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Simplifying Food Regulation

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FDA Reader: Simplifying Food Regulation

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FDA or USDA Jurisdiction?

What You Need to Know:

  • The USDA regulates the production of meat, poultry and egg products. USDA-regulated businesses are required to have a USDA inspector onsite at all times.

  • The FDA regulates the production of everything else (non-meat foods, unusual meats, and fish products). No inspector is required onsite during production.

  • A business that conducts activities falling under both umbrellas is regulated by both agencies.

  • Food produced and sold in a retail environment (i.e. restaurant, deli) is not typically regulated by either the USDA or the FDA.

How to determine food business jurisdiction: Start with USDA. If you can’t positively identify how it falls under USDA jurisdiction, then it’s regulated by the FDA.

Determining USDA Jurisdiction

The USDA typically regulates the following business types:

  • Slaughterhouses

  • Meat Processors*

  • Poultry Processors*

  • Egg Processors

  • Food processors whose products contain meat*

Food products with the following characteristics are regulated by the USDA.

  • Contains >2% cooked meat

  • Contains >3% raw meat

  • Contains >2% cooked poultry meat

  • Contains >10% cooked poultry skins

*For more detail, see the tables below


Examples of Business Regulation

Business Description of Operations Federal Jurisdiction
Meat Product Processor Producer of frozen meat pies, bone broth, steak delivered via mail USDA
Poultry Product Processor Poultry processor USDA
"Egg Product" Processor Producers dried, frozen, or liquid eggs USDA
Egg processing plant Egg washing, sorting, packing FDA
Slaughterhouse Slaughter and processing of carcasses for sale. *Slaughter for personal consumption is not regulated by the USDA USDA
Commissary for retail outlets A commissary produces deli meats to sell at multiple delis, all owned by the same company. Products are shipped ready-to-eat. FDA
Restaurants and retail establishments Retail establishment that sells meat to typical consumers in retail quantities. Not typically regulated by the federal government
:

Examples of Food Product Regulation

Misc Products Regulator
Spaghetti Sauce (2% meat) FDA
Sliced Egg sandwich (closed face) FDA
Shrimp flavored instant noodles FDA
Venison Jerky FDA
Closed Face Sandwiches FDA
Open face sandwiches USDA
Pork Sandwich (open faced) USDA
Corndogs USDA
Frozen Beef pot pie USDA
:
Meat Products Regulator
Cow USDA
Sheep USDA
Pig USDA
Horse USDA
Mules USDA
Goat USDA
Domesticated Birds (chicken, turkey, ducks, geese, guineas, geese) USDA
Wild Birds FDA
Rabbit FDA
Bison FDA
Game animals FDA
Deer, Elk, Moose FDA
Zoo animals FDA
:
Egg Related Products Regulator
Dried Eggs USDA
Frozen Eggs USDA
Liquid Eggs USDA
Egg Substitutes FDA
Dried Custard Mixes FDA
Egg Nog Recipes FDA
Egg Noodles FDA
Milk and Egg Dip FDA
Cake Mixes FDA
French toast Sandwiches Containing Egg FDA
Products containing egg FDA
:

FAQ

What does the USDA inspector do?

The USDA inspector inspects:

  • Slaughtered animals to confirm they were healthy

  • Sanitation conditions of a plant

  • Operations to confirm that they align with the firm’s HACCP plan

  • Product is correctly labeled and packaged to be transported

What it FSIS?

The Food Safety and Inspection Service (FSIS) is the inspection arm of the USDA. So if you see the term FSIS, think USDA.

 
 

This article applies to you if…

∆ You are unsure whether your product is regulated by the FDA or the USDA.

References

USDA Inspection Requirements Overview

USDA Inspection Requirements Overview

FDA vs. USDA Jurisdiction Guide

FDA vs. USDA Jurisdiction Guide


More About Supply Chain


More Posts


Does the FDA Regulate My Food Business?
07_jurisdiction.png

It’s not always clear where  the FDA has jurisdiction when it comes to food businesses. This table provides an overview of FDA Jurisdiction. Specific examples are provided below.

