Updated: FDA Extends Compliance Dates for Ban on Partially Hydrogenated Oils | Practical Law

Updated: FDA Extends Compliance Dates for Ban on Partially Hydrogenated Oils | Practical Law

The Food and Drug Administration (FDA) recently ruled that partially hydrogenated oils (PHOs) are no longer generally recognized as safe (GRAS) for human consumption. The ruling effectively bans PHOs, the main source of trans fats, from processed foods.

Updated: FDA Extends Compliance Dates for Ban on Partially Hydrogenated Oils

Practical Law Legal Update 8-616-5991 (Approx. 3 pages)

Updated: FDA Extends Compliance Dates for Ban on Partially Hydrogenated Oils

by Practical Law Commercial
Published on 22 May 2018 • USA (National/Federal)
The Food and Drug Administration (FDA) recently ruled that partially hydrogenated oils (PHOs) are no longer generally recognized as safe (GRAS) for human consumption. The ruling effectively bans PHOs, the main source of trans fats, from processed foods.
This resource was updated on May 22, 2018 to account for the Food and Drug Administration's (FDA) extension of the compliance date for certain uses of PHOs (see Update).
On June 16, 2015, the FDA finalized its determination that partially hydrogenated oils (PHOs) are not generally recognized as safe (GRAS) for use in food. Food manufacturers have three years to remove PHOs from their products.
PHOs are the primary source of artificial trans fat in processed foods. Manufacturers have been required to include trans fat ingredients on their food labels since 2006. Manufacturers are currently permitted to label foods having 0.5 grams of trans fat per serving as having 0 grams of fat, and this rule effectively bans PHOs as an acceptable source of trans fats.
(80 Fed. Reg. 34274).

Update

On May 21, 2018, the FDA extended the compliance date for removing certain uses of PHOs from processed foods.
The FDA had established a June 18, 2018 compliance date to allow:
  • Food manufacturers to identify replacement ingredients and modify labeling.
  • Time for submission review, and approval of food additive petitions for potential safe uses of PHOs.
  • Current inventories and products containing PHO to be depleted and distributed.

Non-Petitioned and Petitioned PHO Uses

On May 21, 2018, the FDA extended compliance dates to remove petitioned PHO and non-petitioned PHO uses (non-FDA authorized PHO uses) from processed foods.

Non-Petitioned Uses

A group of trade associations informed the FDA that they replaced non-petitioned PHO uses and would be able to stop using PHOs by June 18, 2018. However, other companies complained they would not meet the June 18, 2018 deadline due to product shelf lives. The FDA extended the compliance date for foods manufactured before June 18, 2018 with non-petitioned PHO uses from June 18, 2018 to January 1, 2020.

Petitioned Uses

Additionally, the FDA extended compliance dates for certain uses of PHOs that the Grocery Manufacturers Association (GMA) had previously petitioned to allow as safe uses of PHOs, including as:
  • A solvent for flavoring agents.
  • A processing aid.
  • A pan release agent for baked goods.
The FDA denied GMA's petition on the same day the agency issued the extension of the compliance dates (83 Fed. Reg. 23382).
However, the FDA extended the compliance dates for companies using PHOs in the ways listed in the GMA petition from June 18, 2018 to June 18, 2019.
Companies also requested more time to deplete their inventories made with petitioned PHO uses. The FDA extended the compliance date for food manufactured before June 18, 2018 with petitioned PHO uses from June 18, 2018 to January 1, 2021. Foods manufactured with PHOs after the new compliance dates may be subject to FDA enforcement actions.