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  1. Food Industry

Producing a Food Product that is Regulated by FDA

If you are producing a food product, there is a good chance it is regulated by FDA. The agency regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, except for meat, poultry, certain processed egg products, and catfish, which are regulated by the U.S. Department of Agriculture.  The regulatory requirements may depend on the specific nature of your product.  Below are resources that may be useful starting points. 

How do I know if my product is regulated by FDA?
This general navigation guide may be helpful to companies wondering if their planned activities would be subject to regulation by FDA.

How do I start a food business?
This is an overview of regulatory requirements that relate to starting a food business. It contains links to different issues you may have to consider. 

I have a small business. What kind of help is available for me?
FDA has instituted activities aimed at assisting small businesses.

How can I learn more about FDA’s food labeling requirements?
This page links to labeling and nutrition guidance documents and regulatory information.

How does FDA regulate color additives?
This page lists resources related to the use of color additives in FDA-regulated products.

How does FDA regulate food additives?
This page lists information and guidance documents about food additives and food additive petitions.

How does FDA regulate food contact substances?
This page includes information about packaging and food contact substances.

Where can I find guidance issued by FDA?
Guidance documents represent FDA's current thinking on a topic. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  This page offers a tool to search all of FDA’s guidance documents.

How do I know if I’m working with materials Generally Recognized as Safe?
Learn more about the GRAS program and whether your materials are generally recognized by experts as safe for their intended use.

How can I learn more about what FDA is doing in genome editing?
This Q&A has links to relevant documents that will be helpful.

How can I learn more about how FDA regulates food from genetically engineered plants?
Learn more about the regulatory system for biotechnology.

Who can I call at FDA to talk about my product?
A good place to start is FDA’s hotline at 1-888-SAFEFOOD. This page also enables you to submit your question electronically.