Regulated By the FDA Not Regulated By the FDA
Foods that enter interstate commerce Food Service Establishments
Most packaged foods Restaurants
Most foods solid online Restaurant Chain
Human and animal food Food Truck
Imported Foods Caterer
Farms (if they grow and process food) Grocery Stores
Food Bank
Cafeterias / Institutions
Markets
Home-Food Processor
Alcoholic Beverages
Butcher Shop
Slaughterhouses (USDA)
Farms (if they only grow food)
:

*Note: Domestic food processors of any kind must still register as a Food Facility even if their products do not enter interstate commerce. This is free and purely for record keeping purposes (it will not subject a business to FDA inspections or oversight)


Examples of FDA Jurisdiction Businesses

FDA Jurisdiction Examples
Food products that enter interstate commerce (i.e. businesses whose foods leave the state) Most foods sold online
Most non-meat products that are made and sold in a package
A central kitchen that prepares and distributes foods to locations in multiple states
A transporter that distributes food nationwide
Any business that processes, packs, transports, distributes, receives, or holds food which crosses state lines.
Imported Foods Food distributor that imports foods and sells it
Food importer that warehouses food
:

Businesses Not Under FDA Jurisdiction

Not FDA Jurisdiction Example Who typically regulates
Restaurant (Individual) Fast Food Restaurant Local/State health dept.
Restaurant (Chain) Chain of frozen yogurt restaurants Each would be regulated individually by its respective local or state health department
Restaurant (Delivery only) Meals are ordered via app/web and delivered hot to the consumer Local/State health dept.*
Food Truck Korean food truck Local/State health dept. *
Caterer Facility where a caterer prepares food for immediate service Local/State health dept.*
Grocery Store Grocery store that also serves some hot food or includes a deli Local/State health dept.
Food Bank Food bank that accepts food donations and distributes that food locally Local/State health dept.
Cafeteria / Institution Hospital cafeteria, School lunch cafeteria Local/State health dept.
Farmers Market Weekly market that offers various prepared foods and ingredients for sale Local / State Health Dept
Seafood Market Retail market that supplies seafood products to consumers Local / State Health Dept
Alcoholic Beverage Producer, Importer, Distributor, Wholesaler Winery, Brewery, Distillery State Health Dept / TTB (Note that alcoholic beverages <7% ABC are subjected to FDA labeling standards)
Butcher Shop Retail market that butchers and retails meat for consumers Local/State Health Dept. OR USDA. (This depends on what level of processing is being done to the meat before it is sold)
Home Food Processor Business conducted from the home that involves making food Local / State – Note that many cities and states prohibit or specifically regulate home processing
Meat Product Processor Frozen meat pies, Bone broth, High-quality cuts of steak delivered via mail USDA
Poultry Product Processor Frozen buffalo wings, Roast Chickens USDA
Processed Egg Products Frozen omelets, Egg whites USDA
:

*If you serve or prepare food in multiple areas you may have to license with the local health department for each of those jurisdictions. If the food is crossing state lines, then FDA regulation would apply.

Still Unsure Whether Your Business is Regulated by the FDA?

Ask a question in the comments and I’ll answer it

Try using this dichotomous key

What’s Next?

Understand about Registering a Food Facility with the FDA

 
Facility Requirements

These requirements are a part of the Current Good Manufacturing Practices that relates to Facility Requirements. You can see the full guide to cGMPs here

Plants & Grounds

Grounds must be kept in a condition that protects against contamination. Methods include:

1. Eliminate conditions for breeding/harboring pests
2. Maintain roads, yards, parking lots
3. Drain areas (i.e. puddles) that may breed pests or contribute to food contamination
4. Even if the grounds aren’t in your control, you must still mitigate contamination hazards.


Plant Construction and Design

20180711_115335.jpg

The space must be suitable in size, construction and design for food production.

1. Must have adequate space for equipment and storage.

2. Must allow you to take precautions which reduce allergen contamination and food contamination (for example -- by chemicals, filth, other materials). Ways to eliminate contamination include separating operations by: location, time, partition, air flow systems, dust control system, etc.

