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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

This Article is For You if…

∆ You make or pack food that is consumed in the US.

∆ Your food product enters interstate commerce

More About Operating Requirements

Featured

Introduction to Record Keeping

Facility Requirements

Processes and Controls

Personnel Requirements in Food Processing Spaces

Featured

Developing an ATP Testing Program

Best pH Meters for Food Processing

Best Thermometers for Food Processing

Allergen Labeling Requirements

Picking The Right Storage Containers For Your Shared Kitchen

Working With Unusual or New Ingredients

References

Guidance Document, HubNed KleinFebruary 10, 2019operating requirements, getting started, title requirements for fda food producers, fsma, part 117

Specially Regulated Foods

Contents

Introduction
Animal Foods
Infant Formula
Bottled Water
Dietary Supplements
Fish & Fishery Products
Juice

Introduction

If you are producing human food then you are most likely governed under Title 21 -- Chapter 1 -- Subchapter B -- Part 117.

However, some foods are subject to special requirements. If your business produces one of the food types below, click the link to learn more their special requirements:

If you don't produce any of these specially regulated products, then you are likely regulated under Part 117

Animal Food

If you make animal food (including pet treats), then you will be governed under Title 21 -- Chapter 1 -- Subchapter E.

Unfortunately, this resource doesn't have any detailed information for you, but you can access the regulations at the link above.

Infant Formula

Infant Formula is defined in the FDA regulation as

If your business produces infant formula, you will be required to comply with:

Bottled Water

Bottled water is defined as:

This includes water labeled as "Drinking water", "Mineral water", "Spring water", "Purified water".

To be clear, water is the only ingredient bottled water.

Water with added carbonation (i.e. soda water, tonic water, and seltzer) is generally regulated by the FDA as soft drinks.

If you are still unclear about what is bottled water, read the definition in the FDA Regulation

Bottled Water producers are subject to the following regulations:

Part 129 - Processing and Bottling of Bottled Drinking Water

Dietary Supplements

This term is legally complicated and only a partial definition is offered below. Click through the image to access the full definition from the FD&C Act

The regulation for Dietary Supplements can be found in the FDA Regulations at:

Fish & Fishery Products (Seafood)

Fish / Fishery Products are defined in the FDA Regulation as:

The regulation for Fish & Fishery Products can be found in the FDA Regulations at:

thumbnail-seafood-haccp-and-the-fda-food-safety-modernization-act-guidance.jpg

Note that the Food Safety and Modernization Act has impacted the regulation of Seafood -- in some ways allowing for exemptions to the above regulations. For more detail, see the following guidance document on Seafood HACCP and the FDA FSMA