June 5, 2018Client Alert

FDA Denies PHO Food Additive Petition, Extends Compliance Date

The Food and Drug Administration (FDA) recently denied a petition that requested FDA amend the food additive regulations to allow for the safe use of partially hydrogenated vegetable oils (PHOs) in certain food applications. In a related announcement, FDA also extended the compliance date for removal of PHOs from foods for those uses outlined in the petition and clarified the compliance date for other PHO uses.

In June 2015, FDA announced that it was revoking the Generally Recognized as Safe (GRAS) status of PHOs for use in food and stated that PHOs must be removed from use in food by June 18, 2018. This resulted in PHOs being regulated as food additives, which unlike GRAS substances require FDA approval prior to their use in food. In its announcement, FDA acknowledged that scientific knowledge evolves over time and invited entities to file a food additive petition with supporting data to show that PHOs are safe for use in human food.

The Petition and FDA’s Denial

Following FDA’s revocation of the GRAS status of PHOs, the Grocery Manufacturers Association (Petitioners) filled a food additive petition requesting FDA allow specific and limited uses of PHOs. Petitioners requested that FDA deem safe PHOs when used, at specified maximum levels, as a:

  • Solvent, carrier, or a component of flavoring agents intended for food use
  • Processing aid or component of a processing aid
  • Pan release agent for baked goods

The petition also outlined information about consumption levels of PHOs and other trans fats in the diet and scientific studies about the health effects of their consumption.

After review, FDA denied the petition citing that the petition did not provide sufficient information for the agency to conclude that the requested uses of PHOs are safe.

Compliance Date Extension

In order to provide food manufacturers more time to phase out the use of PHOs in foods, FDA has extended the compliance date for foods containing PHOs in the limited and specific uses requested in the petition. FDA has also clarified the compliance date for foods with longer shelf lives that contain PHOs and are currently on the market.

Specifically, foods manufactured after June 18, 2018 should not contain PHOs unless it is one of the three limited uses included in the denied petition. Companies have until January 1, 2020 to exhaust their inventories of foods that contain any non-petitioned PHOs if the food was manufactured prior to June 18, 2018.

Food manufacturers that use PHOs for the three-petitioned uses should begin reformulating products and completely phase out their use in food by June 18, 2019. Ultimately, no foods in the market should contain any PHOs after January 1, 2021 or they will be deemed adulterated and subject to FDA enforcement.

For convenience, FDA summarized the extended compliance dates in the following table:

Product Uses

Original Compliance Date

Extended Compliance Date

Manufacturing of food with non-petitioned use of PHOs

June 18, 2018

Not Extended

Foods manufacturers with non-petitioned uses of PHOs before June 18, 2018

June 18, 2018

January 1, 2020

Manufacturing of foods with petitioned uses of PHOs

June 18, 2018

June 18, 2019

Foods manufactured with petitioned uses of PHOs before June 18, 2019

June 18, 2018

January 1, 2021

Contact your Michael Best attorney to learn more about how this recent announcement may affect your business.

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