3. Protect food that is stored outside in bulk containers:

4. Floors, Walls, Ceilings must be constructed in a way that allows them to be cleaned. The construction of the space must allow employees to do their jobs and not contaminate food, packaging, and work areas.

5. There should be adequate lighting in all food and employee areas (including food storage areas and employee locker rooms). All bulbs and glass that is suspended over areas where food is exposed should be shatter resistant.

6. There should be adequate ventilation to minimize dust, steam, odors, and vapors.

7. Provide screens or other protection against pests (door sweeps, air curtains)


Sanitary Facilities

Plumbing

Water Supply must be from an adequate source. Running water must be of a suitable temperature and pressure and be provided in all food processing/cleaning areas.

Plumbing must

1. Carry adequate amounts of water around the plant.
2. Remove sewage from the plant.
3. Avoid contaminating food, equipment, water supply, utensils, ec.
4. Provide floor drainage in spaces where floors get very wet
5. Avoid back flow between plumbing systems

Sewage Disposal: Sewage must be disposed of adequately

Toilet Facilities: Each plant must have clean toilet facilities.

Hand-washing facilities: Each plant must provide hand washing facilities.

Rubbish: store rubbish to minimize odor, pests, and contamination


Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

  • Farms

  • Fishing Vessels

  • Establishments who solely hold and transport agricultural products

  • Establishments who only raw process (i.e. shell or dry) nuts.

  • Mixed-Type farm facilities (defined in §1.227)


 
 

This Article is For You if…

∆ You are seeking to understand facility requirements for your FDA-regulated food business.

∆ You manage a facility that makes, holds, or packs food.


More About Operating Requirements

More Posts


References

Guide to Current Good Manufacturing Practices (117 Subpart B)

Guide to Current Good Manufacturing Practices (117 Subpart B)

Personnel Requirements in Food Processing Spaces

These requirements are a part of the Current Good Manufacturing Practices. You can see the full guide to cGMPs here

Personnel Requirements

adult-business-container-1267312.jpg

Employees working in food processing spaces are subject to basic requirements about disease control and cleanliness. The aim of these requirements is to make sure a food processor does contaminate their own food product which could cause a customer to become sick.

Disease Control:

Sick employees must be excluded from operations that could result in food contamination.

The typical way of doing this implementing an Employee Hygiene Policy that excuses sick employees from work. This may require food production employees who have been exposed to a serious contagious illness to refrain from working until they are no longer contagious.

Cleanliness:

This section states that employees must have clean practices

1. Clothing that protects against contamination
2. Adequate personal cleanliness
3. Hand washing
4. Removing unsecured jewelry
5. Wearing gloves in a safe manner
6. Wearing hair restraints
7. Storing other belongings in areas where food is exposed/equipment is washed.
8. Not eating food, chewing gum, drinking beverages, or using tobacco in food areas.
9. Taking other precautions


Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

  • Farms

  • Fishing Vessels

  • Establishments who solely hold and transport agricultural products

  • Establishments who only raw process (i.e. shell or dry) nuts.

  • Mixed-Type farm facilities (defined in §1.227)


 
 

This Article is For You if…

∆ Your business is regulated by the FDA

∆ You have employees who work in a space where food is handled, packed, or produced.


More About Operating Requirements

More Posts


References

Guide to Current Good Manufacturing Practices (117 Subpart B)

Guide to Current Good Manufacturing Practices (117 Subpart B)

Requirements for FDA Food Producers
Requirements for FDA Food Producers.jpg

Introduction

Great! You have already confirmed that your business is regulated somehow by the FDA

The easiest way to understand what regulations apply to your business is to identify what kind of food you make.

Some foods are subject to special requirements. If your business produces one of the food types below, click the link to learn about their special requirements. Otherwise, keep reading

Do you make one of these specially regulated foods?

If you make one of these foods, check out our section on Specially Regulated Foods 
Otherwise, your product likely falls under Part 117 (See Below)


Part 117 Overview

If you are producing human food, then you are most likely governed under Title 21 -- Chapter 1 -- Subchapter B -- Part 117.  This section contains the majority of requirements for typical food producers.

