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.

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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.

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

An FDA Draft Guidance about Shared Kitchen Facility Registration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.

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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

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Keep Reading

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:

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Infant Formula Registration

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

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Contents

Acidified Foods & Low-Acid-Canned-Foods
Infant Formula
New Dietary Ingredient
Shell Egg Producers

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References

Is Your Product an Acidified Food or a Low-Acid-Canned Food?

Do I Need to Register as an FDA Food Facility?

You must register as a Food Facility if you own or operate a facility that manufactures, processes, packs, or holds food for consumption in the US. You must register regardless of whether or not the food enters interstate commerce

Some products will require supplemental registrations (See Supplemental Registrations and Notifications).

You do not need to register as a food facility if you are a:

• Farm

• Restaurant - Businesses that serve food for immediate consumption

• Retail Food Establishment- Grocery Stores, Convenience Stores, A business that sells food to consumers as the business's primary function. The value of food it sells from that establishment must exceed the value of sales to all other customers (i.e. businesses)

• Non-profit food establishments in which the food is served directly to the customer

• Fishing Vessels

• Facilities that are regulated exclusively by the USDA.

• Home-operator: You do not need to register if you are processing food in your private residence

Still unclear about the requirements for Food Facility Registration? Check out this FDA Guidance Document, linked below

What Does it Mean to Be a Registered Food Facility?

Don't worry, it doesn't mean that the FDA is going to inspect you immediately. The FDA is typically a reactive agency and won't bust down the door just because you have registered.

Instead, registering allows the FDA to know that you are producing food in case something goes wrong, such as a widespread health risk associated with your food category.

How to Register as an FDA Food Facility

1. Create an Account on the FDA Website

2. Login and choose "Food Facility Registration

3. Complete the registration process online. You can use this step-by-step guide if you need additional support

4. Record the following information:

   • Registration #

   • PIN

   • Registration Expiration Date (I recommend putting this date into your calendar so you will don't miss it)

Note: If someone other than the owner/operator is registering the facility, then a verification email will be sent to the owner/operator requiring them to confirm the registration. 

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More Posts

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References

FDA Guidance Document: Facility Registration

Retail Exemption Applicability Flowchart

21 CFR Subpart H - Registration of Food Facilities

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Glossary

Farm
Fishing Vessel
Non-Profit Food Establishment
Restaurant
Retail Food Establishment

Types of Exemptions:

The following types of food businesses are exempt from some requirements defined in the Code of Federal Regulations (CFR). However, they may subject to a separate set of requirements (see source texts below)

Click on the links below to learn more about the exemption type:

• Qualified Facilities (Very Small Businesses)

• Fish and Fishery Products

• HACCP Systems (Juice Producers)

• Low Acid Foods

• Dietary Supplements

• Some Produce Processors

• Some Farms

• Alcoholic Beverages

• Agricultural Commodities

What's Next?

Very Small Business Exemptions

More about Registration

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References

21 CFR §117.5 - Exemptions

21 CFR § 123 Fish and Fishery Products

21 CFR §120 HACCP Systems 

21 CFR §113 Thermally Processed Low Acid Foods Packaged in Hermetically Sealed Containers

21 CFR §113 Dietary Supplements

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 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

More About Registration

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Should I apply for a FSMA Exemption?

You should consider applying for a qualified facility exemption if you sell <$1mm of product per year

Several types of businesses are able to exempt themselves from major components of FSMA. The most common way to do this is by being a small business and applying for the “Qualified Facility” exemption. These “Qualified facilities” are subject to modified requirements (found in 117.201)

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What is the Qualified Facility Exemption?

There are two paths that a business can take to apply for a qualified facility exemption. A business must satisfy the criteria of either path:

1st Path: “Very Small Business”

A “very small business” is one that produces less than $1 million (retail value) in product each year, averaged over 3 years. Included in this calculation is both product that is sold but also product that is made and not sold. For a business that exclusively holds food, the retail value of the food they hold must be less than $1 million per year.

2nd Path: Dual Criteria

1. The average annual value of all food sold in the preceding 3 year period was less than $500,000

2. Of your sales yearly value, at least half must have been sold to a “qualified end user”. A “qualified end user” must be:

• An individual (not a business) or

• A retail food establishment that is located in the same state as the manufacturer that is purchasing directly from the facility for sale directly to consumers.

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What am I Exempt From?

If your business applies for the "Qualified Facility Exemption", then you are exempt from Subparts C and G. These two sections include comprehensive requirements related to record keeping and process control.  Small businesses will be delighted to avoid these provisions!

Here's what you can drop:

• Subpart C - This section outlines the requirements for a food safety plan, a hazard analysis, and a recall plan. If you are exempt then you do not need to follow these requirements! See the FDA Reader Guide to Subpart C

• Subpart G - Supply Chain Program. If you are exempt then you do not need to follow this section (although you should work with reputable suppliers. See the FDA Reader Guide to Subpart G

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How do I Apply for an Exemption?

Check out our article on How to Apply for a Qualified Facility Exemption

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References

FDA Guidance Document: Determination of Status as a Qualified Facility