The update confirms a direct final rule issued this summer that addressed “outdated references to PHOs in regulations” that were outside the reach of the June 2015 final determination on the GRAS status of PHOs, the agency explains in a Constituent Update published yesterday.
In the direct final rule, FDA noted it did not anticipate significant adverse comments to the revisions, but in case there were and the agency needed to pull the rule, it also issued a companion proposed rule with the same changes to get a jumpstart on a potential new rulemaking as backup measure.
As there were no significant adverse comments, beginning Dec. 22, FDA will no longer allow PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna, as an indirect food substance or in margarine, shortening and bread, rolls or bus as previously allowed under a pre-1958 authorization.
The direct final rule also clarifies that partially hydrogenated forms of menhaden and rapeseed oils are no longer GRAS.
The direct final rule is the latest step in a long, drawn-out process to remove PHOs from the food supply after FDA determined in 2015 that they could elevate bad cholesterol levels and contribute to increased risk of heart disease.
The agency originally set a compliance date of three years, but extended the deadline to January 2020 “to allow for an orderly transition in the marketplace” given the diverse uses of PHOs from ingredients to cooking aids.
The Grocery Manufacturers Association (now the Consumer Brands Association) petitioned FDA to allow the specific and limited uses of PHOs as a solvent or carrier, a component of flavoring and coloring agents, as a processing aid and as a pan release agent for baked goods.
However, FDA shot down the request in 2018, reasoning that even small amounts of PHOs could negatively impact heart health – a determination the was validated a year earlier by researchers from Yale University School of Medicine who found hospitalizations due to heart attacks and strokes fell dramatically after New York counties restricted trans-fats in restaurants compared to counties without similar restrictions.
Despite FDA’s dogged efforts to remove PHOs as an artificial source of trans fat from the food supply, trans fats still will not be completely removed, the agency acknowledges. It explains that natural sources of trans fat will continue to occur in meat and dairy products and in very low levels in other edible oils.