What You Need To Know To Be FDA Compliant:

Everything a food producer needs to know is located in Subpart B. To find exactly what you're looking for, read the sections below:

Subpart B -- Current Good Manufacturing Practices: This contains Requirements for Facilities, Employees, and Sanitation.
     Guide to Subpart B

Subpart C -- Hazard Analysis and Risk Based Preventive Controls: This section outlines the requirements for a Food Safety Plan and other requirements related to the implementation of preventive controls.
    Guide to Subpart C

Subpart F -- Requirements Relating to Records that Must Be Established and Maintained: This section dictates the record keeping requirements for food businesses. 
     Guide to Subpart F

Subpart G -- Supply-Chain Program: This section outlines the requirement for verifying supplier partners and documenting this process.
Guide to Subpart G

Other Parts of 117:

These sections relate to a minority of food processors. In case you are interested, I have linked them below:

Subpart A -- General Provisions:This section contains definitions, exemptions, and the training requirements for employees working in a food production space.
Source Text: Title 21 -- Chapter 1 -- Subchapter B -- Part 117 -- Subpart A: General Provisions

Subpart D -- Modified Requirements: This section describes modified requirements that apply to Qualified Facilities and Storage Facilities.
Source Text: Title 21 -- Chapter 1 -- Subchapter B -- Part 117 -- Subpart D: Modified Requirements

 Subpart E -- Withdrawal of  a Qualified Facility Exemption: This section describes how a business would transition from being exempt to provisions of the code to non-exempt status. This only applies to businesses who previously but no-longer apply for the Very Small Business Exemption
Source Text: Title 21 -- Chapter 1 -- Subchapter B -- Part 117 -- Subpart E: Withdrawal of a Qualified Facility Exemption

 
Sanitary Operations in Food Processing Facilities

These requirements are a part of the Current Good Manufacturing Practices that relates to Sanitary Operations. You can see the full guide to cGMPs here

Requirements For Sanitary Operations

Inadequate storage of chemicals and poor sanitation indicate a breakdown in food safe systems

Inadequate storage of chemicals and poor sanitation indicate a breakdown in food safe systems

General Maintenance:

Your space and everything in it must be in good repair to prevent food from being contaminated (i.e. no leaky ceilings, which could drip in food). Your cleaning processes should protect your food, packaging, and workspace from contamination.


Cleaning Chemicals:

  1. You must only use safe cleaning chemicals. Toxic chemicals may only be allowed in food areas if they are:

  • Required for cleaning

  • Used in lab testing

  • Necessary for equipment maintenance

  • Absolutely necessary

2. You must store toxic chemicals in a way that protects food from contamination (Label it with the everyday name and keep it away from food and packaging)

Pest Control

Pests aren’t allowed in any area of the plant. You must exclude pests in the space and only use pesticides when it won’t result in contamination of food, packaging or work spaces.

Sanitation

You must clean food contact surfaces, including utensils, tables, equipment, to protect against contamination.

1. If you process low moisture (dry) food, your food contact areas must be clean and dry before use.

2. In “wet processing” food processing areas must be cleaned before use and after any contamination occurs.

3. Paper towels, paper cups and other single-use items must be protected from contamination.

Non-food-contact-surfaces

These surfaces (i.e. walls, ceilings or anything that doesn’t touch food) must be cleaned as much as necessary to prevent contamination of food, packaging, or work areas.

Portable equipment and utensils must be stored in a way that doesn’t contaminate work areas.


Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

  • Farms

  • Fishing Vessels

  • Establishments who solely hold and transport agricultural products

  • Establishments who only raw process (i.e. shell or dry) nuts.

  • Mixed-Type farm facilities (defined in §1.227)


 
 

This Article is For You if…

∆ Your business is regulated by the FDA

∆ You operate a space where food is handled, packed, or produced.

∆ You want to understand cleanliness standards for your space.


