May 18, 2018

Dear Colleagues,

The U.S. Food and Drug Administration is extending the compliance date for certain uses of partially hydrogenated oils (PHOs). For the majority of uses of PHOs, June 18, 2018 remains the date after which manufacturers cannot add PHOs to foods. However, to allow for an orderly transition in the marketplace, the FDA is allowing more time for products produced prior to June 18, 2018 to work their way through distribution. The FDA is extending the compliance date for these foods to January 1, 2020. This action balances the health benefits of removing PHOs from the food supply with the need to provide an orderly transition in the marketplace.

At the same time, the FDA is denying a food additive petition from the Grocery Manufacturers Association (GMA) requesting approval for certain limited uses of PHOs. To allow for time for reformulation, the agency is extending until June 18, 2019 the compliance date to stop manufacturing foods with these specific, limited petitioned uses of PHOs, and until Jan. 1, 2021 for these products to work their way through distribution.

PHOs are the primary dietary source of artificial trans fat in food. Consuming trans fat raises the level of LDL (“bad”) cholesterol and decreases the level of HDL (“good”) cholesterol in the blood. An elevated LDL cholesterol level in the blood increases the risk of developing heart disease, the leading cause of death in men and women in the U.S.

The FDA issued on June 17, 2015 its final determination that PHOs were no longer Generally Recognized as Safe for any use in human food and set a compliance period of three years to allow industry time to either reformulate products without PHOs and/or submit a food additive petition to FDA to permit specific uses of PHOs. Following the final determination, FDA filed a petition submitted by GMA requesting 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. The FDA is denying the petition because the petitioners did not provide sufficient evidence that the requested uses are safe.

The FDA has been informed by trade associations representing many segments of the food industry that they have replaced the PHO uses that are not covered by GMA’s food additive petition and will be able to stop manufacturing food with those non-petitioned uses of PHOs by the June 18, 2018 compliance date. However, food manufactured up to June 18, 2018 with PHOs may still be in commerce and in retail stores because a variety of products have shelf lives that range from 3 to 24 months, according to trade associations. The FDA also recognizes that the food industry needs additional time to identify suitable replacement substances for the petitioned uses of PHOs.

The extended compliance dates distinguish between uses of PHOs for which FDA has been petitioned by GMA and all other uses of PHOs not authorized by FDA that are considered “non-petitioned” uses. After the compliance dates, foods may be subject to enforcement action by FDA.

For convenience, FDA is summarizing the extended compliance dates as follows:

For More Information:

Federal Register notice: Grocery Manufacturers Association; Denial of Food Additive Petition:

https://www.federalregister.gov/documents/2018/05/21/2018-10715/food-additive-petitions-grocery-manufacturers-association

PHO Determination Main Page: https://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm449162.htm

Final Determination on Partially Hydrogenated Oils:

https://www.federalregister.gov/documents/2015/06/17/2015-14883/final-determination-regarding-partially-hydrogenated-oils

This message is being broadcast by the Division of Communications in FDA’s Office of Regulatory Affairs (ORA).

Thank you,

FDA/ORA

Office of Communications and Project Management

Division of Communications

Mailbox: DivComm-ORA@fda.hhs.gov