Why is this research valuable?
On November 8th, 2013, the FDA published a Federal Register (FR) notice tentatively determining that PHOs are no longer Generally Recognized as Safe (GRAS) under any condition of use in food and, therefore, PHOs are food additives subject to FDA approval. This tentative determination was based on the rationale that TFA affect lipid metabolism and pro-inflammatory effects, causing dose-dependent increases in CHD events in humans.
Within the FR notice, the FDA asked a series of questions, with the most relevant to IAFNS being: Are there data to support other possible approaches to addressing the use of PHOs in food?
Current Work
To address this question, the Task Force undertook a two-phased project outlining an evidence-based approach to better understand and more fully delineate the risk of PHO intake at various exposures. The objective of Phase 1 was to develop an evidence map to better characterize the existing literature regarding intervention trials on iTFAs. The objective of Phase 2 was to establish biological understanding of a threshold (mode of action [MOA] determination), conduct a meta-regression based on the relevant epidemiology studies to improve the overall understanding on the shape of the dose-response curve and based on the meta-regression, identify a point of departure and considerations for extrapolation to lower doses of iTFA. The MOA analysis and dose‐response evaluation of PHOs points to the importance of development of experimental design that can fully inform risk assessment of PHOs.
Publications
This committee is no longer active.
This work has been presented during:
- 2014 SOT Colloquium
- Winter Tox Forum, January 2015
- Society of Toxicology 2015 Annual Meeting
- Experimental Biology 2015
Read IAFNS's public comments regarding this work, which were submitted to FDA in 2015 and 2016, on the IAFNS Public Comments page.
Projects Supported by the Committee:
Publications
Trans fatty acids and cholesterol levels: An evidence map of the available science
Food & Chemical Toxicology, 2016
Read more about Trans fatty acids and cholesterol levels: An evidence map of the available science
Mode-of-action evaluation for the effect of trans fatty acids on low-density lipoprotein cholesterol
Food & Chemical Toxicology, 2016
This work systematically considers the data relating to the mode of action (MOA) for the effects of industrially produced trans fatty acid (iTFA) on plasma low-density lipoprotein (LDL) levels.
Meta-regression analysis of the effect of trans fatty acids on low-density lipoprotein cholesterol
Food and Chemical Toxicology, 2016
This meta-regression of controlled clinical trial data was executed to quantitatively investigate the relationship between dietary intake of industrial trans fatty acids (iTFA) and increased low-density lipoprotein cholesterol (LDL-C).
Predicted Changes in Fatty Acid Intakes, Plasma Lipids, and Cardiovascular Disease Risk Following Replacement of Trans Fatty Acid-Containing Soybean Oil With Application-Appropriate Alternatives
Lipids, 2012
This study modeled the effects of replacing TFA-containing partially hydrogenated soybean oil (PHSBO) with application-appropriate alternatives on population fatty acid intakes, plasma lipids, and cardiovascular disease (CVD) risk.
Trans Fatty Acid Intakes and Food Sources in the U.S. Population: NHANES 1999-2002
Lipids, 2012
The 1999-2002 National Health and Nutrition Examination Survey (NHANES) was used to identify a benchmark for TFA intake.
Read more about Trans Fatty Acid Intakes and Food Sources in the U.S. Population: NHANES 1999-2002
Events
Experimental Biology 2015
March 28, 2015 – April 1, 2015
Boston, Massachusetts, USA
Multiple projects being sponsored by IAFNS were presented during this year’s conference.
2015 Society of Toxicology Annual Meeting
March 22, 2015 – March 26, 2015
San Diego, California, USA
IAFNS sponsored multiple projects at the 2015 SOT Meeting.
IUFoST 17th World Congress of Food Science and Technology
August 17, 2014 – August 21, 2014
Montreal, Canada
IAFNS’s recent work on partially hydrogenated oils, public-private partnerships, and food-relevant chemicals in ToxCast will be presented.
Read more about IUFoST 17th World Congress of Food Science and Technology