The Food and Drug Administration is requiring companies to remove partially hydrogenated oils (PHOs) from food and beverage products in the United States by June 18, 2018. The agency last week clarified that products containing PHOs that are already shipped and in stores before the June compliance date can be sold through January 1, 2020. IDFA and stakeholders had urged FDA to clarify that these products would not need to be removed from shelves next month, helping to avoid severe disruption and confusion in the marketplace.

“The dairy industry has been working diligently since FDA finalized its determination to remove uses of PHOs from their product formulations. We’re pleased that the agency heard our concerns and has provided the clarity we need to make an orderly transition in the marketplace,” said Cary Frye, IDFA senior vice president of regulatory affairs.

FDA also denied a proposal by the Grocery Manufacturers Association to grant approval for the limited use of PHOs as carriers for color additives and flavoring agents, pan release agents for baked goods and as processing aids. FDA extended the compliance date for companies using PHOs for these reasons by one additional year, to June 18, 2019, a delay IDFA also called for in comments submitted to the agency.

Some dairy and food companies have inquired about the possibility of using old label inventory that declares PHOs as an ingredient after the company has reformulated the product to remove PHOs. IDFA learned that FDA staff will consider granting enforcement discretion to permit, on a case-by-case basis, the continued use of old labels that declare PHOs as an ingredient after the product has been reformulated to remove PHOs. The agency would require the firm to make a written request by providing the following information:

1. The number of labels implicated

2. The dollar value of the labels implicated

3. The expected timeframe to exhaust the labels

4. An example of the existing label

5. An example of the new label

FDA will consider granting such requests where there are no other “major concerns” with the label.

PHO Rule

In 2015, FDA called for the removal of PHOs from food and beverage products, determining that PHOs should no longer be considered Generally Recognized as Safe (GRAS) because they contain trans fat, which has been associated with negative health consequences.

Most dairy products do not contain PHOs. However, there are naturally occurring trans fats that are created in the cow’s digestive tract and are passed into the milk. The animal sources of trans fats do not have the same health concerns as the industrially produced trans fat. FDA has confirmed that its rule excludes naturally occurring trans fats, fully hydrogenated oils and ingredients derived from PHOs, such as monoglycerides and diglycerides, since the PHOs aren’t added to the products.

For more information, contact Michelle Matto, R.D.N., IDFA’s nutrition and labeling consultant, at amfoodnutrition@gmail.com.