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Research validates FDA's removal of GRAS status for trans fats

By Elizabeth Crawford contact

- Last updated on GMT

Research reinforces FDA's removal of GRAS status for trans fats
New research confirming the deleterious effect of trans-fatty acids on heart health validates FDA’s decision to revoke partially hydrogenated oils’ status as Generally Recognized as Safe, say the study's authors.

In a study published today in JAMA Cardiology, researchers from Yale University School of Medicine found hospitalizations due to heart attack and stroke fell dramatically in New York counties that restricted trans-fats in eateries compared to those in counties without similar restrictions.

“Many years prior to the FDA decision to restrict PHOs​, local authorities took action to reduce exposure,”​ including New York City which banned their use in eateries beginning in July 2007, according to the study. It adds, other New York counties followed suit between 2008 and 2011, and within at least three years of the restrictions going into effect the populations in the counties with restrictions experienced a drop “beyond temporal trends”​ in heart attacks and strokes. 

Specifically, the rate of heart attacks and strokes combined fell 6.2%, heart attacks fell 7.8% and strokes fell an nonsignificant 3.6% compared to the populations in counties that did not restrict PHOs, according to study, which used NYS Department of Health’s Statewide Planning and Research Cooperative System and census population estimates from 2002 to 2013 to identify residents who were hospitalized for heart attack or stroke.

Acknowledging that during the study period consumers in all counties could still consume PHOs from non-eatery sources, such as packaged foods, the study authors argue “our results show the potential benefit of the FDA’s comprehensive restriction on PHOs, which is the source of TFAs in most packaged food.”

According to FDA’s decision in 2015 to revoke the GRAS status of PHOs, manufacturers have until June 2018 to remove them from human food unless otherwise approved by the agency.

While the agency did leave the door cracked for some uses of PHOs, ingredient suppliers have worked aggressively in the past few years to provide sufficient replacement ingredients.

Similarly, the clean label movement in the US has gained significant traction since the FDA’s decision, so even if a company had an approved exception, using a PHO could hurt sales of final products to consumers who increasingly are reading labels and avoiding ingredients that they don’t deem as healthy. 

Related topics: R&D

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