June 2015 – FDA announces Partially Hydrogenated Oils (PHOs) are no longer GRAS. Industry has until June 28, 2018 to remove from products
In November 2013, FDA posted a Tentative determination regarding Partially Hydrogenated Oils (PHOs) and issued a call for scientific data and information to re-investigate the GRAS status of this common ingredient typically seen in margarine, shortening, frozen pizza and bakery goods. PHOs are a major source of trans fat, and thus are linked to significant health risks, such as coronary heart disease. It has long been a staple in the food industry as PHOs aid in extending product shelf life and provide a more satisfying mouthfeel and texture. As of June 16, 2015 FDA has released a Press Announcement finalizing their opinion that PHOs would not be considered ‘generally recognized as safe’ or GRAS for human consumption.
In general, a substance is GRAS if it is ‘generally recognized to be safe under the conditions of its proposed use’ as determined by a consensus of scientific experts, qualified by education, training and experience or through it’s common use in food. When an ingredient has been used in foods prior to January 1, 1958, it could be considered GRAS based on it’s common use. As PHOs have been used as a substance in food since 1911 it had been deemed to be GRAS for food use. However, upon review of the information requested in the 2013 call for data, FDA has now determined that PHOs would no longer be GRAS, as per evidence from expert review panels from the Institute of Medicine (IOM), World Health Organization (WHO), American Heart Association (AHA), American Diabetic Association (ADA), and the FDA Food Advisory Committee Nutrition Subcommittee. Data from these expert panels has led FDA to the conclusion that there is no acceptable threshold for safety for trans fats that would not increase the risk of coronary heart disease.
Under the current determination PHOs would now be classified as food additives, subject to Section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348), requiring prior FDA approval in order for a food manufacturer to use the ingredient. The FDA has set a compliance date of 3 years by which manufacturers must no longer be producing food products containing PHOs. This means that after June 28, 2018 no product shall be manufactured with PHOs, while companies can technically manufacture a product up until June 27, 2018 with PHOs and be in compliance with this determination, FDA expects that many companies will start phasing this ingredient out early from product formulations, with a gradual removal from the market. Although, it is important to note that fully hydrogenated oils (FHO) are not included in this FDA ruling and can still be considered GRAS.
If you plan to continue using PHOs following the June 28, 2018 deadline FDA will require a food additive petition indicating the specific uses and threshold for use. As this can be onerous process it is suggested that companies plan early to either reformulate without PHOs or petition the FDA as a food additive. At dicentra, we can assist you with your product from inception to post market and aid with preparation of food additive petitions, GRAS dossiers, ingredient and formula reviews as well as review and preparation of compliant labelling.
dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can be reached at 1-866-647-3279 or info@dicentra.com.