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:

                CFSAN Constituent Updates

CFSAN Constituent Updates Home
          Food
          News & Events from CFSAN
          CFSAN Constituent Updates
          FDA Completes Final Administrative Actions on Partially Hydrogenated Oils in FoodsCFSAN Constituent Updates FDA Completes Final Administrative Actions on Partially Hydrogenated Oils in Foods
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintWhat's New

December 13, 2023

The FDA is announcing that December 22, 2023 is the effective date for the direct final rule regarding the revocation of uses of partially hydrogenated oils (PHOs) in food. The FDA stated that this would be the effective date unless any significant adverse comment was submitted to the FDA during the comment period. We did not receive any significant adverse comments.

Federal Register Notice: Revocation of Uses of Partially Hydrogenated Oils in Foods; Confirmation of Effective Date


Original Constituent Update

August 8, 2023

The U.S. Food and Drug Administration is issuing a direct final rule to complete administrative actions that reflect the agency’s June 2015 final determination that the use of partially hydrogenated oils (PHOs) in foods is no longer Generally Recognized as Safe (GRAS).  In the 2015 final determination, the FDA indicated that there were outdated references to PHOs in regulations that the FDA would address separately. With respect to removing PHOs from the food supply, the FDA established January 1, 2021, as the final compliance date to allow manufacturers time to reformulate foods and ensure an orderly transition in the marketplace.

The FDA’s actions regarding PHOs address artificial sources of trans fat, but trans fat will not be completely removed from the food supply because it occurs naturally in meat and dairy products and is present at very low levels in other edible oils.

The direct final rule:

Revises regulations to no longer include PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna
	Revises FDA GRAS affirmation regulations to no longer include partially hydrogenated forms of menhaden and rapeseed oils
	Revokes the regulation for partially hydrogenated fish oil as an indirect food substance
	Revokes pre-1958 authorization for using PHOs in margarine, shortening, and bread, rolls and buns. This authorization occurred before the enactment of the Food Additives Amendment of 1958 so these uses of PHOs could not be regulated as food additives.The FDA is issuing these amendments directly as a final rule because it anticipates no significant adverse comments because FDA declared PHOs no longer GRAS for any human food in 2015.  However, the agency is issuing a companion proposed rule in the same issue of the Federal Register in case the direct final rule is withdrawn because significant adverse comments are received, and the agency needs to move forward with a proposed rule to put these changes in place.

The FDA is accepting comments on both the direct final and proposed rules. Comments must be submitted by 75 days after publication in the Federal Register.

Submit electronic comments at https://www.regulations.gov/.

Submit written comments to:

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, room 1061
Rockville, MD 20852

The direct final rule would be effective 135 days after the date of publication in the Federal Register.

**For more information**

Federal Register Notice: Direct Final Rule on Revocation of Uses of Partially Hydrogenated Oils in Foods (August 2023)
	Federal Register Notice: Companion Proposed Rule on Revocation of Uses of Partially Hydrogenated Oils in Foods (August 2023)
	Final Determination Regarding Partially Hydrogenated Oils (Removing Trans Fat)

                                                                                  Content current as of:
      12/13/2023
              
              
Regulated Product(s)
		 Food & BeveragesCFSAN Constituent Updates
 Subscribe to CFSAN Constituent Updates
                        Get email updates delivered to your inbox.
    Enter your email address to subscribe:
 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