FDA Revokes GRAS Status of Partially Hydrogenated Oils

The U.S. Food and Drug Administration (FDA) has issued a determination revoking the generally recognized as safe (GRAS) status of partially hydrogenated oils (PHOs), “the primary dietary source of industrially-produced trans fatty acids.” To comply with the declaratory order, food and beverage companies must remove PHOs from products by June 18, 2018, or request food additive approval for specific uses of PHOs.

Concluding that there is no longer expert consensus as to the safe use of artificial trans fat in human food, FDA argues that the action is “expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.” In the wake of its November 2013 tentative decision, the agency apparently received more than 6,000 comments from individuals, industry and trade associations, consumer groups, and government officials, the majority of which purportedly supported the reduction of trans fat in the food supply. 

“Studies show that diet and nutrition play a key role in preventing chronic health problems, such as cardiovascular disease and today’s action goes hand in hand with other FDA initiatives to improve the health of Americans, including updating the nutrition facts label,” said FDA Center for Food Safety and Applied Nutrition Director Susan Mayne in a concurrent press release. “This determination is based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period.” 

The agency also clarifies that the determination is a partial response to citizen petitions submitted by the Center for Science in the Public Interest (CSPI) and University of Illinois Professor Fred Kummerow, who sued the agency in 2013 over its failure to act on his submission. As CSPI Executive Director Michael Jacobson commented, “The final determination made today by the Food and Drug Administration gives companies more than enough time to eliminate the last of the partially hydrogenated oil that is still used in foods like microwave popcorn, biscuits, baked goods, frostings, and margarines… If FDA approves it for use as a food additive, it must do so only in the tiniest of amounts.” See The Washington Post and CSPI Press Release, June 16, 2015.

Read more in Issue 569 of the Food & Beverage Litigation Update.

This week’s issue also includes articles discussing:

  • draft legislation in the European Union that would ban the cloning of all farm animals;
  • EFSA guidance for renewal applications of genetically modified food and feed authorized under Regulation (EC) No. 1829/2003;
  • a putative class action against H.J. Heinz Co. alleging that the company’s frozen microwave French fries and tater tots contain artificial trans fat despite labeling that indicates otherwise; and
  • a new report condemning the American Society for Nutrition’s financial ties to food and beverage companies.