all of your registrations at the FURLS website

You can create an account and handle all of your registrations at the FURLS website

You can do this online or by mail.  You must first be registered as a food facility 

See "FDA Food Facility Registration"

Your attestation must include the following:

  1. Attestation that your facility meets the provisions for a “Qualified Facility”

  2. Attestation that you’ve identified the potential hazards of your foods and are both implementing controls and monitoring those controls to ensure they are effective.

  3. Attestation that your facility is in compliance with State, local, and federal laws.

If you decide to pursue a qualified facility exemption, remember that you must keep all records to support your attestations. Additionally, starting in 2020, you must also re-submit your attestation every 2 years between October 1st and December 31st.

Source Texts

Looking for more clarity?  Check out the source texts below

21 CFR 117.201 - Qualified Facility Modified Requirements