FDA announces final determination that Partially Hydrogenated Oils are not GRAS.

  • In November 2013, FDA announced its tentative determination that partially hydrogenated oils (PHOs) were not generally recognized as safe (GRAS) based on the link between trans fats and health risks, such as coronary heart disease (CHD), as identified by scientific evidence and expert scientific panels, such as the Institute of Medicine (IOM) and the Centers for Disease Control and Prevention (CDC).  PHOs are the primary dietary source of industrially-produced or artificial trans fatty acids (trans fats).
  • On June 16, 2015, FDA issued a final determination and press release stating that there is no longer a consensus among qualified experts that PHOs are GRAS under any conditions of use in food.  Going forward, PHOs will be regulated as food additives, which — unlike GRAS substances — require FDA approval prior to use in food.  The food industry and other stakeholders have been anticipating FDA’s final determination for quite some time.  The industry voluntarily has removed a significant amount of trans fats from the food supply.  With respect to applications in which trans fats are not readily substitutable, a leading trade association — the Grocery Manufacturers Association (GMA) — has indicated its intent to submit a food additive petition (FAP) to permit the use of PHOs in specific food applications and at limited use levels.
  • Although FDA’s determination in this case comes as little surprise to the food industry and other stakeholders, this development is likely to receive significant attention in the coming weeks and months.  Many look to the trans fats example as a potential precursor to regulatory action involving other ingredients of concern – such as caffeine and sodium – and also as a potential precursor to regulatory restrictions or bans in other countries.