More About Operating Requirements

More Posts


References

Guide to Current Good Manufacturing Practices (117 Subpart B)

Guide to Current Good Manufacturing Practices (117 Subpart B)

What You Need to Know About FSMA

What is FSMA?

The Food Safety Modernization Act was a piece of legislation that went into effect in 2016. It shifted the focus of food safety from responding to foodborne illness outbreaks towards preventing foodborne illness outbreaks. FSMA updates the requirements for many food businesses who fall under FDA Jurisdiction. FSMA has six major sections:

  1. Preventive Controls for Human Food (Part 117) - Requires processors of human food to develop risk-based systems focused on food safety through prevention. This includes,

  2. Foreign Supplier Verification - Ensures imported food is produced to FDA standards.

  3. Sanitary Transportation Aims to protect food in transportation

  4. Intentional Adulteration (Part 121) - Aims to protect from terrorist acts of contaminating the nation's food supply by establishing "Food Defense" requirements.

  5. Preventive Controls for Animal Food (Part 507) - Requires processors of animal food to develop risk-based systems focused on food safety through prevention.

  6. Produce Safety (Part 112) - Increases the standards of processing produce.


What Businesses Does FSMA apply to?

  • Human food processors

  • Animal food processors

  • Food transporters /shippers

  • Farms

  • Food Importers

  • Food Warehouses / Food Storage facilities

When Does FSMA Take Effect?

FSMA is being rolled out over the course of several years. Smaller businesses have been given longer timeframes for compliance. See the image below for compliance dates.

Timeline of FSMA Compliance Dates

Timeline of FSMA Compliance Dates


Selected FSMA Implementation Dates

Deadline for Preventive Controls for Human Food

  • Very Small Businesses (<$1mm sales/Yr) - 9/17/2018

  • Small Business (<500 employees) - 9/18/2017

  • Large Business (>$1mm sales/yr and >500 employees) - 9/19/2016

Deadline for Intentional Adulteration (Human food):

  • Very Small Businesses - July 26, 2021

  • Small Businesses - July 27, 2020

  • Large Businesses - July 26, 2019

FAQ

What are the FSMA requirements for my business?

All content on this website is FSMA-aligned and all articles have been updated to reflect FSMA provisions. You can learn about the major provisions of FSMA by reading this summary or browse by category to understand the specific requirements for your business.

The requirements imposed by FSMA have also been integrated into the FDA regulations, so feel free to dive into the Code of Federal Regulations and find your answers.

What is the difference between FSMA and the FDA Regulation?

FSMA is a law that was passed by congress. This updated the FDA regulation, which is a set of rules put forth by the FDA. If your business practices are aligned with the latest version of the FDA regulations, then your business is also FSMA aligned

This website is FSMA-aligned so you don't have to worry about additional FDA requirements.


What are the record keeping requirements for FSMA?

The record keeping requirements for FSMA are outlined in our summary of Part 117 Subpart F



What is a PCQI?

A PCQI is a preventive-controls-qualified-individual. This is someone who has been trained in the risk-based practices required by FSMA. There are many PCQI courses available in-person and online.

All businesses except those exempt from Part 117 Subpart C - Hazard Analysis and Risk Based Preventive Controls are required to have a PCQI to do the following:

  • Prepare the food safety plan and review as necessary

  • Supervise daily production on site.

The PCQI can be a permanent employee for the food processor but is not required to be.

 
Principal Display Panel

What You Need to Know:

Examples of PDP of different packaging forms

Examples of PDP of different packaging forms

The Principal Display Panel (PDP) is the part of a food label that is most likely to be displayed to the customer when for sale. This is the front label on a product.

Size Requirement: 

The size requirement for a principal display panel is determined by the shape of the product:

Rectangular Package: The PDP must encompass the entire customer facing side of the package

Cylindrical Package: The PDP must encompass 40% of the total side-area of the package (circumference multiplied by height)

Other Packaging Shape: The PDP must encompass 40% of the surface area of the product.

Elements Required on the PDP

The following elements are absolutely required on the PDP. Labeling elements which may appear on other sections of the packaging are not listed below.

