Date: Jun 16, 2015
On June 16, 2015, FDA announced its final determination that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs) are “generally recognized as safe” (GRAS) for any use in human food. In effect, PHOs will now be regulated as food additives, which – unlike GRAS substances – require premarket approval by FDA prior to use in food. FDA has provided a compliance date of June 18, 2018, which means that the food industry will have three (3) years to remove PHOs from food products or seek regulatory clearance for low level use of PHOs, either through a food additive petition or food contact notification.
PHOs are the primary dietary source of industrially-produced or artificial trans fatty acids (trans fats). FDA’s determination applies specifically to PHOs defined as “those fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value (IV) greater than 4.” The determination does not apply to ingredients that contain only naturally occurring trans fats, such as those ingredients derived from ruminant sources. The determination also does not apply to the use of conjugated linoleic acid (CLA) or partially hydrogenated methyl ester of rosin as food ingredients, as neither substance fits the definition of a PHO. Finally, the determination does not apply to the use of PHOs as raw materials to produce other food ingredients, even where such use could result in the incorporation of trans fats into those ingredients. FDA provides no guidance on this last “exclusion,” but cautions that where an ingredient is synthesized using PHOs, and the ingredient is being used on the basis of a GRAS self-determination, revaluation of such a determination “may be appropriate” in light of the current determination.
The food industry and other stakeholders have been anticipating FDA’s final determination for quite some time. In November 2013, FDA announced its tentative determination that PHOs were not 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). The determination that a substance is GRAS requires a consensus among qualified experts that the substance is safe under its intended conditions of use. Based on the existence of conflicting scientific data on trans fats, FDA believes there is no longer a scientific consensus to support the safety of PHOs in food. 21 CFR 170.38 gives FDA the authority to publish a notice when it determines a substance is not GRAS and is a food additive.
FDA sought comments on its tentative determination regarding the GRAS status of trans fats and received over 6,000 comments (including over 4,500 form letters) from individuals, industry and trade associations, consumer and advocacy groups, health professional groups, and state and local governments. After considering the comments received, FDA affirmed its earlier conclusion and further stated that the available science does not support the establishment of any safe “threshold” below which PHOs may be safely used in the food supply.
Although the industry voluntarily has worked to reduce the level of trans fats in foods over the years, especially since trans fats became a mandatory nutrition labeling element, PHOs still are used in specific applications, such as in the bakery industry – which will have difficulty replacing the solid shortenings used in bakery products – as well as in frostings, fillings for candies, chewing gum, snack bars, and as a component of “minor use ingredients” (e.g., coatings, anti-caking agents, encapsulates, emulsifiers, release agents, flavors, and colors).
FDA’s final determination does not necessarily mean that PHOs will disappear from the U.S. food supply, however. FDA expressly states in its determination that if “industry or other interested individuals believe that safe conditions of use for PHOs can be demonstrated, it or they may submit a food additive petition or food contact notification to FDA for review.” A leading food trade association – the Grocery Manufacturers Association (GMA) – already has announced its intent to submit a food additive petition (FAP) on behalf of its members to establish the safe use of PHOs in specific food applications and at limited use levels. If approved, the FAP would provide a viable pathway for at least some low level uses of PHOs. In addition, FDA acknowledges that they have provided a three year compliance period in order to allow time for such petitions to work their way through the regulatory process.
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 added sugar – and also as a potential precursor to regulatory restrictions or bans in other countries. Others are concerned that FDA’s final determination will have an impact on current consumer class action litigation involving trans fats and could possibly prompt additional litigation.
 The pre-publication of the Agency’s announcement is available at https://federalregister.gov/a/2015-14883; FDA’s Press Release is available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm451237.htm.
 See 78 Fed. Reg. 67169 (Nov. 8, 2013), available at http://www.gpo.gov/fdsys/pkg/FR-2013-11-08/pdf/2013-26854.pdf; see also, FDA Press Release, available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm373939.htm.