CFSAN Constituent Update
November 7, 2013
The U.S. Food and Drug Administration has made a preliminary determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” (GRAS) for use in food. A final decision would mean that the use of these oils in the food supply would be phased out over a number of years. Removal of PHOs from the food supply could prevent up to 7,000 deaths from heart disease each year.
FDA has required industry to declare the amount of trans fat in food on the Nutrition Facts label since 2006. FDA data indicate that many processed foods have been reformulated to reduce the amount of trans fat since the requirement was instituted, but a substantial number of products still contain PHOs.
If, after reviewing comments received, FDA determines that PHOs are not GRAS, PHOs could not be used in foods unless authorized by a regulation. One of our core regulatory functions is ensuring that food, including all substances added to food, is safe.
As discussed in more detail in the Federal Register notice, during the 60-day public comment period, FDA is seeking data and information on a number of issues, including:
- Whether FDA should finalize its tentative determination that PHOs are no longer GRAS; and
- How long it would take producers to reformulate food products to eliminate PHOs.
The comment and submission period starts November 8, 2013.
Submit comments electronically to the FDA docket on http://www.regulations.gov, use docket number FDA-2013-N-1317.
To submit comments by mail, send to FDA at:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All submissions must include the agency name and docket number.