  • Identity of the food (common name)

  • Net Quantity of Contents

Next

Nutrition Facts Labeling

Food Product Claims

Basics of FDA Food Labeling


 
Nutrition Facts Labeling

The Scoop: There are very specific requirements for expressing nutrition information on food packaging. Use an online label generator.

What You Need to Know

  • The FDA regulates nutritional information panels, their formats, and requirements.

  • Nearly all packaged products require nutrition information although exemptions do exist

  • You can calculate the nutrition contents of a food using an online nutrition calculator or via a lab analysis of a food sample.

  • The requirements for nutrition labels may vary depending on:

    • Food package size

    • Claims made about the product, its ingredients, and health benefits

New Rule on Nutrition Information Panels

Key Changes in Nutrition Information

In 2016, the FDA updated the requirements for nutrition information panels on foods. The changes include

  • Changing the "Serving Size" to reflect how much someone customarily eats, not how much someone should eat

  • Calories are now in larger and bolder type

  • "Added Sugars" are now required to be included on the label

  • Listings of Vitamin D and Potassium are required

  • Actual amounts must be present for

  • Removal of the "Calories from fat" label requirement

  • Removal of the requirement for Vitamin C and Vitamin A


When Do New Labeling Requirements Take Effect?

Businesses with >$10 million in Annual Food Sales: January 1st 2020 

Businesses with <$10 million in Annual Food Sales: January 1st, 2021.


Components of a Nutrition Information Label:

Serving Size

The serving size must closely equate to the amount that is customarily eaten. This must be expressed in common household measures (i.e. cups, oz, tsp) and include the equivalent metric quantity in parentheses.

Nutrient Components:

The nutrition information label must include some mandatory components (i.e. calories, fat) and may include other voluntary components (vitamin A). No other declarations of nutrition information is allowed on the label, other than those listed below:

Mandatory Nutrient Components

  • Calories

  • "Fat" or "Total Fat"

    • Saturated Fat

    • Trans Fat

    • "Cholesterol"

    • "Sodium"

    • "Total Carbohydrate"

      • "Dietary Fiber"

      • "Total Sugars"

      • "Added Sugars"

      • "Protein

Voluntary Nutrient Components

  • "Calories from saturated fat"

  • "Fluoride"

  • "Soluble Fiber"

  • "Insoluble Fiber"

  • "Sugar Alcohol"

There are specific requirements for how these nutritional elements be described, particularly when there is a small amount of them. This information can be found in 101.9 (c)


Vitamins, Minerals and Macronutrients

The following vitamins and minerals are required on the nutritional label "Supplemental Facts" section. They must be measured in terms of percentage of daily value and weight.

The minimum requirement is listed below (must be listed in this order):

  • Vitamin D,

  • Calcium

  • Iron

  • Potassium

When additional vitamins and minerals are listed, the following order should be preserved:

Vitamins (listed in order)

  • Vitamin A

  • Vitamin C

  • Vitamin D

  • Vitamin E

  • Vitamin K

  • Thiamin

  • Riboflavin

  • Niacin

  • Vitamin B6

  • Folate

  • Vitamin B12

  • Biotin

  • Pantothenic Acid

  • Choline

Macronutrients & Minerals (In order)

  • Calcium

  • Iron

  • Phosphorus

  • Iodine

  • Magnesium

  • Zinc

  • Selenium

  • Copper

  • Manganese

  • Chromium

  • Molybdenum

  • Chloride

  • Potassium

Vitamins and minerals must appear in the label if:

  • They appear in a serving of the product

  • When they are added as a nutrient supplement

  • When a claim is made about them

However, non-required vitamins and minerals  may be excluded if:

  • Neither the nutrient nor component are referred to on the label or advertising of the product

  • If they appear in the product solely for technological purposes

Note that other vitamins and minerals may be required or permitted on the label of standardized foods (i.e. foods that have a specific definition under the FDA Standards of Identity).S


How to Make an FDA Compliant Nutrition Information Label

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FDA Aligned Nutritional Label (New Rule)

  1. Have a final product: It is important that you are producing your product consistently and with the same ingredients so that the nutritional label you generate is accurate.

