On June 16, 2015, the Food and Drug Administration (“FDA”) issued a declaratory order, requiring a phasing out of the use of partially hydrogenated oils (“PHOs”).1 In its order, the FDA stated that partially hydrogenated oils are no longer generally recognized as safe (“GRAS”) for any human food. Food ingredients with GRAS status are presumptively safe under the Federal Food, Drug, and Cosmetic Act (“FFD&C Act”), and food manufacturers are not required to obtain premarket approval to use GRAS ingredients.2 Under the FDA’s order, food manufacturers will be required to either remove PHOs from their food products or petition the FDA for permission to use PHOs, in accordance with 21 U.S.C. § 348(b). Food manufacturers must comply with the FDA’s order by June 18, 2018.
The FDA’s change in position is based on available scientific evidence and findings of expert panels. Kirk Garratt, the director of interventional cardiology research at Lenox Hill Hospital in New York, told Forbes magazine, “We’re continually studying and we’re continually learning . . . [The use of PHOs in foods] wasn’t an evil plot on the part of some corporate interest. It was just incomplete science. We still have incomplete science, and we’ll find out about mistakes we made in 2015."3
Subject of Regulation
Under the FFD&C Act, the FDA has authority to regulate foods except for some meat, poultry, and egg products.4 Within this authority, the FDA regulates food additives, which are substances that are reasonably expected to become a component of food.5 Food additives are subject to premarket approval by the FDA, unless the substance is GRAS or it meets one of the exclusions under the food additive definition.6
For the purposes of this order, PHOs are those fats and oils that have been hydrogenated, but not to complete or near complete saturation, with an iodine value greater than 4.7 Currently, PHOs are the primary source of artificial “trans” fat in processed foods.8 Food manufacturers have undertaken voluntary actions over the last several years to reduce the amount of trans fat used in foods.9 According to Roger Lowe, a spokesman for the Grocery Manufacturers Association, the industry “has already reduced trans fats added to foods by more than 86 percent.”10
What Will Happen Over the Next Three Years?
Over the next three years, interested parties may petition the FDA to approve food additive uses of PHOs for which safe conditions of use may be prescribed.11 Interested parties will need to submit data demonstrating a reasonable certainty of no harm from the proposed use. The FDA has published guidance regarding the petition process. The current Food Additive Petition form is available here.
In addition to submitting petitions, interested parties may also wish to identify suitable replacement ingredients for PHOs, to exhaust product inventories, and to take necessary steps to reformulate and modify labeling of affected products.12
The FDA anticipates that there will be a demand for alternative oil products, and the industry will have this three-year period to respond to that demand by growing, harvesting, and processing new varieties of edible oilseeds.13 The FDA also recognizes that the industry may need to address the supply chain issues associated with the transition to new oils.14
Womble Carlyle has significant experience assisting clients in the food industry. Womble Carlyle’s Food, Beverage, and Agriculture attorneys are ready to help clients understand food safety regulatory issues and develop strategies for compliance and effective communication with regulatory agencies. Additionally, Womble Carlyle’s Supply Chain Management attorneys can assist companies at all levels of a supply chain with everything from strategic partnering arrangements to risk management.
A complete version of the FDA’s declaratory order can be found here.
If you want to learn more about the FDA's declaratory order discussed in this alert, please contact one of our attorneys below.
Womble Carlyle client alerts are intended to provide general information about significant legal developments and should not be construed as legal advice regarding any specific facts and circumstances, nor should they be construed as advertisements for legal services.
IRS CIRCULAR 230 NOTICE: To ensure compliance with requirements imposed by the IRS, we inform you that any US tax advice contained in this communication (or in any attachment) is not intended or written to be used, and cannot be used, for the purpose of (i) avoiding penalties under the Internal Revenue Code or (ii) promoting, marketing or recommending to another party any transaction or matter addressed in this communication (or in any attachment).
1 Final Determination Regarding Partially Hydrogenated Oils, 80 Fed. Reg. 34,650 (June 17, 2015).
2 Paulette Gaynor, How U.S. FDA’s GRAS Notification Program Works, U.S. Food & Drug Admin., http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/ucm083022.htm (last updated Apr. 1, 2015).
3 Matthew Herper, FDA Bans Trans Fact. Hooray!, Forbes (June 16, 2015, 2:07 PM), http://www.forbes.com/sites/matthewherper/2015/06/16/why-the-fdas-trans-fat-ban-is-a-triumph-of-good-government/.
4 What does FDA regulate?, U.S. Food & Drug Admin., http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194879.htm (last updated Apr. 30, 2015).
5 See Generally Recognized as Safe (GRAS), U.S. Food & Drug Admin., http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm (last updated June 4, 2015).
7 Final Determination Regarding Partially Hydrogenated Oils, 80 Fed. Reg. 34,650 (June 17, 2015).
9 News Release, Roger Lowe, Grocery Manufacturer’s Ass’n, GMA Statement: FDA Action on PHOs Provides Needed Transition Time for Food Manufacturers, (June 16, 2015), available at http://www.gmaonline.org/news-events/newsroom/gma-statement-fda-action-on-phos-provides-needed-transition-time-for-food-m/.
10 Sabrina Tavernise, FDA Sets 2018 Deadline to Rid Foods of Trans Fat, N.Y. Times (June 16, 2015), http://www.nytimes.com/2015/06/17/health/fda-gives-food-industry-three-years-eliminate-trans-fats.html; News Release, Roger Lowe, Grocery Manufacturer’s Ass’n, GMA Statement: FDA Action on PHOs Provides Needed Transition Time for Food Manufacturers, (June 16, 2015), available at http://www.gmaonline.org/news-events/newsroom/gma-statement-fda-action-on-phos-provides-needed-transition-time-for-food-m/.
11 See id.
12 Final Determination Regarding Partially Hydrogenated Oils, 80 Fed. Reg. 34,650 (June 17, 2015).