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 ILSI North America being: Are there data to support other possible approaches to addressing the use of PHOs in food?
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.
This study used evidence mapping approaches to characterize the full body of literature on LDL-cholesterol and trans fats at low intake levels.
This work systematically considers the data relating to the mode-of-action for the effects of trans-fats on plasma LDL levels.
This meta-regression of controlled clinical trial data was executed to quantitatively investigate the relationship between dietary intake of trans fats and increased LDL-cholesterol.
This work has been presented during:
- 2014 SOT Colloquium
- Winter Tox Forum, January 2015
- Society of Toxicology 2015 Annual Meeting
- Experimental Biology 2015
Read ILSI North America's public comments regarding this work, which were submitted to FDA in 2015 and 2016, on the ILSI North America Public Comments page.
This study used evidence mapping approaches to characterize the full body of literature on LDL-Cholesterol and Trans fatty acids at low intake levels.
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.
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).
Multiple projects being sponsored by ILSI North America were presented during this year’s conference.
ILSI North America sponsored multiple projects at the 2015 SOT Meeting.
ILSI North America’s recent work on partially hydrogenated oils, public-private partnerships, and food-relevant chemicals in ToxCast will be presented.