  2. Determine the nutritional contents of your product: You can do this in one of several ways:

    • Conduct your own nutritional analysis using an online nutrition calculator. Google it or try Spark Recipes (This may not be the best one, it's the first one I found)

    • Have your product tested by a laboratory (EMSL is a nationwide provider that can do nutritional analysis)

    • Note: If the FDA tests your product due to a complaint or concern, they will conduct a nutritional analysis on 12 samples from 12 different cases.

  3. Build a nutritional panel and align with the formatting guidelines:

    • The lab or online calculator may generate one for you automatically. If so, confirm it is aligned with the new nutritional facts rule (the easy way to tell is that the "calories" section is in a larger font). It should align with all of the standards listed above.

    • If you'd like to design your own, consider the image below for guidance.

Update your nutritional panel every time you make a change to the recipe or the ingredients: Additionally, you may have to change the nutritional panel if you decide to make a health claim in your advertising or on the product label.


Looking for Something Else?

Information about labeling "variety packs" and separately packaged foods sold in one box is available in section  101.9 (11) (h) 

 

FDA Food Facility Registration
03_registration.png

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. 


 
Interstate Commerce and FDA Jurisdiction
Interstate commerce refers to products that cross state lines prior to consumption, or products composed of ingredients that have crossed state lines.

Interstate commerce refers to products that cross state lines prior to consumption, or products composed of ingredients that have crossed state lines.

What is Interstate Commerce?

If a product crosses state lines between the start of the manufacturing process and when it is received by the individual who purchases it, then it has entered "interstate commerce".

Additionally, if the product is composed of ingredients from out-of-state, then it is considered to be a part of "interstate commerce" -- even if the product was created and consumed in state.

The technical definition of interstate commerce is:

"(1) commerce between any State or Territory and any place outside thereof,

and

(2) commerce within the District of Columbia or within any other Territory not organized with a legislative body."

FD&C Act [21 U.S.C. 321(b)] 

Examples of food that enters interstate commerce:

  • A frozen pizza business that has a website and ships to buyers nationwide.

  • A food processing facility that operates in New York and supplies cookies to bakeries in New Jersey.

  • A distributor that holds food products created by local food producers in a warehouse and distributes them to a local retailer who, in turn, sells them in several states

 

How Does Interstate Commerce  Relate to the FDA?

Whether a product enters interstate commerce is a major factor in determining whether a food business falls under FDA Jurisdiction. The other major factor is what type of food business it is. 

However, it is worth noting that all domestic facilities that engage in food processing, production, packing, or holding, must register as a Food Facility.

Additionally, the FDA may regulate any product that is adulterated or misbranded, even if that product doesn't enter interstate commerce.


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

 
Equipment and Utensils

These requirements are a part of the Current Good Manufacturing Practices that relates to Equipment and Utensils You can see the full guide to cGMPs here

Equipment Requirements

  • Equipment and utensils must be designed to be cleanable and maintained to avoid contamination.

  • Equipment and utensils must not contaminate food with lubricants, metal fragments, water, etc.

  • Equipment must be installed in a way that they can be cleaned and maintained.

  • Equipment kept in food areas must be constructed so it can be kept clean -- even if it doesn’t contact food.

  • Machinery must be designed in a way that can be kept clean

  • Each freezer and refrigerator must have a thermometer in it.

  • pH meters, thermometers, and other measuring devices must be accurate.

  • Compressed air must be treated in a way that it does not contaminate food.


Food Contact Surface Requirements

  • Food-contact surfaces must be corrosion-resistant.

  • Food-contact surfaces must be non-toxic

  • Food-contact surfaces must be maintained to protect food from allergen cross-contact

  • Seams on food-contact surfaces must be seamless to minimize accumulation of particles.


References

Guide to Current Good Manufacturing Practices (117 Subpart B)

Guide to Current Good Manufacturing Practices (117 Subpart B)

 
 

This Article is For You if…

∆ Your business is regulated by the FDA

∆ You manage a facility that makes, holds, or packs food.

∆ You use equipment and utensils in your operation


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