PHOs Banned In The U.S.

Landmark FDA Order Declares Partially Hydrogenated Oils No Longer Generally Regarded as Safe

1. Introduction

   On June 17, 2015, the U.S. Food and Drug Administration (FDA) issued its much-anticipated Final Determination Regarding Partially Hydrogenated Oils (Order),1 finding there is "no longer a consensus that partially hydrogenated oils (PHOs), the primary source of industrially-produced trans fat, are generally recognized as safe (GRAS) for use in human food, based on current scientific evidence." See Order at 71. The Order's key points are as follows:

   PHOs are not GRAS for any use in human food. Food additive approval is not granted but the possibility is not foreclosed. Industry is invited to submit food additive petitions for specified uses of PHOs, which will require a compelling scientific showing that the proposed use is reasonably certain not to present a risk of harm to consumers. Industry is provided a three-year phase-out period for reformulation and relabeling of products. As of June 18, 2018, food manufacturers will not be permitted to sell PHOs or food products containing PHOs without prior FDA approval for use as a food additive. The Order does not contain any express preemption or safe harbor from civil litigation. The Order does not change PHO or trans-fat labeling requirements. The Order is the culmination of a process that began with the FDA's November 8, 2013, Tentative Determination Regarding Partially Hydrogenated Oils and more than 18 months of input from stakeholders. During the comment period, the FDA received extensive feedback from the industry - including industry groups such as the Grocery Manufacturers Association and American Baking Association - urging the FDA to reconsider its position. Many of those comments are summarized and addressed throughout the Order. As many stakeholders pointed out, many food manufacturers steadily reduced PHO content in the marketplace since the FDA began requiring trans-fat labeling in 2006. As a result of manufacturers' efforts and consumer education, American PHO consumption has fallen substantially.

   Some stakeholders argued PHOs should remain GRAS and that trans-fat consumption should be addressed using alternative methods, such as labeling. Other stakeholders sought implementation of a threshold level, below which PHOs would be permitted, pointing out that PHOs at certain low levels have not been shown to adversely affect human health, yet play an important role in the texture and stability of products (e.g., frostings, cake sprinkles and chewing gums). These commenters requested that PHOs be allowed below a certain permitted level or for certain limited applications. Commenters also noted that, should the FDA revoke the GRAS status of PHOs, a lengthy implementation period would be necessary to allow the industry time to reformulate products and to cultivate and source appropriate PHO replacements. Finally, many stakeholders requested a safe harbor period from civil litigation, noting the FDA's determination otherwise could lead to a glut of PHO...