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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


 
FDA Food Facility Registration
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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. 


 
Do I Qualify For an Exemption?

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:

What's Next?

Very Small Business Exemptions

 
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

 
Very Small Business Exemptions

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)


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.


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


How do I Apply for an Exemption?

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