FDA Seeks to Remove GRAS Status of Trans Fats

On November 7, the Food and Drug Administration (FDA) issued a Federal Register notice with a preliminary determination that partially hydrogenated oils (PHOs), the major dietary source of trans fat in processed food, are no longer “generally recognized as safe,” or GRAS.  If the preliminary determination becomes permanent, then PHOs will be treated as a food additive required to undergo premarket approval by the FDA.  Foods containing unapproved additives are considered adulterated, and, thus, are illegal to sell.  In 2006, FDA began requiring food product labels to list the amount of artificial trans fats; however, the use of trans fats was not banned.

Dennis M. Keefe, Ph.D., director of FDA’s Office of Food Additive Safety, said that if FDA determines that PHOs are not GRAS, it could mean the end of artificial, industrially-produced trans fat in foods.  Although, trans fat would not be completely gone, as it also is naturally occurring in small amounts in meat and dairy products, as well as in other edible oils.

A 60-day public comment period opened on November 7.  FDA is seeking comments on how long it would take the food industry to phase out the use of PHOs, how revoking PHOs’ GRAS status would impact small businesses, and how to ensure a smooth transaction if a final determination is issued.  Comments can be submitted to FDA docket number FDA-2013-N-1317 at www.regulations.gov.

For more information on FDA’s preliminary determination, trans fats and PHOs, and GRAS, see FDA’s consumer update article on the issue and the Federal Register notice.

Written by Alyssa Looney – Research Assistant

The Agricultural Law Resource and Reference Center

@PSUAgLawCenter

November 8, 2013