Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Food Ingredients & Packaging

Food Ingredients & Packaging

                        Determining the Regulatory Status of a Food Ingredient
          Food Ingredient & Packaging Inventories


                        Food Additives and GRAS Ingredients Information for Consumers
          Food Chemical Safety
          Food Ingredient & Packaging Terms
          Color Additives Information for Consumers
          Food Additives & Petitions
          Food Packaging & Other Substances that Come in Contact with Food Information for Consumers
          Generally Recognized as Safe (GRAS)
          Packaging & Food Contact Substances (FCS)
          Irradiation of Food & Packaging
          Environmental Decisions
          Food from New Plant Varieties
          Human Food Made with Cultured Animal Cells Home
          Food
          Food Ingredients & Packaging
          Determining the Regulatory Status of a Food IngredientFood Ingredients & Packaging Determining the Regulatory Status of a Food Ingredient
  
  	
    Share
    Post
    Linkedin

    Email
    PrintAny substance that is reasonably expected to become a component of food is a food additive that is subject to premarket approval by FDA, unless the substance is generally recognized as safe (GRAS) among experts qualified by scientific training and experience to evaluate its safety under the conditions of its intended use, or meets one of the other exclusions from the food additive definition in section 201(s) of the Federal Food, Drug, and Cosmetic Act (FFDCA). Any food additive that is intended to have a technical effect in the food is deemed unsafe unless it either conforms to the terms of a regulation prescribing its use or to an exemption for investigational use. Otherwise, in accordance with section 409 of the Act, the substance is deemed an unsafe food additive. Any food that contains an unsafe food additive is adulterated under section 402(a)(2)(C) of the FFDCA.

Similarly, any substance that is added to food and imparts color to the food is a color additive (see color additive definition in §201(t) of the FFDCA and 21 CFR 70.3(f)). Any color additive in food is deemed unsafe unless its use is either permitted by regulation or exempt by regulation. Unlike the definition for food additive, there is no GRAS exemption for color additives. Any food that contains an unsafe color additive is adulterated under section 402(c) of the FFDCA.

The decision tree below will help in determining the regulatory status of a food ingredient. It is the responsibility of the manufacturer of any food to ensure that all ingredients used are of food-grade purity and comply with specifications and limitations in all applicable authorizations. The overall regulatory status of a food is affected by the regulatory status of each individual food ingredient. To determine compliance, consider each authorization to be composed of three parts:

The identity of the substance,
	*Specifications*including purity and physical properties, and
	Limitations on the conditions of use.To assure a customer that an ingredient that is being shipped to them is not adulterated or misbranded, the ingredient manufacturer may want to provide a letter of guaranty with the shipment (see 21 CFR 7.13 for suggested forms of guaranty).

Determining the Regulatory Status of a Food Ingredient
References:

Federal Food, Drug, and Cosmetic Act (FD&C Act)
	Dietary Supplements
	Determining the Regulatory Status of Components of a Food Contact Material
	Substances Added to Food
	Codex General Standard for Food Additives (GSFA)
	FDA's Food and Color Additives Regulations
	Petition Process
	Generally Recognized as Safe (GRAS)

                                                                                  Content current as of:
      09/20/2018
              
              
Regulated Product(s)
		 Food & BeveragesFood Ingredients & Packaging

          
                        Determining the Regulatory Status of a Food Ingredient
          Food Ingredient & Packaging Inventories


                        Food Additives and GRAS Ingredients Information for Consumers
          Food Chemical Safety
          Food Ingredient & Packaging Terms
          Color Additives Information for Consumers
          Food Additives & Petitions
          Food Packaging & Other Substances that Come in Contact with Food Information for Consumers
          Generally Recognized as Safe (GRAS)
          Packaging & Food Contact Substances (FCS)
          Irradiation of Food & Packaging
          Environmental Decisions
          Food from New Plant Varieties
          Human Food Made with Cultured Animal Cells
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop