The Task Force works to better understand the nature of the relationship between industrially produced trans-fatty acids (iTFAs) and LDL-cholesterol (LDL-C) and the risk associated with different levels of intake of iTFAs.

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.

Research Findings

The findings from this body of work support the dietary recommendations of low intake levels of iTFA and demonstrate that there is no or minimal health risk at low levels of total iTFA in the diet i.e. below 2.2% energy. The requirement that the Nutrition Facts Panels of all packaged foods must include the quantity of TFA per serving has led to reductions in the current average intakes of TFA to ~ 0.5 % energy and has helped achieve TFA intakes below the no adverse health effect levels. This work shows the application of classic risk assessment modelling to nutritional risk assessment and should have benefits for future nutrition research.

Publications

This committee is no longer active.

This work has been presented during:

Read IAFNS's public comments regarding this work, which were submitted to FDA in 2015 and 2016, on the IAFNS Public Comments page

 

Publications

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

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.

Read more about 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

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