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A Food Producer's Guide to FSMA and FDA Regulation

Specially Regulated Foods

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:

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

Fish & Fishery Products (Seafood)

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

fish-fishery-product-definition.png

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

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

Juice

Juice is defined as:

A juice processor is regulated in the FDA Regulations at:

Unlike many other food types, juice processors must comply with Part 120 even if their product is not entering interstate commerce.

If compliant with Part 120, then Juice processors are exempt from 117 Subpart C (Food Safety Plan) and Subpart G (Supply Chain Program)

For more information on juice processing regulations, check out the Section For Juice Processors on the FDA website or this guidance document, below

What's Next:

Do you produce a different type of product?  Requirements for FDA Food Producers

Not sure if the FDA Regulates your business? Learn about FDA Jurisdiction