What Exactly Are Nutraceuticals?

According to the industry, nutraceuticals are ‘pharmaceutical grade’ nutrients that are consumed for a health benefit. In reality, they are vitamins, minerals, herbs, and extracts.

But you won’t find the word “nutraceutical” in federal law. The only place it appears on the FDA website is in the names of companies that have received warning letters for violating the FDA regulations.

According to the FDA regulations, most nutraceuticals would be categorized as “dietary supplements”. These are extracts, concentrates or combinations of vitamins, minerals, botanicals, herbs, or dietary substances  “for use by man to supplement the diet by increasing the total dietary intake.”

When is a Nutraceutical a Drug?

One of the primary indicators between dietary supplements and drugs relates to health claims. Whereas a dietary supplement is meant to provide nutrients, a drug is designed to treat illness or disease.

So, in order to maintain classification as a dietary supplement (and avoid the FDA’s strict drug approval process), Nutraceuticals must maintain that they are not intended to treat, diagnose, prevent, or cure diseases. So, no label claims about treating pain, or preventing cancer.

How Are Nutraceuticals Regulated?

Producers of nutraceuticals classified as dietary supplements are required to register their facility with the FDA. Much like foods, producers of nutraceuticals are expected to comply with Current Good Manufacturing Practices -- these outline facility standards, employee practices, and sanitation requirements, to ensure that the product is produced in a safe manner.

Labeling standards for dietary supplements are lumped together with those for foods. However, there are unique expectations for how dietary supplements are marketed and what claims they can make.

For the complete set of regulations on producing dietary supplements, check out the guided question set in 21 CFR 111

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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:

• Animal Food (Includes pet treats)

• Infant Formula

• Bottled Water

• Dietary Supplements

• Fish / Fishery Products (Seafood)

• Juice

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:

• Part 107 -- Infant Formula

• Part 106 -- Additional Infant Formula Requirements

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:

• Part 111 - CGMPs in Manufacturing Packaging, Labeling or Holding Operations for Dietary Supplements

• Part 190 Notification Requirements for Dietary Supplements

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:

• Part 123 -- Fish and Fishery Products

• Part 161 -- Requirements for Specific Fish and Shellfish

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:

• Part 120 -- HACCP Systems

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

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More About FDA Jurisdiction